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Gazette
Commonwealth
of Australia
No. C 10, Tuesday 7 November 2006
CHEMICAL
Published by the Commonwealth of Australia
?Commonwealth of Australia 2006
ISBN 1035-9877
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
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The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) commenced on
17 July 1990. As required by Section 5 of the Act, a Chemical Gazette is published on the
first Tuesday in any month or on any days prescribed by the regulations.
CONTENTS
SPECIAL NOTICES
1 LOW REGULATORY CONCERN CHEMICALS (LRCC) - 6
IMPLEMENTATION OF OUTSTANDING REFORMS - OVERVIEW
OF THE PLANNED REFORMS
2 LRCC - DISCUSSION PAPER NO. 1 - LOW-HAZARDOUS 20
CRITERIA FOR THE PURPOSES OF NOTIFICATION AND
ASSESSMENT
3 DISCUSSION PAPER 1 ?APPENDIX 1 47
4 DISCUSSION PAPER 1 ?APPENDIX 2 64
5 DISCUSSION PAPER 1 ?APPENDIX 3 70
6 LRCC - DISCUSSION PAPER NO. 2 - LOW RISK CRITERIA AND 74
SCENARIOS FOR CONTROLLED USE PERMITS
90
7 LRCC - DISCUSSION PAPER NO. 3 - MODULAR ASSESSMENT
OF CHEMICALS THAT HAVE BEEN ASSESSED BY ANOTHER
AUTHORITY
8 LRCC - DISCUSSION PAPER NO. 4 - MODULAR ASSESSMENT 95
OF CHEMICALS FOR WHICH APPROPRIATE ANALOGUES
HAVE BEEN PREVIOUSLY ASSESSED BY NICNAS
9 LRCC - DISCUSSION PAPER NO. 5 - REVIEW OF DEFINITIONS ? 102
NATURALLY OCCURRING CHEMICALS AND ESSENTIAL OILS
10 LRCC - DISCUSSION PAPER NO. 6 - LOW REGULATORY 109
CONCERN POLYMERS
11 NOTICE OF PUBLICATION OF CALCIUM LONG CHAIN ALKYL 113
BENZENE SULPHONATE (INFINEUM C9350) SECONDARY
NOTIFICATION SUMMARY REPORT
12 NOTICE OF PUBLICATION OF HFE7100 SECONDARY 115
NOTIFICATION SUMMARY REPORT
13 AMENDMENT TO ASSESSMENT REPORT 116
POLYMER IN F-25 (PLC/562)
14 ADDITIONAL STUDY ON Z-44 117
15 DATA REQUIREMENTS FOR NOTIFICATION OF NEW 118
CHEMICAL SUBSTANCES CONTAINING A PERFLUORINATED
CARBON CHAIN
16 NOTICE OF OUTCOME OF AAT APPEAL ON FORMALDEHYDE 119
NEW CHEMICALS
SUMMARY REPORTS
17 LTD/1237 BIONOLLE SERIES #1000 120
18 LTD/1243 POLYMER IN A-5D 122
19 LTD/1253 1H-INDOLE-5, 6-DIOL, 2,3-DIHYDRO- 124
HYDROBROMIDE
128
20 LTD/1266 OXIRANE. METHYL-,POLYMER WITH
OXIRANE, ETHER WITH 2, 4, 7, 9-
TETRAMETHYL-5-DECYNE-4, 7-DIOL (2:1)
21 LTD/1269 ZINC ACRYLATE POLYMER IN RC3707 AND 131
RC3708
22 LTD/1272 PHOTOMER 5930F 133
23 STD/1130 MR-8A 135
24 STD/1193 DIUTAN GUM 139
25 STD/1195 POLYMER IN ELASTOPOR H 1129/5/0 142
26 STD/1228 COMPONENT IN TINOCAT TRS KB1/TINOCAT 144
TRS KB2
27 PLC/620 POLY(OXY-1, 4-PHENYLENEOXY-1, 4- 147
PHENYLENECARBONYL-1, 4-PHENYLENE)
28 PLC/656 POLYMER IN PEBAX 33 SERIES 150
29 PLC/658 LATEMAL PD-450/PD-430/PD-420 152
30 PLC/660 POLYMER IN RILSAN 154
31 PLC/663 POLYMER IN PU5 156
32 PLC/664 POLYMER IN TAKELAC W-5661 158
33 SAPLC/50 POLYMER IN D8122 CERAMICLEAN 160
34 SAPLC/60 POLYMER IN EXL-2602 163
35 ACCESS TO FULL PUBLIC REPORT 165
PERMITS ISSUED
36 LOW VOLUME CHEMICAL PERMITS 166
37 COMMERCIAL EVALUATION CATEGORY PERMITS 168
38 EARLY INTRODUCTION PERMITS 169
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
39 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE 170
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE
YEARS AFTER ISSUING OF ASSESSMENT CERTIFICATES
40 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY 172
OF CHEMICAL SUBSTANCES
173
41 NOTICE OF CHEMICALS ELIGIBLE FOR IMMEDIATE LISTING
ON THE AUSTRALIAN INVENTORY OF CHEMICAL
SUBSTANCES AFTER ISSUING OF ASSESSMENT
CERTIFICATES
6
1 LOW REGULATORY CONCERN CHEMICALS (LRCC)
IMPLEMENTATION OF OUTSTANDING REFORMS
OVERVIEW OF THE PLANNED REFORMS
1. PURPOSE
The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) was
amended to provide a framework for the introduction of new industrial chemicals
under the concept of `low regulatory concern'. This paper provides a summary of the
proposals which will enable a number of LRCC recommendations to be implemented,
in particular, those related to low hazard and low risk, and supports a number of
focussed Discussion Papers on those items as follows:
? Low-hazardous criteria (for NICNAS notification and assessment only)
? Low risk criteria (for NICNAS notification and assessment only)
? Guidelines for Notification and Assessment of Analogues of Chemical
Already Assessed by NICNAS
? Modular Assessment of Chemicals Assessed by Other Australian Authority
? Modular Assessment of Chemicals Assessed under Foreign or International
Assessment Scheme
? Low Regulatory Concern Polymers
? Review of Definitions ?Naturally-Occurring Chemicals and Essential Oils
Comment is sought on the proposals and implementation strategy.
2. BACKGROUND
The Low Regulatory Concern Chemicals (LRCC) Reform Initiative gave effect to the
Government's response to the recommendations of the Chemicals and Plastics Action
Agenda. The NICNAS Final Report and Recommendations for LRCC was published
in June 2003, with the Implementation Strategy published soon after in July 2003.
Some of the proposed reforms were administrative in nature, some required legislative
change and others focused on improved consultation.
In the Final Report and Recommendations, it was stated that
`a single definition of LRCC is not possible except in the most generic sense:
Chemicals could qualify for reduced regulatory input on the basis of
low risk or where regulatory input from elsewhere is sufficient to meet
Australian requirements.'
Two of the key concepts critical to the LRCC reforms were low hazard and low risk.
Also important was the concept of modular assessment, where NICNAS could
streamline its assessment process to take account of information already available.
The Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory
Concern Chemicals) Act 2004 (LRCC Amendment Act) received Royal Assent on 13
July 2004 and Proclamation on 9 August 2004 with the passage of the Industrial
Chemicals (Notification and Assessment) Regulations (the LRCC Regs). The LRCC
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
7
Amendment Act and the LRCC Regs provide the legislative framework to implement
the majority of LRCC reforms.
A special edition of the Chemical Gazette was issued on 16 August 2004 to identify
the elements of the LRCC Amendment Act that were effective immediately. The
LRCC Amendment Act put the legislative framework in place to ensure that the
majority of LRCC recommendations could be implemented. A number of
recommendations required the further development of criteria and guidelines. Among
the LRCC reform initiatives requiring further development were the concepts of low
hazard and low risk; which required the development of criteria, guidelines and
regulatory and administrative measures. A number of the recommendations in the
LRCC Final Report concerned low hazard and/or low risk.
The principal outstanding items for implementation are as follows:
?Development of low hazardous criteria (Discussion Paper 1)
?Development of low risk criteria (Discussion Paper 2)
?Introduction of modular assessment fees, incorporating
- assessments conducted under other assessment schemes, national and
international (Discussion Paper 3); and
- analogues (Discussion Paper 4)
?Review of definition and guidance on naturally-occurring chemicals and
essential oils (Discussion Paper 5)
?Assessment of low regulatory concern polymers (Discussion Paper 6)
?Expansion of access to Early Introduction Permit (EIP) system to include low
hazardous and/or low risk chemicals
In addition to definitions of the key terms and development of specific criteria, new
regulations and development of guidance and administrative processes are also
required for implementation.
3. THE CONCEPTS OF LOW HAZARD AND LOW RISK FOR
NOTIFICATION AND ASSESSMENT PURPOSES
3.1 Low hazard
The intent of developing low hazard criteria are for the sole purpose of allowing the
introduction of new chemicals under permit and certificate systems. The aim is to
identify a point below which a hazardous (i.e. classifiable) chemical can be
considered low-hazardous. Here, it is assumed that the degree of hazard may be on a
continuum and that a point on that continuum can be identified as a cut-off below
which the chemical is of low hazard. For determining low-hazardous classification
criteria, more than one degree of hazard is required, i.e. a continuum (e.g. Very Toxic,
Toxic and Harmful for acute toxicity), as if there is only one level of classification, it
is not possible to consider a continuum of degree of hazard, as the least degree is not
distinguished from the highest degree. Furthermore, quantitative classification criteria
are required (e.g. LD50/LC50 values for acute toxicity), as qualitative criteria (e.g.
carcinogenicity) are based on the strength of the available evidence and do not give
specific consideration to the potency of the chemical for the observed effects (i.e. do
not allow a comparison to be made of the same type of toxic effects).
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
8
Australia has no classification criteria for environmental endpoints, however, for the
purposes of setting criteria for chemicals of low hazard to the environment, the intent
is to similarly set a hazard level above that normally applied in international hazard
classification systems, e.g., the current EU hazard classification system for dangerous
substances and preparations.
3.1.1 Proposal
The proposed low-hazardous criteria are detailed in Discussion Paper No. 1, Low
Hazardous Criteria for Notification and Assessment.
3.1.1.1 Chemicals
In summary the following proposed low hazard criteria cut offs will apply
Criteria Options
acute oral toxicity (LD50 values) option 1 LD50 value > 1500 mg/kg bw
option 2 LD50 value > 1100 mg/kg bw
acute dermal toxicity (LD50 values) option 1 LD50 value > 1500 mg/kg bw
option 2 LD50 value > 1100 mg/kg bw
acute inhalation toxicity (LD50 values) LC50> 3mg/L/4hr (for
aerosols/particulates) or > 11 mg/L/4hr
(for gases/vapours)
skin irritation option 1 Cannot be identified
option 2 R38 irritating to skin
option 3 R38 irritating to skin and the
absence of inflammation in 2 or more
animals at the end of the observation
period.
eye irritation R36 irritating to eye.
sensitisation not hazardous
mutagenicity not hazardous
carcinogenicity not hazardous
reproductive toxicity not hazardous
developmental toxicity not hazardous
flammability R10 Flammable
other physical and chemical properties not a dangerous good
acute aquatic toxicity R52 Harmful to aquatic organisms or R53
May cause long term adverse effects in
the aquatic environment with 55 mg/L >
EC50/IC50/LC50 < 100 mg/L
Chemicals which are not hazardous chemicals or dangerous goods would also satisfy
the requirements for notification and assessment under the proposed low hazardous
provisions. Furthermore, chemicals which are persistent and/or bioaccumulative
would not be eligible for notification and assessment under the proposed low
hazardous provisions.
3.1.1.2 Polymers
In developing low hazardous criteria for polymers, it is necessary to recognise that the
range of effects data usually generated for polymers is less than that generated for
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
9
chemicals, particularly for the higher molecular-weight polymers. Therefore, it is
proposed to take a simpler approach for polymers.
For low-hazardous polymers with number-average molecular-weight of 1000 or less,
it is proposed that the criteria developed and proposed for chemicals be adopted.
For low-hazardous polymers with number-average molecular-weight greater than
1000, it is proposed that the polymer has:
?less than 10% by mass of molecules with molecular weight that is less than
500; and
?less than 25% by mass of molecules with molecular weight that is less than
1000; and
?has low charge density, as defined in Regulation 4C.
3.2 Low risk
Risk can defined as "the probability of an adverse effect in an organism, or (sub)
population caused under specific circumstances by exposure to an agent" (OECD,
2003). Risk is a function of hazard and exposure and as such these parameter so offer
potential to develop scenarios where risk can be maintained at low or acceptably
managed levels.
Fundamentally, when determining the risk posed by a chemical two factors need to be
considered; the severity of the hazard of the chemical and the level of exposure to the
chemical. This allows a hazard-exposure paradigm to be created which indicates the
approximate level of risk.
Low risk applies to lower levels of hazard and/or exposure, with an extension of
hazard to `moderate' if there is little exposure and to `high' if there is no exposure.
Higher exposures can be tolerated if the chemical's hazard level is lower.
One of the primary concepts for controlling risk is to control exposure during use to
levels that are considered low or where no exposure occurs. Hence the low risk
category will be restricted to permits, where conditions of use can be stipulated and
where a high degree of compliance can be ensured via auditing and annual reporting.
The low risk criteria are detailed in Discussion Paper No. 2, Low Risk Criteria for
Controlled Use Permits.
3.2.1 Proposal
3.2.1.1 Low Risk Criteria
3.2.1.1.1 Hazard
A number of limitations on hazard have been made for development of low risk
criteria and scenarios; these apply to both low exposure criteria and specific low
exposure scenarios.
Firstly, all the relevant hazards of the chemical must be known. Secondly, high
hazard chemicals will not be eligible, as indicated below.
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No. C 11, 7 November 2006
10
It is proposed that chemicals with similar properties to those prohibited or severely
restricted under Australia's international obligations would not be considered in this
category as they are subject to bans or severe restrictions under different mechanisms.
Further, new chemicals with persistent organic pollutant (POPS) characteristics,
which include persistence and bioaccumulation, will not be considered a low risk for
the purpose of the Controlled Use Permit category. In addition chemicals classified as
carcinogenic, mutagenic, or reproductive toxicants (CMR chemicals) would not be
considered a low risk for the purpose of the Controlled Use Permit category. This
approach is consistent with that taken by other national regulatory schemes, e.g. in the
EU and US.
A new chemical in general will not be introduced under this section if NICNAS
determines that the chemical, any reasonably anticipated metabolites, environmental
transformation products, or by-products of the chemicals, or any reasonably
anticipated impurities in the chemical may cause, under anticipated conditions of
manufacture, processing, distribution in commerce, use, or disposal of the new
chemical:
a. Serious acute (lethal or sublethal) effects;
b. Serious chronic (including carcinogenic and teratogenic) effects; or
c. Significant environmental effects.
3.2.1.1.2 Exposure
All exposure scenarios for workers, the public and the environment are known and
highly controlled for each known use;
i. Consumers and the general population
For exposure of consumers and the general population to the new
chemical during all manufacturing, processing, distribution in
commerce, use, and disposal of the chemical:
a. No dermal exposure;
b. No potential for oral exposure, i.e. from
consumer products; and
c. No inhalation exposure.
ii. Workers
For exposure of workers to the new chemical during all manufacturing,
processing, distribution in commerce, use and disposal of the chemical:
a. No dermal exposure (this criterion is met if adequate
dermal exposure controls are used in accordance
with applicable state and federal guidance); and
b. No inhalation exposure (this criterion is considered
to be met if adequate inhalation exposure controls
are used in accordance with applicable state and
federal guidance)
iii. Environment
Ambient surface water
For ambient surface water releases:
a. No releases resulting in surface water concentrations
above 1 part per billion
Atmosphere
For ambient air releases:
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
11
b. No releases of the new chemical above 1 microgram
per cubic metre maximum annual average
concentration, calculated using the formula:
(kg/day of release after treatment) x (number of
release days per year) x (9.68 x 10-6) micrograms
per cubic metre.
Land
For releases to land:
c. No releases to land or to a landfill unless the
introducer has demonstrated that the new chemical has
negligible groundwater migration potential.
3.2.1.2 Specific low exposure scenarios
To assist in the application of the exposure component of the low risk criteria, two
low exposure scenarios have been developed for inclusion in the guidance documents.
The low exposure scenarios presented are familiar to NICNAS as a result of
experience in assessing a number of new chemicals controlled in this manner.
Notifiers may apply to introduce a new industrial chemical under the Controlled Use
Permit if it can be demonstrated that the exposure is controlled at every stage of the
chemical's lifecycle in accordance with the low exposure elements given in the low
exposure scenarios. As low risk criteria contain both exposure and hazard elements,
the hazard requirements stated above (in 3.2.1.1.1) will also need to be met. The
following low exposure scenarios are given:
Low Exposure Scenario 1 Containment and Controlled Reformulation
Low Exposure Scenario 2 Site-Limited and Closed System
It is anticipated that further low risk scenarios will be determined by NICNAS on a
case by case basis pending applications. Such precedent setting decisions will be
gazetted and added to guidance documents.
4. DEFINITIONS AND CONCEPTS
4.1 Naturally-occurring chemical
Currently a naturally-occurring chemical is defined in section 5 of the Act as:
"(a) An unprocessed chemical occurring in a natural environment, or
(b) a chemical occurring in a natural environment, being a substance that is
extracted by:
(i) manual, mechanical, or gravitational means, or
(ii) dissolution in water; or
(iii) flotation; or
(iv) a process of heating for the sole purpose of removing uncombined
water,
without chemical change in the substance".
This definition is consistent with the US, Canadian and current EU definitions and
excludes extraction through steam distillation. However, it differs from the definition
proposed in the draft EU REACH legislation, which includes steam distillation as an
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
12
allowable process. The OECD New Chemicals Task Force currently has a working
definition of `naturally-occurring chemical', similar to the NICNAS definition, out for
public comment for two years (period ends November 2006). It is noted that once the
EU REACH system is established there will be a need to revisit the definition of
naturally occurring under harmonisation programs.
More detail is included in Discussion Paper No. 5, Review of Definitions ?Naturally-
Occurring Chemicals and Essential Oils.
4.1.1 Proposal
Recommendation 1
The definition of naturally occurring chemicals in section 5 of the Act is to remain
unchanged.
Recommendation 2
In the meantime, it is proposed that NICNAS develop and publish further guidance on
the definition of a naturally-occurring chemical. Any guidance information will
include steam distillation as an acceptable extraction method only if there is sufficient
scientific evidence that the distillation conditions used do not result in chemical
transformation of the components. This will allow a level of consistency with EU
REACH legislation until there is sufficient scientific rationale for the inclusion of
steam distillation in the definition.
4.2 Essential oil
Essential oil is not defined in the Act. It is proposed that the International
Organization for Standardization (ISO) definition is adopted by NICNAS. ISO
defines essential oils as "products obtained from natural raw materials by distillation
with water or steam or from the epicarp of citrus fruits by a mechanical process or by
dry distillation. The essential oil is subsequently separated from the aqueous phase by
physical means". NICNAS will also develop guidance on essential oils in relation to
their definition and interpretation as naturally occurring.
4.2.1 Proposal
Recommendation 1
NICNAS adopts the ISO definition of essential oil, this would be consistent with the
current definition used in SUSDP.
Recommendation 2
Develop guidance on essential oils in relation to their definition and interpretation as
naturally-occurring.
Recommendation 3
Establish an expert essential oils working group to work with NICNAS on the
guidance material.
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No. C 11, 7 November 2006
13
4.3 Analogue
In chemistry, an analogue can be defined as a chemical similar in structure to another
chemical but differing in some slight structural detail. However, it is important to
note that, while the differences in structure may be slight, a chemical with a structure
similar to that of another, but differing from it with respect to a certain component,
may have a similar or opposite action metabolically. Therefore, for a chemical to be
considered an analogue for notification and assessment purposes and to cover set
toxicological data requirements, it must bear both a prima facie case of obvious
structural similarity and demonstrate a similar pattern of activity to another previously
assessed chemical (or chemical with an established safety profile based on test data).
The criteria for determining whether a new chemical is an acceptable analogue are in
the supporting Discussion Paper No. 4, Modular Assessment of Chemicals for which
Appropriate Analogues have been Previously Assessed by NICNAS.
4.3.1 Proposal
That chemicals that are considered acceptable analogues of chemicals previously
assessed by NICNAS will be assessed under the modular assessment concept.
5. MODULAR ASSESSMENT CONCEPT
The intent of modular assessment is to streamline the assessment process where a
particular module, or modules, of the assessment are already fulfilled or deemed
unnecessary. For example, the hazard assessment of the new chemical may have been
completed by another regulatory authority or the chemical being notified may be
structurally similar to one already assessed under NICNAS (an analogue) and a full
risk assessment of the new chemical may not be necessary.
Similarly, the use and exposure pattern may be well characterised and similar to a
chemical already assessed. It is proposed that standard exposure scenarios be
generated for situations where exposure is highly controlled. For example, standard
low exposure scenarios have been generated for:
?contained and controlled reformulation; and
?site-limited and closed system use.
An analysis of estimates of assessment times for the critical modules of the
assessment report indicated that the health and environmental effects components of
the assessment report constituted approximately 40% of assessment time (30% health,
10% environment) and the exposure assessment approximately 20%. Based on these
estimates, it is proposed that the maximum rebate for modular assessment be 60%
(40% hazard assessment, 20% exposure assessment).
It is proposed that modular assessment fees be available for the following:
?Chemicals for which an assessment has been undertaken by another Australian
regulatory authority (Discussion Paper No.3);
?Chemicals for which an international assessment has been conducted
(Discussion Paper No.3);
?Analogue chemicals (Discussion Paper No.4); and
?Polymers regarded as of low regulatory concern (Discussion Paper No.6).
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No. C 11, 7 November 2006
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6. LOW REGULATORY CONCERN POLYMERS
Low regulatory concern polymers (LRCPs) are those polymers where a reduced level
of assessment is required, for example, polymers which do not meet the current PLC
criteria but for which a full risk assessment under the Limited and Standard
assessment certificate categories is not required. LRCPs would include other classes
of low hazard polymers, analogues and polymers assessed under other regulatory
schemes. Typical LRCPs could therefore include the following:
?Polymers of certain classes which are of low hazard;
?Polymers chemically similar to polymers already assessed by NICNAS;
?Consolidated polymer notification, where more than one polymer can be
notified and assessed together; and
?Polymers assessed by other regulatory schemes.
Accordingly, it is proposed that modular assessment fees be available for the
following:
?polymers with one monomer less than a polymer already assessed by
NICNAS;
?polymers containing a reactant similar (analogue) to that in a polymer already
assessed by NICNAS;
?polymers identical to a polymer already assessed by NICNAS but
manufactured by a different pathway and, in some cases, using different
reactants; and
?polymers assessed by another competent authority, both national and
international.
For polymers notified as a family, it is proposed that normal fees would apply to one
member of the family and an administrative fee for other members.
The proposals apply to all certificate categories.
More details are included in the supporting Discussion Paper No.6, Low Regulatory
Concern Polymers and in Discussion Papers No.1 (Low Hazardous Criteria), No.3
(Modular Assessment of Chemicals Assessed by Another Authority) and No.4
(Modular Assessment of Chemicals for which Appropriate Analogues have been
Previously Assessed by NICNAS).
7. IMPACT OF REFORMS ON NEW CHEMICALS NOTIFICATION
AND ASSESSMENT CATEGORIES.
Implementation of the above initiatives will translate into the following changes to the
notification and assessment categories for new chemicals: It is noted that all changes
can be implemented through regulation amendments and/or administrative processes.
No amendments to the Act are required.
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7.1 Permit Assessments
Category Chemicals Polymers Criteria Maximum Data
to be Volume Requirements
met
Low low 1000 kg s 21S(2) and
Volume hazard scientific
Chemical justification of
Permit how the
(LVC) chemical
meets the low
hazard criteria
Controlled low risk Unlimited s 22C(2) and
Use Permits Reg 6B
(CUP)
Early low Unlimited s 30A
Introduction hazard
Permit and/or
(EIP) low risk
Low Volume Chemical Permit (LVC)
For low hazardous chemicals and polymers, the introduction volume will be increased
to 1000 kg per year.
Controlled Use Permit (CUP)
This permit, which has no maximum introduction volume, will be available for
chemicals and polymers which meet the low risk criteria.
Early Introduction Permit (EIP)
The EIP will be extended to chemicals and polymers which meet the low hazardous
criteria and/or to those which meet the low risk criteria. It is proposed that EIPs for
non-hazardous chemicals and polymers will be free of charge.
The permit system has a number of safeguards that are not available under the
certificate system. The chemicals assessed under the permit system are subject to
annual reporting, permit conditions, and the Director may revoke a permit or vary the
conditions at any time.
7.1.1 Information Required With Permit Applications
Low Volume Chemical Permit (LVC)
The data requirements remain unchanged. However, for permit applications for
introduction volumes greater than 100 kg per year, it is proposed that scientific
justification of how the chemical meets the low hazardous criteria will be required.
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Controlled Use Permit (CUP)
The basic information required by NICNAS with an application for a Controlled Use
Permit is listed in subsection 22C(2) of the Act. It is proposed that the other standard
information requirements be consistent with those in Regulation 6B for the recently
introduced Controlled Use Permit for Export Only, except that details of export will
not be required.
Early Introduction Permit (EIP)
An EIP is submitted with a certificate notification. There are no additional data
requirements.
7.2 Certificate Assessments
Category Chemicals Polymers Modular Maximum Data EIP
Assessment Volume Requirements
Available
1
Standard Unlimited Parts A, B, Free
(chemical) and C of (for non-
Schedule hazardous
(will vary for chemical)
modular
assessments)
2
Standard Unlimited Parts A, B, C Free
(polymer) and D of (for non-
Schedule hazardous
(will vary for polymer)
modular
assessments)
1
Limited Less than Parts A and B Free
(chemical) one tonne of Schedule (for non-
per year hazardous
chemical)
2
Limited Unlimited Parts A, B and Free
(polymer) D of Schedule (for non
hazardous
polymer)
3
Polymer Unlimited Section 24A Free
of low
concern
5
Low As per As per Free (for a
regulatory notification notification non-
concern category category hazardous
polymer4 polymer)
1
Assessment undertaken by another Australian regulatory authority; or
Assessment undertaken by a foreign regulatory authority; or
Analogues of previously assessed chemicals
2
Assessment undertaken by another Australian regulatory authority; or
Assessment undertaken by a foreign regulatory authority; or
Analogues of previously assessed polymers; or
Low Regulatory Concern Polymers
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3
Assessment undertaken by another Australian regulatory agency; or
Assessment undertaken by a foreign regulatory agency; or
Analogue polymers.
4
low regulatory concern polymers can be notified under all certificate categories.
5
for polymer already assessed by NICNAS and
one monomer less than a polymer already assessed; or
one monomer substituted for a polymer already assessed; or
if new polymer identical to polymer already assessed by with different CAS number
Standard Notification
It is proposed that:
(i) modular assessment fees be available for
?Chemicals and polymers for which an assessment has been undertaken by
another Australian regulatory authority;
?Chemicals and polymers for which an international assessment has been
conducted;
?Analogue chemicals and polymers; and
?Low regulatory concern polymers; and
(ii) the EIP system be extended to low-hazardous chemicals, with a free EIP
proposed for non-hazardous chemicals.
Limited Notification
It is proposed that similar options be available for chemicals and polymers notified
under the Standard and Limited Notification categories. It is noted that the volume of
introduction of polymers under this category is unlimited.
Polymers of Low Concern (PLC)
It is proposed that modular assessment fees also be available for PLCs, namely:
?polymers for which an assessment has been undertaken by another Australian
regulatory authority;
?polymers for which an international assessment has been conducted; and
?analogue polymers.
It is also proposed that a free EIP be available for PLCs.
Low Regulatory Concern Polymers
It is proposed that modular assessment fees be available, for all assessment certificate
categories, for polymers chemically similar to polymers already assessed by
NICNAS, namely:
?if one monomer less than a polymer already assessed;
?if one monomer substituted for a polymer already assessed; and
?if new polymer identical to a polymer already assessed but with a different
CAS number, e.g. due to different reactants.
It is also proposed that reduced notification requirements, with reduced fees, be
available for the consolidated notification of a group of polymers (the `family
approach'). It is proposed that normal notification requirements and fees apply for the
first member of the group and an administrative fee for other members of the group.
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7.2.1 Information Required With Certificate Applications
Standard Notification
No amendments are proposed for the normal Standard notification, namely, Parts A, B
and C for chemicals and Parts A, B, C and D for polymers.
For modular assessment applications, those information requirements deemed
unnecessary need not be provided. For example, Part C items would not be required
if an acceptable hazard assessment was provided for a chemical assessed under
another regulatory authority. Similarly, for chemicals subject to standard exposure
controls, the detailed exposure items in Part B would not be required.
Limited Notification
No amendments are proposed for the normal Limited notification, namely, Parts A
and B for chemicals and Parts A, B and D for polymers.
Polymers of Low Concern (PLC)
No amendments are proposed for the normal PLC notification.
Low Regulatory Concern Polymers
The data requirements will be in accordance with the relevant certificate category
applicable, that is, Standard Notification, Limited Notification or Polymer of Low
Concern, with variations for information previously assessed or already available.
Where the hazard assessment is already available, e.g. from an overseas scheme, then
separate data need not be submitted.
7.3 Safeguards
The Act provides for a number of safeguards in the notification and assessment of
new chemicals. These will also apply for the proposals outlined above.
For permits, the following safeguards apply:
? the Director has the power to reject any permit application, e.g. if insufficient
data for assessment, or use of the chemical does not satisfy the criterion of `no
unreasonable risk to occupational health and safety, public health and the
environment';
? all permits are subject to conditions enforceable by the Director, and can be
withdrawn if any condition is breached;
? all permits and self-assessment certificates are subject to audit by the NICNAS
compliance team and annual reporting; and
? the Controlled Use Permit is available only for new industrial chemicals that
are low risk to occupational health and safety, public health and environment.
For all applications dependent on the low hazardous and/or low risk criteria, scientific
justification of how the chemical meets the criteria must be demonstrated by the
applicant, otherwise the application is rejected.
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For all modular assessment applications, scientific justification of how certain
elements of the risk assessment may not be necessary must be demonstrated by the
applicant, otherwise the application is rejected.
8. EFFECTIVE ENGAGEMENT
NICNAS has consulted widely with key stakeholders throughout the LRCC process,
with progress reports regularly provided to NICNAS's industry, government and
community committees. For this suite of remaining reforms, NICNAS is now seeking
engagement with interested stakeholders within its Community Engagement Charter.
It is intended to release this overarching paper and its associated discussion papers for
public comment for a period of six weeks by:
?Publishing the papers on the NICNAS website;
?Publishing the papers in the NICNAS Chemical Gazette; and
?Sending the papers to key stakeholders.
Comments may be provided to NICNAS by mail, e-mail or by completing a
questionnaire on the NICNAS website.
For information regarding this notice or matters regarding the LRCC reforms, please
contact Bob Graf on 02 8577 8850 or 1800 638 528 (e-mail bob.graf@nicnas.gov.au).
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2 LRCC - DISCUSSION PAPER NO. 1
LOW-HAZARDOUS CRITERIA FOR THE PURPOSES OF NOTIFICATION
AND ASSESSMENT
1. PURPOSE
The Low Regulatory Concern Chemicals (LRCC) reform initiative resulted in a
number of recommendations which focused on regulatory efficiency and positive
incentives to drive improvements in the safe and sustainable use of new chemicals in
Australia. One key reform was to develop notification and assessment categories
based on low hazard properties. Before this can be implemented, what constitutes a
new industrial chemical to be considered `low-hazardous' must be defined.
This discussion paper seeks comment on:
? The proposed criteria to be used to classify chemicals as `low-hazardous'.
2. BACKGROUND
The aim of the Low Regulatory Concern Chemicals (LRCC) reform initiative was to
introduce flexibility into the regulation of new industrial chemicals without
deregulation. As such the recommendation that came from the LRCC reform initiative
focused on regulatory efficiency and positive incentives to drive improvements in the
safe and sustainable use of new chemicals in Australia. Recommendations contained
within the Final Report and Recommendations for NICNAS Low Regulatory Concern
Chemicals (LRCC) Reform Initiative (`Final Report') (NICNAS, 2003) were
developed in partnership with government, industry and community and cumulated in
The Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory
Concern Chemicals) Act 2004 (LRCC Amendment Act) that received Royal Assent
on 13 July 2004 and Proclamation on 9 August 2004 with the passage of the
Industrial Chemicals (Notification and Assessment) Regulations (the LRCC Regs).
The LRCC Amendment Act and the LRCC Regs provided the legislative framework
to immediately implement the majority of LRCC reforms. However, it was
recognised that a small number of recommendations from the Final Report required
further development of criteria and guidelines before they could be implemented.
One such pivotal issue that needs to be finalised before some recommendations from
the LRCC reform initiative can be implemented is defining what constitutes a new
industrial chemical notification category that is `low-hazardous'. Such a definition
will allow NICNAS to implement the following recommendations:
1) Introduce an audited self-assessment permit for low hazard chemicals
(introduced at low volumes 100 ?1000 kg per year) against NICNAS criteria
and/or guidelines developed by NICNAS/industry and the community
(Recommendation 1.2 in the Final Report).
2) Introduce a low hazard permit for polymers of low volume (1000 kg/yr per
introducer) for 3 years. Low hazard criteria appropriate for polymers would
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need to be developed in consultation with industry and the community
(Recommendation 4.2 in the Final Report).
3) Introduce to the standard certificate assessment category of a new low-
hazardous chemical sub-category with appropriate criteria and (modular)
assessment fee (Recommendation 7.1 in the Final Report).
4) Expand access to the Early Introduction Permit system to include low hazard
and low risk chemicals based on appropriately developed criteria
(Recommendation 7.2 in the Final Report).
5) Introduce a low hazard permit for chemicals of low volume. These chemicals
would be introduced in low volumes, 1000 kg/yr/introducer for three years
(Recommendation 7.3 in the Final Report).
This discussion paper will address the definition of criteria for what constitutes a low-
hazardous industrial chemical for the purposes of notification and assessment only.
This paper also includes criteria for what constitutes a low-hazardous polymer. The
application of low-hazardous criteria into the above permit and certificate systems and
is addressed in the separate Overview of the Planned Reforms.
3. LOW-HAZARDOUS
3.1. Hazard
Hazard can be defined as the inherent property of an agent or situation having the
potential to cause adverse effects when an organism, system, or (sub) population is
exposed to the agent (OECD, 2003). For industrial chemicals hazard is regulated
through classification, and overseas industrial chemicals can be classified for human
health and environmental effects and physicochemical properties. In Australia
industrial chemicals can be classified for human health effects and physicochemical
properties only, as there is presently no classification system for environmental
endpoints1.
Classification systems can be technically highly complex, though essentially such
systems are triggered by a defined cut-off value (`hazard trigger') for an intrinsic
property that can be quantitative (e.g. an acute oral LD50 value of < 2000 mg/kg
bw/day in the rat under the NOHSC Approved Criteria for Classifying Hazardous
Substances [NOHSC, 2004]) (the Approved Criteria) or qualitative (eg explosive
when mixed with oxidising substances [NOHSC, 2004]). Industrial chemicals that
justify classification for human health effects, environmental effects and/or
physicochemical properties are referred to as hazardous, and those that do not as non-
hazardous.
While all classifications systems have a quantitative or qualitative hazard trigger that
defines an industrial chemical as hazardous for human health effects, environmental
effects and/or physicochemical properties, more than one classification category
exists for some endpoints (e.g. there are three classification categories for acute oral
toxicity under the Approved Criteria [NOHSC, 2004]). For such endpoints a grading
1
Currently, for new industrial chemicals a provisional classification for environmental effects is made
under the Globally Harmonised System for Hazard Classification and Communication (GHS) (OECD,
2002) which will only come into force when GHS is adopted by the Australian Government and
promulgated into Commonwealth legislation.
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system has clearly been established for industrial chemicals that are hazardous. The
use of grading in classification (i.e. more than one degree of hazard) has often been
used as a factor to delineate between classes/control of hazardous chemicals in
regulatory programs both nationally and internationally:
?Nationally, in the uniform scheduling of drugs and poisons, substances placed
in Schedule 5 are considered to have a low toxicity with regard to human
health effects and require caution in handling, storage and use, while
substances in Schedule 7 have a high to extremely high toxicity and are too
hazardous for domestic use or use by untrained persons (NDPSC, 2003).
?Internationally, the EU Commission's White Paper proposing a revision of the
EU chemicals policy (EC, 2001) deemed that category 1 and 2 CMRs
(substances that are carcinogenic, mutagenic or toxic to reproduction) were to
be of `very high concern' but not category 3 CMRs.
However the intent here, for the sole purpose2 of allowing the introduction of low
hazardous chemicals under new permit and certificate systems, is to identify for each
intrinsic property where possible a level above that defined by the Act (or the
Approved Criteria) as hazardous where the industrial chemical can be considered to
be low-hazardous (see Figure 1). This `low hazardous' status is limited in its
application to NICNAS notification and assessment purposes and does not apply to
downstream regulatory control frameworks based on hazard determination.
Figure 1 ?Diagrammatic view of low hazard in a classification scheme
3.2 Low-hazardous Evaluation
Each national and international classification system has developed its own
framework for identifying hazardous industrial chemicals. As a first stage in
developing low-hazardous criteria, an overview of national and selected international
schemes for industrial chemicals and pesticides (as a comparison) has been
undertaken to determine whether, for human health effects, environmental effects and
physicochemical properties:
2
In no way do the proposed low-hazardous criteria affect other regulatory requirements, for example,
workplace hazardous substances and dangerous goods legislation.
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? More than one degree of hazard exists in the classification scheme;
? The classification scheme directly identifies what represents low-hazardous;
and
The hazard triggers are quantitative or qualitative3 in nature.
?br>
The national schemes evaluated are:
? National Occupational Health Safety Commission's Approved Criteria
for the Classifying Hazardous Substances (NOHSC, 2004);
? Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) -
Guidelines for the National Drugs and Poisons Schedule Committee
(NDPSC, 2003);
? Australian Pesticide and Veterinary Medicine Authority (APVMA) -
Guidelines for Pesticides Used by Householders (APVMA, 2006); and
? Australian Code for the Transport of Dangerous Goods by Road and
Rail (ADG Code) (FORS, 1998).
The international schemes evaluated are:
? United Nations Globally Harmonised System of Classification and
Labelling Chemicals (GHS) (GHS, 2005);
? New Zealand's Hazardous Substance and New Organism (HSNO) Act
1996 in relation to applications for rapid assessment (ERMA, 2001);
? European Communities' Annex 6 General Classification and Labelling
Requirements for Dangerous Substances and Preparations (as reported
in UK's CHIP Regulations, 2002);
? US EPA's 40 CFR Part 152 Pesticide Registration and Classification
Procedures Sub Part I ?Classification of Pesticides (US EPA, 2004);
and
? US EPA Ecotoxicity Categories for Terrestrial and Aquatic Organisms
(US EPA, 2006).
It should be noted that the overviews presented in Appendix 1 ?3 are not detailed
evaluations of each classification scheme but rather overviews of the hazard
classification categories that allow a low-hazardous evaluation to be undertaken (e.g.
for acute oral toxicity, only the criteria for classification using LD50 values are
presented, though criteria exist for the results from other regulatory test guidelines
such as the Fixed Dose Procedure; and for acute oral toxicity the avian dietary LD50
values are not presented for environmental effects). Additionally, it should be noted
that the information presented here for human health effects does not mention effects
seen in humans, though it is recognised that practical observations in humans can lead
to classification even when results in animal studies do not warrant such.
Summaries of the findings of the evaluation are presented below separately for human
health effects, environmental effects and physicochemical properties.
3
For this assessment, NICNAS considers that classification of a health effect is qualitative in nature if
it does not address the potency of the chemical (see `Human Health Effects' sub-section for a
discussion of this issue).
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3.3 Human health effects
The national classification schemes that make a low-hazardous comment are:
? The APVMA scheme for household pesticides states that skin and eye
irritancy should be low, though no qualitative (i.e. effects seen) and/or
quantitative (i.e. severity of effects) information on what would constitute a
low-hazardous effect are provided.
? The APVMA scheme for household pesticides states that chemicals are of low
hazard from repeated use and should be unlikely to produce irreversible
toxicity. However, though limited qualitative information is provided (i.e.
which effects) no quantitative information is provided (i.e. severity of the
observed effects).
? The SUSDP also states that chemicals placed in Schedule 5 are of low hazard
from repeated use and should be unlikely to produce irreversible toxicity but,
as for the APVMA scheme, provide no quantitative information.
Furthermore, although the APVMA scheme for household pesticides does not
specifically report low-hazardous criteria for acute toxicity, they do delineate hazard
with regards to pesticide use. For consumer use of pesticides the hazard the chemical
represents in the product is much less than other non-consumer uses with regard to:
? Acute oral and dermal toxicity, for which quantitative criteria are provided
(i.e. cut-off LD50 values).
Therefore, although in some of these national schemes it is stated that a chemical must
be of low-hazard for some human effects, detailed criteria that define such, and which
would allow low-hazardous chemicals to be reliably identified, are absent. The
APVMA delineation of hazard is presented in Table 1.
The international classification schemes that propose low-hazardous criteria are:
? The GHS classification scheme identifies what constitutes relative low acute
oral, dermal and inhalation toxicity providing quantitative information on the
dose-range for determined LD50/LC50 values;
? The NZ HSNO Act (which adopted the GHS classification scheme) states that
the low acute toxicity identified in the GHS scheme represent a low hazard.
This distinction of a low hazard is made to allow the rapid assessment of
substances within the NZ regulatory scheme4.
Low hazard is also defined in the NZ rapid risk assessment scheme with quantitative
criteria (severity of effects) for skin and eye irritation.
Low hazard is also defined in the NZ rapid risk assessment scheme for skin and
respiratory sensitisation and mutagenicity, though only qualitative criteria, not
quantitative criteria, are provided for these human health effects.
4
Note: a `lower' classification to that identified as low-hazardous [i.e. not classified] would still allow
rapid risk assessment while a `higher' classification [i.e. Category 4 for acute toxicity] would prevent
such an assessment.
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Low hazard is also defined in the NZ rapid risk assessment scheme for repeat dose
toxicity and, though quantitative criteria are provided (i.e. dose ranges for observed
effects), the criteria also include a qualitative component (see `Qualitative
classification criteria' below).
Furthermore, though the USA EPA Pesticides Guidelines do not specifically report
low-hazardous criteria, they do delineate hazard with regards to pesticide use. For
consumer use of pesticides, the hazard the chemical represents in the product is much
less than other non-consumer uses with regard to:
? Acute oral, dermal and inhalation toxicity, for which quantitative criteria are
provided (i.e. cut-off LD50/LC50 values); and
? Skin and eye irritation, for which qualitative criteria are provided that
incorporate a time period after which effects should not be seen to persist.
Therefore, in contrast to national classification schemes, the NZ rapid risk assessment
scheme provides detailed low-hazardous criteria for a number of human health
effects. A summary of the low-hazardous criteria identified in the NZ scheme and the
US EPA delineation of hazard are presented in Table 1, while a more detailed
evaluation of these and other national and international classification schemes are
provided in Appendix 1.
Degrees of hazard
Clearly, from the viewpoint of determining low-hazardous classification criteria, more
than one degree of hazard is required i.e. a continuum, as if there is only one
classification category there is no possibility of considering a continuum of degree of
hazard, as the least degree is not distinguished from the highest degree. In Table 1,
the NZ scheme proposes low-hazardous criteria for skin and respiratory sensitisation
when only one degree of hazard is available for each health effect and, thus, NICNAS
considers these low-hazardous criteria to be inappropriate. Furthermore, the NZ
criteria for these health effects are not based solely on the chemical's intrinsic
property but also exposure to the chemical (see Appendix 1 Table B), which is not a
factor in hazard classification.
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Table 1: Low-hazardous definitions for human health effects
HUMAN HEALTH
EFFECT LOW-HAZARDOUS CRITERIA
NZ rapid risk assessment scheme
Acute oral toxicity
More than 1 degree of hazard Yes ?5 Categories each for acute oral, dermal and inhalation (dusts/mists, gases,
and vapours) toxicity
Low-hazardous definition Yes ?Oral Category 5: 2000< LD50 < 5000 mg/kg bw, dermal Category 5: 2000<
LD50 < 5000 mg/kg bw, and inhalation Category 5 for dusts/mists, gases, and
vapours where the LC50 is in the equivalent range of the oral and dermal
Category 5 LD50 value (i.e. between 2000 and 5000 mg/kg bw)
Qualitative or quantitative Quantitative for all routes of exposure
US EPA pesticide guidelines
More than 1 degree of hazard Only for use, not classification
Low-hazardous definition No, though hazard is delineated through use. For consumers, the pesticide as
diluted for use has an oral LD50 < 1500 mg/kg bw, dermal LD50 < 2000 mg/kg bw, and
inhalation LC50 < 0.5 mg/L/4hr
Qualitative or quantitative Quantitative for all routes of exposure
APVMA scheme for household pesticides
More than 1 degree of hazard Only for use, not classification
Low-hazardous definition No, though hazard is delineated through use. For consumers pesticide should not
be life threatening to a child up to 1500 mg/kg bw if ingested and 1000 mg/kg bw via
topical application.
Qualitative or quantitative Quantitative for all routes of exposure
Skin irritation NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?2 Categories
Low-hazardous definition Yes ?Category 3 (Mild irritant): in 2 or more of 3 animals tested
erythema/eschar or oedema > 1.5 and < 2.3 (and inflammation does not persist to
the end of the observation period normally 14 days in 2 animals)
Qualitative or quantitative Quantitative
US EPA pesticide guidelines
More than 1 degree of hazard Only for use, not classification
Low-hazardous definition No, though hazard is delineated through use. For consumers, the pesticide as
formulated is not corrosive to the skin or causes severe irritation (severe
erythema or oedema) at 72 hrs (after topical exposure)
Qualitative or quantitative Qualitative
NZ rapid risk assessment scheme
Eye irritation
More than 1 degree of hazard Yes ?2 Categories, though the lowest category consists of two classes
Low-hazardous definition Yes ?Category 2A (reversible effects on the eye) Irritating to eyes: in at least 2
of 3 animals tested corneal opacity 1, iritis 1, conjunctival erythema 2, or
conjunctival oedema 2 and fully reverses within the observation period
(normally 21 days)
Qualitative or quantitative Quantitative
US EPA pesticide guidelines
More than 1 degree of hazard Only for use, not classification
Low-hazardous definition No, though hazard is delineated through use. For consumers, the pesticide as
formulated does not results in corneal involvement or irritation persisting for more than 7
days (after contact with the eyes)
Qualitative or quantitative Qualitative
NZ rapid risk assessment scheme
Skin sensitisation
More than 1 degree of hazard No
Low-hazardous definition Yes ?but is not based solely on the intrinsic hazard: exposure is a condition for
consideration as a low hazard (see note 1 in Appendix 1)
Qualitative or quantitative Qualitative
NZ rapid risk assessment scheme
Respiratory sensitisation
More than 1 degree of hazard No
Low-hazardous definition Yes ?but is not based solely on the intrinsic hazard: exposure is a condition for
consideration as a low hazard (see note 1 in Appendix 1)
Qualitative or quantitative Qualitative
NZ rapid risk assessment scheme
Repeat dose toxicity
More than 1 degree of hazard Yes ?2 Categories each for the oral, dermal and inhalation routes of exposure
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Low-hazardous definition Yes ?Category 2 (Potential to be harmful to human health): oral > 10 to < 100
mg/kg bw/day, dermal > 20 to < 200 mg/kg bw/day, inhalation > 50 to < 250
ppm, 6hr/day for a gas, > 0.2 to < 1.0 mg/L, 6hr/day for a vapour, and > 0.02 to <
0.2 mg/L, 6hr/day for a dust/mist/fume
Qualitative or quantitative Quantitative with qualitative component
NZ rapid risk assessment scheme
Mutagenicity
More than 1 degree of hazard Yes ?2 Categories, though the highest category consists of two classes
Low-hazardous definition Yes ?Category 2: cause concern owing to the possibility it may induce
inheritable mutation in human germ cells (positive results in somatic cells)
Qualitative or quantitative Qualitative
Similarly, NICNAS does not consider the US EPA delineation of hazard to be
appropriate for identifying low-hazardous criteria, as it has no basis in hazard
classification. Additionally, for US EPA skin and eye irritation, the criteria are not
quantitative but qualitative in nature, and NICNAS considers this an important issue
in developing criteria for identifying low-hazardous chemicals.
Qualitative classification criteria
In the NZ rapid assessment scheme, low-hazardous criteria that are not purely
quantitative in nature were proposed for two endpoints that had more than one degree
of hazard classification (repeat dose toxicity and mutagenicity). NICNAS considers
that, for qualitative criteria, classification is taken according to the strength of the
available evidence, and so reflects a level of concern for the seriousness of the health
effect (e.g. Category 1, 2 and 3 for mutagenicity), but does not give specific
consideration to the potency of the chemical for the observed effects (i.e. does not
differentiate between the dose that the adverse effect was observed, or the activity of
the chemical). Consequently, NICNAS considers that qualitative criteria are
inappropriate for identifying low-hazardous chemicals as they do not address the
potency of the chemical. Thus, the NZ proposed low-hazardous criteria for
mutagenicity, which is purely qualitative in nature, are not considered appropriate.
The NZ low-hazardous classification proposal for repeat dose toxicity is slightly
different in that though it is quantitative by differentiating between doses that adverse
effects were observed, it is also qualitative in that it provides guidelines for those
effects that warrant classification but does not give consideration to the potency of the
chemical for the specified effects (e.g. the range of effects are broad, and
classification can be based on death, severe organ damage or major functional
changes). Consequently, while it is presently deemed that a low hazard cannot be
identified for this health effect as it does not address potency, the quantitative aspect
of the classification criteria encourage further discussions on the development of low
hazard criteria for this endpoint.
Thus, NICNAS considers that for those health effects where there is more than one
degree of hazard whose classification criteria are deemed to have a qualitative aspect,5
some means of addressing potency in the classification system would first be required
if criteria are to be developed that identify low-hazardous chemicals possessing a
similar inherent property for that health effect. Furthermore, it is recognised that
some human health effects are complex with such a highly diverse set of effects (e.g.
carcinogenicity and reproductive toxicity) that comparisons of the same type of toxic
5
That is, non-lethal irreversible effects, corrosivity, repeat dose toxicity, mutagenicity, carcinogenicity,
fertility and developmental toxicity.
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effect at a cut-off level for low hazardous (as applied for acute toxicity and irritation)
would not be suitable (i.e. potency cannot be reliably addressed).
Low- hazardous criteria ?human health effects
Therefore, it is proposed that for human health effects the identification of low-
hazardous criteria for classification is restricted to those health effects where:
? There is more than one classification category; and
? The intrinsic property's classification criteria are solely quantitative in nature.
Furthermore, such criteria should allow comparisons to be made for the type of effects
seen (i.e. LD50/LC50 values for acute toxicity).
Human health effects that meet these criteria in the schemes evaluated are:
? Acute toxicity (oral, dermal and inhalation routes of exposure); and
? Skin and eye irritation.
However, for those human health effects that do not meet the above criteria as the
present stage of scientific knowledge and/or classification system do not allow low-
hazardous criteria to be identified, a watching brief should be kept and these
endpoints revisited when scientific advances and/or amendments to classification
systems are made that allow hazard quantification and potency to be addressed. To
this end, it should be noted that work is presently ongoing on how consideration could
be given to potency for carcinogenicity (e.g. determining the daily dose that induces a
tumour incidence of 25 % upon lifetime exposure ?the T25 method [EC, 1999]) and
skin sensitisation (e.g. use of the local lymph node assay for the estimation of skin
sensitisation potency [Basketter et al., 2000]) in classification schemes.
A brief impact analysis on implementing these low-hazardous criteria for skin and eye
irritation into the national classification scheme is provided in section 4.1.
3.4 Physicochemical properties
No national classification scheme specifically proposes low-hazardous criteria, though
the Australian Dangerous Goods Code for Road and Rail (ADG code) states that:
? For explosive properties, chemicals in Class 1.4 present no significant hazard,
however, this is based primarily on packaging considerations; and
? For flammability properties, chemicals in Class 2.2 are non-flammable gases.
The only international scheme that proposed low-hazardous criteria is NZ (which
adopted the GHS classification scheme) for rapid risk assessment. Criteria were
proposed for the following:
? Explosiveness;
? Flammability (see comments below);
? Self-reactivity;
? Organic peroxides; and
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? Emission of flammable gases when wet.
A summary of the low-hazardous criteria proposed in the NZ scheme and the above
comments from the ADG code are provided in Table 2, together with information on
those aspects identified from the human health evaluation as being critical for robust
low-hazardous criteria:
? Degrees of hazard; and
? Nature of the classification criteria (i.e. qualitative or quantitative).
A more detailed evaluation of national and international schemes for physicochemical
properties can be found in Appendix 2.
Table 2: Low-hazardous definitions for physicochemical properties
PHYSICOCHEMICAL
PROPERTY LOW-HAZARDOUS CRITERIA1
NZ rapid risk assessment scheme
Explosive
More than 1 degree of hazard Yes ?6 Divisions
Low-hazardous definition Yes ?Division 1.4: Substances, mixtures and articles which present no
significant hazard
Qualitative or quantitative Qualitative
ADG code
More than 1 degree of hazard Yes ?6 Classes
Low-hazardous definition No ?but the NZ definition that the mixture or article presents no hazard is
also made in the ADG scheme ?Class 1.4.
Qualitative or quantitative Qualitative
Flammable NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?4 Categories for liquids, 2 categories for gases, 2 categories for
aerosols and 2 categories for solids
Low-hazardous definition Yes - Flammable Liquid Cat. 4: Flash point > 60 癈 and 93 癈
Yes - Flammable Gases Cat. 2: at 20 癈 and a standard pressure of 101.3
kPa, have a flammable range while mixed in air
Yes - Flammable Aerosol Cat. 1: on the basis of
its components, of its chemical heat of
combustion and, if applicable, of the results of
the foam test, for foam aerosols, and the ignition
distance test and enclosed space test, for spray
aerosols.
Yes - Flammable Solid Cat. 2: Burning rate test for solids other than metal
powders: wetted zone stops the fire for at least 4 min and the burning time <
45 seconds or burning rate > 2.2 mm/second. Burning rate test for metal
powders: burning time > 5 minutes and 10 minutes.
Qualitative or quantitative Quantitative for liquids, and essentially quantitative for gases, aerosols and
solids
ADG code
More than 1 degree of hazard Yes ?2 Classes
Low-hazardous definition No, there is no low-hazardous criteria, furthermore, chemicals in Class 2.2
stated to be "Non-flammable (non-toxic) gases' are not considered to be
hazardous, while those in Class 2.1 stated to be `Flammable gases' are
considered to be hazardous (i.e. considered to be only 1 degree of hazard)
Qualitative or quantitative Quantitative
Self-reactive substances NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?7 Types
Low-hazardous definition Yes - Self-reactive substances Type G
Qualitative or quantitative Qualitative
Organic peroxides NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?7 Types
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Low-hazardous definition Yes - Organic peroxides Type G
Qualitative or quantitative Essentially Qualitative
NZ rapid risk assessment scheme
In contact with water emit
flammable gases
More than 1 degree of hazard Yes ?3 Categories
Low-hazardous definition Yes ?Category 3
Qualitative or quantitative Essentially Qualitative
1
Low-hazardous criteria are only provided for those properties whose classification is quantitative or essentially
quantitative in nature.
For the flammability of aerosols the proposed low-hazardous criteria is actually the
highest classification of hazard in the NZ scheme and, consequently, NICNAS does
not consider this proposal to be appropriate.
Low- hazardous criteria ?physicochemical properties
Therefore, with the exception of the comments on flammability provided above and in
Table 2, low-hazardous criteria were consistently proposed when there is more than
one degree of hazard, though the intrinsic property's classification criteria were
generally qualitative in nature. However, the findings of the human health effect
evaluation are also considered to be appropriate here for physicochemical properties,
that is, the identification of low-hazardous criteria for classification is restricted to
those physicochemical properties where:
? There is more than one classification category; and
? The intrinsic property's classification criteria are solely quantitative in nature.
Furthermore, such criteria should allow comparisons to be made for the type of effects
seen.
The only physicochemical property that met these criteria in the schemes evaluated
was:
? Flammability (liquids, gases and solids)
As for human health effects a watching brief will be kept on those physicochemical
properties that do not meet the above criteria, and these endpoints revisited when
hazard quantification and potency can be addressed.
A brief impact analysis on implementing the low-hazardous criteria for flammability
into the national classification scheme is provided in section 4.2.
3.5 Environmental effects
As stated previously, there is presently no Australian classification system for
environmental effects.
The only international scheme that proposed low-hazardous criteria was NZ (which
adopted the GHS classification scheme for aquatic toxicity and terrestrial toxicity
derived from the US EPA scheme) for rapid risk assessment. Criteria were proposed
for the following:
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? The aquatic environment;
? The soil environment;
? Terrestrial vertebrates; and
? Terrestrial invertebrates.
Furthermore, though the US EPA scheme does not directly propose low-hazardous
criteria, potential criteria have been identified in the classification scheme for:
? Avian toxicity; and
? Toxicity to wild mammals.
A summary of the low-hazardous criteria proposed in the NZ scheme and identified in
the US EPA scheme are provided in Table 3, together with information on those
aspects identified from the human health evaluation as being critical for robust low-
hazardous criteria:
? Degrees of hazard; and
? Nature of the classification criteria (i.e. qualitative or quantitative).
Table 3: Low-hazardous definitions for environmental effects
ENVIRONMENTAL LOW-HAZARDOUS CRITERIA
EFFECT
AQUATIC ENVIRONMENT
NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?4 Categories
Low-hazardous definition Yes - Category D: 96 hr LC50 (for fish) > 1 - < 100 mg/L, or 48 hr EC50 (for
crustacea) > 1 - < 100 mg/L g/L, or 72 or 96 hr ErC50 (for algae) > 1 - < 100
mg/L and not classified in Category A, B or C, or no acute toxicity and lack
of rapid degradability and bioaccumulative and not classified in Category A,
B or C
Qualitative or quantitative Quantitative
US EPA ecotoxicity categories
More than 1 degree of hazard Yes ?5 Categories
Low-hazardous definition No ?though the category of `Slightly Toxic' (EC50 or LC50 values >10 and
< 100 ppm) between the `Moderately Toxic' and `Practically Non-Toxic'
categories could be considered to be low-hazardous criteria
Qualitative or quantitative Quantitative
NON-AQUATIC
ENVIRONMENT
Soil environment NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?4 Categories
Low-hazardous definition Yes - Category D: 10 < soil ecotoxicity value < 100 mg/kg and Soil DT50 <
30 days
Qualitative or quantitative Quantitative
Terrestrial vertebrates NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?3 Categories
Low-hazardous definition Yes ?Category C: 500 < LD50 < 2000 mg/kg bw, or 1000 < LC50 (diet) <
5000 mg/kg food, or a chronic MATC < 100 ppm in the diet but which does
not meet the criteria for Category A or B
Qualitative or quantitative Quantitative
Avian US EPA ecotoxicity categories
More than 1 degree of hazard Yes ?5 Categories
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Low-hazardous definition No ?though the category of `Slightly Toxic' (500 < LD50 < 2000 mg/kg bw)
between the `Moderately Toxic' and `Practically Non-Toxic' categories
could be considered to be low-hazardous criteria
Qualitative or quantitative Quantitative
Wild mammals US EPA ecotoxicity categories
More than 1 degree of hazard Yes ?5 Categories
Low-hazardous definition No ?though the category of `Slightly Toxic' (500 < LD50 < 2000 mg/kg bw)
between the `Moderately Toxic' and `Practically Non-Toxic' categories
could be considered to be low-hazardous criteria
Qualitative or quantitative Quantitative
Terrestrial invertebrates NZ rapid risk assessment scheme
More than 1 degree of hazard Yes ?3 Categories
Yes - Category C: Invertebrate ecotoxicity value >11 and < 25 礸/bee
Low-hazardous definition
Qualitative or quantitative Quantitative
US EPA ecotoxicity categories
Insects
More than 1 degree of hazard Yes ?3 Categories
Low-hazardous definition No ?it is considered that low-hazardous criteria cannot be identified from
the 3 categories of `Highly Toxic', `Moderately Toxic' and `Practically Non-
Toxic'.
Qualitative or quantitative Quantitative
A more detailed evaluation of the international schemes for environmental effects can
be found in Appendix 3.
Low-hazardous criteria ?environmental effects
The findings of the environmental effects evaluation support those of the human
health evaluation, as the identification of low-hazardous criteria for classification was
restricted to those environmental effects where:
? There is more than one classification category; and
? The intrinsic property's classification criteria are solely quantitative in nature.
Furthermore, such criteria should allow comparisons to be made for the type of effects
seen.
Environmental effects that meet these criteria in the schemes evaluated are for:
? The aquatic environment;
? The soil environment;
? Terrestrial vertebrates (with the US scheme providing specific criteria for
birds and wild mammals); and
? Terrestrial invertebrates.
As for human health effects, a watching brief will be kept on those environmental
effects that do not meet the above criteria, and these endpoints revisited when hazard
quantification and potency can be addressed.
A brief impact analysis on implementing these low-hazardous criteria for the aquatic
and soil environment together with terrestrial vertebrates and invertebrates into the
national classification scheme is provided in section 4.3.
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4. COMPARISON OF THE IDENTIFIED LOW-HAZARDOUS
CRITERIA AGAINST THE AUSTRALIAN CLASSIFICATION
SYSTEMS FOR INDUSTRIAL CHEMICALS
Low-hazardous criteria have been proposed or identified in international but not
national classification schemes when there is more than one degree of hazard and the
criteria are quantitative in nature. A summary of all the human health effects,
physicochemical properties and environmental effects that meet these low-hazardous
criteria are presented in Tables 4, 5 and 6 respectively.
The next step now that low-hazardous criteria have been identified from international
schemes is a brief `impact analysis' of these criteria on the existing national
classification scheme for industrial chemicals (i.e. NOHSC Approved Criteria).
Consequently, for comparative purposes the corresponding lowest degree of hazard in
the NOHSC Approved Criteria is presented for human health effects (Table 4) where
low-hazardous criteria have been identified.
For physicochemical properties, the Australian classification system viz ADG code is
unsuitable for use in setting low hazardous criteria. However, the current EU
classification system as described in the NOHSC Approved Criteria is widely used in
Australia and therefore it is proposed that this approach be applied for setting low
hazardous criteria for physicochemical properties (Table 5).
For environmental effects there is presently no Australian classification scheme, and
while a provisional classification for such is generated for new industrial chemicals
using the GHS scheme, this classification scheme (which only covers the aquatic
environment) is a voluntary non-regulatory activity. Consequently, until an agreed
`version' of GHS has been implemented in Australia, it is proposed that, on the basis
that the NOHSC Approved Criteria for human health effects are adopted from the
European Community's legislation6 for classifying dangerous substances, the same
approach is used for environmental effects. Therefore, as for human health effects and
physicochemical properties, the lowest degree of hazard in the EU scheme is also
presented (Table 6).
Comparisons are presented below separately for human health effects,
physicochemical properties and environmental effects.
4.1 Human health effects
It can be seen from Table 4 (see below) that the identified international definitions of
hazardous (i.e. the hazard trigger) for acute oral, dermal, and inhalation toxicity and
skin and eye irritation are more conservative than the Australian definition, as the
quantitative low-hazardous criteria for all these effects are below the level defined as
hazardous in Australia. Consequently, implementation of the identified overseas low-
hazardous criteria is impracticable as:
? It is incompatible with the present Australian classification scheme; and
6
No low-hazardous criteria were proposed or identified for environmental effects in the EU
classification scheme.
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? If the national classification scheme was adjusted to take account of these
low-hazardous criteria, implementation would lead to an increase in the
incidence of notified industrial chemicals classified as hazardous and, thus,
would be counter productive as it will restrict the number of chemicals that
would potentially meet low-hazardous criteria.
Consequently, it is considered that low-hazardous criteria for human health effects
have to be defined using the present Australian classification scheme. Furthermore,
the comparison indicates that the only human health effects with more than one
degree of hazard and quantitative classification criteria in the national scheme are:
? Acute toxicity (oral, dermal and inhalation); and
? Eye irritation.
However, for acute oral, dermal and inhalation toxicity it is noted that the value range
for the identified hazard grade in the Australian classification system is broad, i.e. 200
< LD50 < 2000 mg/kg bw for acute oral toxicity. It is considered that the higher
values in these ranges are beyond the upper end of a hazard scale that would
constitute a low hazard, thus requiring identification of a low-hazardous cut-off value
within the lowest degree of hazard range.
Of the national and international schemes evaluated both the APVMA house hold
pesticides and US EPA pesticide guidelines delineate hazard through pesticide use by
identifying a cut-off values that must be exceeded if the pesticide is to be used for
residential and institutional purposes and not restricted. The following cut-off values
were identified for acute toxicity:
Acute oral: The APVMA states that the pesticide should not be life threatening to a
child up to 1500 mg/kg bw, while the US EPA states that the pesticide as diluted for
use has a LD50 > 1500 mg/kg bw.
Acute dermal: The APVMA states that the pesticide should not be life threatening to a
child up to 1000 mg/kg bw, while the US EPA states that the pesticide as formulated
has a LD50 > 2000 mg/kg bw.
Acute inhalation: The US EPA states that the pesticide as formulated has a LC50 > 0.5
mg/L/4hr. The APVMA household pesticide guidelines do not address inhalation.
What constitutes a life threatening event in the APVMA scheme is not defined,
however, for the basis of this assessment in identifying a cut-off value for low-
hazardous within the hazard grade the reported values are taken as LD50 values. Thus
for acute oral toxicity a cut-off value LD50 value > 1500 mg/kg bw is identified by
both the APVMA and US EPA. For acute dermal toxicity a cut-off LD50 value of >
1000 mg/kg bw is identified by the APVMA. While the cut-off LD50 value of > 2000
mg/kg bw identified by the US EPA is not appropriate, as in the Australian
classification scheme industrial chemicals with dermal LD50 values > 2000 mg/kg are
considered non-hazardous. Alternatively for acute inhalation toxicity the cut-off LC50
value of > 0.5 mg/L/4hr identified by the US EPA is not appropriate as this could
capture chemicals considered toxic, since the lower cut-off LC50 value for such is < 1
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mg/L/4hr for aerosols and particulates and < 2 mg/L/4hr for gases and vapours in the
Australian classification scheme.
It should be noted that the basis for the above APVMA and US EPA cut-off values
could not be determined. Consequently, additional cut-off values have been proposed
for acute oral, dermal and inhalation toxicity that simply represent the median value
within the range of the identified hazard grade in the Australian classification scheme.
The alternative cut-off values are > 1100 mg/kg bw for acute oral toxicity, > 1200
mg/kg bw for acute dermal toxicity and for acute inhalation toxicity > 3 mg/L/4hr for
aerosols and particulates and > 11 mg/L/4hr for gases and vapours.
Thus, Table 7 includes 2 options for acute oral toxicity are:
? Option 1 ?The chemical meets the criteria for classification with R22 but has
a LD50 value > 1500 mg/kg bw as identified by APVMA and US EPA for
household pesticides;
? Option 2 ?The chemical meets the criteria for classification with R22 but has
a LD50 value equivalent to or greater than the median point of this
classification grade i.e. > 1100 mg/kg bw.
The available options for acute dermal toxicity are:
? Option 1 ?The chemical meets the criteria for classification with R21 but has
a LD50 value > 1000 mg/kg bw as identified by APVMA for house hold
pesticides;
? Option 2 ?The chemical meets the criteria for classification with R21 but has
a LD50 value equivalent to or greater than the median point of this
classification grade i.e. > 1200 mg/kg bw.
In contrast, for acute inhalation toxicity, a cut-off value was not proposed by the
APVMA while the value from the US EPA is not appropriate. Consequently, the only
proposal for identification of a low-hazardous cut-off value is the median value: LC50
> 3 mg/L/4hr for aerosols or particulates and > 11 mg/L/4hr for gases or vapours.
For skin irritation, although there is only one degree of hazard in the NOHSC
Approved Criteria, alternative evaluations of the criteria have been proposed (options
2 and 3 below) as a low-hazardous criteria has been proposed for eye irritation and
identification of such would allow the endpoint of irritation to be dealt with
completely.8 The options proposed are:
? Option 1 - As there is only one degree of hazard for irritation low-hazardous
criteria cannot be identified;
? Option 2 - If it is accepted that skin irritation directly follows on from
corrosivity and represents a lesser (third) degree of hazard for damage to the
skin, then the skin irritation criteria can be considered to be low-hazardous;
8
Excluding respiratory irritation (for which no international low-hazardous criteria were identified), as
not only is classification for this endpoint qualitative but the absence of a regulatory test guideline for
this health effect prevents a reliable comparison of potency between chemicals for effects observed.
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? Option 3 - Alternatively, if the approach outlined in option 2 is adopted, then,
for consistency with the low-hazardous eye irritation criteria, the persistence
of irritation may need to be considered, i.e. additionally, inflammation should
not persist in 2 or more animals at the end of the observation period.
Opinions are sought on the preferred option for acute toxicity and skin irritation
presented in Table 4.
How these low-hazardous criteria would be applied for the purposes of notification
and assessment categories in Australia is provided in Section 5.
Table 4: Comparison of identified low-hazardous criteria for human health
effects with the Australian classification scheme
Australia1
HUMAN HEALTH International scheme
EFFECT
Lowest degree of hazard: 200< LD50 <
Low-hazardous definition: 2000<
Acute oral toxicity
2000 mg/kg bw, however, it is
LD50 < 5000 mg/kg bw
proposed that within this range low
hazardous chemicals have a:
Option 1: LD50 > 1500 mg/kg bw; or
Option 2: LD50 > 1100 mg/kg bw
Lowest degree of hazard: 400< LD50 <
Low-hazardous definition: 2000<
Acute dermal toxicity
LD50 < 5000 mg/kg bw 2000 mg/kg bw, however, it is
proposed that within this range low
hazardous chemicals have a:
Option 1: LD50 > 1000 mg/kg bw; or
Option 2: LD50 > 1200 mg/kg bw
Lowest degree of hazard: 1< LC50 < 5
Low-hazardous definition: for
Acute inhalation toxicity
dusts/mists, gases and vapours the mg/L/4 hr (aerosols and particulates)
LC50 in the equivalent range of the 2< LD50 < 20 mg/L/4 hr (gases and
vapours), however, it is proposed that
oral and dermal Category 5 LD50
(i.e. between 2000 and 5000 mg/kg within this range low hazardous
bw). chemicals have a LC50 > 3 mg/L/4hr
for aerosols/particulates or > 11
mg/L/4hr for gases/vapours
Skin irritation2 Low-hazardous definition: in 2 or Lowest degree of hazard: only one
more of 3 animals tested degree of hazard for skin irritation - in
erythema/eschar or oedema > 1.5 2 or more animals tested
and < 2.3 (and inflammation does erythema/eschar or oedema > 2 or
not persist to the end of the inflammation persists in at least 2
observation period normally 14 days animals at the end of the observation
in 2 animals) time (normally 14 days). Therefore, it
is proposed that:
Option 1: low hazardous criteria can
not be identified;
Option 2: the criteria for skin
irritation are considered low-
hazardous criteria; or
Option 3: the criteria for skin
irritation together with the absence of
inflammation in 2 or more animals at
the end of the observation period are
considered low-hazardous criteria.
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Eye irritation2 Lowest degree of hazard: in at least 2
Low-hazardous definition: in at
of 3 animals tested corneal opacity > 2
least 2 of 3 animals tested corneal
opacity 1 (and < 3), iritis 1 (and and < 3, iritis > 1 and < 2, conjunctival
< 1.5), conjunctival erythema 2, erythema > 2.5), or conjunctival
or conjunctival oedema 2 and oedema > 2 and fully reverses within
fully reverses within the the observation period (normally 21
observation period (normally 21 days)
days)
1
All these human health effects listed in the national scheme have quantitative classification criteria
2
The classification criteria for the next `higher' degree of hazard are provided in brackets for the NZ scheme.
4.2. Physicochemical properties
It can be seen from Table 5 (see below) that the identified international definitions of
hazardous (i.e. the hazard trigger) for flammability is more conservative for liquids
than the EU definition, while low-hazardous criteria cannot be identified for gases and
solids as only one degree of hazard is available and the classification criteria are
qualitative in nature. Consequently, the finding that quantitative low-hazardous
criteria be defined using the current EU classification scheme, is considered to be
applicable for physicochemical properties. The only low-hazardous criteria meeting
this requirement is for:
? Flammability (liquids only).
How the low-hazardous criteria for flammability would be applied for the purposes of
notification and assessment categories in Australia is provided in Section 5.
Table 5: Comparison of identified low-hazardous criteria for physicochemical
properties with the EU classification scheme
EU1
International scheme
Lowest degree of hazard:
Low-hazardous definition:
Flammable
Liquid - Flash point > 21 oC and <
Liquid - flash point > 60 癈 and 93
55 oC
癈
Gas - at 20 癈 and a standard pressure
Gas2 ?no, only 1 degree of hazard
of 101.3 kPa, have a flammable range
while mixed in air (and at 20 癈 and a
Solid2 ?no, only 1 degree of hazard
standard pressure of 101.3 kPa are not
ignitable when in a mixture of 13% or
less by volume in air or have a
flammable range with air of at least 12
percentage points regardless of the
lower flammable limit).
Solid - Burning rate test for solids
other than metal powders: wetted zone
stops the fire for at least 4 min and the
burning time < 45 seconds or burning
rate > 2.2 mm/second. Burning rate
test for metal powders: burning time >
5 minutes and 10 minutes.
1
It should be noted that though a low-hazardous criteria was proposed for aerosols in the international scheme the
classification of aerosols are not addressed in the EU Criteria.
2
Classification criteria are qualitative in nature
4.3. Environmental effects
It can be seen from Table 6 (see below) that the identified international definitions of
hazardous (i.e. the hazard trigger) for the aquatic environment are similar to the EU
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definition, while low-hazardous criteria cannot be identified for the soil environment,
terrestrial vertebrates and invertebrates as only one degree of hazard is available.
However, in an approach similar to that proposed for human health effects, additional
cut offs values have been proposed for acute aquatic toxicity that simply represent the
median value within the range of the international scheme.
Table 6: Comparison of identified low-hazardous criteria for environmental
effects with the EU classification scheme
ENVIRONMENTAL International scheme EU
ENDPOINT
Lowest degree of hazard: 96 hr LC50
Low-hazardous definition: Category D:
Aquatic environment
>10 - < 100 mg/L for fish, or 48 hr
96 hr LC50 (for fish) > 1 - < 100 mg/L,
or 48 hr EC50 (for crustacea) > 1 - < EC50 >10 - < 100 mg/L for daphnia,
100 mg/L g/L, or 72 or 96 hr ErC50 (for or 72 hr IC50 >10 - < 100 mg/L for
algae) > 1 - < 100 mg/L and not algae and is not readily degradable.
classified in Category A, B or C, or no This applies unless there is
acute toxicity and lack of rapid sufficient additional scientific
degradability and bioaccumulative and evidence concerning degradation
not classified in Category A, B or C and/or toxicity to provide adequate
assurance that neither the substance
nor its degradation products will
constitute a potential long-term
and/or delayed danger to the aquatic
environment. Such additional
information could include: a proven
potential to degrade rapidly in the
aquatic environment, or an absence
of chronic toxicity effects at a
concentration of 1.0 mg/L.
However, it is proposed that an
additional low hazardous cut off
value for acute toxicity that
represents the median value of the
harmful hazard grade in the EU
classification system ie. >55 mg/L
Lowest degree of hazard: No, only 1
Low-hazardous definition: Category D:
Soil environment
10 < 1soil ecotoxicity value < 100 degree of hazard
mg/kg and 2Soil DT50 < 30 days
Low-hazardous definition: Category C: Lowest degree of hazard: no, only 1
Terrestrial vertebrates
500 < LD50 < 2000 mg/kg bw, or 1000 degree of hazard
< LC50 (diet) < 5000 mg/kg food, or a
chronic 3MATC < 100 ppm in the diet
but which does not meet the criteria for
Category A or B
Low-hazardous definition: Category C: Lowest degree of hazard: no, only 1
Terrestrial invertebrates
4
Invertebrate ecotoxicity value >11 and degree of hazard
< 25 礸/bee
1
The lowest value (in mg substance/kg dry weight of soil) from: (i) plant or soil invertebrate 14 day exposure EC50
data; or (ii) data demonstrating a 25 % reduction in soil micro-organism respiration or nitrification at completion
of 28 day exposure to the substance
2
Time to reduce original substance soil concentration by 50 %
3
The maximum acceptable toxicant concentration, being the geometric mean of the NOEC and LOEC where the
NOEC and LOEC are derived from the same study
4
Lowest value (in 礸 substance/terrestrial invertebrate) from contact or oral LD50 data 48 hours after exposure
Consequently, the findings of the human health evaluation, that quantitative low-
hazardous criteria be defined using the surrogate EU classification scheme, are also
considered to be applicable for environmental effects. The only low-hazardous
criteria meeting this requirement is for:
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? Aquatic environment.
How the low-hazardous criteria for the aquatic environment identified in the surrogate
EU classification scheme would be applied for the purposes of notification and
assessment categories in Australia is provided in Section 5.
5. IDENTIFIED LOW-HAZARDOUS CRITERIA FOR THE PURPOSES
OF NOTIFICATION AND ASSESSMENT CATEGORIES IN
AUSTRALIA
5.1 Chemicals
For notification and assessment categories in Australia the principles of low-
hazardous criteria identified in this paper (i.e. more than one degree of hazard with
quantitative criteria) should be applied to the NOHSC Approved Criteria for human
health effects and the surrogate EU classification scheme for physiochemical and
environmental effects. In applying this proposed scheme, it should be noted that:
? An inherently low-hazardous chemical may have one or more properties
classified as a low-hazardous property;
? If a chemical exceeds the low-hazardous cut offs or triggers a classification for
which low-hazardous criteria have not been identified, it can no longer be
considered to be an inherently low-hazardous chemical; and
? If a chemical is not classified for any endpoint, it is non-hazardous, not low-
hazardous.
Summaries of the classification endpoints that meet the criteria are presented in
Tables 7, 8 and 9 for human health effects, physicochemical properties and
environmental effects, respectively. These tables also indicate those endpoints for
which low-hazardous criteria could not be identified, as there was only one degree of
hazard and/or the classification criteria were not quantitative in nature (i.e. do not
allow potency to be reliably addressed). The data is presented in these tables as the
appropriate risk phrase within the classification system that represents the lowest
degree of quantitative hazard (i.e. R36 for eye irritation).
Furthermore, for acute oral toxicity, acute dermal toxicity and skin irritation more
than one option is proposed for the identification of low-hazardous criteria (see
section 4.1 for the rationale for each of these different options).
Table 7: Human health effects for which low-hazard criteria are proposed
LOW-HAZARDOUS NOT LOW-HAZARDOUS
ENDPOINT
R22 Harmful if swallowed R22 Harmful if swallowed with a LD50 < 1100
Acute oral toxicity option 1
with a LD50 > 1100 mg/kg mg/kg bw;
R28 Very toxic if swallowed; or
bw
R25 Toxic if swallowed
R22 Harmful if swallowed with a LD50 < 1500
R22 Harmful if swallowed
Acute oral toxicity option 2
with a LD50 > 1500 mg/kg mg/kg bw;
bw R28 Very toxic if swallowed; or
R25 Toxic if swallowed
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R21 Harmful in contact with skin with a LD50
R21 Harmful in contact with
Acute dermal toxicity
skin with a LD50 > 1200 < 1200 mg/kg bw;
option 1
mg/kg bw R27 Very toxic in contact with skin; or
R24 Toxic in contact with skin
R21 Harmful in contact with skin with a LD50
R21 Harmful in contact with
Acute dermal toxicity
skin with a LD50 > 1000 < 1000 mg/kg bw;
option 2
mg/kg bw R27 Very toxic in contact with skin; or
R24 Toxic in contact with skin
R20 Harmful by inhalation with a LC50:
R20 Harmful by inhalation
Acute inhalation toxicity
with a LC50: < 3 mg/L/4hr mg/kg bw for
> 3 mg/L/4hr mg/kg bw for aerosols/particulates; or
aerosols/particulates; or < 11 mg/L/4hr mg/kg bw for gases/vapours;
> 11 mg/L/4hr mg/kg bw for R26 Very toxic by inhalation; or
gases/vapours R23 Toxic by inhalation
R39 Danger of very serious irreversible effects1
Not proposed
Non-lethal irreversible
effects after a single
exposure
Not proposed R65 Harmful: may cause lung damage if
Aspiration hazard
swallowed
Not proposed R35 Causes severe burns; or
Corrosive
R34 Causes burns
Cannot be identified R38 Irritating to skin
Skin irritation option 1
R38 Irritating to skin R35 Causes severe burns; or
Skin irritation option 2
R34 Causes burns
R38 Irritating to skin R35 Causes severe burns;
Skin irritation option 3
R34 Causes burns; or
If inflammation of the skin persists in at least
two animals at the end of the observation time.
R36 Irritating to eyes R41 Risk of serious eye damage
Eye irritation
Not proposed R37 Irritating to the respiratory system
Respiratory irritation
Not proposed R43 May cause sensitisation by skin contact
Skin sensitisation
Not proposed R42 May cause sensitisation by inhalation
Respiratory sensitisation
Not proposed Toxic - R48 Danger of serious damage to
Repeat dose toxicity
health by prolonged exposure
Harmful ?R48 Danger of serious damage to
health by prolonged exposure
Not proposed Category 1: R46 May cause heritable genetic
Mutagenicity
damage;
Category 2: R46 May cause heritable genetic
damage; or
Category 3: R68 Possible risk of irreversible
effects
2
Not proposed Category 1: R45 May cause cancer;
Carcinogenicity
2
Category 2: R45 May cause cancer; or
Category 3: R40 Limited evidence of a
carcinogenic effect
Not proposed Category 1: R60 May impair fertility;
Effects on fertility
Category 2: R60 May impair fertility; or
Category 3: R62 Possible risk of impaired
fertility
Not proposed Category 1: R61 May cause harm to the unborn
Developmental toxicity
child
Category 2: R61 May cause harm to the unborn
child
Category 3: R63 Possible risk of harm to the
unborn child
Other health effects for
substances which have
already been classified3
Not proposed R33 Danger of cumulative effects
Not proposed R64 May cause harm to breastfed babies
Not proposed R66 Repeated exposure may cause skin
dryness or cracking
Not proposed R67 Vapours may cause drowsiness and
dizziness
1
R39 assigned and determined to be very toxic or toxic when effects are seen in the dose ranges (all routes of
exposure) assigned for R26/27/28 and R23/24/25 respectively.
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2
This category also includes classification with the risk phrase R49 May cause cancer by inhalation.
3
Already classified for physicochemical properties, human health or environmental effects. See Approved Criteria
(NOHSC, 2004) for a more detailed explanation of the assignment of these additional risk phrases.
For effects where no separate criterion is proposed, eg sensitisation, mutagenicity,
carcinogenicity, the cut off for "low hazardous" equates to the cut off for non
hazardous. That is, a chemical classified as hazardous on the basis of mutagenicity
will not meet the `low-hazardous' requirements for notification and assessment.
Table 8: Physicochemical properties for which low-hazard criteria are proposed
Note that in the table below the risk phases as applicable in the EU classification
system are used. These are used in Australia, eg in the HSIS, and are described in the
NOHSC Approved Criteria.
ENDPOINT LOW-HAZARDOUS NOT LOW-HAZARDOUS
Not proposed R2 Extreme risk of explosion by shock, friction, fire
Explosive
or other sources of ignition; or
R3 Risk of explosion by shock, friction, fire or other
sources of ignition
Not proposed R7 May cause fire;
Oxidising
R8 Contact with combustible material may cause fire;
or
R9 Explosive when mixed with combustible material
R10 Flammable R12 Extremely flammable; or
Flammable
R11 Highly flammable1
1
Substances classified "Highly Flammable' also include those that are assigned risk phrase R15 (Contact with
water liberates extremely flammable gas) and R17 (Spontaneously flammable in air).
As for human health effects, the criterion for `low hazardous' will equate with non-
hazardous where no separate criterion is proposed. That is, except for a chemical
meeting R10, any chemical classified as dangerous good on the basis of its
physicochemical properties will not meet the `low hazardous' requirements for
notification and assessment.
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Table 9: Environmental effects for which low-hazard criteria are proposed
Note that in the table below the risk phases as applicable in the EU classification
system are used. These are used in Australia, eg in the HSIS, and are described in the
NOHSC Approved Criteria.
ENDPOINT LOW-HAZARDOUS NOT LOW-HAZARDOUS
R50 Very toxic to aquatic organisms;
R52 Harmful to aquatic organisms;
Aquatic environment
and
or
R53 May cause long-term adverse
R53 May cause long-term adverse
effects in the aquatic environment
effects in the aquatic environment
or
with 55 mg/L
<100mg/L R51 Toxic to aquatic organisms;
and
R53 May cause long-term adverse
effects in the aquatic environment
or
R52 Harmful to aquatic organisms;
and
R53 May cause long-term adverse
effects in the aquatic environment
with 10 mg/L
<55mg/L)
Non-aquatic environment
Not proposed R54 Toxic to flora
- Flora
Not proposed R55 Toxic to fauna
- Fauna
Not proposed R56 Toxic to soil organisms
- Soil organisms
Not proposed R57 Toxic to bees
- Terrestrial
Not proposed R58 May cause long-term adverse
effects in the environment1
Not proposed R59 Dangerous for the ozone layer
- Ozone layer
1
Substances which on the basis of the available evidence concerning their toxicity, persistence, potential to
accumulate and predicted or observed environmental fate and behaviour, may present a danger, immediate or long
term and/or delayed, to the structure and/or functioning of natural ecosystems other than those covered for the
aquatic environment.
Safeguard ?chemicals with POPs characteristics are not eligible for consideration as `low hazardous'
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5.2 Polymers
NICNAS currently has low concern criteria for polymers, namely, the criteria for
notifying new chemicals as `polymers of low concern (PLC)'. The criteria are
stipulated in regulation 4 of the regulations to the Act. However, as outlined above,
the intent of this reform has been to set a hazard level above that defined by the
definition of `a hazardous chemical' in the Act (or `hazardous substance' in the
NOHSC Approved Criteria for Classifying Hazardous Substances). The PLC criteria
are more conservative than the definition of `a hazardous chemical' and are therefore
unsuitable for this reform.
In developing low hazardous criteria for polymers, it is necessary to recognise that the
range of effects data usually generated for polymers is less than that generated for
chemicals, particularly for the higher molecular-weight polymers. Therefore, it is
proposed to take a simpler approach for polymers.
For low-hazardous polymers with number-average molecular-weight of 1000 or less,
it is proposed that the criteria developed and proposed for chemicals be adopted.
For low-hazardous polymers with number-average molecular-weight greater than
1000, it is proposed that the polymer has:
?less than 10% by mass of molecules with molecular weight that is less than
500; and
?less than 25% by mass of molecules with molecular weight that is less than
1000; and
?has low charge density, as defined in Regulation 4C.
In both situations, polymers shown to not meet the definition of `a hazardous
chemical' would also be accepted under this proposal.
As a safeguard, polymers classified as a NOHSC Type I ingredient (i.e. carcinogenic,
mutagenic, a skin or respiratory sensitiser, very corrosive, corrosive, toxic or very
toxic, a harmful substance which can cause irreversible effect after acute exposure or
a harmful substance which can cause serious to health after repeated prolonged
exposure) or a reproductive toxicant are excluded from consideration as low
hazardous polymers. New polymers with persistent organic pollutant (POPS)
characteristics, in accordance with Annex D of Stockholm Convention, are also
excluded from consideration as low hazardous. Similarly, polymers would not qualify
as low hazardous if they readily break down to degradation products that may be
persistent and bioaccumulative.
6. NICNAS PROPOSAL
To summarise, while all classifiable properties have a `hazard trigger' that defines an
industrial chemical as hazardous, grading of hazard already occurs in classification
schemes for some intrinsic properties, e.g. hazardous chemicals can be classified as
Very Toxic, Toxic or Harmful for acute toxicity in Australia. However, the intent
undertaken here is to identify a point in the `hazard spectrum' below which a
hazardous (i.e. classifiable) chemical can be considered as "low-hazardous". Thus,
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comments are sought on the NICNAS proposal that low-hazardous criteria for the
purposes of notification and assessment categories be restricted to:
I. Those endpoints for which there already exists grading of hazard in the
classification system (i.e. more than one degree of hazard), and
II. The grading of hazard for the endpoint is quantitative in nature (i.e.
provides cut-off values), therefore allowing a comparison to be made of
the same type of toxic effects (i.e. the criteria allow consideration of the
potency of the chemical).
Furthermore, comments are sought on the proposal that:
III. Grades of hazard with quantitative criteria are identified in the
Australian classification scheme (the NOHSC Approved Criteria) for
human health effects, and
IV. As there is no quantitative Australian classification scheme with grades of
hazard for physicochemical properties, the EU classification scheme is
used to identify low-hazardous criteria for notification and assessment in
Australia; and
V. As there is no Australian classification scheme for environmental effects
of new industrial chemicals, the EU classification scheme is used to
identify low-hazardous criteria (that correspond to points I and II) for
notification and assessment in Australia.
Comments are also sought on the proposal that, in applying the criteria for acute
toxicity (points I, II and III):
VI. The higher LD50/LC50 values contained within the identified lowest degree
of hazard range for acute oral, dermal and inhalation toxicity require that
a low-hazardous cut-off value be identified, and
VII. If point VI is supported, preference is stated for the identification of a cut-
off value for acute oral and dermal toxicity based on the median value
within the LD50 range, or adoption of a cut-off value based on the
delineation of pesticide use in Australia (the basis for which is unclear),
i.e. an LD50 value that determines whether pesticides can be used
residentially or are restricted in their use.
Additionally, comments are sought on the proposal that:
VIII. As skin irritation directly `follows on' from corrosivity in classification
schemes, it can be considered to represent a lesser degree of hazard for
damage to the skin, thus allowing points I, II and III to be met, and
IX. If point VIII is supported, preference is stated for whether the low-
hazardous criteria for skin irritation does (as for the low-hazardous
criteria for eye irritation) or does not address persistence of irritation.
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Finally, comments are sought on the proposal that:
X. There be separate `low-hazardous' criteria for polymers with NAMW >
1000; and
XI. The criteria proposed for polymers are appropriate.
In conclusion, it should be re-iterated that if the above approach is adopted (as defined
in points I - V), then for those human health, physicochemical properties and
environmental effects for which low-hazardous criteria have not been identified (e.g.
skin sensitisation), a watching brief will be kept by NICNAS and a re-evaluation of
low-hazardous criteria for notification and assessment categories undertaken if any
significant advances in scientific knowledge and/or amendments to classification
systems occur, e.g. introduction of the GHS system in Australia.
References
APVMA (2006). Agricultural Requirement Series. Accessed at
http://www.apvma.gov.au/MORAG_ag/MORAG_ag_home.shtml#agMORAGvol3 in
May 2006.
Basketter, D.A., Blaike, L., Dearman, R.J., Kimber, I., Ryan, C.A., Gerberick, G.F.,
Harvey, P., Evans, P., White, I.R and Rycroft, R.J.G (2000). Use of the local lymph
node assay for the estimation of relative contact allergenic potency. Contact
Dermatitis, 22, p344 ?348.
CHIP Regulations (2002). Chemicals (Hazard Information and Packaging for Supply)
Regulations: Approved classification and labelling guide (fifth edition). HSE Books,
Sudbury, Suffolk CO10 2WA, England.
EC (1999). Commission Working Group on the classification and labelling of
dangerous substances. Guidelines for setting specific concentration limits for
carcinogens in Annex 1 of Directive 67/548/EEC. Inclusion of Potency
Considerations. Accessed at
http://ec.europa.eu/comm/environment/dansub/potency.pdf in May 2006.
EC (2001). Commission's White Paper: Strategy for a future Chemicals Policy.
Commission of the European Communities, Brussels, 27.2.2001.
ERMA (2001). Information Requirements for Applications to Import or Manufacture
a Hazardous Substance for Release (Number 4, Series 2, Version 2). Accessed at
http://www.ermanz.govt.nz/resources/publications/pdfs/ER-PR2-04-2.pdf in May
2006.
FORS (1998) Australian Code for the Transport of Dangerous Goods by Road or Rail
(ADG Code), 6th ed. Canberra, ACT, Federal Office of Road Safety.
GHS (2005). Globally Harmonised System of Classification and Labelling of
Chemicals. Accessed at
http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/01files_e.html in May 2006.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
46
NDPSC (2003). Interim Guidelines for the National Drugs and Poisons Schedule
Committee. Commonwealth Department of Health and Ageing, Canberra, Australia.
NICNAS (2003). Final Report and Recommendations for NICNAS Low Regulatory
Concern Chemicals (LRCC) Reform Initiative, June 2003. NICNAS, Sydney,
Australia.
NOHSC (2004). Approved Criteria for Classifying Hazardous Substances, 3rd edition
[NOHSC:1008 (2004)]. National Occupational Health and Safety Commission.
Accessed at
http://www.nohsc.gov.au/pdf/Standards/approved_criteriaNOHSC1008_2004.pdf in
May 2006
OECD (2003). OECD Environment, Health and Safety Publications Series on Testing
and Assessment (No. 44). Descriptions of selected Key Generic Terms Used in
Chemicals. Paris, Organisation for Economic Cooperation and Development.
US EPA (2004). Pesticide Registration and Classification Procedures Subpart I ?br>
Classification of Pesticides. Accessed at http://www.pestlaw.com/x/cfr/part152i.htm
in May 2006.
US EPA (2006). Technical Overview of Ecological Risk Assessment Analysis Phase:
Ecological Effects Characterisation. Accessed at
http://www.epa.gov/oppefed1/ecorisk_ders/toera_analysis_eco.htm in May 2006.
Chemical Gazette Commonwealth of Australia Gazette
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47
3 DISCUSSION PAPER 1 ?APPENDIX 1
Table A ?National classification schemes for human health effects
SUSDP
Toxicological endpoints NOHSC Approved Criteria APVMA ADG Code
Schedules 7 (Dangerous
(household pesticides)
Poison), 6 (Poison) & 5
(Caution) that are applicable
to industrial chemicals
ACUTE ORAL
Yes No Yes
Yes
Potency grading
Very toxic: LD50 < 25 mg/kg bw Sch. 7: LD50 < 50 mg/kg bw Should not be life threatening to Toxic substances
Toxic: 25 < LD50 < 200 mg/kg bw Sch. 6: 50 < LD50 < 5000 mg/kg Packing group I (Great Danger):
a child at dioses up to 1500
Harmful: 200 < LD50 < 2000 mg/kg bw mg/kg bw LD50 < 5 mg/kg bw
Sch. 5: 2000 < LD50 < 5000 Packing group II (Medium
bw
mg/kg bw Danger): 5 < LD50 < 50 mg/kg bw
- life threatening not defined
Packing group III (Minor Danger):
Solids: 50 < LD50 < 200 mg/kg bw
Liquids: 50 < LD50 < 500 mg/kg
bw
No No No No
Delineation/low hazard definition
Quantitative Quantitative Quantitative with quantitative Quantitative
Qualitative or quantitative
component
ACUTE DERMAL
Yes No Yes
Yes
Potency grading
Very toxic: LD50 < 50 mg/kg bw Sch. 7: LD50 < 200 mg/kg bw Should not be life threatening at Toxic substances
Toxic: 50 < LD50 < 400 mg/kg bw Sch. 6: 200 < LD50 < 2000 mg/kg Packing group I (Great Danger):
doses up to 1000 mg/kg bw
Harmful: 400 < LD50 < 2000 mg/kg bw LD50 < 40 mg/kg bw
Sch. 5: LD50 > 2000 mg/kg bw Packing group II (Medium
bw - life threatening not defined
Danger): 40 < LD50 < 200 mg/kg
bw
Packing group III (Minor Danger):
200 < LD50 < 1000 mg/kg bw
No No No No
Delineation/low hazard definition
Quantitative Quantitative Quantitative with quantitative Quantitative
Qualitative or quantitative
component
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SUSDP
Toxicological endpoints NOHSC Approved Criteria APVMA ADG Code
Schedules 7 (Dangerous
(household pesticides)
Poison), 6 (Poison) & 5
(Caution) that are applicable
to industrial chemicals
Not addressed
ACUTE INHALATION
Yes Yes
Yes
Potency grading
Sch. 7: LC50 < 0.5 mg/L/4hr Toxic substances (dusts and mists)
- for aerosols or particulates
Very toxic: LC50 < 0.25 mg/L/4hr Sch. 6: 0.5 < LC50 < 3 mg/L/4hr Packing group I (Great Danger):
Toxic: 0.25 < LC50 < 1 mg/L/4hr Sch. 5: LC50 > 3 mg/L/4hr LC50 < 0.5 mg/L/1hr (equivalent to
Harmful: 1 < LC50 < 5 mg/L/4hr LC50 < 0.25 mg/L/4hr)
Packing group II (Medium
- for gases and vapours
Very toxic: LC50 < 0.5 mg/L/4hr Danger): 0.5 < LC50 < 2 mg/L/1hr
Toxic: 0.5 < LC50 < 2 mg/L/4hr (equivalent to 0.25 < LC50 < 1
Harmful: 2 < LC50 < 20 mg/L/4hr mg/L/4hr)
Packing group III (Minor Danger):
2 < LC50 < 10 mg/L/1hr (equivalent
to 1 < LC50 < 5 mg/L/4hr)
No No No
Delineation/low hazard definition
Quantitative Quantitative Quantitative
Qualitative or quantitative
Not specifically addressed Not addressed Not addressed
NON-LETHAL IRREVERSIBLE
EFFECTS
Yes
Potency grading
Very toxic: effects seen generally
in the very toxic dose ranges given
above for acute oral, dermal or
inhalation toxicity
Toxic: effects seen generally in the
toxic dose ranges given above for
acute oral, dermal or inhalation
toxicity
No
Delineation/low hazard definition
Quantitative with qualitative Not addressed Not addressed
Qualitative or quantitative
component
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Not specifically addressed Not addressed Not addressed
ASPIRATION HAZARD
No
Potency grading
No
Delineation/low hazard definition
Quantitative
Qualitative or quantitative
Not addressed
CORROSIVITY
No No
Yes
Potency grading
Causes severe burns: < 3 min
exposure
Causes burns: > 3 min < 4hr
exposure
- burns (i.e. corrosivity) defined
No No No
Delineation/low hazard definition
Essentially Qualitative Qualitative Qualitative
Qualitative or quantitative
SUSDP
Toxicological endpoints NOHSC Approved Criteria APVMA ADG Code
Schedules 7 (Dangerous
(household pesticides)
Poison), 6 (Poison) & 5
(Caution) that are applicable to
industrial chemicals
Not addressed
SKIN IRRITATION
No No
Yes
Potency grading
Sch. 6: Skin irritation is severe Irritancy should be low
(severe irritation at 72hr) to
corrosive
Sch. 5: Skin irritation is slight
(slight irritation at 72 hrs) to
moderate (moderate irritation at
72 hrs
No No Yes ?but no definition of what
Delineation/low hazard definition
constitutes a low irritation (i.e.
low hazard).
Quantitative Qualitative Qualitative
Qualitative or quantitative
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EYE IRRITATION Not addressed
Yes No
Yes
Potency grading
Sch. 6: Eye irritation is severe Irritancy should be low
Risk of serious damage to eyes:
- mean values: (corneal opacity, not reversible in
Corneal opacity > 3, or 7 days) to corrosive
Sch. 5: Eye irritation is slight (no
Iris lesions > 1.5
corneal opacity) to moderate
- if 3 animals tested then in 2 or
(corneal opacity, reversible in 7
more animals:
days)
Corneal opacity > 3, or
Iris lesion = 2
Or, in both cases, ocular lesion still
present at the end of the
observation period (21 days) or
irreversible colouration of the eyes
seen
Irritating to eyes:
- mean values:
Corneal opacity > 2 and < 3,
Iris lesion > 1 and < 1.5,
Conjunctival erythema > 2.5, or
Conjunctival oedema > 2
- if 3 animals tested then in 2 or
more animals:
Corneal opacity > 2 and < 3,
Iris lesion > 1 and < 2,
Conjunctival erythema > 2.5 or
Conjunctival oedema > 2
Toxicological endpoints NOHSC Approved Criteria APVMA ADG Code
SUSDP (household pesticides)
Schedules 7 (Dangerous
Poison), 6 (Poison) & 5
(Caution) that are applicable to
industrial chemicals
No No Yes ?but no definition of what
Delineation/low hazard definition
constitutes a low irritation (i.e.
low hazard).
Quantitative Qualitative Qualitative
Qualitative or quantitative
Not specifically addressed Not addressed Not addressed
RESPIRATORY IRRITANT
No
Potency grading
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitive
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Required but no information on Not addressed
SKIN SENSITISATION
classification/maximum levels
provided
No Yes
Potency grading
Sch. 6: Moderate to severe
Sch. 5: Slight or nil
No No
Delineation/low hazard definition
Quantitative Qualitative
Qualitative or quantitative
Not specifically addressed Not addressed Not addressed
RESPIRATORY SENSITISATION
No
Potency grading
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
SUSDP
NOHSC Approved Criteria APVMA ADG Code
Toxicological endpoints Schedules 7 (Dangerous
(household pesticides)
Poison), 6 (Poison) & 5
(Caution) that are applicable to
industrial chemicals
Not addressed
REPEAT DOSE TOXICITY
Yes No
Yes
Potency grading
Sch. 7: Severe hazard from Low hazard from repeated use,
Classified as at least toxic:
repeated use, or significant risk of
- oral for instance unlikely to induce
< 5 mg/kg bw/day producing irreversible toxicity irreversible toxicity
Sch. 6: Moderate hazard from
- dermal
< 10 mg/kg bw/day repeated use and low risk of
producing irreversible toxicity
- inhalation
< 0.025 mg/L, 6hr/day Sch. 5: Low hazard from
repeated use and should be
Classified as at least harmful:
unlikely to produce irreversible
- oral
< 50 mg/kg bw/day toxicity
- dermal
< 100 mg/kg bw/day
- inhalation
< 0.25 mg/L, 6hr/day
In both cases guidelines are
provided as to what biological
effects should and shouldn't attract
classification. Furthermore, all
these values are based on effects
seen in a 90-day repeat study. For a
28-day study these values should
be increased approximately 3 fold.
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No Yes ?but no definition of what Yes - but no definition of what
Delineation/low hazard definition
biological effects at what dose biological effects at what dose
level would constitute a low level would constitute a low
hazard hazard
Quantitative with qualitative Qualitative Qualitative
Qualitative or quantitative
component
Toxicological endpoints NOHSC Approved Criteria APVMA ADG Code
SUSDP (household pesticides)
Schedules 7 (Dangerous
Poison), 6 (Poison) & 5
(Caution) that are applicable to
industrial chemicals
Not specifically addressed Required but no information on Not addressed
MUTAGENICITY
classification/maximum levels
provided
Yes
Potency grading
Category 1: Known to be
mutagenic to humans
Category 2: Regarded to be
mutagenic to humans
Category 3: Cause concern for
humans owing to possible
mutagenic effects (somatic cell
mutagens - alert for possible
carcinogenic activity)
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
Not specifically addressed Required but no information on Not addressed
CARCINOGENICITY
classification/maximum levels
provided
Yes
Potency grading
Category 1: Know to be
carcinogenic to humans
Category 2: Regarded to be
carcinogenic to humans
Category 3: Cause concern for
humans owing to possible
carcinogenic effects
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
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Toxicological endpoints NOHSC Approved Criteria APVMA ADG Code
SUSDP (household pesticides
Schedules 7 (Dangerous
Poison), 6 (Poison) & 5
(Caution) that are applicable to
industrial chemicals
Not specifically addressed Required but no information on Not addressed
FERTILITY
classification/maximum levels
provided
Yes
Potency grading
Category 1: Can establish a casual
relationship between human
exposure and impaired fertility
Category 2: Strong presumption
that human exposure will result in
impaired fertility
Category 3: Cause concern for
human fertility
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
Not specifically addressed Required but no information on Not addressed
DEVELOPMENTAL TOXICITY
classification/maximum levels
provided
Yes
Potency grading
Category 1: Can establish a casual
relationship between human
exposure and developmental
toxicity
Category 2: Strong presumption
that human exposure will result in
developmental toxicity
Category 3: Cause concern for
humans owing to possible
developmental effects
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
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Not specifically addressed Not addressed Not addressed
EFFECTS DURING LACTATION
No
Potency grading
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
Not addressed
Not specifically addressed Not addressed
DANGER OF CUMULATIVE
EFFECTS
No
Potency grading
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
Not specifically addressed Not addressed Not addressed
REPEATED EXPOSURE CAUSE
SKIN DRYNESS OR CRACKING
No
Potency grading
No
Delineation/low hazard definition
Qualitative
Qualitative or quantitative
Not specifically addressed Not addressed Not addressed
NARCOTIC EFFECTS
No
Potency grading
No
Delineation/low hazard definition
Quantitative with qualitative
Qualitative or quantitative
component
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Table B ?International classification schemes for human health effects
Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
ACUTE ORAL
Yes Yes ?as GHS Only for use
Yes
Potency grading
Very toxic: LD50 < 25 mg/kg bw Cat. 1: LD50 < 5 mg/kg bw Residential and institutional uses:
Toxic: 25 < LD50 < 200 mg/kg bw Cat. 2: 5 < LD50 < 50 mg/kg bw pesticide as diluted for use LD50 >
Harmful: 200 < LD50 < 2000 mg/kg bw Cat. 3: 50 < LD50 < 300 mg/kg bw 1500 mg/kg bw
Cat. 4: 300 < LD50 < 2000 mg/kg bw All other uses restricted if: pesticide as
Cat. 5: 2000< LD50 < 5000 mg/kg bw formulated LD50 < 50 mg/kg bw
Delineation/low hazard definition No Yes ?Cat. 5 of relatively low acute Yes ?Cat. 5 in the GHS Yes ?distinction made for consumer
toxicity hazard but which under certain use
classification scheme is
considered a low hazard
circumstances may present a danger to
vulnerable populations.
Quantitative Quantitative Quantitative Quantitative
Qualitative or quantitative
ACUTE DERMAL
Yes Yes ?as GHS Only for use
Yes
Potency grading
Very toxic: LD50 < 50 mg/kg bw Cat. 1: LD50 < 50 mg/kg bw Residential and institutional uses:
Toxic: 50 < LD50 < 400 mg/kg bw Cat. 2: 50 < LD50 < 200 mg/kg bw pesticide as formulated LD50 > 2000
Harmful: 400 < LD50 < 2000 mg/kg bw Cat. 3: 200 < LD50 < 1000 mg/kg bw mg/kg bw
Cat. 4: 1000 < LD50 < 2000 mg/kg bw All other uses restricted if: pesticide as
Cat. 5: 2000< LD50 < 5000 mg/kg bw formulated LD50 > 200 mg/kg bw and
pesticide as diluted for use LD50 <
16000 mg/kg bw
Delineation/low hazard definition No Yes ?Cat. 5 of relatively low acute Yes ?Cat. 5 in the GHS Yes ?distinction made for consumer
toxicity hazard but which under certain use
classification scheme is
circumstances may present a danger to considered a low hazard
vulnerable populations.
Quantitative Quantitative Quantitative Quantitative
Qualitative or quantitative
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Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
ACUTE INHALATION
Yes Yes ?as GHS Only for use
Yes
Potency grading
Residential and institutional uses:
- for dusts and mists
- for aerosols or particulates
Very toxic: LC50 < 0.25 mg/L/4hr Cat. 1: LC50 < 0.05 mg/L/4hr pesticide as formulated LC50 < 0.5
Toxic: 0.25 < LC50 < 1 mg/L/4hr Cat. 2: 0.05 < LC50 < 0.5 mg/L/4hr mg/L/4hr
Harmful: 1 < LC50 < 5 mg/L/4hr Cat. 3: 0.5 < LC50 < 1 mg/L/4hr All other uses restricted if: pesticide as
Cat. 4: 1 < LD50 < 5 mg/L/4hr formulated LC50 < 0.05 mg/L/4hr
- for gases and vapours
Very toxic: LC50 < 0.5 mg/L/4hr Cat.5*
Toxic: 0.5 < LC50 < 2 mg/L/4hr - for gases
Harmful: 2 < LC50 < 20 mg/L/4hr Cat. 1: LC50 < 100 ppm
Cat. 2: 100 < LC50 < 500 ppm
Cat. 3: 500 < LC50 < 2500 ppm
Cat. 4: 2500 < LC50 < 5000 ppm
Cat. 5*
-for vapours
Cat. 1: LC50 < 0.5 mg/L/4hr
Cat. 2: 0.5 < LC50 < 2 mg/L/4hr
Cat. 3: 2 < LC50 < 10 mg/L/4hr
Cat. 4: 10 < LC50 < 20 mg/L/4hr
Cat. 5*
*LC50 in the equivalent range of the
oral and dermal Cat 5 LD50 (i.e.
between 2000 and 5000 mg/kg
bodyweight).
Delineation/low hazard definition No Yes ?Cat. 5 of relatively low acute Yes ?Cat. 5 in the GHS Yes ?distinction made for consumer
toxicity hazard but which under certain use
classification scheme is
circumstances may present a danger to considered a low hazard
vulnerable populations.
Quantitative Quantitative Quantitative Quantitative
Qualitative or quantitative
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Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
NON-LETHAL
IRREVERSIBLE EFFECTS
Yes Yes ?as GHS No
Yes
Potency grading
Very toxic: effects seen generally in the
Cat. 1: Oral LD50 < 300 mg/kg bw,
Dermal LD50 < 1000 mg/kg bw, Gas
very toxic dose ranges given above for
LC50 < 2500 ppm, Vapour LC50 < 10
acute oral, dermal or inhalation toxicity
Toxic: effects seen generally in the toxic
mg/L or Dust/Mist/Fume LC50 < 1.0
mg/L/4hr
dose ranges given above for acute oral,
Cat. 2: 300 < Oral LD50 < 2000 mg/kg
dermal or inhalation toxicity
bw, Dermal 1000 < LD50 < 2000 mg/kg
bw, 2500 < Gas LC50 < 5000 ppm, 10 <
Vapour LC50 < 20 mg/L or
Dust/Mist/Fume 1.0 < LC50 < 5.0
mg/L/4hr
Cat. 3: transient irritant effects on the
respiratory tract or transient narcotic
effects
Delineation/low hazard definition No No No No
Quantitative with qualitative component Quantitative with qualitative component Quantitative with qualitative Qualitative
Qualitative or quantitative
for Cat. 1 & 2. Qualitative for Cat. 3 component for Cat. 1 & 2.
Qualitative for Cat. 3
Not addressed
ASPIRATION HAZARD
No Yes Yes ?as GHS
Potency grading
Cat. 1 Known to cause human
aspiration toxicity:
hydrocarbons with a kinematic
viscosity of 20.5 mm2/s or less,
measured at 40 癈
Cat. 2 Presumed to cause human
aspiration toxicity:
hydrocarbons with a kinematic
viscosity of 14 mm2/s or less (measured
at 40?C) taking into account surface
tension, water solubility, boiling point,
and volatility.
Delineation/low hazard definition No No No
Quantitative Quantitative Quantitative
Qualitative or quantitative
Chemical Gazette Commonwealth of Australia Gazette
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58
Not addressed ?see skin
CORROSIVITY
and eye irritation
Yes Yes Only for use
Potency grading
Causes severe burns: < 3 min exposure Cat. 1A: corrosive < 3 min exposure Residential and institutional uses:
Causes burns: > 3 min < 4hr exposure Cat. 1B: corrosive > 3min and > 1hr pesticide as formulated is not corrosive
to the skin or causes severe irritation
exposure
Cat 1C: corrosive > 1hr and > 4hr (severe erythema or oedema) at 72 hrs
- burns (i.e. corrosivity) defined
exposure or results in corneal involvement or
irritation persisting for more than 7
days
- corrosivity defined
All other uses: pesticide as formulated
is corrosive to the skin or eyes or
causes corneal involvement or
irritation persisting for more than 21
days
Delineation/low hazard definition No No Yes ?distinction made for consumer
use
Essentially qualitative Essentially qualitative Qualitative
Qualitative or quantitative
Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
-see corrosivity
SKIN IRRITATION
Yes ?as GHS
No Yes
Potency grading
Cat. 2 (Irritant):
- in 2 or more of 3 animals tested:
erythema/eschar or oedema > 2.3 and <
4
Or if inflammation persists to the end
of the observation period (normally 14
days) in at least 2 animals, particularly
taking into account alopecia (limited
area), hyperkeratosis, hyperplasia, and
scaling. Also in some cases where there
is pronounced variability of response
among animals, with very definite
positive effects related to chemical
exposure in a single animal but less
than the criteria above.
Cat. 3 (Mild irritant):
- in 2 or more of 3 animals tested:
erythema/eschar or oedema > 1.5 and <
2.3
Delineation/low hazard definition No No Yes ?Cat. 3 (Mild irritant)
in the GHS classification
scheme is considered a low
hazard
Quantitative Quantitative Quantitative
Qualitative or quantitative
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Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
-see corrosivity
EYE IRRITATION
Yes Yes ?as GHS
Yes
Potency grading
Cat. 1 (Irreversible effects on the eye):
Risk of serious damage to eyes:
- mean values: in at least one animal, effects on the
Corneal opacity > 3, or cornea, iris or conjunctiva that are not
Iris lesions > 1.5 expected to reverse at the end of the
- if 3 animals tested then in 2 or more observation period (normally 21 days)
animals: or have not reversed; or in at least 2 of
Corneal opacity > 3, or 3 tested animals:
Iris lesion = 2 Corneal opacity 3, or
Or, in both cases, ocular lesion still Iritis > 1.5
present at the end of the observation Cat. 2A (reversible effects on the eye)
Irritating to eyes:
period (21 days) or irreversible
- in at least 2 of 3 animals tested:
colouration of the eyes seen
Corneal opacity 1,
Irritating to eyes:
- mean values: Iritis 1,
Corneal opacity > 2 and < 3, Conjunctival erythema 2, or
Iris lesion > 1 and < 1.5, Conjunctival oedema 2
Conjunctival erythema > 2.5, or and fully reverses within the
Conjunctival oedema > 2 observation period (normally 21 days).
- if 3 animals tested then in 2 or more Cat 2B (reversible effects on the eye)
Mildly irritating to eyes:
animals:
Corneal opacity > 2 and < 3, - in at least 2 of 3 animals tested:
Iris lesion > 1 and < 2, Corneal opacity 1,
Conjunctival erythema > 2.5 or Iritis 1,
Conjunctival oedema > 2 Conjunctival erythema 2, or
Conjunctival oedema 2
and fully reverses within 7 days of
observation.
Delineation/low hazard definition No No Yes ?Cat. 2A or 2B in the
GHS classification scheme
(both have the same trigger
values for ocular effects) are
considered a low hazard as
they relate to reversible
damage.
Quantitative Quantitative Quantitative
Qualitative or quantitative
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Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
See Cat 3 under Non-lethal Irreversible Not addressed
RESPIRATORY IRRITANT
Effects'
No No
Potency grading
No ?as GHS
No No No
Delineation/low hazard definition
Qualitative Qualitative Qualitative
Qualitative or quantitative
Not addressed
SKIN SENSITISATION
No No No ?as GHS
Potency grading
No No Yes ?but is not based solely
Delineation/low hazard definition
on the intrinsic hazard:
exposure is a condition for
consideration as a low
hazard (see note 1 below)
Qualitative Qualitative Qualitative
Qualitative or quantitative
Not addressed
RESPIRATORY
SENSITISATION
No No No ?as GHS
Potency grading
Delineation/low hazard definition No No Yes ?but is not based solely
on the intrinsic hazard:
exposure is a condition for
consideration as a low
hazard (see note 1 below)
Qualitative Qualitative Qualitative
Qualitative or quantitative
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61
Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
REPEAT DOSE TOXICITY
Yes ?as GHS No
Yes Yes
Potency grading
Classified as at least toxic: Cat. 1 Produce significant toxicity in
humans:
- oral
< 5 mg/kg bw/day -oral
< 10 mg/kg bw/day
- dermal
< 10 mg/kg bw/day - dermal
< 20 mg/kg bw/day
- inhalation
< 0.025 mg/L, 6hr/day - inhalation
< 50 ppm, 6hr/day (gas)
Classified as at least harmful:
< 0.2 mg/L, 6hr/day (vapour)
- oral
< 50 mg/kg bw/day < 0.02 mg/L, 6hr/day (dust/mist/fume)
- dermal Cat. 2 Potential to be harmful to human
< 100 mg/kg bw/day health:
- inhalation - oral
< 0.25 mg/L, 6hr/day > 10 to < 100 mg/kg bw/day
In both cases guidelines are provided as
- dermal
> 20 to < 200 mg/kg bw/day
to what biological effects should and
- inhalation
shouldn't attract classification.
> 50 to < 250 ppm, 6hr/day (gas)
Furthermore, all these values are based
> 0.2 to < 1.0 mg/L, 6hr/day (vapour)
on effects seen in a 90-day repeat study.
> 0.02 to < 0.2 mg/L, 6hr/day
For a 28-day study these values should
(dust/mist/fume)
be increased approximately 3 fold.
In both cases guidelines are provided as
to what biological effects should and
shouldn't attract classification.
Furthermore, all these values are based
on effects seen in a 90-day repeat study
and can be used as a basis to
extrapolate equivalent values for
toxicity studies of greater or lesser
duration, using dose/exposure time
extrapolation similar to Haber's rule for
inhalation e.g. for a 28-day study these
values below would be increased by a
factor of three.
Delineation/low hazard definition No No Yes ?Cat. 2 in the GHS No
classification scheme is
considered a low hazard
Quantitative with qualitative component Quantitative with qualitative Quantitative with qualitative Qualitative
Qualitative or quantitative
component component
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Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
Not addressed
MUTAGENICITY
Yes Yes Yes ?as GHS
Potency grading
Category 1: Known to be mutagenic to Cat 1 A: Known to induce inheritable
mutations in human germ cells
humans
Category 2: Regarded to be mutagenic Cat 1 B: Regarded to induce inheritable
mutations in human germ cells
to humans
Category 3: Cause concern for humans Cat 2: Cause concern owing to the
possibility it may induce inheritable
owing to possible mutagenic effects
mutation in human germ cells (positive
(somatic cell mutagens - alert for
results in somatic cells)
possible carcinogenic activity)
Delineation/low hazard definition No No Yes ?Cat. 2 in the GHS
classification scheme is
considered a low hazard
Qualitative Qualitative Qualitative
Qualitative or quantitative
Not addressed
CARCINOGENICITY
Yes Yes ?as GHS
Yes
Potency grading
Category 1: Know to be carcinogenic to Cat 1 A: Known to have carcinogenic
potential for humans
humans
Category 2: Regarded to be Cat 1 B: Presumed to have carcinogenic
potential for humans
carcinogenic to humans
Category 3: Cause concern for human Cat 2: Suspected human carcinogens
owing to possible carcinogenic effects
Delineation/low hazard definition No No No
Qualitative Qualitative Qualitative
Qualitative or quantitative
Not addressed
FERTILITY
Yes Yes ?as GHS
Yes
Potency grading
Category 1: Can establish a casual Cat 1 A: Known human reproductive
toxicant
relationship between human exposure
Cat 1 B: Presumed human reproductive
and impaired fertility
Category 2: Strong presumption that toxicant
Cat 2: Suspected human reproductive
human exposure will result in impaired
toxicant
fertility
Category 3: Cause concern for human
fertility
Delineation/low hazard definition No No No
Qualitative Qualitative Qualitative
Qualitative or quantitative
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Toxicological endpoints EU GHS NZ US EPA Pesticide Guidelines
Not addressed
DEVELOPMENTAL
TOXICITY
Yes Yes ?as GHS
Yes
Potency grading
Category 1: Can establish a casual Cat 1 A: Known human reproductive
toxicant
relationship between human exposure
Cat 1 B: Presumed human reproductive
and developmental toxicity
Category 2: Strong presumption that toxicant
Cat 2: Suspected human reproductive
human exposure will result in
toxicant
developmental toxicity
Category 3: Cause concern for humans
owing to possible developmental effects
Delineation/low hazard definition No No No
Qualitative Qualitative Qualitative
Qualitative or quantitative
Not addressed
EFFECTS DURING
LACTATION
No No No ?as GHS
Potency grading
Delineation/low hazard definition No No No
Qualitative Qualitative Qualitative
Qualitative or quantitative
Not addressed Not addressed Not addressed
DANGER OF CUMULATIVE
EFFECTS
No
Potency grading
Delineation/low hazard definition No
Qualitative
Qualitative or quantitative
Not addressed Not addressed
Not addressed
REPEATED EXPOSURE
CAUSE SKIN DRYNESS OR
CRACKING
No
Potency grading
Delineation/low hazard definition No
Qualitative
Qualitative or quantitative
See Cat 3 under Non-lethal Irreversible Not addressed
NARCOTIC EFFECTS
Effects'
No No No ?as GHS
Potency grading
Delineation/low hazard definition No No No
Quantitative with qualitative component Qualitative Qualitative
Qualitative or quantitative
NOTE 1: NZ has adopted the GHS cut-off levels of 0.1 % for both respiratory and contact senstisers, and will consider for rapid assessment under the least degrees of hazard criteria substances
containing sensitisers provided the following conditions are met:
(1) (a) there is a low frequency or severity of occurrence within an exposed population; or
(1) (b) there is a probability of occurrence of a low sensitisation rate in humans based on animal or other tests; and
(2) the sensitiser is not `released' from the substance during use
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64
4 DISCUSSION PAPER 1 - APPENDIX 2
Table A ?National classification schemes for physicochemical properties
Physicochemical property NOHSC Approved Criteria APVMA ADG Code
(household pesticides)
EXPLOSIVE
Potency grading Yes Required - classification as per the ADG if Yes
Class 1.1: Substances and articles that have a mass
Risk of explosion by shock, friction, fire or other applicable
explosion hazard
sources of ignition: includes substances and
Class 1.2: Substances and articles that have a projection
preparations except those set out below
hazard but not a mass explosion hazard
or
Class 1.3: Substances and articles that have a fire hazard
and either a minor blast hazard or a minor projection
Extreme risk of explosion by shock, friction, fire or
hazard or both, but not a mass explosion hazard
other sources of ignition: includes substances and
Class 1.4: Substances and articles that present no
preparations that are particularly sensitive such as
significant hazard
picric acid salts or PETN
Class 1.5: Very insensitive substances that have no mass
explosion hazard
Class 1.6: Extremely insensitive articles that do not have
a mass explosion hazard
No No No
Delineation/low hazard definition
Qualitative Qualitative Qualitative
Qualitative or quantitative
OXIDISING
Yes Required - classification as per the ADG if No
Potency grading
May cause fire: organic peroxides which have Class 5.1 - Oxidising substance: while in themselves not
applicable
flammable properties even when not in contact with necessarily combustible, may, generally by yielding
other combustible material oxygen, cause, or contribute to, the combustion of other
material
or
Class 5.2 - Organic peroxides: thermally unstable
Contact with combustible material may cause fire:
substances, that may undergo exothermic self-
other oxidising substances and preparations, including
accelerating decomposition, and have one or more of the
inorganic peroxides, which may cause fire or enhance
following properties: be liable to explosive
the risk of fire when in contact with combustible
decomposition; to burn rapidly; to be sensitive to impact
material
or friction; to react dangerously with other substances; or
or
Explosive when mixed with combustible material: other to cause damage to the eyes
oxidising substances and preparations, including
inorganic peroxides, which become explosive when
mixed with combustible materials eg. certain chlorates
No No No
Delineation/low hazard definition
Qualitative Qualitative Qualitative
Qualitative or quantitative
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Physicochemical property NOHSC Approved Criteria APVMA ADG Code
(household pesticides)
FLAMMABLE
Required - classification as per the ADG if
Yes No
Potency grading
applicable
Extremely flammable: Class 3 - Flammable liquids: that give off a flammable
Liquid - Flash pt < 0 oC and a boiling pt < 35 oC vapour at temperatures of < 60.5 oC closed-cup test, or <
65.6 oC open-cup test; normally referred to as the flash
Gas - Flammable in contact with air at ambient
temperature and pressure point
Highly flammable:
Liquid - Flash point < 21 oC but are not extremely Class 2.1 - Flammable gases: at 20 oC and a standard
pressure of 101.3 kPa either ignite when in a mixture of
flammable
13% or less by volume with air, or have a flammable range
Solid ?may readily catch fire after brief contact with a
with air of at least 12 percentage points, regardless of the
source of ignition and which continue to burn or to be
lower flammable limit.
consumed after removal of the source of ignition
Class 2.2 - Non-flammable (non-toxic) gases: that are
Substances - in contact with water or damp air, evolve
transported at a pressure not less than 280kPa at 20 oC, or as
extremely flammable gases in dangerous quantities at a
minimum rate of 1L/kg/hr refrigerated liquids
Substances - may become hot and finally catch fire in
Class 4.1 - Flammable solids: under conditions encountered
contact with air at ambient temperature without any
input of energy in transport are readily combustible or may cause or
Flammable: contribute to fire through friction; self reactive and related
Liquid - > 21 oC and < 55 oC substances that are likely to undergo a strongly exothermic
reaction; and desensitised explosives that may explode if
not diluted sufficiently
No No No
Delineation/low hazard definition
Quantitative for liquids, qualitative for gases and solids Quantitative for liquids and gases, qualitative Quantitative for liquids and gases, qualitative for solids
Qualitative or quantitative
for solids
- -
OTHER PROPERTIES:
No Required - classification as per the ADG if No
Potency grading
applicable
?br>
? Class 4.2 - (Solids) liable to spontaneous
Explosive when dry
? combustion
Forms very sensitive explosive metallic
?br>
compounds Class 4.3 - (Solids) that in contact with water emit
? flammable gases
Heating may cause an explosion
? Explosive with or without contact with air
? May cause fire
? Reacts violently with water
? Explosive when mixed with oxidising
substances
? In use, may form flammable/ explosive vapour-
air mixture
? May form explosive peroxides
? Can become highly flammable in use
? Risk of explosion if heated under confinement
No - for any of these properties No - for any of these properties No - for any of these properties
Delineation/low hazard definition
Qualitative (all) Qualitative (all) Qualitative (all)
Qualitative or quantitative
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Table B ?International classification schemes for physicochemical properties
Physicochemical property EU GHS NZ
EXPLOSIVE
Yes Yes Yes ?as GHS
Potency grading
Risk of explosion by shock, friction, fire or other Division 1.1: Substances, mixtures and articles which
sources of ignition: includes substances and have a mass explosion hazard
Division 1.2: Substances, mixtures and articles which
preparations except those set out below
have a projection hazard but not a mass explosion
or
hazard
Extreme risk of explosion by shock, friction, fire or Division 1.3: Substances, mixtures and articles which
other sources of ignition: includes substances and have a fire hazard and either a minor blast hazard or a
preparations that are particularly sensitive such as minor projection hazard or both, but not a mass
explosion hazard
picric acid salts or PETN
Division 1.4: Substances, mixtures and articles which
present no significant hazard
Division 1.5: Very insensitive substances or mixtures
which have a mass explosion hazard
Division 1.6: Extremely insensitive articles which do
not have a mass explosion hazard
No No Yes ?Division 1.4 in the GHS classification scheme
Delineation/low hazard definition
is considered a low hazard
Qualitative Qualitative Qualitative
Qualitative or quantitative
OXIDISING
Yes Yes ?for liquids and solids, but not gases Yes ?as GHS
Potency grading
May cause fire: organic peroxides which have Oxidising Liquids:
flammable properties even when not in contact with Cat. 1: the 1:1 mixture, by mass, and cellulose tested,
other combustible material spontaneously ignites; or the mean pressure rise time
or of a 1:1 mixture by mass, of substance and cellulose
is less than that of a 1:1 mixture, by mass, of 50 %
Contact with combustible material may cause fire:
perchloric acid and cellulose
other oxidising substances and preparations,
Cat. 2: the 1:1 mixture, by mass, and cellulose tested,
including inorganic peroxides, which may cause
exhibits a mean pressure rise time less than or equal
fire or enhance the risk of fire when in contact with
to the mean pressure rise time of a 1:1 mixture by
combustible material
mass, of 40 % aqueous sodium chlorate solution and
or
Explosive when mixed with combustible material: cellulose; and the criteria for Cat. 1 are not met
Cat. 3: the 1:1 mixture, by mass, and cellulose tested,
other oxidising substances and preparations,
exhibits a mean pressure rise time less than or equal
including inorganic peroxides, which become
to the mean pressure rise time of a 1:1 mixture by
explosive when mixed with combustible materials
mass, of 65 % aqueous nitric acid and cellulose; and
eg. certain chlorates
the criteria for Cat. 1 and 2 are not met
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Physicochemical property EU GHS NZ
Oxidising Solids:
Cat. 1: when tested in a 4:1 or 1:1 sample-to-
cellulose ration (by mass), exhibits a mean burning
time less than the mean burning time of a 3:2
mixture, by mass, of potassium bromate and cellulose
Cat. 2: when tested in a 4:1 or 1:1 sample-to-
cellulose ration (by mass), exhibits a mean burning
time equal to or less than the mean burning time of a
2:3 mixture, by mass, of potassium bromate and
cellulose and the criteria for Cat. 1 are not met
Cat. 3: when tested in a 4:1 or 1:1 sample-to-
cellulose ration (by mass), exhibits a mean burning
time equal to or less than the mean burning time of a
3:7 mixture, by mass, of potassium bromate and
cellulose and the criteria for Cat. 1 and 2 are not met
Oxidising Gas: may, generally by providing oxygen,
cause or contribute to the combustion of other
material more than air does.
No No No
Delineation/low hazard definition
Qualitative Essentially qualitative Essentially qualitative
Qualitative or quantitative
FLAMMABLE
Yes Yes Yes ?as GHS
Potency grading
Extremely flammable: Flammable Liquid Cat. 1: Flash point < 23 癈 and
Liquid - Flash pt < 0 oC and a boiling pt < 35 oC initial boiling point < 35 癈
Flammable Liquid Cat. 2: Flash point < 23 癈 and
Gas - Flammable in contact with air at ambient
temperature and pressure initial boiling point > 35 癈
Highly flammable: Flammable Liquid Cat. 3: Flash point 23 癈 and
Liquid - Flash point < 21 oC but are not extremely 60 癈
Flammable Liquid Cat. 4: Flash point > 60 癈 and
flammable
93 癈
Solid ?may readily catch fire after brief contact with
a source of ignition and which continue to burn or to
be consumed after removal of the source of ignition Flammable Gases Cat. 1: at 20 癈 and a standard
pressure of 101.3 kPa and are ignitable when in a
Substances - in contact with water or damp air,
mixture of 13% or less by volume in air or have a
evolve extremely flammable gases in dangerous
flammable range with air of at least 12 percentage
quantities at a minimum rate of 1L/kg/hr
points regardless of the lower flammable limit.
Substances - may become hot and finally catch fire in
Flammable Gases Cat. 2: other than those of
contact with air at ambient temperature without any
input of energy Category 1, which, at 20 癈 and a standard pressure
Flammable: of 101.3 kPa, have a flammable range while mixed in
Liquid ?Flash point > 21 oC and < 55 oC air.
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Physicochemical property EU GHS NZ
Flammable Aerosol Cat. 1
Flammable Aerosol Cat.2
-classified into Cat 1 or 2 on the basis of its
components, of its chemical heat of combustion and,
if applicable, of the results of the foam test, for foam
aerosols, and of the ignition distance test and
enclosed space test, for spray aerosols
Flammable Solid Cat. 1: Burning rate test for solids
other than metal powders: wetted zone does not stop
fire and the burning time < 45 s or burning rate > 2.2
mm/s. Burning rate test for metal powders: burning
time 5 min
Flammable Solid Cat. 2: Burning rate test for solids
other than metal powders: wetted zone stops the fire
for at least 4 min and the burning time < 45 seconds
or burning rate > 2.2 mm/second. Burning rate test
for metal powders: burning time > 5 minutes and 10
minutes.
No No Yes ?Flammable Liquid Cat. 4, Flammable Gases
Delineation/low hazard definition
Cat. 2, Flammable Aerosol Cat.1, and Flammable
Solid Cat. 2 in the GHS classification scheme are all
considered to be a low hazard
Quantitative for liquids, qualitative for gases and Quantitative for liquids, and essentially quantitative Quantitative for liquids, and essentially quantitative
Qualitative or quantitative
solids for gases, aerosols and solids for gases, aerosols and solids
OTHER PROPERTIES:
No No No ?as GHS for:
Potency grading
? ?br>
Pyrophoric liquids Metallic corrosives
? Pyrophoric solids
? Explosive when dry
Yes ?as GHS for:
? Corrosive to metals
? Forms very sensitive explosive metallic
compounds ? Self-reactive substances
Yes
? Heating may cause an explosion ? Organic peroxides
? Explosive with or without contact with air ? Dangerous when wet substances
? May cause fire
? Self-reactive substances and mixtures1
? Reacts violently with water
? Explosive when mixed with oxidising Type A: Heating may cause an explosion
substances Type B: Heating may cause a fire or
? In use, may form flammable/ explosive explosion
vapour-air mixture Type C: Heating may cause a fire
? May form explosive peroxides Type D: Heating may cause a fire
Type E: Heating may cause a fire
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Physicochemical property EU GHS NZ
? Type F: Heating may cause a fire
Can become highly flammable in use
Type G: (no hazard statement)
? Risk of explosion if heated under
confinement
? Organic peroxides1
Type A: Heating may cause an explosion
Type B: Heating may cause a fire or
explosion
Type C: Heating may cause a fire
Type D: Heating may cause a fire
Type E: Heating may cause a fire
Type F: Heating may cause a fire
Type G: (no hazard statement)
? Self 環eating substances and mixtures
Cat. 1: Self-heating; may catch fire
Cat. 2: Self-heating in large quantities; may
catch fire
? Substances and mixtures which, in
contact with water, emit flammable gases1
Cat. 1: In contact with water releases
flammable gases which may ignite
spontaneously
Cat. 2: In contact with water releases
flammable gases
Cat. 3: In contact with water releases
flammable gases
No - for any of these properties No Yes ?Self-reactive substances Type G, Organic
Delineation/low hazard definition
peroxides Type G, and Dangerous when wet Cat. 3 in
the GHS classification scheme are all considered to
be a low hazard
Qualitative Qualitative for self-reactive substances and Qualitative for self-reactive substances and mixtures
Qualitative or quantitative
mixtures and essentially qualitative for all other and essentially qualitative for all other properties
properties
1
The classification criteria for each degree of hazard for this endpoint are available at http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/01files_e.html
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5 DISCUSSION PAPER 1 ?APPENDIX 3
Table A ?International classification schemes for environmental effects
Environmental endpoint EU GHS NZ US EPA
AQUATIC ENVIRONMENT
Yes Yes Yes
Potency grading
Cat. Acute 1: 96 hr LC50 (for fish) < Category A: 96 hr LC50 (for fish)
Yes
1 mg/L, or 48 hr EC50 (for crustacea) < 1 mg/L, or 48 hr EC50 (for
Very Highly Toxic: value1 < 0.1
Very toxic to aquatic organisms & < 1 mg/L, or 72 or 96 hr ErC50 (for crustacea) < 1 mg/L, or 72 or 96
May cause long-term adverse effects hr EC50 (for algae) < 1 mg/L
algae or other aquatic plants) < 1 ppm
in the aquatic environment: mg/L Category B: 96 hr LC50 (for fish)
Acute toxicity: 96 hr LC50 (for fish) Cat. Acute 2: 96 hr LC50 (for fish) > > 1 - < 10 mg/L, or 48 hr EC50 (for
Highly Toxic: value > 0.1 and <
< 1 mg/L, or 48 hr EC50 (for daphnia) 1 - < 10 mg/L, or 48 hr EC50 (for crustacea) > 1 - < 10 mg/L g/L, or
< 1 mg/L, or 72 hr IC50 (for algae) < crustacea) > 1 - < 10 mg/L g/L, or 72 72 or 96 hr EC50 (for algae) > 1 - 1 ppm
1 mg/L, and is not readily degradable or 96 hr ErC50 (for algae or other < 10 mg/L, and lack of rapid
or the log Pow > 3.0 (unless the aquatic plants) > 1 - < 10 mg/L degradability and/or
experimentally determined BCF < Cat. Acute 3: 96 hr LC50 (for fish) > bioaccumulative (unless NOEC > Moderately Toxic: value > 1
100) 10 - < 100 mg/L, or 48 hr EC50 (for 1 mg/L)
and < 10 ppm
Very toxic to aquatic organisms: crustacea) > 10 - < 100 mg/L g/L, or Category C: 96 hr LC50 (for fish)
Acute toxicity: 96 hr LC50 (for fish) 72 or 96 hr ErC50 (for algae or other > 10 - < 100 mg/L, or 48 hr EC50
< 1 mg/L, or 48 hr EC50 (for daphnia) aquatic plants) > 10 - < 100 mg/L (for crustacea) > 10 - < 100 mg/L Slightly Toxic: value > 10 and <
< 1 mg/L, or 72 hr IC50 (for algae) < Cat. Chronic 1: 96 hr LC50 (for fish) g/L, or 72 or 96 hr ErC50 (for
100 ppm
1 mg/L < 1 mg/L, or 48 hr EC50 (for algae) > 10 - < 100 mg/L, and lack
Toxic to aquatic organisms & May crustacea) < 1 mg/L, or 72 or 96 hr of rapid degradability and/or
cause long-term adverse effects in ErC50 (for algae or other aquatic bioaccumulative (unless NOEC >
Practically Non-toxic: value >
the aquatic environment: plants) < 1 mg/L, and the substance 1 mg/L)
Acute toxicity: 96 hr LC50 (for fish) 1 is not readily degradable and/or the Category D: 96 hr LC50 (for fish) 100 ppm
mg/L < LC50 < 10 mg/L, or 48 hr log Kow > 4 (unless the > 1 - < 100 mg/L, or 48 hr EC50
EC50 (for daphnia) 1 mg/L < EC50 < (for crustacea) > 1 - < 100 mg/L
experimentally determined BCF <
10 mg/L, or 72 hr IC50 (for algae) < 1 g/L, or 72 or 96 hr ErC50 (for
500)
mg/L < IC50 < 10 mg/L, and is not Cat. Chronic 2: 96 hr LC50 (for fish) algae) > 1 - < 100 mg/L and not
readily degradable or the log Pow > > 1 - < 10 mg/L, or 48 hr EC50 (for classified in Category A, B or C,
3.0 (unless the experimentally crustacea) > 1 - < 10 mg/L g/L, or 72 or no acute toxicity and lack of
determined BCF < 100) or 96 hr ErC50 (for algae or other rapid degradability and
Harmful to aquatic organisms & May aquatic plants) > 1 - < 10 mg/L, and bioaccumulative and not classified
cause long-term adverse effects in the substance is not readily in Category A, B or C
the aquatic environment: Acute degradable and/or the log Kow > 4
toxicity: 96 hr LC50 (for fish) 10 (unless the experimentally
mg/L < LC50 < 100 mg/L, or 48 hr determined BCF < 500), unless the
EC50 (for daphnia) 10 mg/L < EC50 < chronic toxicity NOECs are > 1mg/L
100 mg/L, or 72 hr IC50 (for algae) < Cat. Chronic 3: 96 hr LC50 (for fish)
10 mg/L < IC50 < 100 mg/L, and is
not readily degradable. This applies
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71
Environmental endpoint EU GHS NZ US EPA
unless there is sufficient additional > 10 - < 100 mg/L, or 48 hr EC50 (for
crustacea) > 10 - < 100 mg/L g/L, or
scientific evidence concerning
72 or 96 hr ErC50 (for algae or other
degradation and/or toxicity to
aquatic plants) > 10 - < 100 mg/L,
provide adequate assurance that
and the substance is not readily
neither the substance nor its
degradable and/or the log Kow > 4
degradation products will constitute
(unless the experimentally
a potential long-term and/or delayed
determined BCF < 500), unless the
danger to the aquatic environment.
chronic toxicity NOECs are > 1mg/L
Such additional scientific
information could include: a proven Cat. Chronic 4: Poorly soluble
potential to degrade rapidly in the substances with no acute toxicity up
aquatic environment, or an absence to the water solubility, and is not
of chronic toxicity effects at a readily degradable and have a log
concentration of 1.0 mg/L. Kow > 4, indicating a potential to
Harmful to aquatic organisms: Acute bioaccumulate unless evidence to
toxicity: not falling under the above show unnecessary: would include an
criteria (for acute harmful) but on the experimentally determined BCF <
basis of evidence may nevertheless 500, or a chronic toxicity NOECs > 1
present a danger to the structure mg/L, or evidence of rapid
and/or functioning of aquatic degeneration in the environment
ecosystems.
May cause long-term adverse effects
in the aquatic environment: not
falling under the above criteria (for
long-term adverse effects) but on the
basis of evidence may nevertheless
present a long-term or delayed
danger to the structure and/or
functioning of aquatic ecosystems,
for example a water solubility < 1
mg/L if not readily degradable and
the log Pow > 3.0 (unless the
experimentally determined BCF <
100)
Yes ?Category D is considered a No ?though the classification
No No
Delineation/low hazard
low hazard of `Practically non-toxic' could
definition
be considered to represent a low
hazard.
Quantitative Quantitative Quantitative Quantitative
Qualitative or quantitative
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Environmental endpoint EU GHS NZ US EPA
Not addressed
NON-AQUATIC
ENVIRONMENT
No Yes Yes
Potency grading
? ACUTE ORAL TOXICITY
ECOTOXIC TO THE SOIL
Toxic to flora
? AVIAN
ENVIRONMENT
Toxic to fauna
Category A: Soil ecotoxicity value2 < Very Highly Toxic: LD50 < 10
? Toxic to soil organisms
1mg/kg mg/kg bw
? Toxic to bees
Category B: 1 < soil ecotoxicity Highly Toxic: 10 < LD50 < 50
? May cause long-term
value < 10 mg/kg mg/kg bw
adverse effects in the
Category C: 10 < soil ecotoxicity Moderately Toxic: 50 < LD50
environment 3
value < 100 mg/kg and Soil DT50 > < 500 mg/kg bw
? Dangerous for the ozone
Slightly Toxic: 500 < LD50 <
30 days
layer
Category D: 10 < soil ecotoxicity 2000 mg/kg bw
value < 100 mg/kg and Soil DT50 < Practically Non-toxic: LD50 >
2000 mg/kg bw
30 days
ACUTE ORAL TOXICITY
ECOTOXIC TO TERRESTRIAL
WILD MAMMALS
VERTEBRATES
Very Highly Toxic: LD50 < 10
Category A: LD50 < 50 mg/kg bw, or
mg/kg bw
LC50 (diet) < 500mg/kg food
Highly Toxic: 10 < LD50 < 50
Category B: 50 < LD50 < 500 mg/kg
mg/kg bw
bw, or 500 < LC50 (diet) < 1000
Moderately Toxic: 50 < LD50
mg/kg food
< 500 mg/kg bw
Category C: 500 < LD50 < 2000
Slightly Toxic: 500 < LD50 <
mg/kg bw, or 1000 < LC50 (diet) <
2000 mg/kg bw
5000 mg/kg food, or a chronic
Practically Non-toxic: LD50 >
MATC4 < 100 ppm in the diet but
2000 mg/kg bw
which does not meet the criteria for
Category A or B
ACUTE TOXICITY NON-
TARGET INSECTS
ECOTOXIC TO BENEFICIAL
Highly Toxic: value < 2 g/bee
TERRESTRIAL
Moderately Toxic: value > 2
INVERTEBRATES
and <11 g/bee
Category A: Invertebrate ecotoxicity
Practically Non-toxic: value >
value4 < 2 g/bee
Category B: Invertebrate ecotoxicity 11 礸/bee
value > 2 and <11 礸/bee
Category C: Invertebrate ecotoxicity
value >11 and < 25 礸/bee
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Environmental endpoint EU GHS NZ US EPA
Yes ?Category D for the soil No ?though for avian, wild
No ?for any of these properties
Delineation/low hazard
environment, Category C for animals and non-target insects
definition
terrestrial vertebrates and Category C the classification of `Practically
for terrestrial invertebrates are all non-toxic' could be considered
considered a low hazard to represent a low hazard.
Qualitative (all) Quantitative (all) Quantitative (all)
Qualitative or quantitative
1
Lowest tested EC50 or LC50 for freshwater fish and invertebrates and estuarine / marine fish and invertebrates acute toxicity tests
2
Soil ecotoxicity value = the lowest value (in mg substance/kg dry weight of soil) from: (i) plant or soil invertebrate 14 day exposure EC50 data; or (ii) data demonstrating a 25 % reduction in
soil micro-organism respiration or nitrification at the completion of 28 day exposure to the substance
3
Soil DT50 = time to reduce original substance soil concentration by 50 %
4
MATC = the maximum acceptable toxicant concentration, being the geometric mean of the NOEC and LOEC where the NOEC and LOEC are derived from the same study
Invertebrate ecotoxicity value = lowest value (in 礸 substance/terrestrial invertebrate) from contact or oral LD50 data 48 hours after exposure
5
.
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6 LRCC - DISCUSSION PAPER NO. 2
LOW RISK CRITERIA AND SCENARIOS FOR CONTROLLED USE PERMITS
1. PURPOSE
The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) was amended to
provide a framework for the consideration of Low Regulatory Concern Chemicals (LRCC).
Included in the amendments to the Act were special provisions for the introduction of new
industrial chemicals that are considered a low risk under the Controlled Use Permit category
and, secondly, broadening of the criteria for introduction of new chemicals under an Early
Introduction Permit (EIP). This discussion paper seeks comment on:
?the proposed criteria to be used to classify chemicals as "low risk";
?the proposal of the use of the criteria in the Controlled Use Permit system; and
?use of the criteria in the EIP system.
2. BACKGROUND
The LRCC Public Discussion Paper (May 2003) proposed that a new category and criteria for
Controlled Use Permit be established. In the Explanatory Memorandum and the Regulatory
Impact Statement for Proposed LRCC Amendments to the Act, it was proposed that the
category be available to chemicals, which, either alone or in a mixture, or because of the way
they are transported, handled, used and/or disposed, qualify as LRCC. The following
parameters were proposed for assessing these chemicals and establishing that they present a
low risk to human health and the environment due to limited potential exposure in Australia ?br>
one or more of the following may apply:
?Controlled transport and storage;
?Specialised uses;
?Low public, workplace and environmental exposure; and
?Containment in closed systems.
The implication for this permit notification category is that exposure is highly controlled,
either through established good work practices, responsible disposal and compliance with all
relevant chemicals regulations or through specific control measures designed to minimise
exposure.
2.1 Controlled Use Permit
A key plank of the LRCC reform initiative was to provide incentives to industry to introduce
new and safer technologies and chemicals. As part of this new assessment categories and
controls were suggested specifically, Recommendation 6.1 of the LRCC Final Report called
for:
Examine the introduction of a controlled use/specified use assessment (permit/and or
certificate) category based on the history of safe use, limited exposure and/or use in
controlled environments.
Under this category introducers of new industrial chemicals for use in a highly controlled
manner may be granted a permit. Introduction must be of low risk to workers, the public and
the environment. Safeguards have been incorporated into the permit system. Provision for
the Controlled Use Permit system is in Division 1C of the Act, sections 22A to 22O.
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Section 22A of the Act states that:
The object of the controlled use permit system is (a) to provide an alternative to the
assessment certificate system in respect of a new industrial chemical that is a low risk to
occupational health and safety, public health, and the environment because of its use,
handling and disposal are highly controlled, and (b) to ensure that this alternative is subject
to adequate safeguards.
3. PROPOSAL
It is proposed to:
?include low risk (or exposure) criteria in the regulations;
?list acceptable low risk or exposure scenarios;
?introduce guidelines to enable use of the criteria for the introduction of highly
controlled chemicals under the Controlled Use Permit;
?introduce guidelines to enable use of the criteria for the early introduction of highly
controlled chemicals under the Early Introduction Permit; and
?develop safeguards to protect the health of the public, workers and the environment
from the harmful effect of industrial chemicals.
Notifiers who can demonstrate that a chemical meets the low exposure criteria and/or the
standard low exposure scenarios (for introduction, use, handling and disposal of the
chemical) may apply for assessment of the chemical under the Controlled Use Permit system
or early introduction under the EIP system.
3.1 Low Risk Criteria
Risk can be defined as the probability of an adverse effect in an organism, system, or (sub)
population caused under specified circumstances by exposure to an agent (OECD, 2003).
Fundamentally, when determining the risk posed by a chemical, two factors need to be
considered; the severity of the hazard of the chemical and the level of exposure to the
chemical.
It is proposed that the following criteria will be used to determine if a new industrial chemical
poses a low risk for the purposes of the Controlled Use Permit and EIP:
3.1.1 Hazard
A number of limitations on hazard have been made for development of low risk criteria and
scenarios; these apply to both low exposure criteria and specific low exposure scenarios.
Firstly, all the relevant hazards of the chemical must be known. Secondly, it is proposed that
chemicals with similar properties to those prohibited or severely restricted under Australia's
international obligations would not be considered in this category as they are subject to bans
or severe restrictions under different mechanisms. Further, new chemicals with persistent
organic pollutant (POPS) characteristics, which include persistence and bioaccumulation, will
not be considered a low risk for the purpose of the Controlled Use Permit category. In
addition chemicals classified as carcinogenic, mutagenic, or reproductive toxicants (CMR
chemicals) would not be considered a low risk for the purpose of the Controlled Use Permit
category. This approach is consistent with that taken by other national regulatory schemes,
e.g. in the EU and US.
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Also, in general, it is proposed that a new chemical will not be introduced under this section
if NICNAS determines that the chemical, any reasonably anticipated metabolites,
environmental transformation products, or by-products of the chemicals, or any reasonably
anticipated impurities in the chemical may cause, under anticipated conditions of
manufacture, processing, distribution in commerce, use, or disposal of the new chemical:
d. Serious acute (lethal or sublethal) effects;
e. Serious chronic (including carcinogenic and teratogenic) effects; or
f. Significant environmental effects.
Where:
Serious acute effects means:
human disease processes or other adverse effects that have short latency periods for
development, result from short-term exposure, or are a combination of these factors and that
are likely to result in death, severe or prolonged incapacitation, disfigurement, or severe or
prolonged loss of the ability to use a normal bodily or intellectual function with a consequent
impairment of normal activities.
Serious chronic effects means:
human disease processes or other adverse effects that have long latency periods for
development, result from long-term exposure, are long-term illnesses, or are a combination of
these factors and that are likely to result in death, severe or prolonged incapacitation,
disfigurement, or severe or prolonged loss of the ability to use a normal bodily or intellectual
function with a consequent impairment of normal activities.
Significant environmental effects means:
?Any irreversible damage to biological, commercial, or agricultural resources of
importance to society;
?Any reversible damage to biological, commercial, or agricultural resources of
importance to society if the damage persists beyond a single generation of the
damaged resource or beyond a single year; or
?Any known or reasonably anticipated loss of members of an endangered or threatened
species.
3.1.2 Exposure
It is proposed that all exposure scenarios for workers, the public and the environment are
known and highly controlled for each known use.
ii. Consumers and the general population
For exposure of consumers and the general population to the new
chemical during all manufacturing, processing, distribution in
commerce, use, and disposal of the chemical:
a. No dermal exposure;
b. No potential for oral exposure, i.e. from consumer
products; and
c. No inhalation exposure.
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iii. Workers
For exposure of workers to the new chemical during all manufacturing,
processing, distribution in commerce, use and disposal of the chemical:
c. No dermal exposure (this criterion is met if adequate
dermal exposure controls are used in accordance with
applicable state and federal guidance); and
d. No inhalation exposure (this criterion is considered to be
met if adequate inhalation exposure controls are used in
accordance with applicable state and federal guidance)
iv. Environment
Ambient surface water
For ambient surface water releases:
c. No releases resulting in surface water concentrations above
1 part per billion
Atmosphere
For ambient air releases:
d. No releases of the new chemical above 1 microgram per
cubic metre maximum annual average concentration,
calculated using the formula: (kg/day of release after
treatment) x (number of release days per year) x (9.68 x 10-
6
) micrograms per cubic metre.
Land
For releases to land:
e. No releases to land or to a landfill unless the introducer has
demonstrated that the new chemical has negligible
groundwater migration potential.
3.2 Factors to be considered in determining low risk scenarios:
A low risk scenario is one in which exposure is highly controlled at all stages (from cradle to
grave) of the chemical's life cycle by:
? Appropriate packaging;
? Appropriate labelling and safety information;
? Appropriate handling procedures during processing;
? Appropriate treatment, handling, re-use, disposal of original packaging;
? Appropriate control of packaging waste;
? No release or appropriate control of production and cleaning waste;
? Control of occupational exposure during processing, packaging,
cleaning/maintenance and use;
? Control of release of waste and residues to environment;
? Control of waste disposal and/or waste degradation processes; and
? Control of end-use of chemical to prevent public exposure.
Means of control for all uses of the chemical will need to be demonstrated by the notifier.
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There is no upper limit on the introduction volume for Controlled Use Permit category.
Control measures (as described) employed to restrict release and exposure must be
demonstrated by the notifier. Additional data requirements will be required if more than 10
tonnes of the notified chemical is to be introduced.
The introduction volume and data requirements for an EIP are linked to the application for an
assessment certificate in the relevant category.
3.3 Specific low exposure scenarios
To assist in the application of the exposure component of the low risk criteria, two low
exposure scenarios have been developed for inclusion in the guidance documents. The low
exposure scenarios presented are familiar to NICNAS as a result of experience in assessing a
number of new chemicals controlled in this manner. Notifiers may apply to introduce a new
industrial chemical under the Controlled Use Permit if it can be demonstrated that the
exposure is controlled at every stage of the chemical's lifecycle in accordance with the low
exposure elements given in the low exposure scenarios. As low risk criteria contain both
exposure and hazard elements, the hazard requirements stated above for the low risk criteria
(section 3.1.1) will also need to be met. The low exposure scenarios are given in Appendix 1.
It is anticipated that further low risk scenarios will be determined by NICNAS on a case by
case basis pending applications. Such precedent setting decision will be gazetted and added to
guidance documents.
4. SAFEGUARDS
Under Section 22A of the Act, a Controlled Use Permit is available for new industrial
chemicals that are low risk to occupational health and safety, public health and environment
because their use, handling and disposal are highly controlled. The applicants will need to
demonstrate that the use, handling and disposal of the new chemical is highly controlled.
Under section 22F of the Act, the Director may reject an application for a Controlled Use
Permit if not satisfied that (a) sufficient data have been provided for assessment and (b) use
of the chemical satisfies the criterion of `no unreasonable risk to occupational health and
safety, public health and the environment'. Guidance for `no unreasonable risk' has already
been developed by NICNAS and is used to determine if introducers of new chemical need to
apply assessment permit or certificate.
Under the permit system in NICNAS, conditions may be applied to the permit to ensure that
use of the chemical will not result in any unreasonable risk to workers, the public, or the
environment. The conditions may refer to any aspect of the chemical's manufacture,
handling, storage, use, or disposal. The conditions may also specify special packaging and
labelling requirements and procedures relating to potential release of the chemical or its
waste products into the environment. Standard conditions currently applied to permits
acknowledge the role of States and Territory legislation in enforcing workplace and
environmental controls.
Under the permit system, the conditions on the permit are binding, not only on the applicant,
but any user of the chemical. The conditions on the permit can also be varied by the Director
at any time. If any condition on a permit is breached, the permit may be withdrawn by the
Director and/or a penalty imposed.
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As with other permits issued by NICNAS, Controlled Use Permits will be subject to audit by
the NICNAS compliance team. Penalties apply for failure to meet conditions on the permit,
for example, exceeding the maximum volume of introduction specified on the permit.
Under the new annual reporting requirements in the Act (Division 3B), holders of Controlled
Use Permits will be required to keep records of any application for 5 years after issue of the
permit. Holders of the permit must also submit an annual report to NICNAS including details
of the chemical's name and volume and any information about adverse effects of the
chemical on occupational health and safety, public health and the environment.
Similar safeguards apply for EIP applications.
5. PROPOSED GUIDELINES FOR USE OF LOW RISK CRITERIA IN
CONTROLLED USE PERMIT APPLICATIONS
5.1 Information Required in Application
The information required by NICNAS with an application for a Controlled Use Permit is
listed in subsection 22C(2) of the Act, namely:
? all proposed uses of the chemical;
? a summary of the chemical's effects on occupational health and safety, public health
and the environment;
? the volume to be introduced over a 3-year period.
The summary of health and environmental effects requires consideration of the chemical's
health and environmental hazards and an estimate of the impact of the chemical on workers,
the public and the environment. A legislative condition of the permit is that there be low risk
to occupational health and safety, public health and the environment.
Paragraph 22C(2)(e) allows for further data requirements in the regulations and, for an
application for the Controlled Use Permit, the following items are proposed:
? information on chemical identity, as in Part B.1 of the Schedule to the Act (for
polymers, typical molecular weight data would be required);
? summary of how the chemical meets the definition of hazardous chemical in the Act;
? details of any notification of the chemical in another country;
? concentration of the chemical in products;
? exposure of workers, public and to the environment as in Part B (items 6, 7, 8) of the
Schedule;
? detailed information on how the chemical is controlled, e.g. methods of control to
prevent release into the workplace, community and the environment (the Controlled
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Use Permit is only for chemicals which are `highly controlled', so this must be
demonstrated by the applicant);
? precautions taken for safe storage and transport;
? information on emergency procedures, as in Part B.13 of the Schedule;
? label and MSDS for the chemical and products containing the chemical.
? For volumes exceeding 10 tonnes per year, it is proposed that all available
toxicological and ecotoxicological data be provided with notification.
Under section 22D of the Act, the Director may request further information about the
application.
The required data may be measured data, analogue data, accepted predictive models, and
QSAR. Chemicals that are close analogues of previously assessed chemicals and to be used
in the same way could be eligible if the read across assessment indicate that the new chemical
is a low risk.
Chemicals for which overseas assessments are available from recognised overseas regulatory
agencies may be considered for a Controlled Use Permit if the international assessment
indicates that the new chemical is a low risk. The assessed use of the chemical must be same
as the proposed Australian use.
In summary, the information requirements are similar to those required for other types of
permit applications.
Guidance will be provided in the NICNAS Handbook for Notifiers to assist applicants in
submitting their application.
6. GUIDELINES FOR USE OF LOW RISK CRITERIA IN EIP APPLICATIONS
The information required for use of the EIP system will be in accordance with that required
for the relevant assessment certificate category. Detailed information on how the chemical is
controlled will be required in the notification statement.
7. FURTHER INFORMATION
For information regarding the notice or matters regarding chemicals for Controlled Use
Permit, please contact Bob Graf on 02 8577 8850 (e-mail bob.graf@nicnas.gov.au).
References
OECD 2003 OECD Environment, Health and Safety Publications Series on Testing
and Assessment No.44 Descriptions of Selected Key Generic Terms Used in
Chemical Hazard/Risk Assessment Joint Project with IPCS on the Harmonisation of
Hazard/Risk Assessment Terminology October 2003.
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APPENDIX 1
NICNAS Low Exposure Scenario 1 ?Containment and Controlled Reformulation
? Use
Chemical additive or polymer chemical imported for incorporation into masterbatch or
polymer concentrates for the plastics industry.
? Exposure Scenario
o Main route of workplace exposure
Potential skin contact or inhalation exposure when packaged substances are
opened and measured/ weighed by members of the workforce for addition of the
new chemical to mixing vessels or loss in weight feeders for introduction to
masterbatch extruders.
Subsequent exposure eliminated due to extrusion taking place in closed system
and incorporation of new chemical in a bound, non-bioavailable state in a polymer
matrix.
Transport and warehouse workers only exposed in the event of accidental breach
of packaging.
o Main route of public exposure
The new chemical will not be available in technical state for use by the public.
Potential skin contact when finished moulded articles containing the bound, non-
bioavailable chemical are handled by members of the public.
Public exposure only possible in the event of release of the chemical after a
transport incident.
o Main route of environmental exposure
No intentional release of the new chemical to the aquatic, air or terrestrial
environmental compartments. Waste chemical can be generated from residues in
packaging and when bound and not bioavailable in non-recyclable polymer matrix
and when captured in dust/ vapour extraction filters. All residues disposed of by
licensed waste disposal companies to approved hazardous waste landfill.
Environmental exposure only possible in the event of release of the chemical after
a transport incident.
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? Risk Management Measures
Demonstration of controlled exposure at all stages of chemical life cycle.
o Controlled transport and storage
New chemical to be packaged in dangerous goods-approved packaging or in
robust packaging suitable for protection and retention of the contents.
Packaging to be transported by road or rail as dangerous goods according to the
Australian Code for Transport of Dangerous Goods by Road and Rail, if
appropriate, or transported by recognised industrial chemicals transport operators.
Packaging to be stored in dangerous goods stores that are approved under States
and Territories legislation, or stored in general industrial chemicals stores
controlled by experienced stores operators and in a location to prevent damage to
packaging and release to drains, sewer or to the soil.
o Appropriate packaging
New chemical to be packaged in dangerous goods-approved packaging or in
robust packaging suitable for protection and retention of the contents.
o Appropriate labelling and safety information
Packaging to be labelled according to the NOHSC National Code of Practice for
the Labelling of Workplace Hazardous Substances.
o Appropriate handling procedures during processing or specialised uses
Handling operations when packaging is opened for access to the new chemical
must be carried out in designated areas by trained operators who have had specific
training relating to the new chemical or to products containing the new substance.
All operators to be trained in the appropriate operational procedures and
precautions.
The designated handling areas must be serviced with general and local exhaust
ventilation and operators must have appropriate personal protective equipment
(clothing (impervious if necessary), impervious gloves, safety eyewear and
breathing protection (dust mask, filter apparatus or air-supplied apparatus, as
necessary)) available for use during handling operations.
Processing will involve supervision of automated closed or semi-closed systems.
Intervention in operations may occur but appropriate ventilation and personal
protection to be used.
o Appropriate treatment, handling, re-use, disposal of original packaging
Original packaging for the new chemical is expected to retain chemical residues
after emptying for use in production. Empty packaging and any residues to be
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disposed of to regulated landfill.
o Appropriate control of production cleaning waste
Quantities of the new chemical spilled or remaining from batch production will be
collected and placed into sealable containers for reuse or for disposal.
The new chemical will be incorporated in polymer substrate during production.
Waste generated during setting of initial extrusion specifications or from off-
specification material and from cleaning/ purging at the end of production runs
will be either collected for recycling or for disposal.
All production and cleaning waste collected for disposal will be sent to a regulated
landfill.
o Control of occupational exposure during processing, packaging and
cleaning/maintenance.
o Control of exposure in accordance with hierarchy of controls in federal and
state/territory OHS legislation and Codes of Practice.
If required transport, warehouse and stores personnel will wear personal
protective equipment appropriate to the tasks when receiving and handling
consignments of the new chemical in closed packaging
The operations for measuring of batches of the new chemical and supervision of
blending and extrusion will take place under local exhaust ventilation. Batch
addition of the new chemical to extruder machines may take place automatically
using a loss-in-weight feeder. Blending and extrusion will take place in
automated semi-enclosed systems with the new chemical immobilised in
solidified polymer prior to packaging. Production and quality control operators
involved in handling of the new chemical and handling of extruded pellets that
contain the chemical will wear personal protective equipment appropriate to the
tasks.
Packaging of blended and extruded pellets that incorporate the new chemical will
involve use of safety gloves if handling of pellets is necessary.
Cleaning/ Maintenance operations will be conducted after purging processes have
been completed. Purge polymer may contain immobilised new chemical and will
be handled using safety gloves after solidification of the polymer.
o Control of occupational exposure by education and training
Standard work practices are established for use of polymer additives by the end-
user. These practices require a copy of the Material Safety Data Sheet to be
available for all new materials.
Appropriate precautions and personal protective equipment are determined from
the MSDS.
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Occupational exposure will be controlled to prevent occupational risks by use of
appropriate engineering controls, personal protective equipment and workplace
training.
o Control of release of waste, residues to environment
Release of the new chemical during manufacture of the chemical will not occur as
the chemical will not be manufactured in Australia.
Release of the new chemical during shipping, transportation and storage will only
occur due to accidental spillage or leakage from packaging. The packaging of the
chemical is appropriate to ensure release is not likely.
Residual chemical retained in packaging will be disposed of with the empty
packaging to regulated landfill.
Waste chemical generated during extrusion processes will be a minor proportion
of the introduced substance. Quantities of waste chemical may arise from spillage
prior to blending or from waste extruded preparations that are not able to be
recycled. The waste will be collected and consigned to regulated landfill.
All of solid wastes generated that contain the new chemical will either be disposed
of to landfill or recycled.
o Control of waste disposal and/or waste degradation processes
The use and disposal pattern for the new chemical is such that direct release to the
aquatic, air and terrestrial environmental compartments is not expected.
The majority of the new chemical will be contained in a polymer matrix either as
production waste or as moulded articles.
Disposal procedures should be in accordance with Government regulations. Waste
from production and at the end of the life of moulded articles will either be
recycled, released to regulated landfill sites or incinerated.
The chemical when incorporated in the inert polymer matrix and released to
regulated landfill sites will not be directly released to the environment. The
chemical held within the polymer substrate will not be readily mobile and will
slowly undergo abiotic and biotic degradation after disposal to landfill.
The potential for exposure of the new chemical to the environment is highly
controlled to ensure risk to the environment will be low.
o Control of end-use of new chemical to ensure low public exposure
The new chemical will only be used industrially and will not be available for
direct purchase or use by members of the public.
Polymer preparations containing the new chemical will be used to mould end-use
articles that may be used or accessed by the public. The chemical will be bound
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in the polymer system after reformulation into pellets and after moulding of the
end-use articles.
The potential for exposure of the general public to the new chemical during
transportation, storage, handling and manufacture operations will be minimal.
Only in extreme cases of inappropriate handling or accidents during transportation
would there be any likelihood of the new chemical being released from the
packaging and the public being exposed.
The general public will only be exposed to the new chemical when using or
accessing moulded end-use articles that contain the substance. When incorporated
in the end-use articles, the new chemical will not be biologically available and
will be of low risk to the public.
The public risk from exposure to the new chemical through all stages of its life
cycle is considered to be low.
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NICNAS Low Exposure Scenario 2 ?Site-Limited and Closed System
? Use
Industrial chemical intermediate imported for use and total consumption at one site in
chemical synthesis process.
? Exposure Scenario
o Main route of workplace exposure
Potential skin contact or inhalation exposure when packaged substances are
opened for pumping/ weighing by members of the workforce for addition of the
new chemical to enclosed reaction vessels.
Subsequent exposure eliminated due to chemical reaction taking place in closed
reaction vessel. New chemical consumed in process and no residues remaining in
final product or in vessel.
Transport and warehouse workers only exposed in the event of accidental breach
of packaging.
o Main route of public exposure
The new chemical will not be available in technical state for use by the public.
The chemical will not exist after end-use chemical reaction.
Public exposure only possible in the event of release of the chemical after a
transport incident.
o Main route of environmental exposure
No intentional release of the new chemical to the aquatic, air or terrestrial
environmental compartments.
Waste chemical can be generated from residues in packaging. All residues from
packaging will be either incinerated as part of packaging recycling processes or
disposed of by licensed waste disposal companies to approved hazardous waste
landfill.
Environmental exposure only possible in the event of release of the chemical after
a transport incident.
? Risk Management Measures
Demonstration of controlled exposure at all stages of chemical life cycle.
o Controlled transport and storage
New chemical to be packaged in dangerous goods-approved packaging or in
robust packaging suitable for protection and retention of the contents.
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Packaging to be transported by road or rail as dangerous goods according to the
Australian Code for Transport of Dangerous Goods by Road and Rail, if
appropriate, or to be transported by recognised industrial chemicals transport
operators.
Packaging to be stored in dangerous goods stores that are approved under States
and Territories legislation, or to be stored in general industrial chemicals stores
controlled by experienced stores operators and in a location to prevent damage to
packaging and release to drains, sewer or to the soil.
o Appropriate packaging
New chemical to be packaged in dangerous goods-approved packaging or in
robust packaging suitable for protection and retention of the contents.
o Appropriate labelling and safety information
Packaging to be labelled according to the NOHSC National Code of Practice for
the Labelling of Workplace Hazardous Substances.
o Appropriate handling procedures during processing or specialised uses
Handling operations when packaging is opened for access to the new chemical
must be carried out in designated areas by trained operators who have had specific
training relating to the new chemical or to products containing the new substance.
All operators to be trained in the appropriate operational procedures and
precautions.
The designated handling areas must be serviced with general and local exhaust
ventilation and operators must have appropriate personal protective equipment
(clothing (impervious if necessary), impervious gloves, safety eyewear and
breathing protection (dust mask, filter apparatus or air-supplied apparatus, as
necessary)) available for use during handling operations.
Processing will involve operations to pump or weigh the new chemical for
addition to automated closed reaction vessels. Intervention in the reaction process
will not occur after charging of reaction vessels.
o Appropriate treatment, handling, re-use, disposal of original packaging
Original packaging for the new chemical is expected to retain chemical residues
after emptying for use in production. Empty packaging and any residues to be
incinerated during package recycling or to be disposed of to regulated landfill.
o Appropriate control of production cleaning waste
Quantities of the new chemical spilled or remaining from batch production will be
collected and place into sealable containers for reuse or for disposal.
The new chemical will be totally consumed during production. No residues of the
chemical will remain in reaction vessels or be present in the final product after
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completion of the reaction due to the other excess starting reactants.
All production and cleaning waste collected for disposal will be either incinerated
or sent to a regulated landfill.
o Control of occupational exposure during processing, packaging and
cleaning/maintenance
o Control of exposure in accordance with hierarchy of controls in federal and
state/territory OHS legislation and Codes of Practice.
If required transport, warehouse and stores personnel will wear personal
protective equipment appropriate to the tasks when receiving and handling
consignments of the new chemical in closed packaging.
The operations for pumping and measuring of batches of the new chemical and
supervision of charging of vessels will take place under local exhaust ventilation.
Batch addition of the new chemical to vessels may take place automatically from
feeder tanks or via remote control of pumping processes. Chemical reaction will
take place in automated enclosed vessels under controlled reaction conditions. No
exposure to the new chemical will be possible when the reaction vessel is charged.
Production and quality control operators involved in handling of the new chemical
and handling of finished products manufactured from the chemical will wear
personal protective equipment appropriate to the tasks.
Packaging of the finished product based on the new chemical will be carried out
automatically with sealing of packages or containers involving operator
involvement.
Cleaning/ Maintenance operations for vessels will be conducted after automated
wash/ rinse processes have been completed. Rinsate will not contain residues of
the new substance. Appropriate personal protective equipment will be used during
cleaning/ maintenance procedures.
o Control of occupational exposure by education and training
Standard work practices are established for reaction processes by the end-user.
These practices involve procedures for reaction vessel processes and require a
copy of the Material Safety Data Sheet to be available for all new materials.
Appropriate precautions and personal protective equipment for new substances are
determined from the MSDS.
Occupational exposure will be controlled to prevent occupational risks by use of
appropriate engineering controls, personal protective equipment and workplace
training.
o Control of release of waste, residues to environment
Release of the new chemical during manufacture of the chemical will not occur as
the chemical will not be manufactured in Australia.
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Release of the new chemical during shipping, transportation and storage will only
occur due to accidental spillage or leakage from packaging. The packaging of the
chemical is appropriate to ensure release is not likely.
Small amounts of residual chemical retained in packaging after rinsing will be
disposed of either by incineration during recycling of packages or disposed of
with the empty packaging to regulated landfill.
o Control of waste disposal and/or waste degradation processes
The use and disposal pattern for the new chemical is such that direct release to the
aquatic, air and terrestrial environmental compartments is not expected.
During manufacture of the end-use product the new chemical will be consumed.
Therefore, the only sites of release will be import container residues, atmospheric
release from transfers and from mixing vessels and spills.
Container rinsate with residues of the chemical will be transferred to an onsite
effluent treatment plant. Atmospheric release will be captured by the local and
general exhaust system with contaminants removed by a scrubber system and
scrubber water also removed to the effluent treatment plant. Spills will be
collected in sealable containers and disposed of either to a regulated landfill site,
by incineration or retained in an onsite effluent treatment plant.
The potential for exposure of the chemical to the environment is highly controlled
to ensure low risk to the environment will occur.
o Control of end-use of chemical to ensure low public exposure
The new chemical will only be used industrially and will not be available for
direct purchase or use by members of the public. The chemical will be used
entirely in the manufacturing process as a reactant that will be totally consumed to
produce the end-use product.
The potential for exposure of the general public to the new chemical during
transportation, storage, handling and manufacture operations will be minimal.
Transport and storage as general industrial chemicals will provide satisfactory
protection from exposure to the general public. Only in extreme cases of
inappropriate handling or accidents during transportation would there be any
likelihood of the new chemical being released from the packaging and the public
being exposed.
The new chemical will only be used industrially and will not be available for
direct purchase or use by members of the public. The chemical will be used
entirely in the manufacturing process as a reactant that will be totally consumed to
produce the end-use product.
The public risk from exposure to the new chemical through all stages of its life
cycle is considered to be low.
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7 LRCC - DISCUSSION PAPER NO. 3
MODULAR ASSESSMENT OF CHEMICALS THAT HAVE BEEN ASSESSED BY
ANOTHER AUTHORITY
1. PURPOSE
The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) was amended to
provide a framework for, among other things, the issue of certificates for the introduction of
new industrial chemicals following modular assessment. This discussion paper proposes a
strategy for implementing the modular assessment of chemicals that have been assessed by
another Australian or overseas authority; through the development of regulations, criteria,
guidance documents and other administration requirements.
2. BACKGROUND
Among the LRCC reform initiatives provided for in the LRCC Amendment Act, and
requiring further development is modular assessment; which includes the criteria, timeframe
and the regulatory and administrative measures. Recommendation 2.1 of the LRCC Final
Report recommends that:
NICNAS introduce modular assessment fees for low hazard and or low risk chemicals
and targeted assessment for chemicals where controls are in place such as:
Item A
?Situations where an assessment has been undertaken by another Australian
regulatory authority;
Item B
?Substances of known hazard for which risks are specified and controlled;
Item C
?Analogue chemicals;
Item D
?Substances for which an international assessment has been conducted; and/or
Item E
?Polymers of low regulatory concern for which a potential risk is determined during
screening (i.e. from the audited self assessment process).
The modular assessment criteria presented here are for:
Item A
?situations where an assessment of a chemical has been undertaken by another
Australian regulatory authority such as the Therapeutic Goods Administration (under
the Therapeutic Goods Act 1989), the Australian Pesticides and Veterinary Medicines
Authority (under the Agricultural and Veterinary Chemicals Code Act 1994), and
Food Standards Australia New Zealand (under the Food Standards Australia New
Zealand Act 1991); and
Item D
?chemicals for which an international assessment has been conducted ?chemicals
which have been assessed by regulatory agencies overseas (such as an OECD member
country such as any European Union member state or Canada) for which full
assessment reports are available.
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Under the current regulatory arrangements, NICNAS is required to complete a full
assessment for chemicals that have been previously assessed by another competent Australian
regulatory authority. This usually occurs when the chemical use changes and it is considered
an industrial chemical. NICNAS recognises that this may result in commercial delays and
additional costs to industry. By introducing modular assessment, NICNAS will streamline its
assessment of these chemicals. NICNAS will reduce assessment timeframes and costs by
considering assessments reports for the chemical prepared by other authorities that are
available to the notifier.
Due to the global nature of the chemical industry and trade, many new chemicals notified to
NICNAS may have been notified and assessed by other overseas. Presently NICNAS is
required to complete a full assessment for these chemicals. This requires industry to
duplicate efforts in preparing notifications for each country and NICNAS duplicates efforts in
re - assessing the chemical.
There are important difference in the data requirements and assessment process between
NICNAS and other Australian regulatory agencies and foreign regulatory agencies. For
example, NICNAS and APMVA assess the risk to the worker, the public, and the
environment while the other Australian agencies focus on public health. Table One compares
various aspects of federal Australian regulatory agencies and their activities. While when
compared to foreign agencies, NICNAS publishes its assessment reports, while many foreign
regulatory agencies do not. Moreover, many regulatory agencies rely on third party data, i.e.
information provided by another source, such as notification data provided by another
company to fill data gaps that exist for notified chemical. The administrative policy and
procedure developed for modular assessment will need to ensure the proprietary rights are
maintained.
Table 1
AGENCY National Industrial Australian Therapeutic Goods Food Standards
Chemicals Pesticides & Administration Australia New
Notification & Veterinary (TGA) Zealand (FSANZ)
Assessment Medicines Authority
Scheme (NICNAS) (APVMA)
RELEVANT Industrial Agricultural & Therapeutic Goods Food Standards
LEGISLATION Chemicals Veterinary Act 1989 Australia New
(Notification & Chemicals (Code) Zealand Act 1991
Assessment) Act Act 1994 Australia New
1989, as amended Agricultural & Zealand Food
Veterinary Standards Code
Chemicals
Administration Act
1994
MINISTRY Health & Ageing Agriculture, Health & Ageing Health & Ageing
Fisheries and
Forestry
SCOPE Assessment only, Assessment & Assessment & Assessment &
not registration Product Product Product
based Registration Registration Registration
RISK Assessment of the Assessment of the Assessment of the Assessment of the
ASSESSMENT risk to public, risk to the public, risk to the public risk to the public
worker and the worker and the only only
environment environment
ABOUT THE Industrial Agricultural Therapeutic goods Chemicals are
CHEMICALS chemicals are products include include prescription added to food to
varied and cover, chemicals which and non- assist in food
for example, dyes, generally prescription processing or to
solvents, destroy/repel pests (including over- achieve a
adhesives, plastics, or plants. the-counter and technological
laboratory Veterinary complementary purpose in the
chemicals, paints, products are used medicines), as well food, for example,
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as well as to prevent, as medical devices colouring or
chemicals used in diagnose or treat (including some flavouring. Other
cleaning products diseases in sterilants and chemicals may
and cosmetics and animals. disinfectants). occur naturally in
toiletries. food or be present
as a result of
contamination
3. PROPOSAL FOR MODULAR ASSESSMENT
To implement the modular assessment of these chemicals, NICNAS intends to amend the
Regulations of Industrial Chemicals (Notification and Assessment) Regulations 1990 (which
allows the Director to remit fees paid for application) to include the following Acts:
Therapeutic Goods Act 1989
Agricultural & Veterinary Chemicals (Code) Act 1994
Agricultural & Veterinary Chemicals Administration Act 1994
Food Standards Australia New Zealand Act 1991
Australia New Zealand Food Standards Code
An assessment report from an OECD member country such as any European Union member
state or Canada, may allow the modular assessment of chemical.
3.1 Criteria for an Acceptable Assessment Report
The following factors will be considered when the reports from overseas or local agencies are
reviewed:
The reports should provide sufficient information to determine:
?the identity of the notified chemical and where analogue data have been utilised;
?the extent to which the risk to the public, the worker and environment have been
addressed;
?the methodology used to conduct the risk assessment and the relevance of these to the
Australian exposure or use scenario (in the case of local assessment report); and
?the transparency of the assessment process or evidence of agreed standard or
recognised status of the authority through access to the original data submitted for
foreign or local assessment.
A letter of validation from the respective authority should accompany the assessment report
stating that that the report is the full and final report issued for the chemical.
The local or foreign assessment report provided should allow NICNAS to publish a complete
and transparent assessment report while maintaining the confidentiality requirements of the
original notifier and the foreign or local authority.
The assessment report must be for an equivalent assessment category. That is, the chemical
should have been assessed at the same or higher notification level by the original assessing
agency; this will ensure that the data requirements are met and that the level of detail in the
assessment reports is adequate.
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The following specific factors will be considered for local and foreign assessment reports.
3.1.1 Item B ?for local assessment report
? date from post-1994. Electronic reports are also acceptable;
? originate from the Australian regulatory authority given in the Regulations;
? include confidential information, for example, chemical identity. Sanitised documents
are not acceptable;
? include a summary and assessment of physicochemical properties;
? include a summary and assessment of toxicological and environmental effects data, as
appropriate;
? include a health and environmental risk assessment; and
be accompanied by a letter of validation from the Australian authority that the report
?br>
is the full and final report issued for that chemical.
3.1.2 Item D ?for international assessment reports
The assessment report must:
? date from post-1994. Preferably, the report should be in English, however, authorised
translations are acceptable. Electronic reports are also acceptable;
? originate from the national authority of an OECD Member country, preferably Canada
or any European Union Member State;
? include confidential information, for example, chemical identity. Sanitised documents
are not acceptable;
? include a summary and assessment of physicochemical properties;
? include a summary and assessment of toxicological and environmental effects data, as
appropriate;
? include a health and environmental risk assessment; and
? be accompanied by a letter of validation from the overseas authority that the report is
the full and final report issued for that chemical.
In all instances, acceptance of an assessment report is subject to approval by the Director.
Applicants are strongly advised to contact NICNAS their application prior to submission.
Applicants are still required to follow the notification procedures as described in Section 23
of the Act and submit a notification statement about the chemical or polymer that contains the
information required as per the Schedule. Where not already covered by the notification
requirements of Section 23, the following information should also be submitted to the
Director.
? Details of the overseas authority, that is, when and where notified;
? A copy of all the particulars about the chemical that were given under the foreign or
Australian scheme and are available to the applicant; and
? Any other information about the chemical available to the applicant, that is,
assessment information or information given under another foreign or Australian
scheme.
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If not all schedule requirements are met, applicants will need to apply for a Variation of
Schedule Requirements and provide the appropriate scientific argument and fees.
3.1.2.1 Obtaining Assessment Reports from the Canadian Authority
Applicants should first contact NICNAS to obtain a proforma authorising Environment
Canada to transmit the Canadian assessment report to NICNAS. It is planned to recognise
Canada as an approved foreign scheme under Section 43 of the Act in late 2006.
4. METHOD OF APPLICATION AND FEES
It is proposed that applications for an assessment certificate under the modular assessment
provisions will be made on the usual forms. The complete notification including the
assessment report from the foreign or local authority must be submitted with the appropriate
fee. The notification will be screened and assessed against the criteria given above within 14
days of receipt of the submission and fee. NICNAS will advise the applicant if the chemical
has been accepted for modular assessment and the fees and timeframes for the assessment.
The notified chemical will be assessed under the normal notification and assessment process
if the data package supplied is insufficient to allow a modular assessment.
It is anticipated a new part (similar to that for draft assessment reports) will be added to
Regulation 15 to allow introduction the modular assessment fees.
4.1 Form of Application
It is proposed that an electronic template will be available on the website for applications.
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8 LRCC - DISCUSSION PAPER NO. 4
MODULAR ASSESSMENT OF CHEMICALS FOR WHICH APPROPRIATE
ANALOGUES HAVE BEEN PREVIOUSLY ASSESSED BY NICNAS
1. PURPOSE
This discussion paper proposes a strategy for implementing the modular assessment of
chemicals for which appropriate analogues have been previously assessed by NICNAS;
through the development of regulations, criteria, guidance documents and other
administration processes.
2. BACKGROUND
Recommendation 2.1 of the LRCC Final Report recommends that:
NICNAS introduce modular assessment fees for low hazard and or low risk chemicals
and targeted assessment for chemicals where controls are in place such as:
Item C
?Analogue chemicals.
The modular assessment criteria presented here are for Item C; i.e. the modular assessment of
new industrial chemicals notified under the certificate category for which an appropriate
analogue has been previously assessed by NICNAS.
2.1 Current Situation
In Australia, new chemicals require a full notification package regardless of their similarity or
analogy to other chemicals previously assessed by NICNAS.
In many cases, such analogue chemicals represent no greater risk to human health and the
environment than an analogue already assessed by NICNAS or another local or international
regulatory authority. However, manufacturers or importers are required to submit similar
notification packages with similar fees to those required for a new chemical notification. As
well as the assessment periods and the financial costs involved for analogues, there are also
potential issues such as additional animal testing and use of regulatory resources that could
be better utilised.
There currently exists no mechanism to fast track the assessment of analogue chemicals via
reduced testing requirements, even though, both in Australia, and overseas, a notification
may often rely on analogue data for determination of their toxicological and environmental
endpoints. Other countries such as New Zealand and the US make allowance for chemical
analogy in the assessment of new chemicals and in some circumstances provide a specific
notification pathway for such chemicals.
3. CRITERIA FOR ACCEPTABLE ANALOGUES
Where it can be demonstrated that a notified chemical has a similar structure and pattern of
activity to an (analogous) chemical already assessed by NICNAS, it is possible to fast track
the assessment process without compromising human health and the environment.
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3.1 Analogue defined
While an analogue1 can be simply defined as a chemical compound that differs slightly in
structure and properties from another compound2, it is important to recognise that this
permits variation to range from nil to slight, and limits must be determined. In the strict
chemical sense analogues will be similar to each other, and in some cases may be equivalent
(where the same capacity to combine or react chemically is required 3), though rarely
identical.
Under chemical patent law, an analogue can be defined as a compound similar in structure
and function to another, previously described, compound to the point of "obviousness"4,
whereupon, despite differing in some slight structural detail, it is no longer possible to grant
an exclusive license on behalf of the former compound without infringing the rights
previously granted to the latter.
In practice the recognition that one compound is structurally and functionally (spectrum of
activity) "obviously" similar to another for the purpose of establishing patentability entails
one "normally skilled in the art", having the reasonable expectation that compounds similar
in structure will have similar properties, being motivated to deduce that the synthesis of a
particular compound will be opportune.
The test for "obviousness" will be determined by what "one normally skilled in the art"
determines a particular compound to be opportune. Often for chemical patents, a general
class of chemicals is defined, which are presumed to be analogous. However, it is possible
that an opportune compound or compounds may be discovered that have properties otherwise
unknown or not obvious, even if within the defined scope of the class of chemicals and their
previously presumed analogues.
As inventiveness covers all practical arts of human endeavours, the new desirable properties
of the chemicals could relate to physical or chemical properties, different metabolic function
(especially in the case of pharmaceutical chemicals), or alleviate environmental concerns.
The desirable properties may be derived from selecting a certain chain length of alkyl group;
or selecting a particular geometric or optical isomer etc. If such differences are deemed not
to be obvious it follows that a patent could be properly granted and that the chemicals for
which the patent is granted are not analogous to what has been previously broadly defined.
The complexity of defining analogues from a patent sense is contained in numerous examples
of legal findings that establish various principles of chemical similarity. (Some of these are
cited in the examples and guidelines).
From the point of view of human health and ecotoxicity, it is important to note that a
chemical compound with a structure similar to that of another, differing only slightly from it
with respect to a certain component, may yet have a different action metabolically. Thus
while optical and geometric isomers are very similar structurally, where it is known that one
isomer has a different activity (indicated by a significant variation in a toxicological end-
point) or physico-chemical behaviour (such as a dramatically different water-octanol
partition coefficient) from the other, they cannot be regarded as suitable analogues, one for
the other.
Therefore for a chemical compound to be considered an analogue for notification and
assessment involving toxicological data requirements, it must bear both a prima facie case of
obvious structural similarity and demonstrate similar pattern of activity to the previously
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assessed compound. The latter criteria can often be demonstrated through a satisfactory
closeness for at least one key physico-chemical and aquatic toxicity parameter required for
ecotoxicological assessment, and one key toxicological endpoint required for human health
assessment5. It is to be expected that notifiers may often be in the position to submit full
physico-chemical and toxicological data for one member of a group of chemical compounds,
produced for the purpose of exploiting the most functionally efficacious structure from within
the group, and indicative data for all of the other similar structures.
As there will always be a level of uncertainty associated with any chemical on which a
complete suite of (eco)toxicological tests have not been performed, regardless of the amount
of analogue data available, a conservative approach to assessment of analogue chemicals is
necessary to minimise risks. Thus where new chemicals are of particular concern, for
example, because of toxicity to different taxonomic groups, persistence, or significantly
different use patterns which may increase environmental as well as public exposure, data for
the notified chemical should be submitted rather than analogue data.
3.2 Criteria for determination of analogy
For a nominated chemical to be regarded by NICNAS as an analogue of a previously
assessed chemical, the following criteria must be met:
? prima facie structurally identical or similar (see below for criteria and guidelines);
? acute oral toxicity within 0.3 order of magnitude (+/-2x);
? aquatic toxicity within 0.3 order of magnitude (+/-2x) (for standard notifications) by data or
argument as appropriate;
? n-octanol-water partition coefficient within 0.3 order of magnitude (alternatively; for
6
polymers water solubility within 0.3 order of magnitude) ; and
? not the subject of a hazard assessment or otherwise of concern.
3.3 Criteria for determination of structural identity
The following cases are examples of potential structural identity with expected similar
reactivity profiles for toxic effects (if any):
3.3.1 Chemical identity in vivo
An analogue is identical in vivo to the previously notified chemical:
?where the Na+, K+ or NH4+ salt of the acid is present in solution;
?where the Cl-, CO32-, PO43- or SO42- salt is present in solution;
?where it is related through some precursor, metabolite or breakdown product in vivo.
3.3.2 Polymer identity
Where a polymer is manufactured by a different pathway (i.e. by using different reactants)
and chemically identical, though the resulting polymer may be assigned a different CAS
number; it would be considered a candidate for modular assessment as an analogue.
3.4 Criteria for determination of structural similarity
The following requirements are essential for a chemical to be considered prima facie to be
structurally similar to another:
?contains some identical substructure that may play a critical functional role, such as
defined in the USEPA TSCA New Chemicals Program Chemical Categories7;
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? has similar molecular weight (carbon chain homology allows +/- 3x (-CH2- radical)
where carbon chain length exceeds 6)6;
? has similar molecular properties e.g. lipophilicity, electronic or steric parameters.
4. GUIDELINES AND EXAMPLES (OPPORTUNITIES FOR USE OF
ANALOGUE ASSESSMENT)
The following case examples are types of structural analogues where modular assessment
may allow for a reduced level of regulatory assessment input. The notified chemical will
have both a similar structure and pattern of activity to an analogous chemical already
assessed by NICNAS.
4.1 Salts
Salts often demonstrate a similar pattern of activity because the active chemical form is
independent of the cation found in the preparation, and consequently identical in vivo. Salts
formed when the hydrogen of an acid is replaced by an alkali metal or a cation of equivalent
solubility (e.g. NH4+) would be suitable for assessment under this category. Thus the Na+
salt is reasonably expected to be closely similar in activity to that of the K+ salt but quite
different in activity to the Pb+ salt, the latter not being considered an analogue.
4.2 Homologues
A homologous series8 of chemicals may be structurally similar differing only in carbon chain
length. Close chemical similarity will usually involve a degree of expert judgement, and
analogue data should not be used for close homologues containing only a few carbons if the
partition coefficient differs by more than a factor of two. Often, with the exception of
methyl- and ethyl-, the chain length will have little effect on the pattern of activity and the
assessment of homologues greater than C4 can be used for other chemicals in the series
differing by less than 3 additional methylene radicals. Where there are more than ten carbons
in a chain, homologues with addition or subtraction of 4 or more methylene radicals, which
should not affect the activity pattern significantly, are regarded as acceptable analogues.
Structural and positional isomers9
4.3
Positional isomers have the same empirical formula, and acceptable analogues would include
unchanged chemical functional groups and at least a single variation (resulting in, or a
change) to the branch point of a hydrocarbon chain, for example; normal-, iso- and anteiso-
isomeric forms, or a change to the aromatic ring substitution position. However, in
heterocyclic ring systems, both the ring size and the number and ring position of heteroatoms
should not change.
Stereoisomers10
4.4
Optical11 and geometric isomers12 may be a group of chemicals suitable for analogue
assessment if the biological function of the isomers is similar. While the pattern of activity
of stereoisomers is often similar, numerous examples where stereoisomers behave very
different metabolically require that the chosen animal toxicity endpoint of the proposed
analogue be no less than half that for the previously assessed compound (i.e. that the new
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compound be at most twice as toxic as the previously assessed analogue). Thalidomide, for
example, has teratogenic effects only demonstrated to be the responsibility of one of the two
enantiomeric forms.
Bio-isosterism13
4.5
Chemicals related by a simple recognised change between two known bio-isosteric groups
may be suitable analogues if both the Kow and toxicity end-points are within the general
limits prescribed in the criteria; 0.3 order of magnitude (+/-2x).
4.6 Essential Oils
Often essential oils from plants of the same species may be regarded as different chemicals
(with different CAS numbers) if geographical separation has resulted in slightly different
chemical profiles. Often these differences may have little or no impact on the pattern of
activity of the chemical.
4.7 Fatty Acid Resins
In many cases, chemicals that have a fatty acid chain such as alkyd resins, the fatty acid is
not a determinant of chemical properties. Where the saturation profiles are similar (for
example in the case of sunflower oil and soybean oil, or tung oil and linseed oil), one fatty
acid may be substituted for another without significantly changing the properties of the
chemical.
4.8 Animal/Plant Derived Fatty Acids
Fatty acid saturation profiles derived from animals and plants differ slightly; in cases where
the saturation profile of the fatty acid has little impact on the pattern of activity (for example
an organo-clay compound), either type may be considered a suitable analogue for the other.
4.9 Inseparable Mixtures
Where the chemical exists in an inseparable mixture of two or more structurally similar
chemicals with different CAS numbers, the chemical of highest concentration is assessed as
a standard notification with the others treated as analogues of the first assessment where the
concentration exceeds 1%. The toxicological assessment will be performed using
information on the mixture rather than the notified chemical.
5. ASSESSMENT PROTOCOLS FOR ANALOGUES
It is proposed that, where a notifier believes that a close structural relationship exists
between a notified chemical and one previously assessed by NICNAS (including assessed
chemicals listed on AICS), a minimum data package would be required, which would
include:
? Scientific justification for consideration of the chemical as an analogue;
? Details of proposed use, public and environmental exposure;
? Minimum physicochemical data on the notified chemical;
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? Minimum toxicological data on the notified chemical; and for standard notifications; and
? Minimum environmental data on the notified chemical.
The notifier would still be obliged to provide all available data relevant to the normal
scheduled data requirements for the notified chemical. The minimum data requirements for
toxicological and environmental endpoints are suggested above under `determination of
analogy', noting a minimal requirement for animal studies. Minimum physicochemical data
for chemicals and polymers respectively include:
?melting (or boiling) point, water solubility and partition coefficient; and
?density, particle size and water solubility.
5.1 Tier 1 Analogue Assessment (Minimum Testing Packages)
The most streamlined analogue assessment process would be available for chemicals where
analogy has been demonstrated, and accepted by the regulator as meeting the requirements
for the minimum data package. Furthermore, the mode of use of the chemical and expected
public exposure is such that data beyond the minimum dataset is not considered necessary.
It is envisaged that such an assessment strategy would allow for completion of the
assessment within a similar time frame to that of Early Introduction Permits (28 days) when
similar use patterns are proposed. A longer time period (but less than the current 90 days)
will apply when different use patterns are proposed, reflecting the need for a separate risk
assessment using the hazard data from the previously assessed chemical.
Close structural similarity together with closely similar physicochemical properties will
provide an adequate basis on which to assess a chemical nominated for a limited notification
where a full data set is available for its analogue. For standard notifications there is a greater
need to consider the ecotoxicological implications, requiring assurance that the aquatic
toxicity of the new chemical is not significantly greater (preferably less than double) than the
analogue. In many cases, similar toxicity could be demonstrated by argument, with reference
to the partition coefficient and mode of action of the new chemical.
For chemicals with a specific mode of action such as biologically active chemicals, aquatic
toxicity data would be needed to demonstrate analogy when those chemicals are nominated
as standard notifications. Argument based on a risk/hazard-based approach may be accepted
in lieu of data. Thus if the analogue chemical has a low PEC/PNEC ratio (say 0.001 or less; a
wide margin of safety in the aquatic environment), then the need for additional data would be
less than when the safety margin is smaller (say a PEC/PNEC of 0.1 or higher). The
PEC/PNEC ratio would be determined for the most sensitive organism and where the ratio
exceeds a critical threshold of 0.1 for the analogue, toxicity testing for the notified chemical
in the same organism would be indicated.
It is intended that "umbrella-ing" of several chemicals will be possible. For example, a
notifier submitting a sodium salt may nominate other salts such as the potassium and
ammonium salt which may also be expected to be imported/manufactured in the future. A
notifier may nominate chemicals which are analogous to a previously-assessed chemical to
which they have access to the assessment report. In the case where a new chemical and
several analogues are notified together, the notifier will be required to nominate the primary
analogue which will be assessed as a new chemical for which a certificate will be issued. It
is proposed at this stage that each additional analogue will be treated as an "extension" to
the original assessment certificate.
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It is proposed that where a manufactured chemical consists of two or more inseparable
analogues, the chemical may be assessed in the following manner:
(i) The chemical of the highest concentration is the `primary' analogue, and is
notified as a Standard or Limited Notification based on existing criteria. This
chemical would appear on the assessment certificate, the notification and
assessment of which proceeds with usual timeframes and fees.
(ii) Each additional chemical becomes the subject of an extension to the assessment
certificate for the `primary' analogue with appropriately reduced timeframes and
modular fees.
If the notified chemical is deemed to be unsuitable for assessment as an analogue (i.e. the
scientific justification for analogy between two chemicals does not demonstrate beyond
doubt that the chemicals would be expected to have similar physicochemical, toxicological
and environmental properties), the notifier will be required to notify under one of the
existing notification categories.
5.2 Tier 2 Analogue Assessment
In cases where the proposed uses and/or the exposure population are significantly greater
for the notified chemical, NICNAS may determine at the initial screening stage that further
data on the ecological or human health effects would be required in addition to the
minimum data package.
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9 LRCC - DISCUSSION PAPER NO. 5
REVIEW OF DEFINITIONS
NATURALLY OCCURRING CHEMICALS AND ESSENTIAL OILS
1. PURPOSE
This discussion paper reviews the definitions for naturally occurring chemicals and essential
oils that are available nationally and internationally. Recommendations are also made
regarding the amendment of the NICNAS definition of naturally occurring chemicals,
adoption of the International Organization for Standardization (ISO) definition of essential
oils, and NICNAS guidance materials for naturally occurring chemicals and essential oils.
2. BACKGROUND
Among the LRCC reform initiatives requiring further work was a review of the definition of
naturally occurring chemicals. Recommendation 9.3 of the LRCC Final Report recommends
that
"NICNAS review of the definition of naturally occurring chemicals, particularly in
relation to steam distillation extraction of essential oil".
NICNAS has a number of exemptions from new chemicals notification in the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act). NICNAS does not require the
notification of naturally occurring chemicals as these are taken to be on the Australian
Inventory of Chemical Substances (AICS). Naturally occurring chemicals are not considered
industrial chemicals for the purposes of NICNAS Registration. While a definition of the
naturally occurring substance is included in the Act, no guidance on the application of this
definition is currently available, e.g. in the NICNAS Handbook of Notifiers.
It has been noted that the current definition of naturally occurring does not provide certainty
to the essential oils industry when making a decision if notification to NICNAS is required.
This requires NICNAS to make case-by-case decisions on whether an essential oil is
naturally occurring or not based on examination of the extraction processes. This lack of
certainty is further compounded by fact the Act does not contain a definition of an essential
oil. Internationally definitions for both essential oil and naturally occurring substances exist.
3. NATURALLY OCCURRING CHEMICALS
3.1 Australia's definition of naturally occurring.
A naturally occurring chemical is defined in s5 of the Act as:
"(a) An unprocessed chemical occurring in a natural environment,
or
(b) a chemical occurring in a natural environment, being a substance that is extracted by:
(v) manual, mechanical, or gravitational means, or
(vi) dissolution in water; or
(vii) flotation; or
(viii) a process of heating for the sole purpose of removing uncombined water,
without a chemical change in the substance".
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The physical processes that are included in the definition are restricted to those processes,
where minimal chemical change to the chemical is likely to occur during its extraction.
NICNAS considers the following factors when determining whether or not a chemical meets
the definition of naturally occurring under the Act:
(1) origin of the chemical, particularly if manufactured;
(2) physical and chemical changes that occur during any processing, especially in the
case of steam distillation;
(3) consideration of how any heat is applied in any processing; and
(4) variability of chemical composition from batch to batch.
3.2 International Definitions of Naturally Occurring
European Union
The European Union defines naturally occurring substances as "occurring in nature as such,
unprocessed, or processed only by manual mechanical or gravitational means; by dissolution
in water or flotation or by heating solely to remove water, or which are extracted from air by
any means". There is no requirement in the EU to report these chemicals individually in
ELINCS; they are reported in ELINCS under the collective name "naturally occurring".
However, substances (as such or as part of mixtures) that are produced by chemical
modification of naturally occurring products or are separated from them by physical
processing can be reported (European Chemicals Bureau, 2005).
This definition of a naturally occurring substance is expected to change in the EU under the
proposed Registration, Evaluation, Authorisation of CHemicals (REACH) legislation.
Under draft REACH legislation published in late 2005, the definition was amended to include
steam distillation as an acceptable means of extraction. Therefore naturally occurring
substances will be defined as substances which occur in nature means a naturally occurring
substance as such, unprocessed or processed only by manual, mechanical, or gravitational
means; dissolution in water, by flotation, by extraction with water, by steam distillation or by
heating solely to remove water or which is extracted from air by any means. The scientific
rationale for the inclusion of steam distillation as an acceptable means of extraction has not
been published.
US EPA
Advice has been received from the US EPA on definition of naturally occurring substances in
Toxic Substances Control Act 1976 (TSCA). Under TSCA any chemical substance which is
naturally occurring and (1) which is (i) unprocessed or (ii) processed only by manual,
mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely
to remove water; or (2) which is extracted from air by any means, shall automatically be
included in the inventory under the category 'Naturally Occurring Substances'. Substances
that are derived from natural products and are processed by methods other than those above
are subject to reporting and would fall within the unknown or variable composition, complex
reaction products, and biological material (UVCB) category for inventory listing purposes.
Biological substances extracted with solvents other than water or extracted using steam also
would not be considered to be naturally occurring and would this be subject to inventory
reporting; many of these substances also fall into the UVCB category.
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Canada
Under the Canadian Environmental Protection Act 1999, a naturally occurring substance is
defined as a substance which occurs in nature as such, which is chemically unprocessed or
which is extracted from air by any means, or physically processed only by manual,
mechanical or gravitational means, by dissolution in water, by flotation, or by heating solely
to remove water.
"Substances occurring in nature as such, unprocessed or processed only by manual
mechanical, or gravitational means, by dissolution in water, by flotation, or by heating solely
to remove water, or which are extracted from air by any means", are not reported
individually. These substances are covered on the Canadian Domestic Substances List (DSL)
by the entry "naturally occurring substances" (Environment Canada, 1989).
Canada provides the following guidance information on substances occurring in nature -
"Methods which are considered not to alter the chemical identity of substances occurring in
nature include: filtration, milling, cutting, pressing, any gravitational separation (decantation,
centrifugal methods) processing by electrostatic means, extraction with water (not with other
solvents). Isolated substances, or those which are part of mixtures produced by chemical
modification of naturally occurring products or are separated from them by physical
processing, are reported. Physical processing includes such methods as: distillation, steam
distillation, crystallisation, sublimation, heating for reason other than to remove water, salting
out and ion exchange (product obtained by)" (Environment Canada, 1989).
3.3 Organisation of Economic Cooperation and Development (OECD)
The current OECD definition for naturally occurring substances is "substances occurring in
nature that are unprocessed, processed only by manual, gravitational, or mechanical means or
by dissolution in water, or by flotation, or by heating solely to remove water, or are extracted
from air by any means without chemical change in the substance" (OECD, 2005). The Joint
Meeting of the Chemicals Group and Management Committee of the Special Programme on
the Control of Chemicals of the OECD has agreed that this working definition should be
tested, i.e. open for public comment, during 2005-2006 in the context of the work on New
Chemicals and Existing Chemicals.
Comparison with NICNAS
The definitions of naturally occurring substances currently used by most international
regulatory agencies do not differ significantly from the NICNAS definition. Clearly, the
inclusion of steam distillation in the EU definition means that it now differs significantly
from the NICNAS definition. The lack of information on the scientific rationale for the
inclusion of steam distillation has restricted detailed discussion on the difference.
4. ESSENTIAL OILS
4.1 Essential Oils in Australia
The use of essential oils is widespread in Australia. Essential oils are used either in pure
form or compounded with other ingredients. Many of the compounded oils and fragrance
oils are a mixture of the synthetic and natural essential oils. Pure essential oils and
preparation of essential oils are widely used, including in aromatherapy, therapeutic
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preparation, as repellents, in food flavouring, in domestic cleansers, and environmental
fragrances.
AICS lists a large number of essential oils. To accurately search AICS for an essential oil,
the full chemical name, CAS Number, botanical name and extraction method are required.
Many of the essential oils that were in use in Australia at the time of creating AICS were not
grandfathered on AICS as the industry at the time assumed they fell under naturally occurring
chemicals (which did not need notification as they are assumed to be an existing chemical, on
the inventory whether listed or not). One of the concerns expressed by the essential oil
industry is that all the essential oils not grandfathered on AICS would need to be notified
before they can be added to AICS. This matter is dependent on the definitions of both
naturally occurring and essential oils.
4.2 Definition of Essential Oils
International Organization of Standardization (ISO)
ISO defines essential oil as "products obtained from natural raw materials by distillation with
water or steam or from the epicarp of citrus fruits by a mechanical process or by dry
distillation. The essential oil is subsequently separated from the aqueous phase by physical
means". Synthetic or "nature identical" oil are not included in the ISO definition.
Australia
Essential oils are not defined in the Act. The National Drugs and Poisons Scheduling
Committee (NDPSC) has adopted the ISO definition of essential oils and this definition is
included in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The
SUSDP is the decisions of the NDPSC regarding the classification of drugs and poisons into
Schedules for inclusion in the relevant legislation of the Australian states and territories. It
also includes model provisions about containers and labels, and recommendations about other
controls on drugs and poisons (NDSPC, 2005).
European Union
In EINECS plant extracts are defined as "extractives and their physically modified
derivatives such as tinctures, concretes, essential oils, oleoresins, terpenes, terpene-free
fractions, distillates, residues etc. obtained from (Genus species, family name). No definition
of "essential oil" could be found in the EU legislation. However, the terms of "oil" and "oils,
expressed" have been defined for the inventory of ingredients employed in cosmetic
products. The term "oil" is used for all types of essential oils, obtained either by dry
distillation or by steam distillation, flash pasteurisation etc. The term `oils, expressed" is
used for the essential oils obtained by mechanical processes mainly for the cold-pressed
essential oils obtained from the epicarp of citrus fruits.
USA EPA
Essential oils are listed on the inventory by names, CAS number, and definitions. TSCA
definitions generally contain the phrase "extractives and their physically modified
derivatives" followed by the genus and species of the biological source. The definition may
also include a list of the primary components of the oil (US EPA, 2006).
It is noted that critical to the definition to essential oil and naturally occurring is the process
of distillation.
4.3 Toxicity of Essential Oils
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The toxic mechanisms of essential oils can be divided into two categories: specific and non -
specific toxicity. In specific toxicity, there is a clear biochemical explanation for the
observed effect, such as inhibition of a vital enzyme activity or the blockage of a receptor
molecule. Non-specific toxicity is used to describe situations where the only demonstrable
interaction is a non-specific, reversible, hydrophobic combination between the cellular or
organelle membrane components and the chemical. It generally accepted that when the
single acute toxic dose is in excess of one gram/kilogram (g/kg), the non-specific toxicity is
most likely to be the mechanism of toxic effects. It should be noted some essential oils
clearly have both specific and non-specific toxic activity, these are mainly the compounds
with an acute toxic dose below one g/kg (NDPSC, 1998).
Metabolites of essential oils have been shown to lead to hepatotoxicity, lung toxicity, or
nephrotoxicity, sensitisation, mutagenicity, and carcinogenicity. Most essential oils have
been shown to cause contact sensitisation in some individuals. Furthermore, some essential
oils which contain methoxypsoralens can cause primary photosensitisation in all exposed
individuals following local application or ingestion (NDPSC, 1998).
In its opinion concerning "Essential Oils" in June 2003, the European Union's Scientific
Committee on Cosmetic Products and Non Food Products Intended for Consumer (SCCNFP)
stated "there is no demonstration in the peer review scientific literature that fragrances
compounds of natural origin are "safer" than synthetics".
An essential oil can be regulated by number of agencies in Australia, depending on its use.
NICNAS regulates essential oils when these are used in aromatherapy, as environmental
fragrance, and for household cleaning purposes. The Therapeutic Goods Administration will
regulate essential oils used for therapeutic purpose. While, the Australian Pesticides and
Veterinary Medicines Authority and Food Standards Australia and New Zealand regulate
essential oils that are used as a repellent and as flavouring in foods, respectively.
Essential oils that are likely to be hazardous to the public may be referred to NDPSC for
consideration. The NDSPC when scheduling the essential oil will consider its toxicity,
purpose of use, potential for abuse, safety in use, and the need for the essential oil.
5. STEAM DISTILLATION
5.1 Essential oil extraction
There are three main methods used to concentrate plant flavour and fragrance substances:
1. Distillation;
2. Mechanical separation; and
3. Solvent extraction.
The method used will determine the quantitative and qualitative composition and hence the
organoleptic properties of product (Ullmann's Encyclopaedia of Industrial Chemistry, 2005).
Essential oils are usually liquids isolated from plant parts. The majority of constituents of the
commercial viable essential oils are terpenes eg hydrocarbons, alcohols, aldehydes, ketones,
acids and esters. Essential oils are either distilled or expressed. Distillation of essential oils
can be by water, steam, water-steam, or dry with steam distillation being the most common
form of distillation. High-pressure steam distillation is used to extract the essential oil when
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botanical material and the essential oils are sufficiently heat resistant or non - hydrolysable.
A number of essential oils require the enzymatic release of the volatile component before
steam distillation (Smith et al 2005).
In addition, the distillation of essential oils at elevated temperatures results in the
transformation of thermolabile substances and some typical components are only released
from their precursor in the plant under distillation conditions (Ullmann's Encyclopaedia of
Industrial Chemistry, 2005).
5.2 Steam Distillation and Naturally Occurring Chemicals
It is NICNAS's opinion that steam distillation is a physical process that falls outside the
current definition of naturally occurring chemicals. In addition, NICNAS recognises some
chemical changes may occur during steam distillation, particularly if high-pressure steam is
used. While others have noted that distillation of essential oil at elevated temperature is
known to result in the transformation of some thermolabile substances (Ullmann
Encyclopaedia of Industrial Chemistry, 2005).
6. PROPOSAL
Recommendations
Recommendation 1: That the definition of naturally occurring chemicals in s5 of the
Act is to remain unchanged as:
Naturally-occurring chemicals means:
1. an unprocessed chemical occurring in a natural environment or
2. a chemical occurring in natural environment, being a substance
that is extracted by:
i. manual, mechanical or gravitational means; or
ii. dissolution in water; or
iii. flotation; or
iv. a processing of heating for the sole purpose of
removing uncombined water.
The NICNAS definition will thus continue to be consistent with the current OECD, US and
Canadian definitions of naturally occurring substances. This definition will be reviewed
again when the OECD public comment period for the working definition ends. This process
will consider the arrangement in REACH.
Recommendation 2: That NICNAS adopts the ISO definition of essential oil, this would
be consistent with the current definition used in SUSDP.
Recommendation 3: That NICNAS develop and publish the guidance on naturally
occurring substances. Any guidance information will include steam distillation as an
acceptable extraction method provided there is sufficient scientific evidence that the
distillation conditions used do not result in chemical transformation of the components.
This will allow a level of consistency with EU REACH legislation until there is sufficient
scientific rationale for the inclusion of steam distillation (unqualified) in the definition.
Recommendation 4: Develop guidance on essential oils in relation to their definition
and interpretation as naturally occurring.
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Recommendation 5: Establish an expert essential oils working group to work with
NICNAS on this guidance material.
References:
Smith, R.L., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Portoghese,
P.S., Wadell, W.J., Wagner, B.M., Hall, R.L., Higley, N.A., Lucas-Gavin, C., Adams, T.B.,
2005, A procedure for safety evaluation of natural flavor complexes used as ingredients in
foods: essential oils. Food and Chemical Toxicology 43, 345-363
Scientific Committee on Cosmetic Products and Non Food Products Intended for Consumers
2003 Opinion on the Scientific Committee on Cosmetic Products and Non Food Products
Intended for Consumers concerning essential oils adopted by the SCCNFP during the 24th
plenary meeting of 24-25 June 2003.
National Drugs and Poison Schedule Committee 1998 Essential Oils Working Party ?br>
Chairman's Final Report December 1998.
National Drugs and Poison Schedule Committee 2005 Standard for the uniform Scheduling
of Drugs and Poisons No 20. Effective date 1 June 2005
European Chemicals Bureau 2005 Manual of decisions for implementation of the sixth and
seventh amendments to Directive 67/548/EEC, on dangerous substances (Directive
79/831/EEC and 92/32/EEC) non - confidential version (pg 22-23).
Environment Canada 1989 "Reporting for the Domestic Substances List Revised July 1989 ?br>
Guidelines" http://www.ec.gc.ca/substances/nsb/cpdsl/eng/cg_app1_e.htm
Accessed 3/02/06.
Organisation for Economic Co-operation and Development (2005) Working Definitions of
Key Terms 30 March 2005
US EPA (2006) Toxic Substances Control Act Inventory for chemical substance of unknown
or variable composition, complex reaction products, and biological materials: UVCB
substances http://www.epa.gov/oppt/newchems/pubs/uvcb.txt. Accessed 17/01/06
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10 LRCC - DISCUSSION PAPER NO. 6
LOW REGULATORY CONCERN POLYMERS
1. PURPOSE
This discussion paper seeks comment on proposals to extend the number of polymers which
qualify for reduced notification and assessment requirements via the consideration of low
regulatory concern.
2. BACKGROUND
In the Final Report and Recommendations for the Low Regulatory Concern Chemicals
(LRCC) Reform Initiative (June 2003) and the subsequent Implementation Strategy (July
2003), Recommendation 4.3 stated for low regulatory concern polymers (LRCPs):
Introduce audited self-assessment for low regulatory concern polymers (i.e. polymers
which do not meet the existing PLC criteria). New NICNAS criteria will need to be
developed with industry and community involvement.
Preliminary work by LRCC technical working groups defined LRCPs as those polymers
which do not meet the PLC criteria but, for one reason or another, do not warrant a complete
risk assessment. LRCPs would include other classes of low hazard polymers, analogues and
polymers assessed under other regulatory schemes. Typical LRCPs could therefore include
the following:
? Polymers of certain classes which are of low hazard;
? Polymers chemically similar to polymers already assessed by NICNAS;
? Consolidated notification, where more than one polymer can be notified and assessed
together; and
? Polymers assessed by other regulatory schemes.
3. PROPOSAL
It is proposed to implement regulations and guidelines to enable the introduction of polymers
identified as LRCPs. These proposals apply to all certificate categories and are listed below.
3.1 Polymers chemically similar to polymers already assessed by NICNAS
(a) If one monomer less
The reactive functional groups in a polymer are derived from the reactive functional groups
of the component monomers and other reactants. In the risk assessment of polymers, the
characteristics of these reactive functional groups play a large part in determining the
polymer's health and environmental effects. For this reason, the type and content of reactive
functional groups are key criteria in determining whether a polymer is a polymer of low
concern.
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For a polymer assessed by NICNAS, the contribution by the functional groups of the
component monomers and other reactants to the polymer's health and environmental effects
is taken into account in the hazard assessment. Consequently, for a new polymer with one
monomer less than an assessed polymer, the health and environmental effects are largely
known and the hazard assessment effectively completed.
It is therefore proposed that, for a polymer with one monomer less than a polymer already
assessed, a reduced fee of 40% will apply. If the use is similar, a further 20% reduction is
proposed.
It is proposed that this approach and reduction in fees be available to all certificate categories,
including PLCs.
(b) If similar monomer substituted
Additionally, this proposal applies for a new polymer containing a reactant similar to that in a
polymer already assessed, provided that the substituted reactant meets the Guidelines for
Acceptable Analogues prepared as a separate discussion paper. For example, if propanediol
is replaced by butanediol as a monomer in a polymer, then the new polymer would be
regarded as an acceptable analogue.
(c) Polymer identical to assessed polymer
In some cases, a polymer may be manufactured by different reaction pathways and, in some
cases, using different reactants. This can lead to the identification and naming of a particular
polymer in more than way, with different CAS registry numbers, as polymers are usually
identified and named in accordance with the names of the reactants used to manufacture the
polymer.
It is proposed that, in these circumstances, a similar approach to (a) and (b) above will apply,
with similar reductions in fees.
3.2 Consolidated notification, where more than one polymer can be notified and
assessed together (`family approach')
In some cases, polymer analogues are developed together, leading to marketing and
notification within similar timeframes. It is proposed that where analogues are notified
together, as a family, and that one assessment suffices for the group of analogues (family), an
administrative fee only will apply for subsequent members of the family. An example is the
notification of three salts of a polymer, where one assessment would suffice for the group of
polymers. Consideration as suitable analogues for this proposal will be in accordance with
the Guidelines for Acceptable Analogues prepared as a separate discussion paper (No. 4).
3.3 Polymers assessed by other regulatory schemes
Under the Act, NICNAS is required to complete a full risk assessment for new chemicals and
polymers. If the chemical or polymer has been previously assessed by a competent overseas
regulatory authority formally declared an approved foreign scheme under section 43 of the
Act, the previous risk assessment can be taken into account. In this case, a reduced fee
applies, however, no foreign scheme has been approved to date, although it is proposed to
recognise the Canadian notification and assessment scheme in the near future.
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Transitional regulatory arrangements have been in place for some years which allow the
Director to remit fees at up to 40% on provision of an assessment report from a recognised
foreign scheme. For polymers notified as PLCs in Australia, a free Early Introduction Permit
is also available under the transitional arrangements for polymers assessed in Canada.
However, these provisions have not applied to other national regulatory schemes or
international assessment schemes.
It is proposed that, for polymers assessed by any competent authority, both national and
international, and an assessment is available, that reduced fees apply, namely, 40% for the
hazard assessment and an additional 20% for a similar use, where exposures are equivalent.
3.5 Low hazardous classes of polymer
Low hazardous criteria for notification and assessment purposes have been proposed for
polymers and are included in the separate discussion paper on low hazardous criteria
(Discussion Paper No. 1). For convenience, the criteria are as follows:
For low-hazardous polymers with number-average molecular-weight of 1000 or less,
it is proposed that the criteria developed and proposed for chemicals be adopted
(criteria in separate discussion paper on low hazardous criteria for notification and
assessment purposes).
For low-hazardous polymers with number-average molecular-weight greater than
1000, it is proposed that the polymer has:
? less than 10% by mass of molecules with molecular weight that is less than 500; and
? less than 25% by mass of molecules with molecular weight that is less than 1000; and
? low charge density, as defined in Regulation 4C.
In both situations, polymers shown to not meet the definition of `a hazardous
chemical' would also be accepted under this proposal.
Polymers classified as NOHSC Type I ingredients or which are persistent or bioaccumulative
would not be eligible for consideration as low hazard polymers.
In addition, NICNAS is working with the US and Canada and through the OECD New
Chemicals Task Force to identify additional specific classes of polymer which can be
accepted as `low regulatory concern'.
3.6 Self-assessment
It is proposed that the self-assessment option for low regulatory concern polymers be
deferred until some assessment experience is developed with these new notification
categories.
4. SAFEGUARDS
It is intended that all polymers will undergo some level of assessment and therefore provide a
safeguard to workers, the public and the environment. Concerns which arise during the
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112
prescreening phase can be addressed and, if necessary, additional data requested and/or
additional risk management controls applied. For example, where the monomer ratio in a
new polymer may be increased in comparison to a previously assessed polymer, leading to a
higher concentration of a particular reactive functional group, these concerns can be
addressed during the assessment process.
5. INFORMATION REQUIRED IN APPLICATION
The proposals outlined above for low regulatory concern polymers are intended to apply to
all certificate categories. Therefore the data requirements will depend on the certificate
category applicable, that is, Standard Notification, Limited Notification or Polymer of Low
Concern. Where the hazard assessment is already available, e.g. from an overseas scheme,
then separate data need not be submitted.
5.1 Form of Application
An electronic template will be available on the website for applications.
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11 NOTICE OF PUBLICATION OF CALCIUM LONG CHAIN ALKYL BENZENE
SULPHONATE (INFINEUM C9350) SECONDARY NOTIFICATION SUMMARY
REPORT
Calcium long chain alkyl benzene sulphonate (Infineum C9350) has been assessed as an
existing chemical secondary notification under the Commonwealth Industrial Chemicals
(Notification and Assessment) Act, 1989 (the Act).
A summary report has been prepared in accordance with subsection 60F(4) of the Act, and is
published here.
Calcium long chain alkyl benzene sulphonate secondary notification summary report
1. Chemical Identity
1.1 Name
Calcium long chain alkyl benzene sulphonate
1.2 Registry numbers
CAS No.: Confidential
EINECS No.: None
1.3 Trade names
Infineum C9350
2. Applicants
INFINEUM AUSTRALIA PTY LIMITED
Level 2, 6 Riverside Quay
Southbank VIC 3006
MOBIL OIL AUSTRALIA PTY LIMITED
12 Riverside Quay
Southbank VIC 3006
An assessment report (Report No.486S) has been published under section 60F of the Act and
is available from the NICNAS website at:
http://www.nicnas.gov.au/Publications/CAR/Other.asp
The publication of this report revokes the declaration of calcium long chain alkyl benzene
sulphonate (Infineum C9350) as a chemical for secondary notification under section 62 of the
Act.
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Hard copies of the report are available from NICNAS at the following address:
GPO Box 58, Sydney,
NSW 2001, Australia
Freecall: 1800 638 528
or may be requested by:
Tel: (02) 8577 8883; Fax: (02) 8577 8888; Email: stephen.zaluzny@nicnas.gov.au
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115
12 NOTICE OF PUBLICATION OF HFE7100 SECONDARY NOTIFICATION
SUMMARY REPORT
The industrial chemical, HFE 7100 (CAS number not assigned) has been assessed as an
existing chemical secondary notification under the Commonwealth Industrial Chemicals
(Notification and Assessment) Act, 1989 (the Act).
A summary report has been prepared in accordance with subsection 60F(4) of the Act, and is
published here.
HFE 7100 secondary notification summary report
1. Chemical Identity
1.1 Name Mixture of methoxynonafluoroisobutane & methoxynonafluorobutane
1.2 Registry numbers
CAS No.: None
USA Premanufacture Notice (PMN) Number P99-531
1.3 Trade name
HFE 7100
2. Applicant
3M Australia Pty Ltd
25-27 Bridge St
Pymble
NSW 2073
An assessment report (Report NA/482S) has been published under section 60F of the Act and
is available from the NICNAS website at:
http://www.nicnas.gov.au/Publications/CAR/Other.asp
The publication of this report revokes the declaration of HFE 7100 as a chemical for
secondary notification under section 62 of the Act.
Hard copies of the report are available from NICNAS at the following address:
GPO Box 58, Sydney,
NSW 2001, Australia
Freecall: 1800 638 528
or may be requested by:
Tel: (02) 8577 8883; Fax: (02) 8577 8888; Email: stephen.zaluzny@nicnas.gov.au
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13 AMENDMENT TO ASSESSMENT REPORT
POLYMER IN F-25 (PLC/562)
Please note that an addendum has been attached to the full public report for Polymer in F-25,
Reference No. PLC/562, to incorporate further toxicological details. The summary report
remains unchanged.
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14 NEW DATA ON Z-44
Z-44 was assessed by NICNAS as NA/907 and a public report published in 2001. Lubrizol
International Inc recently submitted an additional study report: "A 4-week dermal toxicity
study in rats with a 2-week recovery phase using OS162170C" for the notified chemical, Z-
44. This study was not available at the time of assessment of Z-44 as a new chemical.
A summary of the new study is provided below. The summary will be appended to the
NA/907 public report.
The study was performed according to the USEPA Health Effects Test Guidelines (OPPTS
870.3200) which is similar to the OECD TG410. The study was conducted in rats with
dermal application of 0, 100, 250, 500, 1000 mg/kg bw/day, 6 hours per day, 5 days per week
for 4 weeks. No mortality was observed in male or female rats. Sporadic instances of mild
irritation were observed in all groups during the main phase of this study, but were more
prominent in the males. No dermal irritation was observed in either males or females during
the recovery phase of this study. The No Observed Adverse Effect Level (NOAEL) was
established as 1000 mg/kg/day in the males and 500 mg/kg/day in the females based on
thyroid effects seen in females only at 1000 mg/kg/day.
Due to the low toxicity profile shown in this 4-week dermal toxicity study in rats, this
additional study does not trigger a secondary notification, according to Section 64(2)(e) of the
Industrial Chemicals (Notification and Assessment) Act 1989.
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15 POSITION PAPER ON DATA REQUIREMENTS FOR NOTIFICATION OF
NEW CHEMICAL SUBSTANCES CONTAINING A PERFLUORINATED CARBON
CHAIN
The widespread occurrence of certain perfluorinated substances in the environment, in certain
animal species and in humans has attracted regulatory concern and/or action globally.
Perfluorinated substances are known to be persistent, some of them bioaccumulate,
particularly those with long carbon chains and some have been reported to cause toxic effects
in laboratory animals.
Given these concerns, NICNAS is adopting a default position for assessing potential health
and environmental hazards of new chemicals containing a perfluorinated carbon chain.
The NICNAS Position Paper is available on the NICNAS website at
http://www.nicnas.gov.au/Industry/New_Chemicals/Information_Requirements_Perfluorinate
d_PDF.pdf. This position paper outlines the default position and the data that would be
required where a notifier believes that the default position should not apply for a specific
chemical.
If you wish to discuss submission of notifications of perfluorinated chemicals covered in the
NICNAS Position Paper please contact Hana Hamdan on tel 02 8577 8855 (email:
hana.hamdan@nicnas.gov.au) or Louise Stedman on tel 02 8577 8830 (email:
louise.stedman@nicnas.gov.au)
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16 NOTICE OF OUTCOME OF AAT APPEAL ON FORMALDEHYDE
Formaldehyde was assessed as a priority existing chemical (PEC) under the Industrial
Chemicals (Notification and Assessment) Act, 1989 (the Act), as amended.
The publication of the assessment report was withheld in December 2005 due to the lodging
of applications in the Administrative Appeal Tribunal (AAT) for review of some decisions
made by the NICNAS Director on the variation requests to the draft assessment report.
The applications were withdrawn and the AAT has ordered that the applications be dismissed
and the final report can now be published.
The report is being formatted and it is anticipated that it will be available (on the NICNAS
website and in hard copy form) by 30 November 2006.
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120
17 PUBLICATION SUMMARY REPORT
Bionolle Series #1000
Summary Report
Reference No: LTD/1237
Bio-Deg Mouldings Pty. Ltd. (ABN: 40 090 078 489) of 3 Crane Court, Toowoomba, QLD,
4350 has submitted a limited notification statement in support of their application for an
assessment certificate for Bionolle Series #1000. The notified polymer is intended to be used
in the industrial manufacture of biodegradable plant pots for commercial and consumer use.
The notified polymer may also be potentially used for the manufacture of coffins and
furniture (such as chairs and tables). Up to 920 tonnes of the notified polymer will be
imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data the notified polymer is not classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical as introduced, during cutting or wher
dust is generated:
- Local exhaust ventilation
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer as introduced:
- Avoid skin and eye contact
- Avoid breathing dust
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? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced:
- Gloves
- Safety goggles
- Coveralls
- Dust masks
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? The notified polymer should be disposed of to landfill or by incineration.
Emergency procedures
? Spills or accidental release of the notified polymer should be handled by containment
and collected (via sweeping generally) and then placed in labelled containers ready
for disposal.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the polymer has a number-average molecular weight of less than 1000; or
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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18 PUBLICATION SUMMARY REPORT
Polymer in A-5D
Summary Report
Reference No: LTD/1243
OFB Flexible Solutions Distribution Australia Pty Ltd (ACN: 116 511 034 1) of Unit 3, 27
Jeays St, Bowen Hills QLD 4006 has submitted a limited notification statement in support of
their application for an assessment certificate for Polymer in A-5D. The notified polymer is
intended to be used as a scale inhibitor in on and offshore oil field applications. Up to 30
tonnes of the notified polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data the notified polymer is not classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced:
- Eye protection
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
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Disposal
? The notified polymer should be disposed of by landfill.
Emergency procedures
? Spills or accidental release of the notified polymer should be contained with an
absorbent material and dispose of in accordance with federal, state and local
regulations.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the polymer has a number-average molecular weight of less than 1000; or
- there is a significant release into the soil and aquatic environments from the proposed
use in oil field application.
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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19 PUBLICATION SUMMARY REPORT
1H-Indole-5,6-diol, 2,3-dihydro-,hydrobromide
Summary Report
Reference No: LTD/1253
Henkel Australia Pty Ltd (ABN 82 001 302 996) of 20 Rodborough Road, Frenchs Forest
NSW 2086 has submitted a limited notification statement in support of their application for
an assessment certificate for 1H-Indole-5,6-diol, 2,3-dihydro-, hydrobromide. The notified
chemical is intended to be used as a component of hair dye formulation. Up to one tonne of
the notified chemical will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data the notified chemical is classified as hazardous under the NOHSC
Approved Criteria for Classifying Hazardous Substances. The classification and labelling
details are:
R22 Harmful if swallowed
R33 Danger of cumulative effects
R41 Risk of serious damage to eyes
R43 May cause sensitisation by skin contact
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health when used in the proposed manner and
provided the hair dye formulations are adequately labelled to indicate skin sensitisation and
eye irritation potential.
Environmental Effects
The chemical is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Regulatory Controls
Hazard Classification and Labelling
? The Office of the ASCC, Department of Employment and Workplace Relations
should consider the following health hazard classification for the notified chemical:
- R22 Harmful if swallowed
- R33 Danger of cumulative effects
- R41 Risk of serious damage to eyes
- R43 May cause sensitisation by skin contact
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125
- S24/25 Avoid contact with skin and eyes
- S26 In case of contact with eyes, rinse immediately with plenty of water and
seek medical advice
- S37 Wear suitable gloves
- S39 Wear eye/face protection
? Use the following risk phrases for products/mixtures containing the notified chemical:
- Conc 25%: R22;
- Conc 10%: R41
- 5% < Conc < 10%: R36/37/38
- Conc 1%: R33; R43
? The National Drugs and Poisons Standing Committee (NDPSC) should consider the
notified chemical for listing on the SUSDP.
? Products containing the notified chemical and available to the public must carry the
following safety directions on the packaging label and the use directions:
- WARNING: This product contains ingredients which may cause skin irritation
to certain individuals. A preliminary test according to the accompanying
directions should be made before use. This product must not be used for dyeing
eyelashes or eyebrows; to do so may be injurious to the eye.
- USE AS DIRECTED. May cause cumulative effects if use exceeds the
recommended application volumes and/or pattern.
- If in eyes wash out immediately with water.
- Keep out of reach of children.
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical in the hair dye
formulation:
- Avoid contact with skin and eyes
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical in the hair dye
formulations:
- impermeable gloves
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
provisions of State and Territory hazardous substances legislation must be in
operation.
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Public Health
? The notified chemical should not be used in personal cosmetic products in
concentration >2%.
? The following measures should be taken by the notifier to minimise public exposure
to the notified chemical:
- Gloves should be supplied with hair dyes containing the notified chemical
intended for sale to the public
Disposal
? The notified chemical should be disposed of by landfill.
Emergency procedures
? For small and large spills, wear eye protection and rubber gloves. Wipe area with a
wet mop/cloth and rinse spill area and cloth with water. Absorb any escaping liquid
with an inert absorbent material (sand, vermiculite). Dispose of waste in accordance
with local, state and federal regulations.
Post-Assessment Obligations
AICS annotation?br>
When the notified chemical is added to the Australian Inventory of Chemical Substances
(AICS), it should be annotated with the following condition of use:
? When used as a hair dye, use is restricted to formulations applied without peroxide or
other oxidative agent, at concentrations 2%.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- used in personal care products other than hair dye formulations;
- additional toxicity studies such as Local Lymph Node Assay (LLNA) for skin
sensitisation and Subchronic Dermal Toxicity: 90-day Study, become available
- any adverse reaction reports related to the use of the notified substance become
available
- if any regulatory action concerning the notified chemical occurs in other jurisdictions,
eg the European Union.
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
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The Director will then decide whether secondary notification is required
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20 PUBLICATION SUMMARY REPORT
Oxirane, methyl-, polymer with oxirane, ether with 2,4,7,9-tetramethyl-5-
decyne-4,7-diol (2:1)
Summary Report
Reference No: LTD/1266
Swift & Company Ltd (ABN 44 000 005 578) of Level 1, 372 Wellington Rd, Clayton VIC
3170 has submitted a limited notification statement in support of their application for an
assessment certificate for Oxirane, methyl-, polymer with oxirane, ether with 2,4,7,9-
tetramethyl-5-decyne-4,7-diol (2:1). The notified polymer is intended to be used in coating,
ink and adhesive applications for industrial and do-it-yourself (DIY) applications. Less than
1 tonne of the notified polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data the notified polymer is classified as hazardous under the NOHSC
Approved Criteria for Classifying Hazardous Substances. The classification and labelling
details are:
Xi: Irritant
R41: Risk of serious damage to eyes
S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice
S39: Wear eye/face protection
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health when used in the proposed manner.
Environmental Effects
On the basis of the PEC/PNEC ratio:
The chemical is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Regulatory Controls
Hazard Classification and Labelling
? The Office of the ASCC, Department of Employment and Workplace Relations
(DEWR), should consider the following health hazard classification for the notified
polymer:
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129
- Xi: Irritant
- R41: Risk of serious damage to eyes
? The following safety phases for the notified polymer are recommended:
- S26: In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice
- S39: Wear eye/face protection
? Use the following risk phrases for products/mixtures containing the notified polymer:
- > 10%: R41
- 5% < concentration < 10%: R36
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer as introduced in
coating, ink and adhesive product:
- Avoid contact with skin and eyes
- Avoid splashes and spills
- Wash eye promptly if exposed
- Do not breathe spray
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced in
coating, ink and adhesive product:
- Suitable protective clothing
- Eye/face protection
- Suitable gloves
- Suitable respirators where inhalation exposure is possible
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical as introduced and in the formulated
paint product:
- Avoid generation of aerosols during paint formulation and preparation
- Spray application should be carried out in an enclosed automated spray booth
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
provisions of State and Territory hazardous substances legislation must be in
operation.
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Public Health
? The following measures should be taken by D.I.Y. applicators to minimise exposure
to formulation containing the notified polymer:
- Avoid contact with skin and eyes
- Do not breathe spray
Disposal
The notified polymer should be disposed of by authorised landfill. If the notified polymer is
part of a paint product allow to harden before disposal.
Emergency procedures
Spills or accidental release of the notified polymer should be handled by physical
containment such as diking of the product. Absorb using inert material such as vermiculite or
sand and collect and transfer to suitable labelled containers for disposal.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the notified polymer is included in products for consumer use at concentrations >5%
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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131
21 PUBLICATION SUMMARY REPORT
Zinc Acrylate Polymer in RC3707 and RC3708
Summary Report
Reference No: LTD/1269
Akzo Nobel Pty Limited (ABN: 59 000 119 424) of 115 Hyde Rd Yeronga QLD 4104 has
submitted a limited notification statement in support of their application for an assessment
certificate for Zinc Acrylate Polymer in RC3707 and RC3708. The notified polymer is
intended to be used as an additive in the manufacture of anti-fouling paint to be used on
ships. Up to 50 tonnes of the notified polymer will be imported per annum for each of the
first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data have been provided for the notified polymer and therefore the
substance cannot be classified in accordance with the NOHSC Approved Criteria for
Classifying Hazardous Substances.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used as described.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer as introduced, and as
diluted for use in formulated paint products:
- Avoid skin and eye contact
- Avoid breathing spray
- Collect and dispose of over-spray without exposing workers to dust
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced, and
as diluted for use in formulated paint products:
- Chemical resistant gloves
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- Protective clothing
- Appropriate respiratory protection where there is potential exposure to spray or dust
during end use
? Spray application of paint containing the notified polymer should be in accordance
with the NOHSC National Guidance Material for Spray Painting.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? The notified polymer should be disposed of by authorised landfill.
Emergency procedures
? Spills or accidental release of the notified polymer should be handled by physical
containment. Prevent entry into watercourses or drains. Remove sources of ignition
do not turn lights or unprotected electrical equipment on or off. Adsorb with inert
material (vermiculite, sand, earth etc.) and place in closed containers for disposal.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the polymer has a number-average molecular weight of less than 1000
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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22 PUBLICATION SUMMARY REPORT
Photomer 5930F
Summary Report
Reference No: LTD/1272
Cognis Australia Pty Ltd (ABN 87 006 374 456) of 4 Saligna Drive, Tullamarine, VIC, 3043
and BASF Coatings Pty Ltd (ABN 93 080 438 464) of 231-233 Newton Road Wetherill Park,
NSW, 2164 have submitted a limited notification statement in support of their application for
an assessment certificate for Photomer 5930F. The notified polymer is intended to be used as
a component of a radiation cured surface coating. Only application is expected to take place
in Australia. Up to 10 tonnes of the notified polymer will be imported per annum for each of
the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data was available and hence the notified polymer cannot be classified as a
hazardous substance in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances (NOHSC, 2004).
The notifier has classified the product in which the polymer is found as a skin, eye and
respiratory irritant (R36/37/38) based on the characteristics of similar polymers and the
potential effects of the impurity present at ~ 40%.
The notified polymer, as well as the impurity, contains a structural alert for skin sensitisation.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The chemical is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical as introduced:
- Avoid skin and eye contact
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134
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced:
- Chemical resistant gloves
- Protective clothing
- Safety goggles
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
provisions of State and Territory hazardous substances legislation must be in
operation.
Disposal
? The notified chemical should be disposed of by licensed contractor.
Emergency procedures
? Spills or accidental release of the notified chemical should be handled by physical
containment with reuse of the polymer to the extent practicable. Any residue should
be absorbed with dry inert material (sand vermiculite etc.) and placed into suitable
containers for disposal.
? Prevent product from entering drains.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the polymer has a number-average molecular weight of less than 1000
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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135
23 PUBLICATION SUMMARY REPORT
MR-8A
Summary Report
Reference No: STD/1130
Carl Zeiss Vision Australia Holdings Ltd (ABN 47 007 719 708) of Sherriffs Road Lonsdale,
South Australia 5162 has submitted a standard notification statement in support of their
application for an assessment certificate for MR-8A. The notified chemical is intended to be
used as a component of a thermoset resin system. Up to 5 tonnes of the notified chemical will
be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data the notified chemical is classified as hazardous under the NOHSC
Approved Criteria for Classifying Hazardous Substances. The classification and labelling
details are:
R26 Very toxic by inhalation
R22 Harmful if swallowed
R34 Causes burns
R42/43 May cause sensitisation by inhalation and skin contact
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used to produce cured, finished articles for
sale to the public.
Environmental Effects
The chemical is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Regulatory Controls
Hazard Classification and Labelling
? The Office of the ASCC, Department of Employment and Workplace Relations
should consider the following health hazard classification for the notified chemical:
T+: R26 Very toxic by inhalation
-
- Xn: R22 Harmful if swallowed
- C: R34 Causes burns
- R42/43 May cause sensitisation by inhalation and skin contact
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136
? Use the following risk phrases for products/mixtures containing the notified chemical:
- 25%:
- R26 Very toxic by inhalation
- R22 Harmful if swallowed
- R34 Causes burns
- R42/43 May cause sensitisation by inhalation and skin contact
- 25%> conc 10%
- R26 Very toxic by inhalation
- R34 Causes burns
- R42/43 May cause sensitisation by inhalation and skin contact
- 10%> conc 7%:
- R26 Very toxic by inhalation
- R36/38 Irritating to eyes and skin
- R42/43 May cause sensitisation by inhalation and skin contact
- 7%> conc 5%
- R23 Toxic by inhalation
- R36/38 Irritating to eyes and skin
- R42/43 May cause sensitisation by inhalation and skin contact
- 5%> conc 1%
- R23 Toxic by inhalation
- R42/43 May cause sensitisation by inhalation and skin contact
- 1%> conc 0.1%
- R20 Harmful by inhalation
Health Surveillance
? As the notified chemical is a health hazard, and belongs to a chemical class that is a
Schedule 3 sensitiser, employers should carry out health surveillance for any worker
who has been identified in the workplace risk assessment as having a significant risk
of inhalation or dermal exposure, in accordance with the relevant NOHSC guidelines
(NOHSC, 1990).
Control Measures
Exposure to the notified chemical should be controlled in all cases in accordance with the
NOHSC guidelines for this chemical class (NOHSC, 1990).
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical as introduced:
- Automated pumping of notified chemical from import containers to mixing vessel
- Automated dispensation of liquid resin to fill moulds
- Local exhaust ventilation during formulation, mould assembly, QA sampling and
maintenance work
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical as introduced, and
after curing during mould cleaning and assembly:
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137
- Avoid spills and splashing
- Ensure oven is cooled before opening to remove mould trays
- Only carry out mould assembly in a well ventilated room
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced,
and after curing during mould cleaning and assembly:
- Chemically impervious gloves
- Clothing that protects the body, arms and legs
- Goggles or face shield
- Respirator with appropriate filtering cartridge during transfer of notified chemical
from import containers to mixing vessel
- Positive pressure supplied air respirator during manual mould cleaning and mould
assembly
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? Atmospheric monitoring should be conducted during manufacture of cured articles
from the notified chemical, to ensure that workplace concentrations of notified
chemical do not exceed the exposure standards for this chemical class (NOHSC,
1990; NOHSC, 1995).
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
provisions of State and Territory hazardous substances legislation must be in
operation.
Disposal
? The notified chemical should be disposed of by incineration or secure landfill.
Storage
? The following precautions should be taken regarding storage of the notified chemical:
- Store in a fully bunded, well ventilated area
Emergency procedures
? Spills of the notified chemical and liquid resin should be contained with suitable
adsorbent material and care should be exercised not to allow material to enter drains
and watercourses. The adsorbent material should be transferred to plastic bags sealed
inside a drum and incinerated.
Secondary Notification
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138
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- the use pattern changes in such a way as to increase the exposure to the aquatic
compartment. At this time a full set of test aquatic toxicity testing should be supplied
for the notified chemical.
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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139
24 PUBLICATION SUMMARY REPORT
Diutan Gum
Summary Report
Reference No: STD/1193
Nuplex Industries (Aust) Pty Ltd (ABN 25 000 045 572) of 49-61 Stephen Road Botany
NSW 2019 has submitted a standard notification statement in support of their application for
an assessment certificate for Diutan gum. The notified polymer is intended to be used for a
wide variety of thickening and suspending applications. Up to 100 tonnes of the notified
polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data the notified polymer is not classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances.
Adverse lung effects eg congestion are possible if solid particles of the notified polymer are
inhaled.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described, with adequate controls to reduce inhalation exposure.
Public Health
There is No Significant Concern to public health when used in the proposed manner.
Environmental Effects
On the basis of the PEC/PNEC ratio the use of the chemical in:
- onshore uses will not pose a risk to freshwater organisms;
- offshore use may pose a potential problem in a narrow static cone under the release
point to marine organisms. However, if the effects of currents are taken into account
there will be an increased dissipation of the chemical, thus decreasing the risk.
Therefore, the potential risk associated with the use of the chemical in off-shore oil
rigs is likely to be acceptable.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering control to minimise
occupational exposure to the notified polymer during compounding and formulation:
- Operations should take place under local exhaust ventilation
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140
? Employers should implement the following safe work practices to minimise
occupational exposure during compounding and formulation:
- Avoid skin and eye contact
- Avoid breathing dust
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer during
compounding and formulation:
- Coveralls
- Impervious gloves
- Eye protection
- Suitable respiratory protection against respirable particles of the notified
polymer where dust is generated and adequate ventilation is not present.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
- The MSDS should contain the statement "May cause adverse effects on the lung
(congestion and mechanical irritation) if inhaled" under the heading "Chronic
health effects"
- The MSDS should provide instructions on avoiding inhalation exposure to the
notified polymer, including suitable engineering controls, safe work practices
and PPE.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Public Health
? The following measure should be taken by formulators and marketers to minimise
public exposure to the notified chemical:
- Where release of dry polymer from consumer products is possible, appropriate
labelling regarding ventilation and use of personal protective equipment should
be provided.
Disposal
? The notified polymer should be disposed in according to federal, EPA and state
regulations. Landfill should be acceptable.
Emergency procedures
? Spills or accidental release of the notified polymer should be handled by removing all
sources of heat. Increase ventilation. Sweep up material avoiding dust generation or
dampen spilled material with water to avoid airborne dust. Seal wastes in vapour tight
labelled plastic containers for eventual disposal. If large quantities of this material
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141
enter waterways contact Environmental Protection Authorities, or local Waste
Management Authorities.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(1) of the Act; if
- toxicity data is available on the notified polymer, including the results of any
inhalation toxicity studies.
- they become aware that products containing > 0.1% of the notified polymer in powder
form are available to the public.
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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142
25 PUBLICATION SUMMARY REPORT
Polymer in Elastopor H 1129/5/0
Summary Report
Reference No: STD/1195
BASF Australia Ltd (ABN 62 008 437 867) of 500 Princes Highway Noble Park Vic 3174
has submitted a standard notification statement in support of their application for an
assessment certificate for Polymer in Elastopor H 1129/5/0. The notified polymer is intended
to be used as a polyol component for production of rigid polyurethane foam. Up to 2000
tonnes of the notified polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the limited data available the notified polymer is not classified as hazardous under
the NOHSC Approved Criteria for Classifying Hazardous Substances.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The chemical is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer as introduced in the
products Terate 2541 V and Elastopor H 1129/5/0:
- Avoid skin and eye contact
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced in
the products Terate 2541 V and Elastopor H 1129/5/0:
- Chemical resistant gloves
- Protective clothing
- Safety goggles
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143
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? The notified polymer should be disposed of by landfill or incineration
Storage
? The following precautions should be taken regarding storage of the notified polymer:
- The notified polymer solution should be stored separate from acids, oxidising agents
and isocyanates.
Emergency procedures
? Spills/releases of products containing the notified polymer should not be released to
waterways, stormwater, soils or sewerage system.
? Spills/leaks of product should be contained by applying absorbent materials to the
spill and/or pumping to labelled sealable container(s). Scoop absorbed substance into
labelled sealed containers. Carefully collect all spill/leftover residues. Remove
contaminated soil and place in labelled sealable containers for appropriate disposal.
Clean contaminated surfaces with an excess of water and contain and collect all wash
waters for appropriate disposal. Wash equipment and clothing after clean-up and
contain wash waters for appropriate disposal and dispose of used personal protection
equipment appropriately. Dispose of all wastes in a manner consistent with local
waste management regulations.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
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26 PUBLICATION SUMMARY REPORT
Component in Tinocat TRS KB1/Tinocat TRS KB2
Summary Report
Reference No: STD/1228
Ciba Specialty Chemicals Pty Ltd (ABN 97 005 061 469) of 235 Settlement Road.
Thomastown VIC 3074 has submitted a standard notification statement in support of their
application for an assessment certificate for Component in TINOCAT TRS KB1/
TINOCAT TRS KB2. The notified chemical is intended to be used as an oxidation catalyst
for laundry care products and automatic dishwasher powders/tablets. Less than one tonne of
the notified chemical will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
Based on the available data, the notified chemical is classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances. The classification and
labelling details are:
- R43: May cause sensitisation by skin contact
Based on the results of a LLNA test in mice, the imported products TINOCAT?TRS KB1
and TINOCAT TRS KB2 (containing <10% notified chemical) are not classified as
hazardous in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances.
Occupational Health and Safety
There is low concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is insignificant concern to public health when used in laundry care products and
dishwasher powders/tablets.
Environmental Effects
The notified chemical is not considered to pose a risk to the environment based on its
reported use pattern.
RECOMMENDATIONS
Regulatory Controls
Hazard Classification and Labelling
? The Office of the ASCC, Department of Employment and Workplace Relations
(DEWR), should consider the following health hazard classification for the notified
chemical:
- R43: May cause sensitisation by skin contact
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145
? Use the following risk phrases for products/mixtures containing the notified chemical
(unless the product/mixture has been tested for its sensitisation potential as a whole):
- Conc 1%: R43: May cause sensitisation by skin contact
Control Measures
Occupational Health and Safety
? As the notified chemical is a skin sensitiser, employers should determine whether it is
necessary to carry out health surveillance for any worker who has been identified in
the workplace risk assessment as having a significant risk of the health effect.
? Sensitised workers should be advised not to further handle the notified chemical.
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical:
- a downdraft weighing booth or efficient local exhaust ventilation should be used
during operations involving handling the notified chemical.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical:
- face shield or safety goggles
- respiratory protection where inhalation of dust may occur
- protective gloves
- industrial clothing
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
provisions of State and Territory hazardous substances legislation must be in
operation.
Disposal
? The notified chemical should be disposed by incineration.
Emergency procedures
? Spills or accidental release of the notified chemical should be collected by licensed
waste contractors and be incinerated.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
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Under Section 64(1) of the Act; if
- the importation volume exceeds one tonne per annum notified chemical;
- the consumer product contains 1% of the notified chemical.
or
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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27 PUBLICATION SUMMARY REPORT
Poly(oxy-1,4-phenyleneoxy-1,4-phenylenecarbonyl-1,4-phenylene)
Summary Report
Reference No: PLC/620
Fluoro Pacific Pty Ltd (ABN 31 358 935 194) of 4 Chilvers Rd, Thornleigh NSW 2120 has
submitted a polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Poly(oxy-1,4-phenyleneoxy-1,4-
phenylenecarbonyl-1,4-phenylene). The notified polymer is intended to be
moulded/extruded/coated into various shapes and finished components for use in all
industrial sectors, including aerospace, automotive, food and beverage, wire and cable. Up to
10 tonnes of the notified polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were submitted. The notified polymer meets the PLC criteria and can
therefore be considered to be of low hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer during the powder coating process
where dust may be generated:
- Use of LEV if necessary when filling the hopper of a powder coating applicator
- Powder coating process being carried out in a spray booth design including the use of
LEV
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer during the powder
coating process where dust may be generated:
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148
- Use of a dust mask or respirator if necessary when filling the hopper of a powder
coating applicator
- Use of a mask or respirator while cleaning up dust residues with an industrial vacuum
cleaner and emptying and cleaning of the industrial vacuum cleaner
- Use of gloves and safety goggles
? In the interest of occupational health and safety, the following guidelines and
precautions should be observed for use of the notified polymer as introduced in
powder form
- The level of atmospheric nuisance dust should be maintained as low as possible. The
ASCC exposure standard for atmospheric dust is 10 mg/m3.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
MSDS
? The MSDS should be generated in accordance with NOHSC (2003) National Code of
Practice for the Preparation of Material Safety Data Sheets, 2nd edn. National
Occupational Health and Safety Commission, Canberra, Australian Government
Publishing Service.
Disposal
? The notified polymer should be disposed of by authorised landfill.
Emergency procedures
? Spills and/or accidental release of the notified polymer should be handled by physical
collection, while preventing dust build up. Reuse to extent practicable and place any
residue into suitable containers for disposal.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
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The Director will then decide whether secondary notification is required.
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28 PUBLICATION SUMMARY REPORT
Polymer in Pebax 33 Series
Summary Report
Reference No: PLC/656
Arkema Pty Ltd (ABN 44 000 330 772) of Ground Floor, 600 Victoria Street, Richmond VIC
3121 has submitted a polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Polymer in Pebax 33 series. The notified polymer
is intended to be used for plastic moulding and adhesive. Up to 10 tonnes of the notified
polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified polymer meets the PLC criteria and can therefore be considered to be of low
hazard. This is supported by toxicological endpoints observed in testing conducted on the
notified polymer or analogue chemical.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
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151
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? The notified polymer should be reused or recycled but otherwise can be disposed of to
landfill or by incineration , if available.
Emergency procedures
Spills and/or accidental release of the notified polymer should be handled by containment,
collection by sweeping and then placed in a sealable container ready for washing and reuse, if
possible, other wise disposed of to landfill.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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29 PUBLICATION SUMMARY REPORT
Latemul PD-450/PD-430/PD-420
Summary Report
Reference No: PLC/658
Kao (Australia) Marketing Pty Ltd (ABN 59 054 708 299) 1-5 Commercial Road
Kingsgrove NSW has submitted a polymer of low concern (PLC) notification statement in
support of their application for an assessment certificate for LATEMUL PD-450/PD-
430/PD-420. The notified polymer is intended to be used as an emulsifier for automotive
paint. Up to 5 tonnes of the notified polymer will be imported per annum for each of the first
five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified polymer meets the PLC criteria and can therefore be considered to be of
low hazard. This is supported by toxicological endpoints observed in testing conducted
on the notified polymer.
Endpoint Result Classified Effects Test Guideline
? Observed
?
Genotoxicity - bacterial non mutagenic no no OECD TG 471
reverse mutation (pre-
incubation method)
The result is indicative of low hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
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Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? Spray application of paint containing the notified polymer should be in accordance
with the NOHSC National Guidance Material for Spray Painting.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
Disposal
? The notified polymer should be disposed of to landfill.
Emergency procedures
? Spills and/or accidental release of the notified polymer should be handled by
sweeping or vacuuming spills to drums or containers.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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30 PUBLICATION SUMMARY REPORT
Polymer in Rilsan
Summary Report
Reference No: PLC/660
ARKEMA Pty Ltd (ABN: 44 000 330 772) of Ground Floor, 600 Victoria Street, Richmond
VIC 3121 has submitted a polymer of low concern (PLC) notification statement in support of
their application for an assessment certificate for Polymer in Rilsan. The notified polymer is
intended to be used in powder coating for interior and exterior of pipes carrying potable
water. Up to 100 tonnes of the notified polymer will be imported per annum for each of the
first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were submitted. The notified polymer meets the PLC criteria and can
therefore be considered to be of low hazard.
The molecular weight of the notified polymer is > 10, 000 and the fraction < 1000 MW is
low, therefore it is not likely to cross biological membranes to create systemic toxicity.
The notifier states that the notified polymer has been used in the EU and there is no record or
occurrence of work related health effects attributable to the handling and manufacture of the
polymer
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Engineering controls should be used to minimise levels of dust and any
decomposition products at the powder coating site.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
155
? No specific work practices or personal protective equipment are required for the safe
use of the notified polymer itself, however, these should be selected on the basis of all
ingredients in the formulation and the safe operation of powder coating procedures.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
Disposal
The notified polymer should be disposed of by thermal decomposition in an incinerator or to
landfill.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
156
31 PUBLICATION SUMMARY REPORT
Polymer in PU5
Summary Report
Reference No: PLC/663
Toxikos Pty Ltd (ABN 30095051791) of 293 Waverly Rd Malvern East, Vic 3145 has
submitted a polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Polymer in PU5. The notified polymer is
intended to be used as a component of printing ink. Up to 20 tonnes of the notified polymer
will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified polymer meets the PLC criteria and can therefore be considered to be of low
hazard. This is supported by toxicological endpoints observed in testing conducted on the
product PU5 containing 10-30% notified polymer. All results were indicative of low hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? Service personnel should wear cotton or disposable gloves and ensure adequate
ventilation is present when removing spent printer cartridges containing the notified
polymer and during routine maintenance and repairs.
? A copy of the MSDS should be easily accessible to employees.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
157
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
? Do not allow material or contaminated packaging to enter drains, sewers or water
courses.
Disposal
? The notified polymer should be disposed of in landfill.
Emergency procedures
? Spills/release of the notified polymer should be contained and absorbed with sand or
absorbent material. The used absorbent material, containing the notified polymer,
should be placed in a labelled, sealable container ready for disposal to landfill.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
158
32 PUBLICATION SUMMARY REPORT
Polymer in Takelac W-5661
Summary Report
Reference No: PLC/664
Ricoh Australia Pty Ltd (ABN: 30 000 593 171) of 8 Rodborough Road, Frenchs Forest,
NSW 2086 and Lanier Australia Pty Ltd (ABN: 39 001 568 958) of 854 Lorimar Street, Port
Melbourne, VIC 3207 have submitted a polymer of low concern (PLC) notification
statement in support of their application for an assessment certificate for Polymer in
TAKELAC W-5661. The notified polymer is intended to be used as a component of inks for
use in inkjet printer cartridges. Up to one tonne of the notified polymer will be imported per
annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were submitted. The notified polymer meets the PLC criteria and can
therefore be considered to be of low hazard.
An MSDS for the notified polymer in a more concentrated form states that it can cause some
eye irritation, and cause skin irritation after prolonged exposure. However, it is not classified
as a hazardous substance.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described
Public Health
There is No Significant Concern to public health when used in the proposed manner
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
159
? Service personnel should wear cotton or disposable gloves and ensure adequate
ventilation is present when removing spent printer cartridges containing the notified
polymer and during routine maintenance and repairs.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
? Do not allow material or contaminated packaging to enter drains, sewers or water
courses
Disposal
? The notified polymer should be disposed of in landfill.
Emergency procedures
? Spills/release of the notified polymer should be contained and absorbed with sand or
absorbent material. The used absorbent material, containing the notified polymer,
should be placed in a labelled, sealable container ready for disposal to landfill.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
160
33 PUBLICATION SUMMARY REPORT
Polymer in D8122 Ceramiclear
Summary Report
Reference No: SAPLC/50
PPG Industries Pty Ltd (ABN No.: 82 055 500 939) of Mc Naughton Road, Clayton, Victoria
3168 has submitted a polymer of low concern (PLC) notification statement in support of their
application for a self-assessed assessment certificate for Polymer in D8122 Ceramiclear. The
notified polymer is intended to be used in automotive refinish applications. Less than 3
tonnes of the notified polymer will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were submitted. The notified polymer meets the PLC criteria and can
therefore be considered to be of low hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? In the interest of occupational health and safety, the following guidelines and
precautions should be observed for use of the notified polymer as a component of
paint products:
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
161
- Adequate training for staff in handling paint products, including enforcing the
adherence of industrial spray painters to the NOHSC National Guidance Material for
Spray Painting;
- Implementation of general health surveillance and monitoring programs as required.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
? The following control measures should be implemented by customers to minimise
environmental exposure during use of the notified polymer:
- Bunding
- Exhaust ventilation with filter
Disposal
? The notified polymer should be disposed of to landfill or incinerated
? Empty containers should be sent to local recycling or waste disposal facilities.
Storage
? The following precautions should be taken by the notifiers regarding storage of the
notified polymer:
- bunding
Emergency procedures
? Spills/release of the notified polymer should be handled by absorbing with sand and
put into suitable containers for disposal. Contaminated containers can be reused after
cleaning.
? Do not flush the product containing the notified polymer into surface water or sewer
system.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
162
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
163
34 PUBLICATION SUMMARY REPORT
Polymer in EXL-2602
Summary Report
Reference No: SAPLC/60
Rohm and Haas Australia Pty. Ltd. (ABN 29 004 513 188) of 4th Floor, 969 Burke Road,
Camberwell, VIC, 3124 has submitted a polymer of low concern (PLC) notification
statement in support of their application for a self-assessed assessment certificate for
Polymer in EXL-2602. The notified polymer is intended to be introduced as a component of
a plastic moulding resin which will be used in injection moulding equipment to mainly
produce Original Equipment Manufacturers (OEM) automotive and electronic equipment
components. Up to 10 tonnes of the notified polymer will be imported per annum for each of
the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were submitted. The notified polymer meets the PLC criteria and can
therefore be considered to be of low hazard.
The notified polymer is, however, a high molecular weight, insoluble polymer and the
inhalation of respirable particles of this class of polymer has been linked with lung
overloading.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used in the proposed manner.
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its reported use
pattern
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? During the moulding process where dust may be generated, it is recommended that
local exhaust ventilation, dust respirators and safety glasses are used to minimise
exposure to the notified polymer dust, however, these and other engineering controls
and personal protective equipment should be selected on the basis of all ingredients in
the formulation.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
164
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? The notified polymer waste should be disposed of to landfill or incinerated.
- Empty containers should be sent to local recycling or waste disposal facilities
Emergency procedures
? Spills/release of the notified polymer should be collected and placed in suitable
containers for disposal.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
165
35 ACCESS TO FULL PUBLIC REPORT
NICNAS publishes a Full Public Report for each new chemical assessed. These reports are
available for public inspection at the library of the National Occupational Health & Safety
Commission at their Canberra office by appointment only. Please call the library on (02)
6121 7205 to arrange to view the Full Public Report.
Reports can also be viewed and downloaded free of charge from our website at
www.nicnas.gov.au. Copies of these reports may also be requested, free of charge, by
contacting the Administration Section of NICNAS by phone: (02) 8577 8800 or fax: (02)
8577 8888.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
166
36 LOW VOLUME CATEGORY PERMITS
The permits listed in Table 2 were issued to import or manufacture the following chemicals
under section 21U of the Industrial Chemicals (Notification and Assessment) Act 1989. Low
Volume Category Permits are approved for 36 months.
Table 1
Low Volume Category Permits
PERMIT COMPANY COMPANY CHEMICAL OR TRADE HAZARDOUS USE DATE
NUMBER NAME POSTCODE NAME SUBSTANCE
729 Givaudan Pty 2128 Florhydral ND Fragrance 26/09/06
(Renewal) Limited ingredient
730 Givaudan Pty 2128 Okoumal ND Fragrance 26/09/06
(Renewal) Limited ingredient
731 Givaudan Pty 2128 Pharaone Yes Fragrance 26/09/06
(Renewal) Limited ingredient
732 Givaudan Pty 2128 Floridile Yes Fragrance 26/09/06
(Renewal) Limited ingredient
733 Givaudan Pty 2128 Belambre Yes Fragrance 26/09/06
(Renewal) Limited ingredient
734 Givaudan Pty 2128 Carbamic acid, ND Fragrance 10/10/06
Limited dimethyl-, 1-ethenyl- ingredient
1,5-dimethyl-4-
hexenyl ester
735 Firmenich Ltd 2093 Aladinate Yes Fragrance 17/10/06
(Renewal) ingredient
736 Firmenich Ltd 2093 Sclareolate ND Fragrance 17/10/06
(Renewal) ingredient
737 Firmenich Ltd 2093 Lilyflore Yes Fragrance 17/10/06
(Renewal) ingredient
738 Firmenich Ltd 2093 Rosoxime ND Fragrance 17/10/06
(Renewal) ingredient
739 Firmenich Ltd 2093 Aldolone Yes Fragrance 23/10/06
(Renewal) ingredient
Chemical Gazette Commonwealth of Australia Gazette
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167
740 Firmenich Ltd 2093 Centifolether ND Fragrance 23/10/06
(Renewal) ingredient
741 Firmenich Ltd 2093 Jasmonitrile Yes Fragrance 23/10/06
(Renewal) ingredient
742 Firmenich Ltd 2093 Cyclopentol ND Fragrance 23/10/06
(Renewal) ingredient
N.D.: not determined; insufficient data available to effect a health effects classification under
Approved Criteria [NOHSC:1008(1999)]
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
168
37 COMMERCIAL EVALUATION CATEGORY PERMIT
The permits listed in Table 1 were issued to import or manufacture the following chemicals for
commercial evaluation under section 21G of the Industrial Chemicals (Notification and
Assessment) Act 1989.
Table 2
Commercial Evaluation Category Permits
PERMIT COMPANY COMPANY CHEMICAL OR HAZARDOUS QUANTITY USE PERIOD
NUMBER NAME POSTCODE TRADE NAME SUBSTANCE APPROVED
Yes 4000 kg Chemical 1 yr
672 Nuplex 2019 ADEKA
used in
Industries REASOAP
synthesis
(Aust) Pty Ltd SR-10
2 yrs
Yes 2000 kg Additive used
673 T.R. 2152 ACRYLATE
in the
(Chemicals ESTER IN
manufacture of
Australia) SARTOMER
flexographic
Pty Ltd CD278 printing plates
Yes 4000 kg Curable resin 2 yrs
674 DIC 3106 COMPONENT IN
for surface
International DAICURE 6200
coatings
(Australia)
(Renewal)
Pty Ltd
2 yrs
Yes 4000 kg Catalyst for
675 Qenos Pty 3018 COMPONENT OF
polyethylene
Ltd PRODZGY UT-
manufacture
B2-TRIM-X2
2 yrs
Yes 4000 kg Catalyst for
676 Qenos Pty 3018 COMPONENT OF
polyethylene
Ltd PRODIGY BMC-
manufacture
200-X2
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
169
38 EARLY INTRODUCTION PERMITS FOR NON-HAZARDOUS INDUSTRIAL
CHEMICALS
The permits listed in Table 3 were issued to import or manufacture the following chemicals
prior to the issue of their respective assessment certificates under section 30A of the Act.
Table 3
Early Introduction Permits
PERMIT COMPANY CHEMICAL OR TRADE USE
NUMBER NAME NAME
462 Bayer Desmophen C1200 and Component of surface coating
Australia Ltd Desmophen XP2501 and sealers
463 Ciba Polymer in IRGASURF SR Additive in thermoplastics
Specialty 100 manufacture to improve
Chemicals Pty scratch resistance
Ltd
464 General Lexan DMX2415/C891182 Plastic moulding
Electric
Plastics
(Australia)
Pty Ltd
465 Nuplex
Industries
(Aust) Pty Ltd
Polymer in Setalux 1157 XS- Component of paints used in
466 Akzo Nobel 54 the automotive industry
Car
Refinishes Pty
Ltd
467 DIC Polymer in Urotuf L522- Component of industrial
International MPW-40 paints
(Australia)
Pty Ltd
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
170
39 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES FIVE YEARS AFTER ISSUING OF
ASSESSMENT CERTIFICATES
Notice is given in accordance with section 14(1) of the Industrial Chemicals (Notification and
Assessment) Act 1989, that the following chemicals have been added to the Australian
Inventory of Chemical Substances.
Table 4
Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances
CHEMICAL NAME MOLECULAR CAS NUMBER
FORMULA
Cesium formate CH2O2.Cs 3495-36-1
Hexanedioic acid, polymer with 1,2- (C6H14O3.C6H10O 85214-48-8
ethanediol, 2-ethyl-2- 4.C4H10O3.C2H6O
(hydroxymethyl)-1,3-propanediol and 2)x
2,2'-oxybis[ethanol]
Aziridine, homopolymer, compound (C3H6O)nC4H11O4 222638-72-4
with alpha-phosphono-omega- P.x(C2H5N)x
butoxypoly[oxy(methyl-1,2-
ethanediyl)]
Oxirane, methyl-, polymer with C17H22N2O4.2(C3 908249-64-9
oxirane, ether with ethyl 3-[4-[bis(2- H6O.C2H4O)x
hydroxyethyl)amino]-2-
methylphenyl]-3-cyano-2-propenoate
(2:1)
Linseed oil, reaction products with Unspecified 908017-17-4
pentaerythritol, phthalic anhydride,
soybean oil and tung oil
2-naphthalenecarboxamide, 3- C25H20N4O4 56396-10-2
hydroxy-4-[[2-methoxy-5-
[(phenylamino)carbonyl]phenyl]azo]-
Poly(oxy-1,2-ethanediyl), .alpha.- (C9H6N2O2.(C2H4 908017-65-2
polymer O)n
hydro-.omega.-hydroxy-,
2,4-diisocyanato-1- C15H24O.(C2H4O)
with
methylbenzene and .alpha.- n H2O)x
(nonylphenyl)-.omega.-
hydroxypoly(oxy-1,2-ethanediyl)
9H-fluorene, 9,9- C17H18O2 182121-12-6
bis(methoxymethyl)-
2-Propenoic acid, 2-methyl-, telomer (C9H15NO2.C6H10 908017-61-8
with N-(1,1-dimethyl-3-oxobutyl)-2- O2.C5H8O2.C5H8
propenamide, ethyl 2-methyl-2- O2.C4H6O2)x.C3H
propenoate, ethyl 2-propenoate, 3- 6O2S.xH3N
mercaptopropanoic acid and methyl
2-methyl-2-propenoate, ammonium
salt
64366-79-6
1,2,3 propanetriol, homopolymer, C22H44O2.x(C3H8
O3)x
docosanate
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171
(C4H2O3.C3H4O2. 251479-97-7
2-Propenoic acid, polymer with
(C2H4O)nC6H12O
.alpha.-[4-(ethenyloxy)butyl]-
2)x.x Na
.omega.-
hydroxypoly(oxy-1,2-ethanediyl)
and 2,5-furandione, sodium salt
4-phenylbenzophenone C19H14O 2128-93-0
Propanoic acid, 3-hydroxy-2- (C12H18N2O2.C6H 908252-91-5
10O2.C5H12O2.C5
(hydroxymethyl)-2-methyl-, polymer
with 2,2-dimethyl-1,3-propanediol, H10O4.C3H10N2.(
.alpha.-hydro-.omega.- C3H6O)n
hydroxypoly[oxy(methyl-1,2- H2O)x.C6H15N
ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, 2-oxepanone
and 1,2-propanediamine, compd. with
N,N-diethylethanamine
Reaction product of 1,3-butadiene, Unspecified 147170-46-5
homopolymer, oligomeric with 2,5-
furandione
Fatty acids, C16-18 and C18-unsatd., Unspecified 870721-77-0
branched and linear, polymers with
adipic acid, benzoic acid, ethylene
glycol, glycerol, maleic anhydride,
phthalic anhydride and
trimethylolpropane
Rosin, polymer with bisphenol A, Unspecified 908015-44-1
branched 4-nonylphenol,
formaldehyde, fumaric acid,
pentaerythritol, soybean oil and
stearic acid
Fatty acids, sunflower-oil, Unspecified 870721-78-1
conjugated, polymers with benzoic
acid, glycerol, phthalic anhydride and
trimethylolpropane
Fatty acids, tall-oil, polymers with Unspecified 908015-51-0
C8-16-cycloalkadiene conc.
debenzenized light steam-cracked
petroleum naphtha, isophthalic acid,
light steam-cracked petroleum
naphtha C5-fraction oligomer conc.,
1-octadecene and soybean oil
Alcohols, C11-14-iso-, C13-rich, Unspecified 503044-91-5
ethoxylated, polymers with
epichlorohydrin and polyethylene
glycol
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
172
40 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF
CHEMICAL SUBSTANCES
Notice is given in accordance with section 20 of the Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act) that the following amendment have been made to the
Australian Inventory of Chemical Substances (AICS).
Table 5
Amendment to AICS
The following chemical details have been amended:
CAS NUMBER DELETED OTHER CORRECT OTHER
NAME NAME
79-33-4 d-lactic acid L-lactic acid
16731-55-8 Potassium metabisulfate Potassium metabisulfite
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
173
41 NOTICE OF CHEMICALS ELIGIBLE FOR IMMEDIATE LISTING ON THE
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES AFTER ISSUING OF
ASSESSMENT CERTIFICATES
Notice is given in accordance with section 13B of the Industrial Chemicals (Notification and
Assessment) Act 1989, that the following chemicals have been added to the Australian
Inventory of Chemical Substances.
Table 6
Chemicals Eligible for Immediate Listing on the Australian
Inventory of Chemical Substances
CHEMICAL NAME MOLECULAR CAS
FORMULA NUMBER
Acetic acid, (1-oxopropoxy)-, 1-(3,3- C15H26O4 236391-76-7
dimethylcyclohexyl) ethyl ester
(C15H22N2O2.C6H15 105167-53-1
Hexanedioic acid, polymer with N,N-
diethylethanamine 3-hydroxy-2- N.C6H10O4.C5H12O2
(hydroxymethyl)-2-methylpropanoate, 2,2- .C5H10O4.C2H8N2)x
dimethyl-1,3-propanediol, 1,2-ethanediamine and
1,1'-methylenebis[4-isocyanatocyclohexane]
2-Propenoic acid, 2-methyl-, methyl ester, (C5H8O2. 51822-08-3
polymer with 1,3-butadiene, and ethyl 2- C5H8O2.C4H6)x
propenoate
Oxirane, ethyl-, polymer with oxirane, mono(3- C5H10O. 438578-81-5
methyl-3-butenyl) ether (C4H8O.C2H4O)x
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 7 November 2006
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