Gazette
Commonwealth
of Australia
No. C 1, Tuesday, 1 January 2002
CHEMICAL
Published by the Commonwealth of Australia
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
NEW CHEMICALS
SUMMARY REPORTS
1 NA/897 ESCALOL HP 610 5
2 NA/920 1,1,1,3,3-PENTAFLUOROPROPANE 9
3 NA/933 NEXGUARD/NGIT POLYMER 17
4 NA/944 SUCRALOSE 20
5 NA/945 IMWITOR 370 23
6 NA/961 LUVIQUAT CARE (POLQUATERNIUM 44) 25
7 NA/973 KUDE-2 28
8 NA/985 FRUCTALATE 32
9 NA/988 POLYETHER EPOXY ACRYLIC E1CI06 35
10 PLC/245 E-1275 38
11 PLC/258 LE3590 42
12 PLC/262 POLYMER IN RP0971 45
13 PLC/266 POLYMER IN TECHNOLOGIC VARNISH 84FI400 48
14 PLC/270 DYNAPOL H700 51
15 ACCESS TO FULL PUBLIC REPORT 55
PERMITS ISSUED
16 COMMERCIAL EVALUATION PERMITS 56
17 LOW VOLUME CHEMICAL PERMITS 57
18 EARLY INTRODUCTION PERMITS 58
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE
19 59
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE
YEARS AFTER ISSUE OF ASSESSMENT CERTIFICATE
EXISTING CHEMICALS
PRIORITY EXISTING CHEMICALS PROGRAM-CALL FOR
20 62
INFORMATION-SECTION 48
SPECIAL NOTICES
AMENDMENTS TO ADOPTED NATIONAL EXPOSURE 64
21
STANDARDS FOR ATMOSPHERIC CONTAMINANTS IN THE
OCCUPATIONAL ENVIRONMENT
5
1 PUBLICATION SUMMARY REPORT
Escalol HP 610
Summary Report
Reference No: NA/897
ISP (Australasia) Pty Ltd (ACN No.: 000 011 923) of 73-75 Derby St Silverwater NSW 2141
has submitted a standard notification statement in support of their application for an
assessment certificate for Escalol HP 610. The notified chemical is intended to be used as a
component in cosmetic formulations. Up to 1 tonne of the notified chemical will be imported
per year for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified chemical was of very low acute oral toxicity in rats (LD50 > 5000 mg/kg) and
low dermal toxicity (LD50 > 2000 mg/kg) in rabbits. The notified chemical was a slight skin
irritant in rabbits and, at the least, a severe eye irritant in rabbits. The notified chemical was
negative in a human repeat insult patch test, human photoallergy and human phototoxicity
tests and was neither mutagenic in bacteria nor clastogenic in human lymphocytes.
The notified chemical did not exhibit appreciable organ toxicity in a 28-day repeated dose
toxicity study in rats. The NOEL was 15 mg/kg/day and the NOAEL, 150 mg/kg/day.
The notified chemical is determined to be a hazardous substance in accordance with NOHSC
Approved Criteria for Classifying Hazardous Substances and is assigned the risk phrase R41:
risk of serious damage to eyes.
The notified chemical is to be imported at a concentration of 65% and formulated into
products at a maximum concentration of 1%. The products would not be classified as eye
irritants in accordance with NOHSC Approved Criteria for Classifying Hazardous
Substances.
Occupational Health and Safety
The notified chemical as imported is a severe eye irritant. If the plastic containers in which
the notified chemical is to be imported are ruptured accidentally, any spillage should be
contained as the notified chemical is a waxy solid and eye contact can be avoided.
The containers of the notified chemical are heated prior to weighing out either into a plastic
bucket for manual addition to a large mixing vessel or into a large plastic container of diluent
prior to addition to a similar large mixing vessel via a stopcock. Inhalation exposure is
unlikely due to the low vapour pressure of the notified chemical but dermal exposure is
possible. Ocular exposure would most likely occur via secondary transfer from gloves or
possibly from splashes. Workers are said to be wearing either full protective equipment or
overalls, industrial safety shoes, facemask and gloves. Under these conditions the risk of
serious eye damage is minimised. Mixing and dispensing the final products is automated and
worker exposure should be minimal. Quality control sampling should also result in limited
worker exposure as the maximum concentration is less than 2% and there is minimal risk of
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No. C 1, 1 January 2002
6
eye irritation. Equipment washing and maintenance procedures should also result in minimal
exposure and little risk of eye irritation.
One of the products, a hair colourant, is for consumer use. If the other product, a hair
conditioner, is used in salons, there should be little risk of eye irritation in hairdressers due to
the low concentration of the notified chemical in the product.
Public Health
The use of the finished hair protection products is likely to be widespread among consumers.
The nature and extent of the public exposure to the notified chemical is likely to vary with the
frequency of application, the care taken with applications, the amount of hair care product
applied on any occasion and with the frequency of hair washing. The product will be applied
to the hair but dermal contact with the notified chemical is likely and ocular contact is
possible. Nevertheless the low concentration of the notified chemical in the proposed
consumer formulations and the toxicological profile of the notified chemical suggest that it
will not pose a significant hazard to public health when used in the proposed manner and at
the proposed concentrations in the finished products.
Environmental Effects
The intended use pattern of the notified chemical is expected to result in the majority of the
chemical being eventually released to the environment. However, this will be in a dilute
form as the notified chemical contained within the hair care products will be released from
domestic use at low concentrations. The ecotoxicity data indicate the notified chemical is
practically non-toxic to activated sludge, moderately toxic to fish, highly toxic to daphnia and
very highly toxic to algae based on measured concentrations.
In a worst case based on maximum annual imports of 1 tonne per annum, all of which is
released to sewer and assuming that none is removed during sewage treatment processes,
assuming a national population of 19,000,000 and that each person contributes an average
150 L/day to overall sewage flows, the predicted concentration in sewage effluent on a
nationwide basis is estimated as 0.96 microgram/L.
When released to receiving waters the concentration is generally understood to be reduced by
a further factor of at least 10, and so the Predicted Environmental Concentration (PEC) is
approximately 0.1 microgram/L.
The nationwide PEC estimate indicates that after discharge to receiving waters the
environmental concentration of the notified chemical will be 2 orders of magnitude less than
the demonstrated toxicity to algae (EC50 = 0.064 mg/L). This is just inside the 100 safety
margin recommended by the OECD and note above the discussion about the reliability of the
result. However, the risk to aquatic organisms will be further mitigated by the removal of the
notified chemical through association with dissolved organic carbon from soils and sediment.
This is expected to bind to the notified chemical, neutralising its positive charge and
removing it from the aquatic compartment thus making it less bioavailable and less toxic to
aquatic organisms. Therefore even though the notified chemical is soluble in water, its
concentration in the aquatic compartment is expected to be significantly less than the
calculated PEC because it will adsorbed to soil and sediment due to its cationic nature and be
removed from the aquatic compartment. If a total of 50 or 90% of the notified chemical was
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7
adsorbed to soil and sediment the revised PECs would be 0.048 and 0.0096 microgram/L, the
latter being 3 orders of magnitude less than the demonstrated toxicity to algae.
Wastes containing the notified chemical including residues from imported drums and from
repackaging will also be disposed of in landfill where it is expected to adsorbed to soil and
sediment due to its cationic nature.
Therefore, the environmental exposure and overall environmental hazard from the notified
chemical is considered to be acceptable.
RECOMMENDATIONS
Regulatory controls
? The NOHSC Chemicals Standards Sub-committee should consider the following
health hazard classification for the notified chemical:
- R41: risk of serious damage to eyes
? Use the following risk phrases for products/mixtures containing the notified chemical:
- concentration cut-off: > 10%, risk phrase: R41; 5% < conc < 10%, risk phrase:
R36: irritating to eyes
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:
- spillage should be avoided and should be cleaned up and placed in container for
disposal
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced, as:
- chemical goggles with side shields or full facemask, gloves and protective
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.
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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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2 PUBLICATION SUMMARY REPORT
1,1,1,3,3-Pentafluoropropane
Summary Report
Reference No: NA/920
Honeywell Polymers of 71 Queens Rd, Melbourne, VIC, together with Huntsmen
Polyurethanes of Gate 3 Ballarat Rd, Deer Park, VIC. and Ariel Industries of 26 Kembla St.
Cheltenham, VIC., have submitted a standard notification statement in support of their
application for an assessment certificate for HFC-245fa. The notified chemical is intended to
be used as a blowing agent for production of polyurethane, polyisocyanurate, polystyrene,
polyolefin and other polymeric foams; also as a refrigerant and as an industrial aerosol
solvent. The volume of HFC-245fa used in refrigerant and industrial aerosol solvent uses will
be small, at approximately 5-10% of the total volume imported. Less than 500 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
The notified chemical, HFC-245fa, is a liquid or vapour at ambient temperature and pressure
so most of the toxicological studies conducted to date have used the inhalation route of
exposure. In inhalation studies in rats and mice, HFC-245fa was of very low acute toxicity.
Consistent with findings in structurally similar chemicals, HFC-245fa was shown to induce
cardiac sensitisation. In an inhalation study in dogs, a NOAEL of 34 100 ppm (187 mg/L)
was established, based on cardiac arrhythmias and clinical responses at the next dose, 44 000
ppm. In a 2-week dog study, cardiac sensitisation was not observed at vapour concentrations
up to 35 500 ppm.
Several repeated dose inhalation studies were conducted in rats. In a 2-week range-finding
study at concentrations up to 50 433 ppm, findings were limited to clinical chemistry
parameters including blood urea nitrogen and liver enzyme changes. In the following 28-day
study at concentrations up to 49 600 ppm, similar results were obtained, with a NOEL of 516
ppm (2.83 mg/L) established, based on statistically significant increases in urinary fluoride
levels. In the subsequent 13-week study at concentrations up to 50 555 ppm, a dose-related
incidence in myocarditis was observed in addition to the clinical chemistry changes noted in
the preliminary studies. Focal myocarditis was taken to be spontaneous as it was seen in
control and treated rats, however, diffuse myocarditis was observed in animals at the 10 000
and 50 000 nominal doses and in one animal at 2069 ppm, with the NOAEL taken to be 508
ppm (2.78 mg/L).
In an inhalation study in pregnant rats, the NOEL for maternal toxicity and developmental
toxicity were determined to be 2069 ppm (11.3 mg/L) and 10 347 ppm (56.7 mg/L)
respectively, based on decreased body weight and food consumption in dams and decreased
mean weights in foetuses. No skeletal abnormalities were observed in foetuses at any dose.
In bacteria HFC-245fa was not mutagenic. In human peripheral lymphocytes, HFC-245fa
was weakly clastogenic without metabolic activation. In vivo, the notified chemical did not
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show evidence of chromosome damage or bone marrow cell toxicity in a mouse
micronucleus assay.
Based on the data provided, the notified chemical is not classified as a hazardous substance
according to the NOHSC Approved Criteria for Classifying Hazardous Substances. However,
as a NOHSC exposure standard is recommended (see below), HFC-245fa is a hazardous
substance for the purposes of workplace regulations.
Being a liquid with a low boiling point (15癈), HFC-245fa is generally handled as a
refrigerated liquid in a pressure vessel. Under these circumstances, the notified chemical does
not meet the Class 2.2 dangerous good classification in accordance with the ADG Code.
However, when packaged with a nitrogen pad, HFC-245fa is a Class 2.2 dangerous good.
At elevated temperatures (250oC), HFC-245fa decomposes to produce hazardous
hydrofluoric acid, which is highly toxic and corrosive and has a NOHSC exposure standard
of 3ppm peak limitation.
Occupational Health and Safety
The critical health effect for acute exposure is cardiac sensitisation, with the lowest NOAEL
being 34 100 ppm, established in a dog inhalation study. For chronic effects, the critical
health effect is diffuse myocarditis, observed in a 90-day rat inhalation study. For the
purposes of the risk assessment, the NOAEL from this study, 508 ppm, will be used for
chronic exposure.
Due to the volatility of HFC-245fa, exposure to the notified chemical is largely by the
inhalation route. Dermal exposure may occur when handling the chemical in concentrated
form at room temperature or below, however, evaporation would be rapid in these
circumstances.
Use as blowing agent rigid polymeric foams
Manufacture of polyol blend
Manufacture of the blend occurs in a closed system, however, dermal and inhalation exposure
may occur during addition of HFC-245fa to the mixing vessel and during discharge of the
blend to steel drums or IBCs. Exposure may also occur when connecting and disconnecting
pump lines, during cleaning and maintenance, and during sampling by laboratory quality
control staff.
From limited monitoring data available, the margin of exposure (MOE) for cardiac
sensitisation is 34 100/1255 = 27, indicating some cause for concern.
In the absence of time-weighted average (TWA) monitoring data, e.g. for an 8-hour shift, the
vapour concentration predicted from EASE, 100 ppm, is used. The resultant MOE for
myocarditis is 508/100 = 51, indicating a slight cause for concern.
Foam manufacture and use
Exposure during foam manufacture is likely to be similar to polyol blend manufacture as the
process is largely enclosed with opportunities for exposure to HFC-245fa during the charging
and discharging operations. Exposure may be higher during discharge as it is estimated that
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up to 3% of the blowing agent (HFC-245fa) may be lost. Using a worst-case EASE estimate
of 200 ppm, the MOE for myocarditis is 508/200 = 25, indicating some cause for concern,
particularly when 8-hour exposures of up to 488 ppm have been reported for a similar
chemical HCFC-141b.
During foam application, exposure to the notified chemical may be more open, however,
HFC-245fa is present at a lower concentration in the matrix (5-15% in foam). The only
personal monitoring data available were for roof insulation, where 8-hour TWA results up to
43 ppm were obtained for the spray nozzle cleaner. Lower values were obtained for the gun
operator (19 ppm) and hoseman (15 ppm). Taking 50 ppm as a typical atmospheric
concentration during such application, the MOE is 508/50 = 10, indicating some cause for
concern. European exposure monitoring data indicated lower personal exposures (3-10 ppm)
during foam application.
Several sets of instantaneous atmospheric monitoring (grab sampling) data were provided by
the notifier for foam application, primarily for the foam filling of refrigerator cabinets and
doors. Vapour concentrations were extremely variable, ranging from not detectable to greater
than 6000 ppm, a value obtained immediately after the foam shot. However, an operator
would not be expected in the vicinity of this reading, so a concentration of 288 ppm obtained
near an operator at the same time is regarded as more suitable for the risk estimate. Taking
300 ppm as a worst-case scenario, the MOE for cardiac sensitisation is 34 100/300 = 114,
indicating little cause for concern. One set of data was available for boardstock production,
with vapour concentrations ranging from not detectable to 795 ppm, a value obtained directly
above the foam pour area. Taking 800 ppm as a worst-case scenario, the MOE for cardiac
sensitisation is 34 100/800 = 43, indicating a slight cause for concern.
Once manufactured, losses of HFC-245fa from the foam matrix are expected to be minimal
as long as the foam remains uncut due to the closed cell nature of the foam and the
compatibility of HFC-245fa with the foam matrix.
Use as working fluid in centrifugal water chillers
As a refrigerant for centrifugal water chillers, HFC-245fa will be used in closed systems.
Exposure to the notified chemical is not expected once the chiller has been charged with
HFC-245fa, except in the case of a cylinder or chiller leak. In data provided by the notifier,
measured service technician exposure levels were rarely found to exceed 0.5 ppm for an 8
hour day, with 2 ppm at jobsites with marginal occupational hygiene. However, monitoring
data available for the less volatile chemical which is being replaced (HCFC-123), indicate
that higher vapour concentrations, up to several hundred ppm, can be obtained under certain
circumstances, for example, chiller repair operations.
Using the data available for HFC-245fa, the MOE for is 508/2 = 254, indicating that the risk
of adverse health effects to service technicians resulting from repeated inhalation exposure
during charging and servicing of chillers is low.
Control measures available for reducing the occupational health and safety risks for chiller
technicians during refrigerant handling can be found in the following codes and standards:
? Safety Code for Mechanical Refrigeration;
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? The Australian Refrigeration and Air Conditioning Code of Good Practice; and
? AS/NZ 1677 (1998) - Refrigeration Systems.
Use as solvent in aerosol applications
Manufacture of aerosol products
The manufacture of aerosol products is largely enclosed and highly automated. Exposure to
workers may arise if leaks occur during the filling operation or maintenance, however, no
monitoring data were available. Using an EASE estimate of 100 ppm, the MOE for
myocarditis is 508/100 = 51, indicating a slight cause for concern. The occupational risk
posed to aerosol filling operators from the notified chemical is therefore expected to be low.
Use in contact cleaners
Aerosol contact cleaners are expected to be used at a rate of one can per week. Emissions
data for contact cleaners containing HFC-245fa were not available, however, CFC-113
vapour concentrations up to 27 ppm were obtained for an aerosol contact cleaner containing a
mixture of CFC-113 and alcohols. The EASE model predicted considerably higher vapour
concentrations (500-1000 ppm), assuming direct handling with dilution ventilation. For
regular use, this equates to an MOE for myocarditis of 508/1000 = 0.5, which would indicate
a high level of concern for workers. However, on the basis that usage will be intermittent
only, the risk to workers will be much lower.
Due to the small quantities used during application, the instantaneous vapour concentrations
are unlikely to exceed 1000 ppm. For cardiac sensitisation, this corresponds to an MOE of 34
100/1000 = 34, indicating a slight cause for concern.
Use in mould release agents
The use pattern for workers using mould release agents containing HFC-245fa will be similar
to workers using contact cleaners except that it is estimated that the frequency of use ill be
higher, up to three cans per day. Emissions data were not available, however, a short-term
exposure estimate of 216 ppm was provided, assuming a high use rate in a relatively small
facility with no air changes. With normal ventilation (one air change per hour) and assuming
the aerosol was used constantly throughout an 8 hour shift, the HFC-245fa vapour
concentration would be 36 ppm. The EASE model predicted considerably higher vapour
concentrations (500-1000 ppm), assuming direct handling with dilution ventilation.
Taking the predicted value of 36 ppm, the MOE for myocarditis is 508/36 = 14, indicating
some cause for concern. However, if the EASE estimate is used, the MOE is 508/1000 = 0.5,
which would indicate a high level of concern for workers. As for contact cleaners, the level of
concern for cardiac sensitisation is lower, due to the smaller volumes being used.
Conclusion
The risk characterisation indicates some cause for concern for workers potentially exposed to
HFC-245fa. The risk of cardiac sensitisation is greatest where larger volumes are handled, for
example, in manufacture of the polyol blend and foam application. The risk of longer term
effects, that is, myocarditis, is greatest in the more open work systems, for example, some
foam applications and aerosol can use. The MOEs obtained indicate that risk reduction
measures are necessary to minimise occupational exposure to HFC-245fa.
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Exposure standard
The American Industrial Hygiene Association (AIHA) has set a workplace environmental
exposure level (WEEL) of 300 ppm (1644 mg/m3) TWA, based on a LOAEL of 2000 ppm in
the 13-week rat inhalation study and comparison with the toxicity of similar hydro-
fluorocarbons. Documentation is available.
Based on the LOAEL of 2000 ppm established in the same study in this evaluation, and
taking into account the lack of personal monitoring data available for the notified chemical, a
provisional exposure standard of 200 ppm TWA is recommended until a NOHSC standard is
established. The available monitoring data suggest this vapour concentration is achievable.
Public Health
Public contact with HFC-245fa is unlikely as a result of the industrial uses of products
containing the chemical. Exposure of the public will occur only in the event of accidental
release of the gaseous form and is not likely to result in the inhalation of any significant
amount of the chemical. Therefore, the risk to public health is considered to be minimal due
the unlikely exposure and low toxicity of the notified chemical.
Environmental Effects
The new compound is a volatile gas and its use pattern as a blowing agent for production of
polyurethane foams indicates that it will be released mainly to the atmosphere, although
diffusion from the polymer foam may be extended over several years. It is possible that
HFC-245fa may also be used as a refrigerant and as a specialised solvent. However, these
use patterns would involve relatively small quantities of the chemical, but again almost all
would be released to the atmosphere with release of solvent being immediate and release
from refrigeration equipment due to slow leaks and diffusion occurring over the lifetime of
the plant.
Only minor releases to the water and soil compartments are expected, and due to the high
values of vapour pressure and Henry's Law constant any compound released to water or soil
is expected to quickly evaporate to the atmosphere. Consequently exposure to aquatic
organisms will be low, but in any case the available test data indicates that the compound is
of low toxicity to aquatic species, and would also have little potential for bioaccumulation.
The notified chemical will be slowly degraded in the atmosphere through reaction with
hydroxy radicals, and will eventually degrade to HF and CO2, However, due to its relatively
long anticipated atmospheric half life (estimated as 6-7.6 years) together with its large
infrared cross section the most environmentally significant effect resulting from use of the
compound will be its contribution to global warming. On a 100 year horizon basis use of the
compound as a foam blowing agent at the indicated import quantities are estimated to
annually add less than 475,000 tonnes of CO2 equivalent to Australia's greenhouse gas
emission inventory which (based on 1999 data) represents a contribution of less than 0.1% to
Australia's total greenhouse gas emissions. However, when it is considered that the new
chemical will replace HCFC-141b as a blowing agent, and that this compound also has
significant global warming potential, the nett additional annual release of CO2 equivalents is
reduced to around 165,000 tonnes, or an approximate 0.04% increase. However, HCFC-141b
is not currently considered in the Australian Greenhouse Gas Inventory, and so the full
475,000 tonnes of CO2 equivalent will appear in this document.
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Due to the absence of chlorine and bromine in the notified chemical, it is not expected to
have potential for removing ozone from the stratosphere, and this represents a definite
environmental advantage over blowing agents such as HCFC-141b for which the new
chemical is intended as a replacement.
When used in the indicated manner in the production of polymer foams the new compound is
not expected to be a hazard to the aquatic or soil environmental compartments, but may
effectively contribute to Australia's greenhouse gas emissions.
RECOMMENDATIONS
Regulatory controls
HFC-245fa does not meet the NOHSC Approved Criteria for classification as a hazardous
substance. However, since the chemical needs to have an exposure standard, it should be
labelled as `Hazardous', with the safety phrases
S3/9 ?Keep in a cool, ventilated place
S23 ?Do not breathe vapours
S38 ?In case of insufficient ventilation, wear suitable respiratory equipment
S41 ?In the case of fire and/or explosion, do not breathe fumes
Products containing the notified chemical, for example, aerosol products, should be similarly
labelled.
When stored or transported as a pressurised liquid with a nitrogen pad, HFC-245fa must be
labelled as a Class 2.2 dangerous good (UN number 3163).
The NOHSC Chemicals Standards Sub-committee should consider establishing a national
exposure standard for HFC-245fa, with this report serving as supporting documentation.
Based on the incidence of myocarditis in a 13-week rat inhalation study, a provisional
atmospheric concentration of 200 ppm TWA is recommended until a national standard is
established.
Control Measures
Occupational Health and Safety
?Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical:
- Local exhaust ventilation at potential points of emission during polyol blend
manufacture and foam manufacture, including transfer to and discharge from
mixing vessels
- Local exhaust ventilation in foam application areas
? Employers should implement safe work practices in accordance with the NOHSC
Model Regulations to Control Workplace Hazardous Substances. For use of HFC-
245fa as a refrigerant, employers should follow the safe work practices outlined in the
available codes and standards, that is, the Safety Code for Mechanical Refrigeration,
The Australian Refrigeration and Air Conditioning Code of Good Practice, and
AS/NZ 1677 (1998) - Refrigeration Systems.
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? Employers should ensure that use of aerosol products containing HFC-245fa is
conducted in a safe manner. For example, application must be in a well-ventilated
work area, application must be away from the breathing zone and respiratory
equipment must be available if required.
? Employers should ensure that personal protective equipment is used by workers to
minimise occupational exposure to HFC-245fa when engineering controls are
insufficient to maintain vapour concentrations below the provisional exposure limit.
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? Personnel atmospheric monitoring should be conducted by employers to measure
workplace HFC-245fa vapour concentrations to establish baseline exposure patterns
for each use of the notified chemical. If it is established that sites for the same use
pattern are equivalent in terms of worker exposure to HFC-245fa, then representative
monitoring will be sufficient. The results should be forwarded to NICNAS.
? Employers should ensure that workers potentially exposed to the notified chemical are
educated in the hazards of the chemical and trained to use, handle and store the
chemical safely. Education should include instruction from the available standards
and codes where relevant.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing HFC-245fa 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
?Due to the global warming potential of HFC-245fa and the expected substantial
releases to the atmosphere, annual data on import quantities should be reported to the
Australian Greenhouse Office.
? When HFC-245fa is used as a refrigerant, all usage of the chemical and its eventual
removal from retired appliances should be performed in compliance with the
appropriate Australian standard relating to refrigerating systems, that is, AS/NZ 1677
(1998) - Refrigeration Systems.
Storage
?The notified chemical must be stored in a cool, well ventilated place.
Emergency procedures
?An emergency response plan must be available at all sites where large volumes of the
notified chemical are to be stored or handled.
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Transport and Packaging
?HFC-245fa must be transported in accordance with the provisions of the ADG Code,
in particular, its transport as a Class 2.2 pressurised liquid when packaged with a
nitrogen pad.
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 chemical is to be used as a general cleaning or degreasing solvent in
open systems; 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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3 PUBLICATION SUMMARY REPORT
Nexguard/NGIT
Summary Report
Reference No: NA/933
Nalco Australia Pty Ltd of 2 Anderson Street, Botany NSW 2019 (ABN 41 000 424 788) has
submitted a limited notification statement in support of their application for an assessment
certificate for NEXGUARD/NGIT Polymer. The notified polymer is intended to be used as a
scale and rust inhibitor in industrial boiler systems. Less than 20 tonnes of the notified
polymer will be imported per year for the first 5 years
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information has been provided for the notified polymer. However, due to its
high molecular weight and likely low bioavailability, it is unlikely to be a hazardous
substance in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances. The MSDS for the imported polymer products indicates that it may be irritating
to skin, eyes and mucous membranes. These effects may be due to residual monomer rather
than the polymer itself.
Occupational Health and Safety
The polymer will be imported and used as a minor component (12%) of a formulated rust
inhibitor for use in industrial boiler systems. It will be repackaged for introduction via
automatic dosing equipment. Potential exposure to the notified polymer is most likely during
repackaging and end use where containers are opened and spears and transfer lines are
connected and disconnected. Manual sampling from import containers by quality control staff
may also provide a scenario for exposure. During these operations, dermal contact with the
polymer is possible through slops, spills and residue. Ocular contact from minor splashes
may also occur. The likely low vapour pressure of the polymer, enclosed transfer lines and
general ventilation make inhalation exposure unlikely. Although aerosols containing the
polymer may be encountered through contact with steam during end use, steam release is
unlikely during normal boiler operations and so the possibility of inhalation exposure during
end use is low.
The MSDS for the inhibitor product warns of the possibility of irritation following dermal,
ocular or respiratory contact. Given the risk of irritation, good occupational hygiene would
consider the prudent use of personal protective equipment consisting of impervious clothing,
gloves and chemical goggles during handling of the polymer solution in an area of good
general ventilation. For workers who will engage in activities where the polymer is decanted
or sampled and where these controls are used, the health risk associated with the polymer
would be assessed as low.
Following addition to boiler water, the risk associated with the polymer for workers involved
in boiler operations would be assessed as negligible given the low level of polymer in boiler
water and the enclosed plant.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
18
Given no requirement for opening polymer containers and therefore the low possibility of
exposure, the health risk associated with the polymer for import, transport and storage
workers would be assessed as negligible.
Public Health
The imported product containing the notified polymer will not be sold to the public. It will
only be used in boiler water systems where steam is generated for industrial, commercial and
institutional uses. In view of its high molecular weight, likely low volatility, low toxicity and
the use pattern (in boilers for generating steam used in heating and other purposes), the
potential risk to public health induced by the notified polymer should be very low.
Environmental Effects
The intended use pattern of the notified polymer is expected to result in the majority of the
notified polymer being eventually released to the environment. However, this will be diluted
as the notified polymer contained within the water treatment solution released from boiler
systems will mix with other effluent at municipal sewage treatment plants for small boilers
and additionally with effluent from on-site treatment plants for large boilers. Treatment at
local sewage treatment plants would reduce the notified chemical to very low concentration
levels. If the notified polymer is used at other sites that do not have on-site treatment plants
then environmental exposure is still expected to be low since the polymer is only expected to
be used at a maximum concentration of 100 mg/L.
In a worst case based on maximum annual imports of 20 tonnes/year, all of which is released
to sewer and assuming that none is removed during sewage treatment processes, assuming a
national population of 19,000,000 and that each person contributes an average 150 L/day to
overall sewage flows, the predicted concentration in sewage effluent on a nationwide basis is
estimated as 15.4 礸/L.
When released to receiving waters, the concentration is generally understood to be reduced
by a further factor of about 10, and so the predicted environmental concentration (PEC) is
1.92 礸/L. If the notified polymer were all to be used in one major capital city such as
Sydney (population 4.04 million), the PEC of the receiving waters would be 9.0 礸/L.
The nationwide PEC (1.92 礸/L) indicates that after discharge to receiving waters, the
environmental concentration of the notified polymer will be four orders of magnitude less
than the demonstrated toxicity to the alga Selenastrum capricornutum (96-h EbC50 = 47 (45,
50) mg/L). As this toxicity value was based on only one draft report and no other ecotoxicity
data were submitted, a 1,000 fold safety factor was applied which brings the predicted no
effect concentration (PNEC) down to 47 礸/L. This is 25 times higher than the PEC of 1.92
礸/L which indicates a low hazard to aquatic organisms. Similarly, the PNEC is 5.2 times
lower than the large city PEC of 9.0 礸/L which also indicates a low hazard.
Wastes containing the notified polymer including residues from imported drums, from
formulation and sludge will be disposed of in landfill and are expected to be immobile. Even
though the notified chemical is soluble in water, it is expected to adsorb to soil and sediment
if released from boiler systems to soil.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
19
Therefore, the environmental exposure and overall environmental hazard from the notified
polymer is expected to be low.
RECOMMENDATIONS
Regulatory Controls
? Use the following safety phrases for the MSDS and label for the imported product
containing the notified polymer:
- S24/25 ?Avoid contact with skin and eyes
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 chemical in the product
NEXGUARD/NGIT:
- Impervious clothing and footwear;
- Impervious gloves eg. rubber;
- Chemical 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.
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(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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
20
4 PUBLICATION SUMMARY REPORT
Splenda/Sucralose
Summary Report
Reference No: NA/944
Johnson & Johnson Pacific Pty Ltd (ACN 001 121 446) of Stephen Road Botany NSW 2019
has submitted a standard/limited notification statement in support of their application for an
assessment certificate for 1,6-dichloro-1,6-dideoxy--D-fructofuranosyl-4-chloro-4-deoxy--
D-galactose (SPLENDA/SUCRALOSE). The notified chemical is intended to be used as a
sweetener in mouth wash products. 175 kg 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 toxicological data provided, the notified chemical would not be acutely toxic
via the oral routes. It is not likely to be genotoxic or clastogenic.
Decreased bodyweight gain, a minimal increase in the incidence of renal pelvic
mineralisation and epithelial hyperplasia lesions and a decrease in erythrocyte count have
been observed upon repeated exposure to 3% sucralose. The dietary NOEL for mice and rats
was determined to be 30 000 ppm (equivalent to 1500 mg/kg bw/day).
The notified chemical was not teratogenic or neurotoxic and had no effect on reproduction,
insulin secretion and carbohydrate metabolism. Sucralose was found to induce a reduction in
thymus weight in rats dosed orally with 3000 mg/kg bw/day. The NOEL for immunological
endpoints was 750 mg/kg bw/day.
The notified chemical would not be classified as a hazardous substance according to NOHSC
Approved Criteria for Classifying Hazardous Substances in terms of the toxicological data
provided.
Occupational Health and Safety
Factory workers will have the potential for exposure to the notified chemical during the
formulation of the mouth wash products containing 0.06 % notified chemical. Possible
dermal and ocular exposure to spills and splashes containing the notified chemical may occur
during the addition of Splenda (25 % notified chemical) to the mixing vessel, during the
mixing of the mouth wash products, and when connecting lines for filling into PET bottles.
Dermal and ocular exposure will be controlled by the use of overalls, protective gloves and
eye protection. Inhalation exposure to any aerosols generated during the mixing of the mouth
wash is expected to be negligible, as the mixing process occurs in a semi automated closed
system in an area with an exhaust ventilation system.
QC sampling and testing workers may receive dermal and ocular exposure to drips and spills
containing the notified chemical during sampling and testing of mouth wash formulations.
Although not indicated by the notifier, QC sampling and testing workers should wear
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
21
laboratory coats, protective gloves and eye protection when handling solutions containing the
notified chemical to control exposure.
Retail outlet workers are unlikely to be exposed to the notified polymer unless the packaging
is breached. Waterside, warehouse and transport workers are unlikely to be exposed to the
notified polymer unless the packaging is breached.
Given the non-hazardous nature of the notified chemical and the low potential for exposure,
the health risk to workers handling the notified chemical is negligible.
Public Health
The notified chemical is approved for use in foods and therapeutic goods for oral ingestion.
The transient nature of the contact with the oral cavity, the very low concentration of the
notified chemical in the mouth wash, the low enteric absorption rate and the low toxicity of
the notified chemical and its metabolites, suggest that the notified chemical will not pose a
significant hazard to public health when used as proposed.
Environmental Effects
The intended use pattern of the notified chemical is expected to result in the majority of the
chemical being eventually released to the environment. However, this will be in dilute
manner as the notified chemical contained within a mouthwash will be released from
domestic use at low concentrations. The ecotoxicity data indicates the notified substance is
practically non-toxic fish, daphnia and algae and very slightly toxic to sewage micro-
organism based on measured concentrations.
In a worst case based on maximum annual imports of 175 kg per annum, all of which is
released to sewer and assuming that none is removed during sewage treatment processes,
assuming a national population of 19,000,000 and that each person contributes an average
150 L/day to overall sewage flows, and a dilution factor of 10 when released to the receiving
waters, the Predicted Environmental Concentration (PEC) is around 0.017 礸/L.
The nationwide PEC estimate indicates that after discharge to receiving waters the
environmental concentration of the notified chemical will be at least 6 orders of magnitude
less than the demonstrated toxicity to micro-organism (LC50 >320 mg/L).
Wastes containing the notified chemical including residues from imported drums and from
repackaging will also be disposed of in landfill where it may leachout at very low
concentrations.
Therefore, the environmental exposure and overall environmental hazard from the notified
chemical is expected to be acceptable.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
22
? 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.
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(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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
23
5 PUBLICATION SUMMARY REPORT
Imwitor 370
Summary Report
Reference No: NA/945
Beiersdorf Australia of 4 Khartoum Road North Ryde NSW 2113 has submitted a limited
notification statement in support of their application for an assessment certificate for
Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts. The notified
chemical is intended to be used as a surface enhancing agent in a selection of facial creams
and moisturisers. 188 kg 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 toxicological data provided for a close structural analogue, the notified chemical
would not be acutely toxic via the oral or dermal routes. It is not likely to be a skin sensitiser
or genotoxic. It is not likely to be an eye irritant but could be a slight skin irritant. The
notified chemical would not be classified as a hazardous substance according to NOHSC
Approved Criteria for Classifying Hazardous Substances in terms of the toxicological data
provided.
Occupational Health and Safety
The notified chemical will be imported in facial creams and moisturisers at a maximum of
2%.
Exposure to facial creams and moisturisers containing the notified chemical during transport
and storage should not result in exposure except in the event of accidental spillage.
Dermal exposure of retail workers to the notified chemical should not occur except in the
event of accidental spillage.
Beauticians may experience repeated dermal exposures to the notified polymer during
application of creams and moisturisers containing the notified chemical while serving clients.
Given the product containing the notified chemical is used in relatively small portions and
only contains up to 2% of the notified chemical, it is unlikely that the chemical would pose a
significant threat. Beauticians experiencing dermal irritation while using products containing
the notified chemical should wear impervious gloves.
Based on the information provided, it is concluded that the risk of health effects in workers
involved in transport, storage, retail and use of the notified chemical in this application is
low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
24
Public Health
The product containing the notified chemical is used in relatively small portions and only
contains up to 2% of the notified chemical. Given the chemical has been widely used
internationally without any known adverse effects and that the public will be exposed to
approximately 0.33 mg/kg bw/day, which is well below the level for acute dermal toxicity, it
is unlikely that the chemical would pose a significant risk to public health.
Environmental Effects
The intended use pattern of the notified chemical is expected to result in the majority of the
chemical being eventually released to the environment. However, this will be in dilute
manner as the notified chemical contained within the skin care products will be released from
domestic use at low concentrations. The ecotoxicity data indicates the notified substance is
not toxic to fish up to the limit of its water solubility.
In a worst case based on maximum annual imports of 400 kg per annum, all of which is
released to sewer and assuming that none is removed during sewage treatment processes,
assuming a national population of 19,000,000 and that each person contributes an average
150 L/day to overall sewage flows, the predicted concentration in sewage effluent on a
nationwide basis is estimated as 0.4 礸/L. When released to receiving waters the
concentration is generally understood to be reduced by a further factor of at least 10, and so
the Predicted Environmental Concentration (PEC) is around 0.04 礸/L.
The nationwide PEC estimate indicates that after discharge to receiving waters the
environmental concentration of the notified chemical will be 5 orders of magnitude less than
the highest concentration that demonstrated no toxicity to fish (EC50 = 2.9 mg/L).
Wastes containers containing the notified chemical will be disposed of in landfill where it is
expected to adsorbed to soil and sediment due to its low water solubility.
RECOMMENDATIONS
Occupational Health and Safety
Spillage of the notified chemical should be avoided. Spillages should be cleaned up
?br>
promptly with absorbents which should be put into containers for disposal;
A copy of the MSDS should be easily accessible to employees;
?br>
If products and mixtures containing the notified chemical are classified as hazardous
?br>
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
25
6 PUBLICATION SUMMARY REPORT
Luviquat Care (Polyquaternium 44)
Summary Report
Reference No: NA/961
Johnson and Johnson Pacific Pty Ltd of Stephen Rd, Botany, NSW 2019 (ABN 73 001 121
446) and BASF Australia Pty Ltd of 500 Princes Highway, Noble Park, VIC 3174 (ABN 62
008 437 867) have submitted a limited notification statement in support of their application
for an assessment certificate for Luviquat Care (Polyquaternium 44). The notified polymer) is
intended to be used as a component of the ready-to-use hair shampoo. Less than 1 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
A 7.4 % aqueous solution of the notified polymer was found to be of low acute oral toxicity
in rats, not sensitising to guinea pig skin, and not mutagenic in a bacterial assay. The solution
was found to be slightly irritating to rabbit eyes and skin, and the skin reactions observed
indicated that high concentrations of the notified chemical may be hazardous. The 7.4 %
solution is not classified as a hazardous substance in accordance with the NOHSC Approved
Criteria for Classifying Hazardous Substances.
Occupational Health and Safety
The notified polymer will only be introduced as a constituent of a ready to use shampoo, in
consumer packaging. Therefore minimal occupational exposure to the notified polymer is
expected during transport, storage, distribution and retail sale. Exposure would only occur on
breakage of packages. Due to the small amounts of shampoo involved and the low
concentration (0.28 %) of the notified polymer in the shampoo, the risk to occupational health
and safety is expected to be very low.
Public Health
The notified polymer is present in the shampoo at a concentration of 0.28 %. At this
concentration it is not expected to cause irritation of the skin or eyes, nor is it a skin
sensitiser. The notified polymer has a high molecular weight and is unlikely to penetrate
biological membranes. The low concentration of the notified polymer in hair care shampoo
products and the low toxicity of the notified chemical suggest that the notified polymer will
not pose a significant hazard to public health when used in the proposed manner.
Environmental Effects
The intended use pattern of the notified polymer is expected to result in the majority of the
polymer being eventually released to the environment. However, this will be in dilute manner
as the notified polymer contained within the hair care products will be released from
domestic use at low concentrations. The ecotoxicity data for the notified polymer indicates
that it is slightly toxic to fish but no other data was available.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
26
In a worst case based on a maximum annual import of 983 kg per annum, all of which is
released to sewer and assuming that none is removed during sewage treatment processes,
assuming a national population of 19 million and that each person contributes an average 150
L/day to overall sewage flows, the predicted concentration in sewage effluent on a
nationwide basis is estimated as 0.95 礸/L. When released to receiving waters the
concentration is generally understood to be reduced by a further factor of at least 10, and so
the Predicted Environmental Concentration (PEC) is around 0.095 礸/L.
In view of the absence of data to indicate the toxicity of the notified polymer to daphnia and
algae, an assumption has been made that the algal toxicity will be six times greater than that
experienced for fish (assumed LC50 = 10 mg/L, the lower bound of the range of results
quoted for Luviquat Care). Furthermore, due to the uncertainty, an extra safety factor of 10 in
addition to the 1000 recommended by the OECD has been applied.
The nationwide PEC estimate indicates that after discharge to receiving waters the
environmental concentration of the notified polymer will be one order of magnitude below
the estimated most sensitive toxicity (LC50 = 1 礸/L). However, the risk to aquatic
organisms will be further mitigated by the removal of the notified polymer through
association with dissolved organic carbon from soils and sediment. This is expected to bind
to the notified polymer, neutralising its positive charge and removing it from the aquatic
compartment thus making it less bioavailable and less toxic to aquatic organisms. Therefore,
even though the notified polymer is soluble in water, its concentration in the aquatic
compartment is expected to be significantly less than the calculated PEC because it will
adsorbed to soil and sediment due to its cationic nature and be removed from the aquatic
compartment. If a total of 95% of the notified polymer is adsorbed to soil and sediment as
indicated after 3 h in the test for Luviquat Care the revised PEC would be 0.0048 礸/L, which
is 3 orders of magnitude below the estimated toxicity to algae.
Wastes containing the notified polymer including residues from import containers will be
disposed of in landfill where the polymer is expected to adsorbed to soil and sediment due to
its cationic nature.
Given the large safety factor applied, the environmental exposure and overall environmental
hazard from the notified polymer is expected to be acceptable.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? 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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
27
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 importation volume increases above 1 tonne per annum, in which case standard
notification, including a full suite of ecotoxicity testing including tests against aquatic
invertebrates and algae, will be required;
- the notified polymer is introduced in a form containing more than 25 % quaternised
monomer, or in a form where the Number Average Molecular Weight is lower than
250000, in which case skin and eye irritation tests and ecotoxicity tests against fish,
aquatic invertebrates and algae for the form to be introduced will be required.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
28
7 PUBLICATION SUMMARY REPORT
KUDE-2
Summary Report
Reference No: NA/973
Epson Australia Pty Ltd of 70 Gibbes Street, Chatswood, NSW 2067 (ABN 91 002 625 783)
has submitted a standard notification statement in support of their application for an
assessment certificate for KUDE-2. The notified chemical is intended to be used as a
component (< 5%) of liquid ink formulations for ink-jet printers. It will be imported in
ready-to-use printer cartridges at the rate of 2 tonnes/year for the first year rising to 5
tonnes/year for years 2 ?5.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified chemical was of low acute oral and dermal toxicity in rats. A skin irritation test
in rabbits showed that the chemical was slightly irritating. In contrast, an eye irritation test in
rabbits showed conjunctival irritation and corneal opacity with irreversible staining of the iris
and cornea.
Positive responses were observed in a skin sensitisation study in guinea pigs indicating
potential of the notified chemical to induce allergic sensitivity.
A 28-day repeat dose oral toxicity study in rats revealed significant toxicity. High dose
animals (150 mg/kg/day) showed haemolytic anaemia with haemosiderin deposition in
multiple organs, compensatory splenic enlargement, generalised hepatocyte enlargement,
enzyme changes and kidney weight changes and diuresis. Severe, irreversible testicular
atrophy in these high dose animals indicated by substantial reductions in organ weights and
confirmatory macroscopic and histopathological changes identified the testes as a target
organ. Hepatocyte enlargement and haemosiderin deposits were observed also in intermediate
dose animals (15 mg/kg/day). On the basis of these findings a NOAEL of 1.5 mg/kg/day was
assigned.
The notified chemical was non mutagenic and non clastogenic in an in vitro bacterial reverse
mutation assay and chromosome aberration assay respectively.
Given this toxicological profile, on the basis of the NOHSC Approved Criteria for
Classifying Hazardous Substances the notified chemical should be classified Irritant (Xi) and
Harmful (Xn) with the risk phrases R41 ?Risk of serious damage to eyes; R43 ?May cause
sensitisation by skin contact; R48/22 ?Harmful: danger of serious damage to health by
prolonged exposure if swallowed and R62 ?Possible risk of impaired fertility.
A skin sensitisation study on a product with a slightly high concentration (6%) of the notified
chemical was provided. The study showed that the product was not a skin sensitiser in guinea
pigs.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
29
Occupational Health and Safety
The main exposure to KUDE-2 will be via the dermal route to service personnel who will
change printer cartridges and may come into contact with internal printer componentry that
may be contaminated with ink. Office workers may also come into contact with KUDE-2
under normal circumstances during the routine replacement of spent printer cartridges or
clearing paper jams. The design of the cartridge and normal installation processes should be
such that contact with the notified chemical is minimal during replacement. Exposure will be
minimised in these workers also by the low level of KUDE-2 (<5%) present in the ink
cartridges.
Inhalation exposure to KUDE-2 is not expected due to the low vapour pressure and low level
of aerosol formation during the printing process.
Despite low level of KUDE-2 in the ink, levels are above those for which a hazardous
classification for the ink, on the basis of skin sensitisation, is warranted. Prolonged or
repeated dermal exposure to the ink containing the notified chemical may cause allergic
sensitisation. Dermal or ocular exposure may also cause local irritation. Therefore, service
personnel and office workers should wear impervious gloves when contact with ink
contaminated internal printer components is likely during printer servicing, when replacing
spent or damaged printer cartridges or clearing paper jams.
Exposure to KUDE-2 is not expected to occur once the ink containing the chemical is bound
to paper and so the health risk for workers handling printed paper would be assessed as low.
Transport and storage workers will only be exposed to KUDE-2 in the event of an accident or
damage to packaging. Despite the significant toxicological profile of the notified chemical,
the occupational health risk to these workers is negligible considering the low quantities
(<5%) in ink jet printer cartridges and the low possibility of exposure.
Public Health
The risk to public health is expected to be low since exposures are expected to be
intermittent, of short duration and involve only small amounts of ink containing a low
concentration of the notified chemical.
Environmental Effects
The notified chemical will not be manufactured in Australia, but will be imported in an ink
blend in sealed inkjet cartridges. As such, direct release of the chemical to the environment is
not anticipated, except for a small amount released as residues left in used containers.
The majority of notified chemical will enter water or soil compartments indirectly during
disposal or recycling of the printed paper onto which the ink blend is fixed. In aquatic
environments, the chemical is expected to disperse in the water column owing to its moderate
water solubility. In soil environments, the chemical is expected to be mobile owing to its poor
affinity to organic matter, and hence could enter aquatic compartments via surface runoff or
percolating groundwater.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
30
The chemical has very low octanol-water partition coefficient indicating a poor affinity to
lipids, hence it is not expected to bioaccumulate. The new chemical is not readily
biodegradable, but is expected to be inherently degradable and to undergo slow degradation
in the environment.
A worst case scenario Predicted Environmental Concentration (PEC), calculated assuming all
of the chemical is released on a nationwide basis into the aquatic environment was several
orders of magnitude below the highest concentrations to which fish and daphnia were
exposed during toxicity testing, and which showed no adverse effects. The PEC is also many
orders of magnitude below the concentrations able to inhibit respiration of microorganisms.
Hence, safety margins toward these organisms are expected to be high. The notified
substance is moderately toxic to algae. The chemical is able to adversely affect algal growth
by reducing the amount of light available for photosynthesis due to its dark colouration.
Despite the adverse effects on algae, the chemical is not expected to pose a significant hazard
to algae or other organisms in the natural environment. In reality, release of the chemical into
sewage treatment facilities is not expected to occur all at once as was assumed when
calculating the PEC, but would be distributed over a longer period of time. Upon release of
treated effluent water from sewage treatment facilities to the receiving waters, the notified
chemical would be further diluted, thereby further reducing the PEC value. As such, the
overall environmental risk of the notified chemical is expected to be low.
RECOMMENDATIONS
Regulatory controls
? The NOHSC Chemicals Standards Sub-committee should consider the following
health and physico-chemical hazard classification for the notified chemical:
- R2 ?Risk of explosion by shock, friction, fire or other sources of ignition;
- R41 ?Risk of serious damage to eyes;
- R43 ?May cause sensitisation by skin contact;
- R48/22 ?Harmful: danger of serious damage to health by prolonged exposure if
swallowed;
- R62 ?Possible risk of impaired fertility.
? Use the following risk phrases for Ink Cartridge T026 containing the notified
chemical:
- 5% - <10%: R36, R62;
- 10%: R41, R48/22, R62
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 chemical in the product Ink
Cartridge T026:
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
31
- Wear impervious gloves when servicing printers, when replacing spent or
damaged printer cartridges or clearing paper jams where contact with ink residual
is likely.
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.
Storage
? The following precautions should be taken regarding storage of the notified chemical:
- Keep containers tightly closed;
- Keep in a cool, well ventilated place;
- Avoid exposure to heat, sources of ignition and direct sunlight.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
32
8 PUBLICATION SUMMARY REPORT
Fructalate
Summary Report
Reference No: NA/985
Firmenich Ltd of 73 Kenneth Road Balgowlah NSW 2093 (ACN 002 964 794) has submitted
a limited notification statement in support of their application for an assessment certificate for
Fructalate. The notified chemical is intended to be used as a fragrance ingredient in cosmetics
and domestic cleaning products. Less than 1000 kg 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
The notified chemical has low acute toxicity by the oral and dermal routes. It is a slight skin
irritant, possibly due to defatting, but not irritating to eyes beyond slight redness on
instillation, or sensitising to skin. In a 28-day oral repeat dose study, no differences from
controls were consistent across the sexes or clearly dose dependent. All differences from
controls were slight, and the NOEL is therefore set at 1000 mg/kg bw/day (the highest dose
tested). In two in vitro genotoxicity studies, negative results were obtained.
Based on the available data the notified chemical is not classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances.
Occupational Health and Safety
Occupational exposure to the notified chemical in fragrance preparations is expected to be
very limited, due to the low concentration of the notified chemical present in these. The use
of the fragrance preparations will generally be automated, limiting exposure to dermal
contact with small quantities of the preparations. While the notified chemical is a slight skin
irritant, the concentration handled in the reformulation activities in Australia is not expected
to result in significant occupational risk. The presence of a wide range of additional
ingredients in the preparations may require that more stringent precautions be taken to
prevent worker exposure. Consumer products contain smaller proportions of notified
chemical, and the occupation risk posed by the notified chemical in these products is
expected to be low. The use of enclosed systems or exhaust ventilation, as well as the
personal protective equipment specified in the Material Safety Data Sheet (MSDS), should
ensure that the occupational risk posed by the notified chemical is low when used as specified
in the notification.
Public Health
It is expected that public exposure to compounded fragrances containing 1 % Fructalate for
industrial use will be minimal except in the rare event of an accidental spill. There will be
public exposure to the notified chemical from dermal, inhalation, oral and ocular exposure to
cosmetics, toiletries, and household cleaning products containing up to 0.2 % of the notified
chemical. Although the notified chemical caused slight skin irritation, the irritation hazard
posed by consumer products containing 0.2 % of the notified chemical are likely to be
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
33
minimal. Consequently the public hazard from exposure to the notified chemical through all
phases of its life-cycle is considered to be low.
Environmental Effects
Usage patterns for products containing the notified chemical indicate that all of the chemical
will eventually be released into sewage treatment facilities, either when the cosmetics are
washed off the skin, or during cleaning activities.
The notified substance is highly water-soluble and not readily biodegradable. The partition
coefficient indicates some adsorption onto sewage sludge, and the vapour pressure and
Henry's Law Constant suggest some partitioning into the atmosphere, in sewage treatment
facilities. Nevertheless, modelling suggests up to 88 % of the chemical may partition into the
aquatic compartment and eventually enter receiving waters following sewage treatment.
The highest worst case scenario PEC for the aquatic environment prior to release from the
sewer is 9.3 x 10-4 mg/L (or 0.9 礸/L). In calculating this value it is assumed that all of the
yearly import volume of chemical is released to the sewer on a nationwide basis, over a 365
day period.
The notified substance is slightly to moderately toxic to aquatic organisms. A predicted no
effects concentration (PNEC) was determined by taking the LC50 value of the most sensitive
species (fish), and dividing this value by an assessment safety factor of 100, giving a PNEC
(aquatic) of 0.071 mg/L. The PEC/PNEC ratio determined for the aquatic environment is
significantly less than 1, indicating no immediate concern to the aquatic compartment.
The chemical properties indicate a potential to cross biological membrane and bioaccumulate,
however, the substance is not expected to persist and pose a bioaccumulation hazard. While
the substance is not readily biodegraded or hydrolysed, once released into the environment it
is expected to undergo degradation by biotic and abiotic processes.
Given the above considerations, the notified chemical is not expected to pose any significant
hazard to the environment. The low import volumes and the anticipated nationwide use of the
product indicate that the levels of release of the chemical to the environment will be low, and
significantly lower than the levels of exposure shown to be toxic to aquatic organisms.
RECOMMENDATIONS
Occupational Health and Safety?br>
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical as introduced:-
- Local exhaust ventilation should be employed if reformulation is carried out in
open systems.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced:
- Gloves (natural rubber), safety goggles and industrial clothing and footwear
should be worn.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
34
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 incineration or landfill.
Emergency procedures?br>
?Spills/release of the notified chemical should be handled by containing spills with
sand or inert powder, and disposing of the material in accordance with Government
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
35
9 PUBLICATION SUMMARY REPORT
Polyether Epoxy Acrylic E1CI06
Summary Report
Reference No: NA/988
Coates Brothers Australia Pty Ltd of 323 Chisholm Rd Auburn NSW (ABN 12 000 079 550)
has submitted a limited notification statement in support of their application for an
assessment certificate for Polyether Epoxy Acrylic E1CI06. The notified polymer is intended
to be used as a component of printing inks for application to food packaging. Less than 10
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
Toxicity data for skin and eye irritation were provided by the notifier. The notified polymer is
non-irritating to rabbit skin, and slightly irritating to rabbit eyes. It is not classified as a
hazardous substance in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances for either end point. No toxicity data for other toxicological endpoints
were submitted, and the notified polymer accordingly cannot be classified against the
Approved Criteria. However, the high molecular weight and low reactivity indicate that it is
not likely to have significant systemic toxicity.
Occupational Health and Safety
Exposure to the notified polymer will be predominantly during the use of pre-prepared inks,
containing < 15 % notified polymer. There may at some stage be reformulation in Australia
of the pure notified polymer to produce inks, and worker exposure to the pure liquid notified
polymer may occur at this stage.
Use of the inks will be in enclosed automated systems, and the printed substrates will be
cured by exposure to UV light, which will incorporate the notified polymer into a high
molecular weight film, from which it will not be separately available for exposure. There may
be exposure to the notified polymer in uncured inks during replacement of ink containers or
during cleaning of the printing equipment. This is likely to involve dermal contact with small
amounts of ink, with possible ocular exposure to splashes. Neoprene or nitrile gloves,
industrial clothing and safety goggles should be worn during cleaning and ink container
replacement.
In the case of reformulation in Australia, there may be dermal exposure to drips and spills of
pure liquid notified polymer during addition to the blending tanks, and exposure to small
amounts of inks is possible at a number of stages. Neoprene or nitrile gloves, industrial
clothing and safety goggles should be worn during reformulation operations.
Due to the low toxicological hazard presented by the notified polymer, use under the
specified conditions should not pose a significant risk to occupational health and safety.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
36
Public Health
The notified polymer is intended for industrial use in commercial printing inks for
professional use and will not be sold to the public. Since printing inks, containing the notified
polymer, will be cured with UV light to form an inextricably bound matrix, the risk to the
public from exposure to the notified polymer is considered low.
Environmental Effects
A maximum of about 355 kg of notified polymer go to waste as a result of container residues,
operational spills, and cleaning, and is expected to be disposed of through licensed waste
contractors. Most of the imported volume of polymer will be bound up in the polymer matrix
of the cured ink and deposited on packaging. At the end of their useful life, most printed
packaging items will be recycled, sent to landfill or incinerated. Under normal usage, the
notified polymer is not expected to enter the aquatic environment.
No degradation data were provided in the notification dossier. Acrylic ink coatings are
resistant to thermal and photooxidation and to hydrolysis. Hence at landfill sites, the polymer
is not expected to degrade rapidly, but will undergo slow degradation by abiotic and
microbial degradation processes. Given its low water solubility, the polymer is not expected
to be mobile in soils or to leach from the soil environment. The negligible vapour pressure
indicates the polymer is unlikely to partition into the atmosphere through volatilisation.
Incineration will result in destruction of the polymer and evolution of oxides of carbon.
The high partition coefficient indicates the notified polymer will have an affinity to lipids,
however, given its high molecular weight, the polymer it is not expected to cross biological
membranes or to bioaccumulate. Therefore the overall environmental hazard is expected to
be low.
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:
- gloves (neoprene or nitrile), safety goggles and industrial clothing should be worn.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
37
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
38
10 PUBLICATION SUMMARY REPORT
E-1275
Summary Report
Reference No: PLC/245
Salkat Australia Pty Ltd of 55 Halstead Street South Hurstville NSW 2221 (ABN 30 318 540
786) has submitted a synthetic polymer of low concern (PLC) notification statement in
support of their application for an assessment certificate for E-1275. The notified polymer is
intended to be used as an emulsifier for cosmetic and personal care products, such as
antiperspirant gels and roll-on emulsions, clear gels, hair gels, make up emulsions, body
lotions and anti-ageing creams. Approximately 2 tonnes of the product containing 85%
notified polymer will be imported during the first year and increasing to 5 - 10 tonnes/year in
the next four years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
A limited number of toxicological tests carried out on the imported product containing 85%
notified polymer showed low acute dermal toxicity and slight eye irritation effects. A
Cosmetic Ingredient Review on dimethicone copolyols, which are structurally similar to the
notified polymer, was also provided. Dimethicone copolyols have low acute toxicity, slight
eye and skin irritation effects but no skin sensitisation effect. No death or overt toxicity was
observed in a repeat oral study (89 days) and repeat dermal study (28 days). Slight to
moderate skin irritation at the application sites were observed during the repeat dermal study.
The polymer meets the PLC criteria, has high molecular weight and is not expected to cross
biological membranes. Based on the information provided, the notified polymer is not
classified as a hazardous substance in accordance with the NOHSC Approved Criteria for
Classifying Hazardous Substances.
Occupational Health and Safety
The imported product containing 85% notified polymer will be formulated into cosmetic and
personal care products. The formulation process is largely enclosed. Filling and packing of
end-use products into <100 mL capacity containers also involves enclosed and automated
processes. The most likely points at which exposure may occur are during weighing and
transfer to the mixing vessel. Incidental exposure to the end use formulation may occur
during transfer to the filling lines, and when cleaning equipment through skin and limited eye
contact to spills and splashes. Local exhaust ventilation is employed in the formulation area
and general ventilation in the packaging area. The end-use product contains 1.3 ?2.6%
notified polymer.
QC testing provides the possibility of dermal exposure to small quantities of the notified
polymer. Laboratory testing is performed in a fume hood.
The engineering controls in place and the low toxicity of the notified polymer render the
health risk from the notified polymer for the plant operators and laboratory personnel as low.
Possible skin and eye irritant effects will be further minimised by the wearing of PPE,
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
39
including overall, safety boots, impervious gloves and safety glasses/goggles during the
above activities.
Exposure of transport and storage workers is only possible in the event of accidental spillage.
The health risk for transport and storage workers handling the notified polymer is expected to
be negligible.
The notified polymer is of low hazard to human health and safety. The control measures in
place during formulation, and protective measures during quality control, transfer and filling
operations will ensure sufficient protection against exposure to the notified polymer.
Therefore, the notified polymer is of low concern to human health and safety and no specific
reduction measures are necessary.
Public Health
The imported products containing a high level of the notified polymer will be used by
industrial customers, and not be available to the general public. The public will be exposed to
the notified polymer once it becomes a component in cosmetic formulations. Given that the
notified polymer is of low toxicity, and presents at low concentrations in end-use cosmetic
products and used in relatively small amounts, it is unlikely to cause significant public health
concerns.
Environmental Effects
Almost all of the notified polymer contained in personal care products would be released to
the sewage system, when it is washed off the skin or hair during bathing, and to a lesser
extent during the formulation process. Release into the sewer during bathing is expected to be
diffuse as a consequence of the nationwide usage pattern of the product.
The new polymer is surface-active preferring to reside at or on the interfaces between polar
and apolar media. Hence in aquatic environments and sewage treatment facilities, the
polymer is expected to partition mainly to soils and sediments or become associated with the
sludge. Residues that persist after sewage treatment, either sorbed onto particles or associated
with the aquatic compartment, are expected to enter marine and freshwater environments in
effluent released from city and country wastewater treatment systems. The concentrations of
the notified polymer in the water compartment are expected to be very low, because of
adsorption and dilution once released into the receiving waters.
A worst case scenario Predicted Environmental Concentration (PEC), determined assuming
all of the imported polymer was released into the sewer on a nation wide basis, over a 365
day period, was 10 礸/L per year. Upon release to receiving waters after treatment at the
sewage treatment plant the effluent would be further diluted. It is assumed that the effluent is
diluted by a factor of 10 giving a final PEC in receiving waters of 1 礸/L of notified polymer.
No ecotoxicological data were provided in the notification dossier. Published studies
generally indicate that polydimethylsiloxane is of low order toxicity to aquatic organisms and
does not significantly accumulate in fish either from aqueous or dietary exposure, mainly
because its high molecular weight precludes it crossing biological membranes. As such the
safety margins toward aquatic organisms are expected to be high.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
40
A small amount of notified polymer will be released to landfill during disposal of residuals in
empty containers. Some polymer may also enter the soil environment during disposal of solid
wastes from sewage treatment facilities. In soil environments, the polymer is expected to
eventually degrade through abiotic and biotic processes. Research shows that silicone
polymers are hydrolysed in soils to low molecular weight water soluble products, which are
in turn mineralised by microorganims to inorganic silicate.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
No specific precautions are required to control exposure to the notified polymer. However, in
the interests of good occupational health and safety, the following guidelines and precautions
should be observed:
?Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer:
- Enclosed and automated formulation processes
- Exhaust ventilation during transfer and filling processes
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer:
- During transfer operations and cleaning of equipment, avoid spills and splashing
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Chemical resistant gloves
- Protective clothing which protects the body, arms and legs
- 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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
41
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 1, 1 January 2002
42
11 PUBLICATION SUMMARY REPORT
LE 3580
Summary Report
Reference No: PLC/258
International Sales and Marketing Pty Ltd of 55 Halstead Street South Hurtsville NSW 2221
(ABN 36 467 259 314) has submitted a synthetic polymer of low concern (PLC) notification
statement in support of their application for an assessment certificate for LE 3580. The
notified polymer is intended to be used as a deaerator for radiation curable coatings. Three to
five tonnes per year of the notified polymer will be imported for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified polymer fulfils the criteria for a synthetic polymer of low concern and can be
considered not to be a health hazard. This was confirmed for skin sensitisation using guinea
pigs where no sensitisation was detected. The notified polymer is imported in a 98% pure
form.
Occupational Health and Safety
Transport and storage of the containers of notified polymer should result in minimal worker
exposure and consequent health effects except in the event of accidental container rupture.
Workers may be involved in some blending of colours with the notified polymer in which
small volumes are tested for colour matching prior to pumping inks and the notified polymer
to enclosed blending vessels. Small samples are taken for colour determination and
adjustment if necessary. Typically inks are blended by hand until recipes are established. The
final batch is then pumped into vessels of 10 kg capacity. The blend tanks, pumps and lines
and flushed with short chain alcohols or detergents and the washings collected in drums for
disposal. The notifier suggests that losses during these processes are small. This, together
with the low concentration of notified polymer in the blended inks suggests that the risk to
workers of adverse health effects from exposure to the notified polymer should be minimal.
There may be some risk of skin, eye or respiratory irritation from exposure of workers to
other components of typical inks but this is controlled by the use of coveralls, gloves and eye
goggles. Employers are responsible for maintaining the atmospheric concentration of ink
components below the NOHSC exposure standards.
After transport to printers the ink is pumped to an enclosed printing press. The ink is cleaned
from the press infrequently with short chain alcohols or detergent and the washings placed in
drums for disposal. Printers wear eye goggles, coveralls and gloves which, together with the
low concentration of the notified polymer in the inks should result in minimal exposure.
Therefore, the risk to printers of adverse health effects from exposure to the notified polymer
is low. Again, there may be some risk of skin, eye or respiratory irritation from exposure of
workers to other components of the inks but this is controlled by the use of coveralls, gloves
and eye goggles.
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No. C 1, 1 January 2002
43
Conclusion
The notified polymer is of low concern to human health and safety and no specific risk
reduction measures are necessary.
Public Health
In view of its high molecular weight, low toxicity, low concentrations in the inks and the use
pattern, the notified polymer is unlikely to pose a significant hazard to public health.
Environmental Effects
Up to 5 tonnes of the notified polymer will be imported into Australia each year. Of this
amount, about 100 kg will enter the environment directly as a result of residues or operational
spills and cleaning. Most of the imported volume of polymer will be used in the manufacture
of ink, and will be bound up in the polymer matrix of the cured ink and deposited on
packaging.
The fate of most of the polymer will follow the fate of the products onto which the inks and
coating are deposited. At the end of their useful life, most printed or coated products will be
sent to landfill or incinerated. At landfill sites, the polymer is not expected to readily degrade,
but will undergo slow degradation by abiotic and microbial degradation processes along with
the packaging materials or substrates containing the polymer blend.
Under normal usage, the new polymer is not expected to enter the aquatic environment, and
given its high molecular weight, the polymer it is not expected to cross biological membranes
or to bioaccumulate. As such the overall environmental hazard is expected to be low.
RECOMMENDATIONS
Control Measures
No specific precautions are required to control exposure to the notified polymer. However, in
the interests of good occupational health and safety, the following guidelines and precautions
should be observed:
Occupational Health and Safety
Spillage of the notified polymer should be avoided. Spillages should be cleaned up
?br>
promptly with absorbents which should then be put into containers for disposal;
Good personal hygiene should be practised to minimise the potential for ingestion;
?br>
A copy of the MSDS should be easily accessible to employees.
?br>
If products containing the notified chemical are hazardous to health in accordance with the
NOHSC Approved Criteria for Classifying Hazardous Substances, workplace practices and
control procedures consistent with State and Territory hazardous substances regulations must
be in operation.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
44
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 introduced in a chemical form that does not meet the PLC
criteria.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
45
12 PUBLICATION SUMMARY REPORT
Polymer in RP0971
Summary Report
Reference No: PLC/262
Akzo Nobel Pty Ltd of 51 McIntyre Rd, Sunshine, VIC 3020 (ABN 59 000 119 424) has
submitted a synthetic polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Polymer in RP0971. The notified polymer is
intended to be used as a film-forming component of paint. Less than 500 tonnes of the
notified chemical will be manufactured in each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified polymer in RP0971 is considered stable under normal conditions of use. No
toxicological information has been provided for the notified polymer, however, due the high
molecular weight and lack of reactive functional groups, it is unlikely to be a hazardous
substance according to the NOHSC Approved Criteria for Classifying Hazardous Substances.
Since the notified polymer has a high NAMW, absorption across biological membranes
would be restricted.
Occupational Health and Safety
The notified polymer will be manufactured in Australia and blended into paint that is used
only in industry as a primer for coil coating. Exposure to the notified polymer in its pure form
(97% notified polymer) is expected to constitute the most significant exposure scenario.
Reactor operators may be exposed to polymer dust during formulation of the product RP0971
(60% w/w notified polymer). The use of an enclosed vessel and local exhaust ventilation and
personal respirators should serve to limit inhalation exposure.
Dermal and ocular exposure of reactor and paint plant operators to the 60% notified polymer
solution may occur when taking samples for testing, during connecting and disconnecting
pump lines during drum filling and reaction vessel charging. Laboratory technicians and
development and maintenance personnel are only expected to receive incidental dermal
contact to RP0971. The use of gloves, safety goggles and overalls should serve to limit
dermal and ocular exposure.
Dermal exposure of paint plant operators to the paint product (10-30% notified polymer) may
occur when taking samples for testing, during connecting and disconnecting pump lines
during drum filling. Laboratory technicians and development and maintenance personnel are
only expected to receive incidental dermal contact to the paint product. In all cases the use of
personal protective equipment, such as gloves and safety glasses, should limit exposure.
Coating operators may experience dermal and ocular exposure to spills and splashes of the
paint product (10-30% notified polymer) when connecting pump lines between the tanks or
drums and the coating operations and when thinning the paint solution. The use gloves and
safety glasses should limit dermal exposure. Possible inhalation and dermal exposure to
fumes may also occur during coating and baking. Inhalation and dermal exposure to fumes of
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
46
the notified polymer during coating and baking is unlikely, as the coating process is
controlled from a panel that is removed from the application site, the baking system uses a
fully enclosed air forced oven, and both occur in the presence of a local exhaust ventilation.
The notified polymer becomes biologically unavailable for absorption once it is incorporated
in the paint during curing. The health risk for workers handling products coated with paint
containing the notified polymer is considered to be negligible.
There is little potential for significant occupational exposure to the notified polymer in the
transport and storage of the polymer or paint solutions other than in the event of an accidental
spill.
Given the risk reduction measures indicated and that the notified polymer is unlikely to be
hazardous, Polymer in RP0971 is of low concern to human health and safety in the
workplace.
Public Health
Given that public exposure is expected to be negligible, it is considered that Polymer in
RP0791 will not pose a significant risk to public health when used in the proposed manner.
Environmental Effects
The new polymer is intended for use as a film-forming agent in heat cured external coil
coating of steel used in the manufacture of household appliances.
Minimal release of the polymer into the environment is expected to occur. Most of the
polymer will form an inert, heat-cured coil coating on steel, and hence no release is expected
from end use. A small amount may enter the environment as waste generated during
manufacturing of the polymer, blending of the polymer-solvent blend, and during coil
coating.
At the end of their useful life, the coated steel products will be disposed of in landfill, or
recycled for scrap metal. Metal recycling will destroy the polymer converting it to oxides of
carbon and water vapour. Polymer incorporated as coating on landfilled domestic appliances
would degrade over much longer time scales after being released from the metal substrates by
degradation processes such as rusting. Polymer wastes generated during manufacturing and
disposed of directly into landfill, are expected to eventually enter the soil environment and
gradually breakdown through biotic and abiotic processes.
Under normal usage, the notified polymer is not expected to enter the aquatic environment, or
to cross biological membrane and bioaccumulate, given the high molecular weight. As such,
the polymer is not a significant hazard to the environment.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
47
? 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.
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 1, 1 January 2002
48
13 PUBLICATION SUMMARY REPORT
Polymer in Technologic Varnish 84FI400
Summary Report
Reference No: PLC/266
SICPA Australia Pty Ltd of 3 Millers Rd, Brooklyn VIC 3025 (ACN 007 114 338) has
submitted a synthetic polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Polymer in Technologic Varnish 84FI400. The
notified polymer is intended to be used as a component of printing inks for application in
laminated food packaging. Between 26 and 85 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
No toxicological information has been provided for the notified polymer. Therefore, the
substance cannot be assessed against the NOHSC Approved Criteria for Classifying
Hazardous Substance. The polymer itself meets the criteria for a Synthetic Polymer of Low
Concern, and is not reactive and non-volatile, and because of the high molecular weight is not
expected to cross biological membranes. The notifier states that there have been no reported
incidences of adverse effects on the occupational health of workers using similar polymers in
Australia and overseas. The polymer solution Technologic Varnish 84FI400 is a hazardous
substance due to the presence of the solvents ethanol and ethyl acetate. It is classed as a Class
3 dangerous good (flammable liquid) because of the solvent content.
The MSDS for the polymer solution Technologic Varnish 84FI400 lists a number of potential
health effects, namely eye, skin, respiratory system and mucous membrane irritation, and
headache, shortness of breath, dizziness, drowsiness, nausea, vomiting and central nervous
system depression. Dermatitis may also occur on repeated exposure. The symptoms relate
mainly to the solvents, ethanol and ethyl acetate, rather than the notified polymer.
Occupational Health and Safety
There is little potential for occupational exposure to the notified polymer in the transport and
storage of the imported polymer solution. The greatest exposure is in the formulation and use
of printing inks. As these processes occur mainly in enclosed, automated systems, exposure is
likely to be limited to small scale dermal exposure to drips and spills when containers are
decanted or filled and when drum spears are inserted or removed. The use of protective
gloves will minimise the exposure to the notified polymer.
The primary hazard associated with the use of the notified polymer arises from the volatile
and highly flammable solvents used. Precautions including a high level of ventilation and
removal of ignition sources, along with use of gloves, safety eyewear, industrial clothing and
footwear, are required to control exposure to the solvents, and these should result in minimal
exposure to the notified polymer.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
49
The notified polymer is of low concern during occupational use, and no additional controls
are required.
Public Health
The inks containing the polymer are applied between two plastic films and, because the inks
are unable to transfer to the packaged food therein or to the skin of a person holding a
wrapper, the extent of public exposure to the notified polymer is assessed as negligible.
Environmental Effects
Minimal release of the notified polymer is expected to occur during normal use of the
polymer. Most of the polymer will become bound between the plastic substrate film after
printing. A small amount of polymer may enter the environment during the reformulation of
the polymer product into printing ink. Polymer released in this way will be disposal to landfill
as industrial waste. In landfill, the polymer is expected to become associated with the soil
matrix rather than leach into the aquatic environment, due to its predicted poor solubility in
water.
The majority of the polymer will follow the environmental fate of the food packaging into
which it is incorporated and be disposed of to landfill as domestic waste. The food packaging
will eventually degrade at which time the polymer will partition to the soil due to its
predicted low solubility in water.
The polymer is not expected to bioaccumulate due to its high molecular weight and low
solubility in water.
The low environmental exposure of the notified polymer as a result of the proposed
reformulation and use indicates the overall environmental hazard should be low.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer in the products Technologic Varnish
84FI400 and Access Lam Blending Varnish:
- adequate exhaust ventilation should be used to control solvent vapours
- employers should ensure that the NOHSC exposure standards for solvent vapours
are not exceeded in the workplace
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer in the products
Technologic Varnish 84FI400 and Access Lam Blending Varnish:
- eye protection, impermeable gloves, overalls and industrial footwear
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 1, 1 January 2002
50
? A copy of the MSDS should be easily accessible to employees.
? As the products 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.
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 introduced in a chemical form that does not meet the PLC
criteria.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
51
14 PUBLICATION SUMMARY REPORT
Dynapol H700
Summary Report
Reference No: PLC/270
Degussa Australia Pty Ltd of 17 Raglan St South Melbourne VIC 3205 (ACN 80 005 415
752) has submitted a synthetic polymer of low concern (PLC) notification statement in
support of their application for an assessment certificate for 1,3-Benzenedicarboxylic acid,
polymer with dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol and hexanedioic acid. The notified polymer is intended to
be used as an original equipment manufacturing base coat and repair metallic base coat for
two coat metallic automotive refinish coatings.. 250-1000 kg 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
No toxicological information has been provided for the notified polymer. Based on its high
molecular weight, low reactivity and low content of residual monomers, it is unlikely to be a
hazardous substance according to the NOHSC Approved Criteria for Classifying Hazardous
Substances. The polymer solution Dynapol H 700-22 is a hazardous substance due to the
content of the solvents xylene and n-butyl acetate. It is classed as a Class 3 dangerous good
(flammable liquid) because of the solvent content.
The MSDS for the polymer solution Dynapol H 700-22 lists a number of potential health
effects, namely eye, mucous membrane and respiratory irritation, headaches, dizziness,
vomiting and central nervous system depression. Skin irritation or contact dematitis may also
occur on repeated exposure. Skin defatting may also occur. The symptoms relate mainly to
the solvents, xylene and n-butyl acetate, rather than the notified polymer.
The polymer itself is not reactive and non-volatile, and because of the high molecular weight
is not expected to cross biological membranes. The notifier states that there have been no
reported incidences of adverse effects on the occupational health of workers using the
notified polymer overseas.
Occupational Health and Safety
The notified polymer will be imported into Australia and blended into paint that is used only
in automotive finish coatings. Exposure to the imported solution Dynapol H 700-22, which
contains 50 % notified polymer, may occur during paint manufacture. Workers involved in
paint formulation and end use may be exposed to paint solutions containing 10 % notified
polymer.
Dermal and ocular exposure of paint formulation workers to drips, spills and splashes of the
product Dynapol H 700-22 may occur when charging the mixing vessel. Inhalation exposure
to Dynapol H 700-22 aerosols and vapours may also occur when charging the mixing vessel.
Ocular and dermal exposure should be limited by the use of coveralls, goggles and
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
52
impervious gloves. The use of local ducted fume extraction located adjacent to the loading
hatch should limit inhalation exposure.
Paint formulation workers may be exposed to the vapours of the paint solution (containing
10% notified polymer) during paint mixing prior to application. Inhalation exposure will be
limited by the use of fully enclosed mixers fitted with an exhaust ventilation system.
Laboratory development workers and QC technicians may receive dermal and ocular
exposure to drips, spills and splashes of the paint solution when taking and testing paint
samples and during batch adjustment. The use of gloves, safety goggles and overalls should
serve to limit dermal and ocular exposure.
Drum filling personnel may receive dermal contact to paint solutions during connecting and
disconnecting pump lines during drum filling. As the drum filling process is automated and
workers wear gloves, safety goggles and overalls, exposure is expected to be incidental.
Coating application operators may experience dermal exposure to spills and drips of the paint
(10 % notified polymer) when connecting pump lines between the drums and the spray
equipment, when thinning the paint solution and when cleaning the spray equipment. The use
of gloves and safety glasses or goggles should limit dermal exposure. The spraying procedure
is expected to produce a dense aerosol. The use of the paint containing the notified polymer
should be in accordance with the NOHSC National Guidance Material for Spray Paintiing.
The use of a well ventilated, down draft spray booth with an effective fume extraction system
as well as anti-static flame retardant overalls, anti-static footwear, impervious gloves, eye
protection and air fed breathing apparatus should adequately serve to limit any dermal or
inhalation exposure from aerosols.
The notified polymer becomes biologically unavailable for absorption once it is incorporated
in the paint during curing. The health risk for workers handling products coated with paint
containing the notified polymer is considered to be negligible.
There is little potential for significant occupational exposure to the notified polymer in the
transport and storage of the polymer or paint solutions other than in the event of an accidental
spill.
Engineering controls and personal protective equipment necessary for reduction of exposure
to hazardous solvents should be more than adequate to reduce exposure to the notified
polymer.
Given the risk reduction measures indicated and that the notified polymer is unlikely to be a
hazardous substance, the notified polymer is of low concern to human health and safety in the
workplace.
Public Health
In view of its high molecular weight, low toxicity and the use pattern, the notified polymer is
likely to pose a minimal hazard to public health.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
53
Environmental Effects
The notified polymer will be imported as a 50% polymer-solvent solution at up to 1 tonne per
year for the first 5 years. The polymer-solvent solution will be used to formulate spray paints
for automotive refinish coatings.
No direct release of the notified polymer to the environment is expected to occur during the
manufacturing and blending processes, however, a small amount of waste will be generated
mainly through incidental spills, equipment cleaning, and container residues. Some release of
the notified polymer will also occur during application of the paint to car bodies. Transfer
efficiency of paint during spray painting is approximately 30%, hence 70% of paint
containing the new polymer could be released as overspray. It is expected that spray painting
will occur in closed workshops where the over-sprayed paint will be captured by filters and
other masking materials for disposal. The rest of the new polymer will be incorporated into
the coating formulation and deposited on motor vehicles, where once dried, will be inert.
Waste generated during manufacturing, application and container residues is expected to be
disposed of in approved landfill sites or by incineration. In landfill, the new polymer will
only slowly degrade. Leaching of the polymer from landfill sites is unlikely given the low
water solubility. Hydrolysis, although theoretically possible because of the presence of ester
groups in the polymer, is unlikely in the normal environmental pH range. Incineration of
polymer wastes would destroy the polymer releasing combustion products comprising mainly
oxides of carbon and water. Polymer incorporated onto car bodies will share the fate of the
vehicles, which are likely to be recycled as scrap at the end of their useful life.
The overall environmental hazard posed by the new polymer is expected to be low. The
polymer is not expected to enter the aquatic environment during normal use, and it is unlikely
to cross biological membranes, due to the low solubility and high molecular weight, and as
such should not bioaccumulate.
RECOMMENDATIONS
No special precautions are required for the notified polymer, however, due to the presence of
hazardous solvents in the polymer solution, the following recommendations are made.
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the product Dynapol H 700-22:
- Ensure ventilation is adequate.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the product Dynapol H 700-22:
- Overalls
- Safety shoes
- Goggles
- Gloves
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
54
- Respirator where engineering controls inadequate
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.
Emergency procedures
? Spills/release of the product Dynapol H 700-22 should be taken up with absorbent
material.
? In the event of a spillage, all possible sources of ignition should be shut down.
? Action should be taken to prevent a spill entering drains or waterways.
Transport and Packaging
? The product Dynapol H 700-22 is a flammable liquid and should be transported as a
dangerous good.
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 introduced in a chemical form that does not meet the PLC
criteria.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
55
15 ACCESS TO FULL PUBLIC REPORTS
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)
6279 1161 or (02) 6279 1163 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) 9577 9579 or fax: (02)
9577 9465.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
56
16 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 1
Commercial Evaluation Category Permits
PERMIT COMPANY COMPANY CHEMICAL HAZARDOUS QUANTITY USE PERIOD
NUMBER NAME POSTCODE OR TRADE SUBSTANCE APPROVED
NAME
11/12/01
3006 Yes 2000 kg Component
Infineum ECA 10793
496
of automotive
Australia Pty
transmission
Lyd
fluid
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
57
17 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 2
Low Volume Category Permits
PERMIT COMPANY COMPANY CHEMICAL OR TRADE HAZARDOUS USE DATE
NUMBER NAME POSTCODE NAME SUBSTANCE
411 Amway 2154 Jojoba Wax PEG-80 No Cosmetic 23/11/01
of Esters ingredient
Australia
412 Estee 2018 Hydrogenated No Cosmetic 10/12/01
Lauder polyisobutene ingredient
Pty Ltd
413 Estee 2018 D-glucopyranose, No Ingredient 14/12/01
Lauder oligomeric, 6- of
Pty Ltd (dihydrogen 2-hydroxy- shampoo
1,2,3-
propanetricarboxylate),
1-(coco alkyl) ethers,
sodium salts
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
58
18 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 USE
NUMBER NAME TRADE NAME
189 Rohm & Polymer in Optidose Water conditioner
Haas 3100
Australia Pty
Ltd
190 Rohm & Polymer in Optidose Water conditioner
Haas 1000
Australia Pty
Ltd
191 PPG Polymer in HC-96- Surface coating
Australia Pty 3259
Ltd
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
59
19 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 3
Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
(C8H6O4.C8H4O3.C4H2O3.C3H8O2.C2H6O2) x
31742-81-1
1,4-Benzenedicarboxylic acid, polymer with 1,2-
ethanediol, 2,5-furandione, 1,3-isobenzofurandione
and 1,2-propanediol
1-Dodecene, dimer with 1-decene, hydrogenated 151006-58-5 Unspecified
1-Dodecene, trimer with 1-decene, hydrogenated 151006-59-6 Unspecified
1-Dodecene, polymer with 1-decene, hydrogenated 151006-60-9 Unspecified
144468-32-6 Unspecified
1,3-Propanediol, 2,2-bis(bromomethyl)-, reaction
products with ethanethiol-tetrafluoroethylene telomer,
polymers with 1,6-diisocyanato-2,2,4(or 2,4,4)-
trimethylhexane, 2-heptyl-3,4-bis(9-isocyanatononyl)-
1-pentylcyclohexane and 2,2'-
(methylimino)bis[ethanol]
C26H20N4O2
154440-80-9
5,12-Dihydroquino[2,3-b]acridine-2-(3,5-
dimethylpyrazol-l-ylmethyl)-7,14-dione
C43H36F2N18O20S6.xNa
143683-24-3
1,3,6-Naphthalenetrisulfonic acid, 7,7'-[1,3-
propanediylbis[imino(6-fluoro-1,3,5-triazine-4,2-
diyl)imino[2-[(aminocarbonyl)amino]-4,1-
phenylene]azo]]bis-, sodium salt
C45H38F2N16O14S4.xNa
149850-32-8
1,5-Naphthalenedisulfonic acid, 3,3'-[1,3-
propanediylbis[imino(6-fluoro-1,3,5-triazine-4,2-
diyl)imino[2-(acetylamino)-4,1-phenylene]azo]]bis-,
sodium salt
C46H42F2N14O16S4.xK.xNa
152397-21-2
2-Naphthalenesulfonic acid, 7,7'-[(2-methyl-1,5-
pentanediyl)bis[imino(6-fluoro-1,3,5-triazine-4,2-
diyl)imino]]bis[4-hydroxy-3-[(4-methoxy-2-
sulfophenyl)azo]-, potassium sodium salt
C43H36F2N14O22S6.xNa
155522-07-9
1,4-Benzenedisulfonic acid, 2,2'-[(1-methyl-1,2-
ethanediyl)bis[imino(6-fluoro-1,3,5-triazine-4,2-
diyl)imino(1-hydroxy-3-sulfo-6,2-
naphthalenediyl)azo]]bis[5-methoxy-, sodium salt
C33H26N8O14S4.xLi.xNa
124605-82-9
2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4-[[4-[(8-
amino-1-hydroxy-3,6-disulfo-2-naphthalenyl)azo]-2-
methylphenyl]azo]phenyl]azo]-4-hydroxy-, lithium
sodium salt
155613-89-1 Unspecified
Cuprate(6-), [mu-[[2,2'-[(1-methyl-1,2-
ethanediyl)bis[imino(6-fluoro-1,3,5-triazine-4,2-
diyl)imino(2-hydroxy-5-sulfo-3,1-
phenylene)azo(phenylmethylene)azo]]bis[4-
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
60
sulfobenzoate]](10-)]]di-, sodium
C49H34ClFN14O20S6.xNa
155522-05-7
2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[[3-[[8-
[[4-fluoro-6-(methylphenylamino)-1,3,5-triazin-2-
yl]amino]-1-hydroxy-3,6-disulfo-2-naphthalenyl]azo]-
4-sulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-4-
hydroxy-3-[(1-sulfo-2-naphthalenyl)azo]-, sodium salt
C29H30N6O20S6.4Na
116889-78-2
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-
[[3-[[[2-[[2-
(sulfooxy)ethyl]sulfonyl]ethyl]amino]carbonyl]phenyl]
azo]-3-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-,
tetrasodium salt
1,5-Naphthalenedisulfonic acid, 2-[[8-[[4-[[3-[[[2-
C34H27FN8O16S5.4Na
116912-36-8
(ethenylsulfonyl) ethyl] amino] carbonyl] phenyl]
amino]-6-fluoro-1, 3,5-triazin-2-yl] amino]-1-hydroxy-
3,6-disulfo-2-naphthalenyl]azo]-, tetrasodium salt
Phenol, 4,4'-(1-methylethylidene) bis-, polymer with
186359-26-2 Unspecified
(chloromethyl) oxirane and. alpha.,. alpha.'-[(1-
methylethylidene)di-4,1-phenylene]bis[.omega.-
(oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)]],
4-(1-methyl-1-phenylethyl)phenyl ethers
331718-61-7
2-Propenoic acid, 2-methyl-, butyl ester, polymer with (C16H30O2.
C12H22O2.C8H14O2.C8H8.C7H12O3.C6H10O3.
dodecyl 2-methyl-2-propenoate, ethenylbenzene, 2-
C3H4O2) x
ethylhexyl 2-methyl-2-propenoate, 4-hydroxybutyl 2-
propenoate, 2-hydroxyethyl 2-methyl-2-propenoate
and 2-propenoic acid
2-Propenoic acid, 2-methyl-, butyl ester, polymer with
331718-60-6 (C16H30O2.C12H22O2.C8H14O2.C8H8.C6H10O3.
dodecyl 2-methyl-2-propenoate, ethenylbenzene, 2-
C6H10O3.C3H4O2) x
ethylhexyl 2-methyl-2-propenoate,2-hydroxyethyl 2-
methyl-2-propenoate, 2-hydroxypropyl 2-propenoate
and 2-propenoic acid
Octadecanoic acid, 12-hydroxy-, polymer with butyl 2- (C18H36O3.C13H15NO. C12H22O2. C8H8. C7H12O3.
331718-57-1
C7H12O2. C7H10O3. C5H8O3. C5H8O2. C4H6O2.
propenoate,ethenylbenzene, 2-ethylhexyl 2-methyl-2-
C4H6O2. C3H4O2. C3H3N) x
propenoate, 2-hydroxyethyl 2-propenoate, 1-(1-
isocyanato-1-methylethyl)-3-(1-
methylethenyl)benzene, methyl 2-methyl-2-
propenoate, methyl 2-propenoate, 2-methyl-2-
propenoic acid, oxiranylmethyl 2-methyl-2-
propenoate, 1,2-propanediol mono(2-methyl-2-
propenoate), 2-propenenitrile and 2-propenoic acid
2-Propenoic acid, 2-methyl-, methyl ester, polymer
331733-15-4 (C8H10O3.C7H12O3.C7H12O2.C6H10O3.C5H8O2.(C2
with butyl 2-propenoate, hexahydro-1,3-
H4O)n C4H6O2)x
isobenzofurandione, 4-hydroxybutyl 2-propenoate, 2-
hydroxypropyl 2-propenoate and .alpha.-(2-methyl-1-
oxo-2-propenyl)-.omega.-hydroxypoly(oxy-1,2-
ethanediyl)
2-Propenoic acid, 2-methyl-, 2-ethylhexyl ester, (C12H22O2.C8H10O3.C8H8.C7H12O3.C7H12O2.C7H1
331749-39-4
polymer with butyl 2-propenoate, ethenylbenzene, 0O3.C6H10O3.C5H8O2.C3H4O2.C3H3N) x
hexahydro-1,3-isobenzofurandione,4-hydroxybutyl 2-
propenoate, 2-hydroxypropyl 2-propenoate, methyl 2-
methyl-2-propenoate, oxiranylmethyl 2-methyl-2-
propenoate, 2-propenenitrile and 2-propenoic acid
2-Propenoic acid, 2-methyl-, oxiranylmethyl ester, (C8H8.C7H12O2.C7H10O3. (C2H4O) n C5H8O2) x
331753-58-3
polymer with butyl 2-propenoate, ethenylbenzene and
.alpha.-(2-methyl-1-oxo-2-propenyl)-omega.-
methoxypoly(oxy-1,2-ethanediyl)
(C8H8.C7H12O3.C4H6O2. (C2H4O) n C5H8O2) x
331753-77-6
2-Propenoic acid, 2-methyl-, polymer with
ethenylbenzene, 2-hydroxypropyl 2-methyl-2-
propenoate and .alpha.-(2-methyl-1-oxo-2-propenyl)-
.omega.- methoxypoly(oxy-1,2-ethanediyl)
2-Propenoic acid, 2-methyl-, polymer with (C12H22O2. C11H20O2.C8H8.C6H10O3.
331942-17-7
C6H10O2.C4H6O2) x
ethenylbenzene, 2-ethylhexyl 2-methyl-2-propenoate,
2-ethylhexyl 2-propenoate, 2-hydroxyethyl-2-methyl-
Chemical Gazette Commonwealth of Australia Gazette
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61
2-propenoate and 2-oxepanone
Fatty acids, tall-oil, polymers with glycerol, light Unspecified
175779-57-4
steam-cracked petroleum naphtha C5 fraction oligomer
conc., maleic anhydride, pentaerythritol, rosin, steam-
cracked petroleum distillates C8-12 fraction and tall oil
Hexanedioic acid, polymer with 2-amino-2-methyl-1- (C12H18N2O2. C6H14O3. C6H14O2. C6H10O4.
331735-25-2
C6H10O2. C5H10O4.C4H11NO) x
propanol, 2-ethyl-2- (hydroxymethyl)-1,3-
propanediol, 3-hydroxy-2-(hydroxymethyl)-2-
methylpropanoic acid, 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, 3-
methyl-1,5-pentanediol and 2-oxepanone
C52H32CrN18O20S4.3Na
178452-72-7
Chromate(3-), bis[3-[[6-amino-1,4-dihydro-2-[[[4 [(2-
hydroxy-1-naphthalenyl)azo]phenyl]sulfonyl]amino]-
4-(oxo-kappa O)-5-pyrimidinyl]azo-kappa N1]-4-
(hydroxy-kappa O)-5-nitrobenzenesulfonato(3-)]-,
trisodium
163149-28-8 Unspecified
1-Dodecene, polymer with 1-decene and 1-octene,
hydrogenated
141091-64-7 Unspecified
2-Propenoic acid, 2-methyl-, 2-(diethylamino)ethyl
ester, polymer with butyl 2-propenoate and
ethenylbenzene, 2,2'-azobis[2-methylbutanenitrile]-
initiated, compd. with Me p-toluenesulfonate
Chemical Gazette Commonwealth of Australia Gazette
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20 PRIORITY EXISTING CHEMICAL PROGRAM
CALL FOR INFORMATION
In accordance with Section 48 of the Industrial Chemicals Notification and Assessment Act
(the Act) the Director of the National Industrial Chemicals Notification and Assessment
Scheme (the Director) is seeking information on the chemicals listed below. These industrial
chemicals were nominated in 1999 during the call for nominations. The chemicals have been
selected for further work mainly because of environmental concerns.
The information sought on these chemicals are:
?Quantities imported and/or manufactured
?Amounts produced and/or released as by-products of processing and/or manufacture
?Products imported containing the chemical and quantities of chemical in the products
?Uses of the chemical or the products containing the chemical.
The notice is directed to all persons who have manufactured or imported one or more of the
chemicals or products containing the listed chemicals since August 1999. Any other persons
with information on these chemicals including users, past importers or manufacturers are also
encouraged to provide this information to the Director.
Persons who provided information for some of the chemicals listed below during the August
1999 call for information are also required to provide data to ensure that the information is
up-to-date.
Chemical Name CAS Number
Polychlorinated naphthalenes including but not limited 70776-03-3
to
1-Chloronaphthalene 90-13-1
2-Chloronaphthalene 91-58-7
Pentachloronaphthalene 1321-64-8
Trichloronaphthalene 1321-65-9
Hexachloronaphthalene 1335-87-1
Tetrachloronaphthalene 1335-88-2
1,4-Dichloronaphthalene 1825-31-6
1,2-Dichloronaphthalene 2050-69-3
1,6-Dichloronaphthalene 2050-72-8
1,7-Dichloronaphthalene 2050-73-9
1,8-Dichloronaphthalene 2050-74-0
2,3-Dichloronaphthalene 2050-75-1
2,6-Dichloronaphthalene 2065-70-5
1,3-Dichloronaphthalene 2198-75-6
2,7-Dichloronaphthalene 2198-77-8
Octachloronaphthalene 2234-13-1
Chloronaphthalene 25586-43-0
Heptachloronaphthalene 32241-08-0
Chlorinated styrenes including but not limited to
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
63
m-Chlorostyrene 2039-85-2
o-Chlorostyrene 2039-87-4
octachlorostyrene 29082-74-4
p-chlorostyrene 1073-67-2
Tetrachlorobenzyltoluene (TCBT)
Ugilec 141 {dichloro[(dichlorophenyl)methyl] methyl 76253-60-6
benzene}
Ugilec 121 {(chlorophenyl)(chlorotolyl)methane, mixed No CAS number
isomers}
No CAS number
Polychlorinated di(bi)phenyl ethers (PCDEs/PCBEs)
including but not limited to:
Mono-chlorinated diphenyl ethers No CAS number
Di-chlorinated diphenyl ethers No CAS number
Tri-chlorinated diphenyl ethers No CAS number
Tetra-chlorinated diphenyl ethers No CAS number
Penta-chlorinated diphenyl ethers No CAS number
Hexa-chlorinated diphenyl ethers No CAS number
Hepta-chlorinated diphenyl ethers No CAS number
Octa-chlorinated diphenyl ethers No CAS number
Nona-chlorinated diphenyl ethers No CAS number
Deca-chlorinated diphenyl ethers No CAS number
The polychlorinated naphthalenes and tetrachlorobenzyltoluenes are used overseas, as PCB
alternatives, as dielectric fluids in transformers and capacitors and hydraulic fluid in the
mining industry. The polychlorinated diphenyl ethers (PCDEs) and chlorinated styrenes are
formed as by-products of industrial processes involving chlorine. Chlorinated styrenes are
also used in some plastic and foam manufacture.
The information gained from this data call-in will be considered by NICNAS when
conducting Section 48 assessments on the chemicals. These assessments will be published
and publicly available. A description of the process is available from NICNAS.
Responses on the chemicals are required by 15 February 2002. The penalty for non-
compliance with this notice is up to $33000.
If you would like any further information please contact Ms Sneha Satya on 02 8577 8880 or
email sneha.satya@nicnas.gov.au
The information is to be sent to: Warwick Shaw
Existing Chemicals
NICNAS
G P O Box 58
Sydney
NSW 2001.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
64
21 AMENDMENTS TO ADOPTED NATIONAL EXPOSURE STANDARDS
FOR ATMOSPHERIC CONTAMINANTS IN THE OCCUPATIONAL
ENVIRONMENT (SOURCE A UPDATES BATCH 1) 2001
Under section 38 of the National Occupational Health and Safety Commission Act 1985
(Cwlth), the National Occupational Health and Safety Commission (NOHSC) declares
amendments to the Adopted National Exposure Standards for Atmospheric Contaminants in
the Occupational Environment [NOHSC:1003(1995)].
TITLE
The amendments may be cited as Amendments to Adopted National Exposure Standards for
Atmospheric Contaminants in the Occupational Environment (Source A Updates Batch 1)
2001.
OBJECTIVE
The objective of these amendments is to update the National Exposure Standards maintained
by the National Occupational Health and Safety Commission by:
replacing existing standards for eight substances; and
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adding standards for five substances.
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HOW COPIES MAY BE OBTAINED
Copies of the amendments may be obtained from the National Occupational Health and
Safety Commission's web-site at
http://www.nohsc.gov.au/OHSLegalObligations/HazSubstancesAndDngGoods/NES/firstbatch.htm.
Robin Stewart-Crompton
Chief Executive Officer
National Occupational Health and Safety Commission
GPO Box 1577
Canberra ACT 2601
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 1 January 2002
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