Environmental Effects
Gazette
Commonwealth
of Australia
No. C 11, Tuesday, 6 November 2001
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/732 COMPONENT OF OLOA 246R 5
2 NA/800 SILICONE QUATERNIUM-8 8
3 NA/811 CAESIUM FORMATE 10
4 NA/917 AM2 13
5 NA/918 TG-440 16
6 NA/923 POLYMER IN DISPERBYK 140 20
7 NA/939 PLA POLYMER 24
8 NA/942 Z-43 27
9 NA/948 Z-45 30
10 NA/952 CHEMICAL IN CATALYST MC 34
11 NA/959 SPEEDCURE PBZ 37
12 NA/966 SENSIVA SC 50 40
13 NA/968 LEXMARK ACRYLIC TERPOLYMER 44
14 PLC/244 Z-34 47
15 PLC/248 POLYMER IN URALAC SE 901 SZG3-55 50
16 PLC/252 EVCOTE PS6-100 54
17 PLC/254 POLYMER IN AFRANIL SLO 57
18 PLC/255 MVA 2453L 60
19 PLC/256 EVCOTE PWRH-100 63
20 PLC/257 EVCOTE PWR-100 66
1H-PYRAZOLE-1-ETHANOL, 4,5-DIAMINO-,
21 EX/30 70
SULFATE (1:1) SALT (PYRAZOLE DHE)
22 ACCESS TO FULL PUBLIC REPORT 75
PERMITS ISSUED
23 COMMERCIAL EVALUATION PERMITS 76
24 LOW VOLUME CHEMICAL PERMITS 77
25 EARLY INTRODUCTION PERMITS 78
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE 79
26
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES UNDER
AN AMNESTY
NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE
27 80
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE
YEARS AFTER ISSUE OF ASSESSMENT CERTIFICATE
NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF
28 82
CHEMICAL SUBSTANCES
SPECIAL NOTICES
29 NICNAS RELOCATION-NEW CONTACT DETAILS 85
OZONE PROTECTION PROGRAM-ENVIRONMENT AUSTRALIA-
30 86
REQUEST FOR INFORMATION ON OZONE DEPLETING
SUBSTANCES USED AS PROCESS AGENTS
CHANGES TO THE INDUSTRIAL CHEMICALS (NOTIFICATION AND 87
31
ASSESSMENT) ACT 1989
NEW TRANSITIONAL ARRANGEMENTS TOWARDS APPROVAL
32 89
OF APPROVED FOREIGN SCHEMES
5
1 PUBLICATION SUMMARY REPORT
Component of OLOA 246R
Summary Report
Reference No: NA/732
Chevron Oronite Australia of 520 Collins St, Level 8, Melbourne VIC 3000 (ABN 001 010
037) has submitted a standard notification statement in support of their application for an
assessment certificate for Component of OLOA 246R. The notified chemical is intended to
be used as detergent in hydraulic fluid lubricating oils. A quantity in the range of 10 to 50
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
No toxicity studies were presented for the notified chemical or the product, OLOA 246R.
Analogue data for similar long chain alkarylsulphonate calcium salts were provided. OLOA
246S, containing around 50 % of the analogue to the notified chemical, is of very low acute
oral and low dermal toxicity. OLOA 246S was slightly irritating to the eyes and skin of
rabbits.
In a Beuhler skin sensitisation study in guinea pigs, OLOA 246S was found to be strongly
sensitising, although the notifier states that no anecdotal evidence of skin sensitisation in
humans handling calcium sulphonate additives has been found over 60 years of use. Based on
the analogue data, the risk phrase R43 "May cause sensitisation by skin contact" is warranted
for the notified chemical.
The notifier has indicated that the analogue subchronic toxicity studies which were provided
as part of the NICNAS notification NA/177 and NA/178 should be taken as indicative of the
subchronic toxicity of the notified chemical. In a 28 day repeat dose oral rat study, a NOEL
of 500 mg/kg/day was established for the analogue to the notified chemical, AS 702 calcium
sulphonate. Decreased serum cholesterol was observed in both male and female rats given
1000 mg/kg. In a 28 day repeat dose dermal rat study with the analogue OLOA 247E, no
systemic toxicity was seen.
The three analogues of the notified chemical mentioned above were not mutagenic in in vivo
and in vitro test systems. The paraffinic petroleum distillates listed as adjuvants with the
notified chemical are Category 2 carcinogens, with concentration cutoffs of 0.1 %, unless the
petroleum distillate is shown to satisfy the condition that it contains less than 3 % DMSO
extract as measured by IP 346.
Occupational Health and Safety
The notified chemical will be imported in drums, isotanks or in bulk vessels as a component
(20 ?25 % OLOA 246R) of a lubricant additive package. The additive package will be
reformulated in Australia, by blending with oils and other additives. The final product is then
repackaged into 1 L and 4 L containers and 200 L drums, or transferred to road tankers for
bulk delivery to customers.
Dermal exposure would be the predominant route of occupational exposure to the notified
chemical. Inhalation exposure is expected to be minimal because the product containing the
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
6
notified chemical and the finished oil are viscous and therefore have reduced potential to
generate aerosols. In addition, the notified chemical has a very low vapour pressure, so
vapour accumulation in the workplace air is not likely. The notified chemical is a skin
sensitiser, and so protective gloves and clothing should be worn when the possibility of
exposure to drips and spills exists.
Workers involved in transferring the imported oil additive containing the notified chemical,
including bulk oil terminal workers and transport workers, and workers involved in blending
the additive into oil may be exposed to drips and spills of the additive package, containing 20
?25 % OLOA 246R (10.8 ?13.5 % notified chemical). Occupational exposure to the drips
and spills of the final hydraulic oil containing 0.5 ?1 % notified chemical is possible for
workers handling the final hydraulic oil. Workers involved in cleaning and maintenance of
tanks and blending equipment may also have general dermal exposure to oil residues. It is
recommended that all workers handling the notified chemical and the hydraulic oil containing
the notified chemical wear gloves when potentially exposed.
Occupational exposure to the products containing the notified chemical will occur for a range
of customers who use hydraulic equipment. The use is estimated to be 60 ?70 % in farming
applications, and 30 ?40 % in industrial applications. Dermal exposure is likely during filling
and top ups, and while handling equipment which has been in contact with the hydraulic oils.
The workers who are likely to be exposed include farmers, during filling and maintenance of
hydraulic equipment, mechanics who work on the hydraulic systems, and industrial
tradesmen who may have contact with the oil during top ups of the equipment. Dermal and
ocular exposure to the notified chemical at a concentration of 0.5 ?1 % is possible. It is
recommended that the workers wear protective clothing and use appropriate protective gloves
while working with hydraulic oils containing the notified chemical, as the notified chemical
is a hazardous substance at a concentration of 1 %.
Public Health
The potential for public exposure to the notified chemical during transport, storage, or arising
from its disposal is considered to be low. Exposure may occur for members of the public who
deal with hydraulic equipment. The health risk would be expected to be similar to that during
occupational exposure for tradesmen and farmers detailed above. Overall, it is considered that
the notified chemical will not pose a significant hazard to human health.
Environmental Effects
Environmental exposure from the oil blending sites is expected to be low as the majority of
the waste from the process is incinerated or recycled back into the blending process. Overall,
approximately 50 kg of waste OLOA 246R is generated per annum at each of the ten
potential blending sites in Australia. Assuming that API oil separation results in 95 %
removal of the oil from waste water (as claimed by the notifier), then approximately 2.5 kg
per annum of OLOA 246R is likely to enter the sewers from each of the blending sites.
OLOA 246R is expected to be associated with the sludge at sewerage treatment works and its
ultimate fate will either be in landfill or incineration.
The ecotoxicity data for the notified chemical indicate that it is unlikely to be toxic to fish,
algae or bacteria up to the limit of its solubility. However, the toxicity levels for daphnia and
the dispersion to fish are higher but cannot be quantified due to the uncertain exposure levels.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
7
The notifier estimates that up to 50 % of the notified chemical may be released to the
environment due to improper disposal of the waste hydraulic oil. This oil would be expected
to be disposed of by burning, down drains, to landfill or possibly just poured onto the soil.
OLOA 246R that enters the sewers will be adsorbed to the sludge due to its low water
solubility and large molecular size and will be disposed of to landfill or incinerated. Waste
chemical that is improperly disposed of in remote rural locations is also unlikely to enter the
water compartment due to the low water solubility of the notified chemical, and hence should
not present a significant hazard to aquatic organisms.
The notified chemical is unlikely to present a hazard to the environment when imported and
used according to the outlined directions. Improper disposal of waste oil by unapproved
methods significantly increases the risks to the environment from this chemical and this
practice should be discouraged.
RECOMMENDATIONS
To minimise occupational exposure to Component of OLOA 246R the following guidelines
and precautions should be observed:
Products containing the notified chemical at above 1 % should be classified as skin
?br>
sensitisers with the risk phrase R43;
Personal protective equipment during blending operations and end use should include
?br>
industrial clothing, impermeable gloves and occupational footwear;
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>
Used oil containing the notified chemical should only be disposed of by approved
?br>
methods.
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
8
2 PUBLICATION SUMMARY REPORT
Silicone Quaternium-8
Summary Report
Reference No: NA/800
Lever Rexona of 219 North Rocks Road, North Rocks, NSW 2151 has submitted a limited
notification statement in support of their application for an assessment certificate for Silicone
Quaternium-8. The notified polymer is to be used as a skin conditioning in the facial skin
cleanser product, Pond's Clear Solutions Deep Pore Foaming Cleanser. 0.4 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 toxicology data has been submitted in support of the notified chemical.
Based on information on the MSDS and known data for quaternary ammonium salts, the
notified chemical is classified as hazardous according to NOHSC Approved Criteria for
Classifying Hazardous Substances with the risk phrase R36 ?Irritating to eyes.
Due to the listing of quaternary ammonium compounds on the Drugs and Poisons Schedule
(SUSDP) in Australia, Lambent Quat AD is a Schedule 6 poison.
Occupational Health and Safety
Occupational exposure to the notified polymer during transport, storage, relabelling,
repackaging and stacking of supermarket shelves with the ready-to-use product Pond's Clear
Solutions Deep Pore Foaming Cleanser, should not occur except in the event of accidental
spillage.
Given the low concentration of the notified polymer in Pond's Clear Solutions Deep Pore
Foaming Cleanser and that it is imported as a ready-to-use product, the risks to human health
through occupational exposure to the notified polymer are considered as low.
Public Health
Based on the expected low level and transient exposure, it is considered that Silicone
Quaternium-8 will not pose a significant hazard to public health when used in the proposed
manner.
Environmental Effects
The notified polymer is to be imported as an ingredient in a cosmetic formulation to be used
as a facial cleanser and will be imported in a ready-to-use form for the general public.
Almost all of the notified polymer contained in the skin cleanser product would be released to
the sewage system when washed off the skin. Only a small amount of the notified polymer
would be released to landfill with residuals in empty containers.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
9
Due to the anticipated nationwide use of the product and the low levels of release the final
Predicted Environmental Concentration of the notified polymer is estimated to be very low
and safety margins towards aquatic organisms are expected to be high.
The notified chemical is not expected to cross biological membranes due to its high
molecular weight and size and as such it should not bioaccumulate.
The only other source of environmental contamination is from accidental spills and disposal
of packaging. The MSDS is adequate to limit the environmental exposure and, therefore,
limit the environmental effects.
Given the above, environmental exposure and the overall environmental hazard is expected to
be low.
RECOMMENDATIONS
To minimise occupational exposure to Silicone Quaternium-8, the following guidelines and
precautions should be observed:
Employers should ensure that the following personal protective equipment is used by
?br>
workers to minimise occupational exposure to the notified chemical;
-eye protection
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
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;
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;
A copy of the MSDS should be easily accessible to employees
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
10
3 PUBLICATION SUMMARY REPORT
Caesium Formate
Summary Report
Reference No: NA/811
Central Chemical Consulting Ltd of 7 Silica Road, Carine 6020, West Australia and Cabot
Australasia of 300 Millers Road, Altona, Victoria, 3018 have submitted a standard
notification statement in support of their application for an assessment certificate for caesium
formate. The notified chemical is intended to be used in coal laboratories for preparation of
media of different densities to classify coal on the basis of whether the coal fractions sink or
float in the different density media. It will also be used as a drilling fluid in the development
of oil and natural gas wells. Up to 2250 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 was found to be of low acute oral toxicity to rats (LD50 = 1780 mg/kg),
low dermal toxicity in rats, a slight skin irritant and a moderate eye irritant in rabbits, and
non-sensitising to the skin of guinea pigs. The results of genotoxicity testing were equivocal.
The notified chemical is not expected to cause significant chronic effects based on the known
properties of the formate anion and caesium cation. The notified chemical is classified as a
hazardous substance in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances and the following risk phrases apply: R22 `Harmful if swallowed' and
R36 `Irritating to eyes'.
Occupational Health and Safety
The notified chemical will be used in Australia only in the form of concentrated aqueous
solutions. Due to the hygroscopic nature of the notified chemical, it is unlikely to be isolated
in solid form. Approximately 12 laboratory workers may be exposed to solutions of the
notified chemical during coal classification procedures. An unspecified number of workers in
Australia may be exposed to the notified chemical on oil platforms, although the notifier
estimates that the total worldwide will be of the order of 200 workers. Exposure is expected to
be primarily dermal, through drips, spills and splashes while transferring the solutions.
The main risk on exposure to the notified chemical is associated with ocular exposure.
Precautions to prevent ocular exposure to splashes of the solutions should be taken whenever
the solutions are handled. To minimise the risk of eye irritation, eye protection (goggles or
face shield) should be worn.
Public Health
Given that the intended use of the notified chemical will be restricted to coal testing
laboratories and onshore/offshore drilling operations, no public exposure is anticipated except
in the event on an accidental spill, during transport from the docks to drilling sites or
laboratories. Based on this information, the notified chemical is unlikely to pose a significant
hazard to public health when used in the proposed manner.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
11
Environmental Effects
The notified chemical is not likely to present a hazard to the environment when it is used as a
variable density medium for coal classification since little release to the water compartment is
likely as a result of this use. It is estimated that approximately 2.5 tonnes per annum will be
used in coal classification laboratories where it will be used to prepare graded density media
for sink/float classification tests. Most will be released with coal returned to the stockpiles for
sale, and the caesium component will consequently become assimilated into coal ash.
Subsequent release of the caesium through leaching of the ash will be very diffuse and at low
levels.
Larger environmental releases of the notified chemical will arise from use in oil/gas drilling
operations. It is likely that up to 600 tonnes per annum may be used as a drilling fluid in
development of oil/gas wells. Localised high concentrations of caesium may result from the
disposal of drill cuttings to the marine environment. It is estimated that up to 170 tonnes of
the notified chemical may be released each year in this manner. Releases may total up to
around 42 tonnes (up to 32 tonnes of caesium) from any particular well. Since the notified
chemical is very water soluble the caesium is expected to eventually diffuse into the
surrounding water column. Sea water has an ambient caesium concentration of 0.002 mg/L
and so assuming a release of 42 tonnes of notified chemical in the cuttings from a given well,
it is estimated that diffusion into approximately 160 cubic kilometres of water is required to
bring the caesium concentration to within 10 % of the ambient. If it is assumed that the
average water depth around a given off shore well is 1 km, then the water around the well for
a radius of approximately 7 km could have significantly elevated concentrations of this
element. When water depth is less than 1 km, a larger area of ocean will have higher than
ambient caesium levels.
Toxicity results for a wide variety of aquatic organisms were provided in the notification.
Lower toxicity was demonstrated against marine organisms compared with their freshwater
counterparts. The notified chemical has been shown to exhibit slight toxicity to the brown
shrimp (96 hour LC50 = 91 mg/L), so sensitive organisms may be exposed to toxic
concentrations of the chemical in the immediate vicinity of the cutting mounds as the
chemical diffuses into the surrounding sea water. However, without a detailed analysis of the
relevant diffusion rates (taking into account likely current strengths and other localised
factors), it is impossible to further quantify the risk to susceptible organisms. Due to the high
water solubility it may be expected that, once desorbed from the cuttings, diffusion would be
rapid.
The formate component of the notified chemical is readily biodegradable, although the
caesium will be persistent. The chemical is assessed as having low potential for
bioaccumulation, and also is not expected to have large affinity for the organic component of
soils or sediments. The high water solubility indicates that the chemical should be very
mobile in soils and sediments.
RECOMMENDATIONS
Regulatory controls
? The NOHSC Chemicals Standards Sub-committee should consider the following
health hazard classification for the notified chemical:
- R22 Harmful if swallowed
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
12
- R36 Irritating to 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 solution:
- eye protection should be worn at all times when the solutions are handled;
impervious gloves (rubber or nitrile), and industrial clothing and footwear 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.
? As concentrated solutions of 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.
Environment
? Special efforts should be made to bring the contents of the final reports on the present
chemical, and other drilling mud components, to the attention of relevant State
Authorities. In particular the WA Department of Minerals and Energy conduct their
own assessment on formulated drilling fluids prior to granting approval for the use of
these materials. This authority requires data on toxicity test performed against local
marine species prior to granting approval for use.
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 11, 6 November 2001
13
4 PUBLICATION SUMMARY REPORT
AM2
Summary Report
Reference No: NA/917
Ausmelt Ltd of 12 Kitchen Road Dandenong VIC 3175 (ABN 72 005 884 355), Clariant
(Australia) Pty Ltd of 100 Heales Road Lara VIC 3212 (ABN 30 069 435 552) and
Megachem Pty Ltd of 49 Nicholas Drive Dandenong South VIC 3175 (ACN 007 076 477)
have submitted a standard notification statement in support of their application for an
assessment certificate for AM2. The notified polymer is intended as a mineral processing
reagent to be used during the processing of ores by flotation. Less than 3000 tonnes of the
notified chemical will be imported per annum for the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were provided for the notified chemical. However, data on a similar
chemical, caprylohydroxamic acid (CHA), and n-decanoic acid were submitted. These serve
to build conclusions regarding the toxicological profile of the notified chemical, AM2.
By analogy, the toxicity of the notified chemical is not expected to differ substantially from
that of CHA and n-decanoic acid. AM2 is expected to have very low acute oral, dermal and
inhalation toxicity. It is irritating to skin and eyes but is not expected to be sensitising to skin.
Upon repeated exposure to high dose, haematogenous functions, the liver, the spleen and the
kidney may be affected. It is unlikely to have teratogenic, genotoxic or tumour causing
properties. On the basis of the data supplied, AM2 would be classified as a hazardous
substance in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances and warrants the risk phrases: Irritating to eyes and skin (R36/38).
Occupational Health and Safety
The notified chemical will be manufactured in Australia, hence worker exposure to the
notified chemical may occur during manufacture and drumming off the chemical for
distribution to mining operators. The manufacturing process is largely automated and
enclosed, therefore exposure is limited to intermittent dermal exposure when connecting and
disconnecting pipes during transfer and filling operations. Dermal exposure of maintenance
workers to the notified chemical is possible during routine maintenance but is expected to be
low. Therefore, as skin and eye irritation effects may occur, gloves, safety glasses, boots and
protective clothing are required during handling of the notified chemical.
Similarly, during end-use of the notified chemical as ore flotation agent, the reagent storage,
mixing and flotation processes are automated and continuous, thus minimising worker
exposure. Plant operators and maintenance personnel will have intermittent exposure to the
notified chemical when connecting, disconnecting and cleaning the pumping equipment. As
the notified chemical has skin and eye irritation potential, precautions should be taken during
handling of the chemical. Therefore, flotation plant operators are required to wear protective
clothing, gloves and safety glasses when carrying out their tasks.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
14
Overall, it is concluded that there is a risk of skin and eye irritation during manufacture, use
and disposal of the notified chemical and precautions are required to minimise exposure. The
risk of systemic health effects is low, as is the risk of adverse health effects during transport.
Public Health
AM2 is manufactured and used with well engineered protective processes on sites not
available to the public, therefore, the likelihood of members of the public being exposed to it
is very low. Any exposure that does occur is most likely to be by dermal contact. Because
AM2 has low toxicity, the consequences of such contact are unlikely to be significant.
Environmental Effects
The notifier estimates that approximately 98% of the notified chemical will be exported with
the metal concentrates and destroyed during smelting, with the production of water vapour,
and oxides of carbon and nitrogen.
Approximately 2% of the reagent may be disposed of into tailings dams. The notifier has
shown that after 19 minutes the initial concentration of unbound notified chemical in the
water under test condition was reduced by 99.99%. Therefore, the concentration of the
notified chemical present in tailings dam water is expected to be at or below 0.5 礸/L. The
ecotoxicity data indicate that the notified chemical is moderately toxic to fish, highly toxic to
daphnia and very highly toxic to algae. However, the concentration of the notified chemical
present in the tailings dam water will be two orders of magnitude below the EC50 for the most
sensitive species (algae).
It is a characteristic of most sulphide metal mines that pyrite and other gangue metal
sulphides will slowly oxidise when exposed to air with production of sulphuric acid and
solutions of metal sulphates. Consequently, the water in the tailings dams becomes very
acidic (pH 1-2). The acid or based catalysed hydrolysis of hydroxamates to carboxylic acid
and hydroxylamine derivatives proceeds readily and the hydrolysis mechanism is said to
resemble that of amides. Therefore, decomposition of the notified chemical in tailings dams
as a result of hydrolysis is likely. In this case this would result in the formation of fatty acids
and hydroxylamine derivatives. These products are further expected to slowly degrade to
simpler compounds through chemical and physical processes. Release to the wider
environment is not expected as tailings dams are designed to reduce the potential for seepage.
Therefore, exposure to natural waters is expected to be low.
Up to 10 kg of the notified chemical will be released into the sewer from the manufacturing
facility per year. Subsequent treatment at local sewage treatment plants would further dilute
and remove the notified chemical to very low concentration levels.
Therefore, the environmental exposure and overall environmental hazard from the notified
chemical is expected to be low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
15
RECOMMENDATIONS
Regulatory controls
?The NOHSC Chemicals Standards Sub-committee should consider the following
health hazard classification for the notified chemical:
- R36/38: Irritating to eyes and skin
? The NOHSC Chemicals Standards Sub-committee should also consider the
appropriate environmental hazard classification of the notified chemical.
Control Measures
Occupational Health and Safety
?Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical:
- Enclosed and automated manufacturing process
- Exhaust ventilation during manufacture and filling processes
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical:
- Avoid spills and splashing during weighing and transfer operations
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical:
- 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 AM2 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 11, 6 November 2001
16
5 PUBLICATION SUMMARY REPORT
TG-440
Summary Report
Reference No: NA/918
CHT Australia of 33 Elliot Road, Dandenong VIC 3175 (ABN 54 006 849 869) has
submitted a limited notification statement in support of their application for an assessment
certificate for TG-440. The notified polymer is intended to be used as water and oil repellent
in textiles such as carpets, blankets, furnishings and upholstery fabric. Up to 20 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
Health Hazard
A limited number of toxicological tests have been provided for the imported polymer
emulsion, Unidyne TG-440, containing <30% notified polymer. The acute oral toxicity of the
polymer emulsion is very low. It is a slight eye irritant but not a skin irritant in rabbits. It is
not mutagenic in an Ames assay.
A number of potential health effects are also listed in the Material Safety Data Sheet for the
imported polymer emulsion. These include eye, skin, mucous membrane and respiratory
irritation, and central nervous depression which may lead to loss of coordination and
impaired judgement. These effects are related to the presence of co-solvents, dipropylene
monomethyl ether and isopropyl alcohol, rather than effects due to the notified polymer.
Dipropylene glycol monomethyl ether and isopropyl alcohol are on the NOHSC List of
Designated Hazardous Substances.
The notified polymer has a high NAMW, and absorption across biological membranes and
resultant systemic toxicity would be restricted. Therefore, the notified polymer is unlikely to
be a hazardous substance according to the NOHSC Approved Criteria for Classifying
Hazardous Substances.
The notified polymer is not a dangerous good for road or rail transport.
Occupational Health and Safety
Occupational exposure to the notified polymer can be divided into exposure to the imported
polymer emulsion (containing <30% notified polymer) and the coating product (containing
<1.5% notified polymer). Dermal and ocular exposure to spills, drips and splashes is the most
probable hazard for workers involved in the reformulation, drumming of coating product,
treatment of textiles and in cleaning equipment. Workers involved in the reformulation and
preparation of treatment bath will be exposed to the imported polymer emulsion (<30%
notified polymer), and exposure for these workers may be high. Therefore, there is a risk of
eye irritation for these workers.
The workers involved in drumming of the coating product, treatment of textile and cleaning
equipment may be exposed to the diluted polymer solution (<1.5% notified polymer).
Exposure is likely to be dermal and ocular exposure to drips and spills. Dermal exposure to
treated textile prior to curing can also occur if treated materials become entangled with the
rollers during application. However, the risk of adverse health effects arising from exposure
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
17
to the notified polymer is low due to the low toxicity of the polymer and its low concentration
in the textile coating.
Workers involved in handling the polymer emulsion and coating product should wear safety
glasses, overalls, safety shoes and protective gloves.
Although inhalation exposure to the notified polymer is unlikely, the presence of co-solvents
in formulations containing the notified polymer will require that adequate precautions be
taken to prevent inhalation exposure. The relevant NOHSC exposure standards are: isopropyl
alcohol, 400 ppm (time-weighted average) and 500 ppm (short term exposure limit);
dipropylene glycol monomethyl ether, 100 ppm (TWA) and 150 ppm (STEL), with skin
notation.
Occupational exposure to the notified polymer after the treated material is cured is unlikely
since the notified polymer is fixed onto the fibre surface or embedded in a matrix of other
polymers and ingredients. In this form, the polymer is not bioavailable, hence no risk to
workers is expected.
Exposure to the notified polymer is not expected during transport and storage as long as the
packaging is intact. The risk of adverse effects for transport and storage workers is
considered to be low.
Public Health
It is expected that public exposure to the products containing the notified polymer will be
minimal except in the rare event of an accidental spill. There will be public exposure from
dermal contact with textiles treated with the notified polymer. However, in this form, the
notified polymer is thermo-fixed, and consequently will be encapsulated within an inert, very
high molecular weight polymer matrix. This will render the notified polymer biologically
unavailable. Therefore, the public hazard from exposure to the notified polymer through all
phases of its life cycle is considered low.
Environmental Effects
Ultimately, most of the polymer will be released to landfill or incinerated at the end of the
useful life of the treated textiles. Significant leaching from the treated material is not
expected because of the negligible water solubility of the notified polymer and its affinity for
the textile surfaces to which it is heat cured. The majority of wastes generated from the
reformulation and application of the polymer will go to landfill (up to 292.5 kg per annum).
The notified polymer is not volatile and little release to the atmosphere is expected. The
hydrophobic and oleophobic nature of the polymer suggests that it will initially have little
affinity with either organic matter (sediments, soil or sludge) or the aqueous phase. In
landfill, the hydrocarbon portions of the polymer will probably slowly degrade to carbon and
nitrogen oxides through abiotic and biotic processes, with the fluorocarbon fraction
remaining. If incinerated, the polymer would be rapidly destroyed and converted to water
vapour and oxides of carbon, nitrogen and hydrogen fluoride.
The reformulation and application of the notified polymer will generate waste polymer,
which will be released to the sewer system (up to 32.5 kg per annum). The PEC of the
notified polymer for the metropolitan sewerage system, is 0.097 礸/L, which is unlikely to
present a significant toxicological risk to aquatic organisms. Within the sewer system, the
hydrocarbon portion is likely to become assimilated with the organic phase (sediments and
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
18
sludges), while it is possible that the fluorocarbons will partition to surface waters where they
will be subject to cleavage by UV radiation with subsequent volatilisation to the atmosphere
and abiotic degradation to hydrogen fluoride.
Given the available data, the overall environmental risk associated with the introduction of
the notified polymer appears to be low. However, there are uncertainties surrounding the
behaviour of fluorocarbon compounds in the environment and these are addressed in the
recommendations below.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer in the product, Unidyne TG-440:
- Enclosure of process as much as possible to reduce splashing
- exhaust ventilation during reformulation, preparation of treatment bath and
application of coating product
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer in the product,
Unidyne TG-440:
- when manually weighing and charging the mixing vessel, prevent splashes and
spills
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer in the product,
Unidyne TG-440:
- chemical goggles or safety glasses
- PVC or rubber gloves
- safety shoes
- overalls
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 11, 6 November 2001
19
Secondary Notification
The NICNAS Director must be notified in writing within 28 days by the notifier, or other
importer or manufacturer:
(1) Subsection 64(1) of the Act:
- if new information becomes available which may impact on the environmental
exposure or fate or ecotoxicity of the notified polymer, particularly in relation
to understanding the behaviour of fluorocarbons in the environment; or
(2) Subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
20
6 PUBLICATION SUMMARY REPORT
Polymer in Disperbyk 140
Summary Report
Reference No: NA/923
Nuplex Industries of 49-61 Stephen Road, Botany NSW 2019 (ACN 000 045 572) and
Clariant (Australia) Pty Ltd of 675 Warrigal Road Chadstone VIC 3148 (ACN 069 435 552)
have submitted a limited notification statement in support of their application for an
assessment certificate for Polymer in Disperbyk 140. The notified polymer is intended to be
used as an additive in solvent based paint systems. Less than 20 tonnes of the notified
polymer will be imported per annum for the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Limit toxicological information has been provided for the notified polymer. It was a slight
eye irritant in animals and was non-mutagenic in bacteria. There was insufficient
toxicological data for a classification of the notified polymer according to NOHSC Approved
Criteria for Classifying Hazardous Substances. However, the notified polymer is of high
molecular weight and low water solubility which prevents it from crossing biological
membranes. The levels of residual monomers are low.
The polymer solution, Disperbyk 140, is a hazardous substance because of the high
concentration of a solvent, 2-methoxy-1-methylethyl acetate. The risk phrases for Disperbyk
140 are R10 (Flammable) and R36 (Irritating to eye). The MSDS for the polymer solution
Disperbyk 140 lists a number of potential health effects, namely skin, eye and respiratory
irritation, headaches, dizziness, loss of consciousness, along with and damage to kidney,
liver, blood and/or bone marrow from repeated exposure. These relate to the solvent rather
than the notified polymer.
The MSDS for Sandosperse Blue A-B2G, a Sandosperse A product containing Disperbyk
140, indicates that it is classified as a hazardous substance. It will cause eye irritation. Any
inhalation exposure should be avoided.
Both Disperbyk 140 and Sandosperse Blue A-B2G are classed as a Class 3 dangerous good
(flammable liquid) because of the solvent content.
Occupational Health and Safety
There is little potential for significant occupational exposure to the notified polymer in the
transport and storage of the polymer solution and paint components containing this polymer
unless the packaging is breached. The risk of adverse effects in these workers is minimal.
During the reformulation process, the main exposure route for the notified polymer will be
dermal. The polymer is not expected to be hazardous by dermal exposure as the high
molecular weight will preclude absorption through the skin. Protective measures used to
prevent exposure to the hazardous solvents should provide sufficient protection against the
notified polymer.
The final paint mix containing <1% notified polymer could contain a variety of additional
ingredients, including solvents that may introduce additional human health hazards. The
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
21
spraying procedure also produces a dense aerosol of paint particles which could adversely
affect human health in the absence of additional hazardous components. It is also probable
that professionals involved in the spray painting industry will use a number of different paint
formulations.
For these reasons, the notified polymer must be assessed for the contribution it makes to the
hazards associated with use of the spray paints. The presence of many potential and actual
hazardous substances in the formulations requires the use of stringent engineering controls,
such as a correctly constructed and maintained spray booth, and of a high level of personal
protective equipment, such as impermeable overalls and gloves and a full face shield and
respirator. The use of the paint containing the notified polymer should be in accordance with
the NOHSC National Guidance Material for Spray Painting. Employers will need to adhere
to any relevant exposure standards. The level of protection from exposure afforded by the
standard protective measures will provide adequate protection from the notified polymer,
which is likely to be less intrinsically toxic than most of the solvents, pigments and other
paint resins.
Once the applied final paint mix has hardened, the polymer will not be separately available
for exposure or absorption.
The paint components containing the notified polymer are flammable due to their solvent
content. Precautions must be taken to avoid sources of ignition, e.g. use of earthing leads.
Operators should wear antistatic overalls and footwear.
Similar considerations apply in the disposal of the polymer. The wastes containing the
notified polymer may be hazardous substances on the basis of the solvent and other resin
content, and the precautions used on the basis of these additional materials should be
adequate for protection from the notified polymer. In addition, much of the polymer will be
crosslinked, hardened and immobilised by the time of disposal.
Public Health
Public exposure to the notified polymer is essentially limited to dermal contact with the cured
paint. Curing binds the polymer in the paint matrix and to the underlying primer. The notified
chemical will therefore not be biologically available. The notified chemical also has a high
molecular weight and is present at low concentrations, ?- 1%. As such the notified chemical
is not likely to pose a significant risk to public health.
Environmental Effects
The majority of the notified polymer will be crosslinked with other paint components to form
a very high molecular weight and stable paint film. Therefore, once incorporated into the
paint formulation, the notified polymer is expected to be immobile and pose little risk to the
environment.
The notified polymer in waste from spills, equipment cleaning and drum recycling will be
collected by licensed waste disposal contractors and treated by a distillation process whereby,
the solvent is reclaimed and the remaining solid containing the notified polymer will be
disposed of in landfill. The notified polymer in overspray will also be disposed of in landfill.
The notifier indicates that incineration of waste may also occur.
The notified polymer is not water soluble and therefore will not be mobile in either the
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
22
terrestrial or aquatic compartments. As a consequence of its polycationic nature, the notified
polymer is expected to eventually associate with the soil matrix and sediments. The notified
polymer is not expected to cross biological membranes due to its high molecular weight and
low water solubility and is therefore not expected to bioaccumulate.
The notified polymer is not likely to present a hazard to the environment when it is stored,
transported and used in the proposed manner.
RECOMMENDATIONS
Regulatory controls
? Use the following risk phrases for Disperbyk 140 and Sandosperse A products
containing the notified polymer:
- R10 Flammable
- R36 Irritating to eyes
? Disperbyk 140 and Sandosperse A products should be classified as follows under the
ADG Code:
- Class 3 Packaging group III
Control Measures
? Employers should implement the following engineering controls and safe work
practices to minimise occupational exposure to Disperbyk 140 and Sandosperse A
products containing the notified polymer:
- The use of the paint containing the notified polymer should be in accordance with
the NOHSC National Guidance Material for Spray Painting.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to Disperbyk 140 and Sandosperse A
products containing the notified polymer:
- impervious gloves,
- anti-static flame retardant overalls,
- safety boots,
- safety glasses/goggles,
- full face shield and respirator while inside the spray booth.
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? Atmospheric monitoring should be conducted to measure workplace concentrations
during formulation and use of the paints containing the notified polymer. Exposures
must be maintained at lower than the relevant NOHSC Exposure Standards.
? A copy of the MSDS should be easily accessible to employees.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
23
? 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 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 11, 6 November 2001
24
7 PUBLICATION SUMMARY REPORT
PLA Polymer
Summary Report
Reference No: NA/939
Dow Chemical (Australia) Limited of 541-583 Kororoit Creek Road, Altona, Victoria 3018
(ACN 000 264 979) has submitted a limited notification statement in support of their
application for an assessment certificate for PLA Polymer. The notified polymer is intended
to be used as a replacement for a number of common polymers including polyesters,
polyolefins, polystyrene and cellulosics. Less than 100 tonnes of the notified polymer will be
imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
The notified polymer is of very low oral toxicity in rats and low dermal toxicity in rabbits,
and is a slight skin and eye irritant to rabbits. The MSDS for the notified polymer indicates
that moderate eye irritation may occur on acute exposure. It is not a skin sensitiser in guinea
pigs. For the endpoints tested, the notified polymer is not classified as a hazardous substance
in accordance with the Approved Criteria.
Occupational Heath and Safety
Little occupational exposure to the notified polymer is likely due its physical form (pellets or
fabricated fibres, sheets or articles). In these forms the notified polymer is unlikely to be
bioavailable. Handling is generally automated and enclosed. Should dusts occur, ocular
exposure is possible, and safety glasses should be worn. A dust mask or respirator should be
used in very dusty conditions. The NOHSC exposure standard for dusts in general of 10
mg/m3 should be adhered to in handling the notified polymer in powder form.
The pellets pose a slip hazard, and should be cleaned up immediately. Processing involves
elevated temperatures, and precautions should be taken where newly fabricated polymer
products are handled. Toxic fumes may be generated if the notified polymer is overheated
(> 230oC), and precautions should be taken to prevent overheating; respiratory protection
may be required should decomposition products be formed.
Public Health
Public exposure to the notified polymer will be through contact with moulded products,
however, in this form it is not bioavailable. Chewing, in particular by children, of the
products and raw pellet form, which could be mistaken for lollies, is not likely to pose a
significant toxicological risk due to the very low oral toxicity. The use of the polymer in food
containers is not likely to pose a threat to public health as the oral toxicity is very low and
very little of the notified polymer would become available in the food. Similarly the use in
textiles, particularly clothing, is unlikely to pose a public health threat due to the low dermal
toxicity and skin irritancy of the polymer. Dust generated through cutting or grinding will
render the polymer bioavailable, however, as it is of low toxicity and a low skin and eye
irritant, it is unlikely to pose a significant public health hazard.
Environmental Effects
Spills of the pelletised polymer will be collected and either reused or disposed of to landfill.
Empty carton liners containing residual polymer will also be disposed of in landfill or
incinerated to produce water vapour and oxides of carbon.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
25
The notifier has produced three separate composting tests: an Aerobic Biodegradation Test
under controlled composting conditions; a Pilot Scale Composting Test; and a Pilot Scale
Composting and Sieving Test for Measurement of Disintegration. The aerobic biodegradation
test indicated the percentage degradation of cellulose after 90 days was approximately 92 %.
After the same period the notified polymer degraded up to 95.5 %. Therefore, the notified
polymer was biodegraded by microorganisms under the test conditions. All three tests
indicate that under composting conditions the notifier polymer completely disintegrates
within 90 days.
Manufacturing waste and notified polymer incorporated into final articles will eventually be
disposed of in landfill. In landfill, the polymer is unlikely to be mobile in soil due to its low
water solubility and is expected to degrade to gases such as carbon dioxide through abiotic
and biotic processes. The large molecular weight and low water solubility of the notified
polymer should prevent bioaccumulation.
The ecotoxicity data indicates the degradation products formed during the composting of
samples of several different forms of the notified polymer are no more toxic to earthworms,
daphnia, the rotifer Brachionus calyciflorus and the crustacean Thamnocephalus platyurus
than the control and cellulose compost and compost eluant. The germination and growth of
summer barley and the germination of cress plants are not inhibited when grown in compost
in which the degradation products of the notified polymer were present when compared with
control and cellulose compost.
Therefore, the environmental exposure and overall environmental hazard from the notified
chemical is expected to be low.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer:
- The NOHSC exposure standard for dusts in general of 10 mg/m3 should be
adhered to in handling the notified polymer in powder form; if work practices and
engineering controls do not reduce exposure to dust or thermal decomposition
products sufficiently, respiratory protection should be used;
- Spillages are a slip hazard and should be swept up promptly and put into
containers for disposal.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Protective eyewear, industrial clothing and footwear should be used during
occupational handling of the notified polymer.
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
26
? 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 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 11, 6 November 2001
27
8 PUBLICATION SUMMARY REPORT
Z-43
Summary Report
Reference No: NA/942
Lubrizol International Inc. of 28 River Street, SILVERWATER NSW 2128 (ARBN 002 747
944) has submitted a limited notification statement in support of their application for an
assessment certificate for Z-43. The notified polymer is intended for use as an additive to
engine oils. Less than 100 tonnes of the notified polymer will be imported per annum for the
first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Z-43 is of very low acute oral toxicity. A product containing Z-43 was a slight skin irritant
and a slight to moderate eye irritant. The notified polymer has a NAMW greater than 1000
which is expected to preclude absorption across biological membranes and any potential
systemic effects. The levels of low molecular weight species and residual monomers will not
render the polymer hazardous. Based on available (limited) information, Z-43 cannot be
classified against the NOHSC Approved Criteria for Classifying Hazardous Substances. The
notified polymer degrades thermally to emit toxic fumes, so there is some risk of acute health
effects by inhalation when handling or disposing of previously heated oil. Respiratory
protection may be required during these activities.
The notified polymer will be used in the presence of mineral oil, which may be slightly
irritating to the skin in the short term and cause dermatitis after chronic exposure. Mineral oil
mists may cause respiratory irritation at high concentrations and employers should ensure that
the NOHSC exposure standard for mineral oil mist of 5 mg/m3 TWA is not exceeded.
Information on the MSDS indicates that dermatitis may occur after prolonged or repeated
skin contact and that respiratory irritation may occur if mists or vapours are generated.
Occupational Health and Safety
Under normal working conditions, waterside, transport and storage workers are unlikely to be
exposed to the notified polymer and the occupational health risk posed to these workers is
considered very low.
Reformulation occurs in enclosed systems so that the potential for exposure is limited to
dermal contact with residues in lines and on couplings and during clean up of any spills.
Except in cases where there is a large spill, exposure would be expected to be low. Following
blending, automatic filling of containers of oil should not result in exposure unless overfilling
or spillage occurs. In any case, the concentration of the notified polymer in the final products
is <5% and in the event of exposure, the health risk to the notified polymer would be low.
Ventilation should be installed at the blending sites. The wearing of safety goggles would
protect against splashes and any consequent eye irritation. Under routine working conditions,
workers are expected to wear protective clothing, gloves and goggles.
End use of the formulated products may potentially result in frequent exposure if gloves are
not employed, but the risk of adverse health effects is low given the likely low hazard and
low concentration of the notified polymer. Gloves should be worn to minimise the risk of
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
28
dermatitis through frequent skin contact. When workers enter into confined space, poorly
ventilated areas or large spill clean-up sites, a disposable dust/mist mask is also
recommended.
Public Health
The potential for public exposure during transport, storage, formulation or from disposal is
expected to be low. Exposure may result from the use of the product, and during home car
maintenance. This is expected to result in limited dermal contact, with the potential for
accidental ocular contact. At the concentration of the notified polymer in the formulated
product, this is not expected to pose a significant hazard.
Environmental Effects
The environmental hazard from the notified polymer is considered to be low provided that the
polymer is used as indicated, and that disposal of waste oil follows approved practices. Apart
from transport accidents or accidental spills or leaks, limited release of the notified polymer
is expected as a result of lubricant formulation and transfer to engine crankcases, and the
waste generated would either be incinerated or placed into landfill. However, as a component
of passenger vehicle engine lubricants, the potential exists for the notified material to be
inappropriately released to the environment through disposal of waste engine oil by DIY
automobile enthusiasts e.g. used for weed control, tipped in landfill, tipped into stormwater
drains, painting fences etc. As no information was provided on the market share of the
notified polymer in the lubricants market and the total amount of notified polymer used as an
additive in passenger vehicle lubricants, the worst case was assumed, with 14% of the
notified polymer sold to DIY enthusiasts. Up to 7.7 tonnes of the notified polymer may be
released inappropriately to the environment by DIY users and this material could end up in
the water or soil compartments. In addition, up to 1 000 kg of the polymer could be sent to
landfill from the disposal of used containers and 500 kg could be released to soils from the
leakage of seals and gaskets. Overall, up to 9.2 tonnes per annum of the polymer may be
released to the environment.
If deposited on soil or into landfill, the notified polymer will be immobilised through
adsorption onto soil particles, while if released into waterways it would become associated
with organic matter and sediments. The notified polymer is not readily biodegradable, but in
landfill it would be expected to slowly degrade through biological and abiotic processes.
Incineration of waste oil containing the notified polymer would destroy the substance with
evolution of water vapour and oxides of carbon and magnesium compounds that would be
assimilated with the ash. Sludges from waste treatment plants or oil recycling facilities could
also be incinerated. In the event of release into the water compartment or inappropriate
disposal, the polymer is likely to become associated with suspended organic material, and
eventually be incorporated into sediments.
Ecotoxicity test results indicate that the 96 hour Lethal Loading Rate for the Water
Accommodating Fraction (WAF) of the polymer is >1000 mg/L for fish, and the 72 hour No
Effect Loading Rate for the WAF for algae is >1000 mg/L. Therefore, the polymer may be
regarded as non toxic to both fish and algae up to the limit of its water solubility. It may be
concluded that despite some inappropriate disposal, levels in water are unlikely to reach those
presenting a hazard to aquatic organisms.
Overall, the environmental risk presented by the introduction of the notified polymer is
predicted to be low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
29
RECOMMENDATIONS
Control measures (for formulator/end-user)
OHS
Employers should implement the following engineering controls and safe work practices to
minimise occupational exposure to Z-43:
- enclosure of mixing tanks during formulation to prevent exposure to aerosols
- local exhaust ventilation during transfer of notified polymer from drum to mixing
tank.
- during transfer to mixing tank, avoid splashing and generation of aerosols
- workers using products containing the notified polymer should be instructed in their
proper handling and use, including information about the additional risks posed by heat.
Employees should wear the following personal protective equipment to minimise
occupational exposure to the notified polymer:
- chemical resistant gloves
- protective clothing
- 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 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.
Atmospheric monitoring should be conducted during formulation of the notified polymer to
ensure that no relevant exposure standards are exceeded.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
30
9 PUBLICATION SUMMARY REPORT
Z-45
Summary Report
Reference No: NA/948
Lubrizol International, Inc. (ACN 002 747 944) of 28 River Street, SILVERWATER NSW
2128 has submitted a standard notification statement in support of their application for an
assessment certificate for Z-45. The notified chemical is intended to be used as a lubricant
additive. Less than 100 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 was of very low acute oral toxicity in rats (LD50 > 2000 mg/kg) and
was of low acute dermal toxicity in rats (LD50 > 2000 mg/kg). It was a slight to moderate
skin irritant and a slight to moderate eye irritant in rabbits. It was not mutagenic in bacteria
and was not clastogenic in CHL cells (chromosome aberration assay) or mouse bone marrow
cells (micronucleus assay). It was a skin sensitiser in guinea pigs. In a 4-week oral repeated
dose study organ toxicity was ascribed to adaptive effects in the liver with associated thyroid
follicular hypertrophy. The NOAEL was considered to be 500 mg/kg/day.
The notified chemical is determined to be a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances in terms of skin sensitisation and is
assigned the risk phrase R43: Sensitising to skin. The same is true for oil containing the
notified chemical at a concentration of greater than 1% (unless contrary test data exist),
which is above the cut-off for classification as sensitising to skin.
A representative concentrate product to be imported containing up to 20% of the notified
chemical may be an eye irritant according to the supplied MSDS but would not be assigned
the risk phrase R36: Irritating to eyes. The MSDS also states that the product may cause skin
irritation on repeated or prolonged exposure.
Occupational Health and Safety
The potential imported product containing the notified chemical is a skin sensitiser from the
content of the notified chemical and other components may cause eye irritation or skin
irritation on repeated or prolonged contact.
The risk of skin sensitisation, eye irritation or skin irritation in transport or storage workers is
considered to be low given that exposure may only occur in the event of accidental spillage.
Skin sensitisation in workers involved in formulating the final products may occur through
repeated exposure to residues in piping and on drum bungs and couplings as the additive
package is pumped to a blending vessel. There may also be a risk of skin sensitisation should
exposure occur during clean up of spills and during sampling for QC testing. However, the
risk of adverse health effects, which also includes skin and eye irritation, is lowered by the
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
31
use of dry couplings, enclosed blending tanks, personal protective equipment and the fact that
all exposure scenarios are likely to be of short duration.
Following blending, the final product is normally packaged in a closed system. The system
does not require cleanup after each batch. The risk of skin sensitisation and skin and eye
irritation to workers involved in these operations or to maintenance workers should be low,
given the frequency of handling by workers, the engineering controls and use of safety
glasses, long sleeved shirts, apron and nitrile or neoprene gloves (as recommended in the
MSDS for Z-45 and the product to be imported) and the low concentration of chemical in the
final products. However, it is possible that for some batches, the blend tank may be unloaded
into 205 L drums manually. In this case, extensive exposure of the hands to the finished oil
may occur and gloves need to be worn to protect against allergic dermatitis.
End use of the formulated products involves factory filling of automotive components.
Normally, workers will not be exposed to gear oil in this process and the risk of adverse
health effects should be negligible. Refilling automotive components with gear oil is
expected to occur rarely at which time there may be a risk of skin sensitisation and nitrile or
neoprene gloves and chemical protective clothing should be worn.
Public Health
The potential for public exposure during transport, storage, formulation, use, recycling or
disposal is expected to be very low. There is a possibility of limited dermal contact and
accidental eye contact. Z-45 is a skin sensitiser and the product will carry a risk phrase to that
effect. The public is not expected to be in contact with the product as it is contained within
the gear encasement. The notified chemical will pose a negligible hazard to the public.
Environmental Effects
The environmental hazard from the notified chemical is considered to be low provided that it
is used as indicated, and that disposal of used oil is carried out as expected. Losses during
lubricant formulation would be small. As a component of gear oil, the potential for the
notified chemical to be released to the environment is likely to be low until the end of the
useful life of the vehicle. It is expected that approximately 97% of the notified chemical
would be destroyed through incineration and/or oil recycling activities. Incineration would
produce water vapour and oxides of carbon. About 3% will be lost due to spills and possible
disposal to landfill, stormwater drains, and other routes. If deposited into landfill the gear oil
containing the notified chemical would ultimately associate with the soil where it is expected
to be immobile.
Since lubricating oils will be used throughout Australia, all releases resulting from use or
disposal of used oil will be diffuse, and release of the notified chemical in high
concentrations is unlikely except as a result of transport accidents. The procedures outlined in
the MSDS are adequate to limit the environmental exposure and the environmental effects.
When used as indicated in the notification statement, the notified chemical is unlikely to
present a hazard to the environment.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
32
RECOMMENDATIONS
Regulatory controls
The NOHSC Chemicals Standards Sub-committee should consider the following
?br>
health hazard classification for the notified chemical:
? R43: Sensitising to skin
Use the following risk phrases for products/mixtures containing the notified chemical
?br>
at or above 1%:
- R43: Sensitising to skin
Control Measures
Occupational Health and Safety
Employers should ensure that the following personal protective equipment is used by
?br>
workers to minimise occupational exposure to the notified chemical as introduced and
in the final gear oil:
?nitrile or neoprene gloves, chemical impervious clothing, apron, safety glasses
or face shield.
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
Employers should implement the following engineering controls to minimise
?br>
occupational exposure to the notified chemical as introduced:
- dry couplings should be employed for transfers between storage and blending
tanks and blending tanks should be fully enclosed.
Employers should implement the following safe work practices to minimise
?br>
occupational exposure during handling of the notified chemical as introduced and in
the final gear oil:
- spillage should be avoided; spillage should be cleaned up using
appropriate absorbents and placed 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 11, 6 November 2001
33
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 11, 6 November 2001
34
10 PUBLICATION SUMMARY REPORT
Chemical in Catalyst MC
Summary Report
Reference No: NA/952
Basell Australia Pty Ltd of Level 13, 90 Collins St, Melbourne VIC 3000 (ABN 42 004 327
762) has submitted a limited notification statement in support of their application for an
assessment certificate for Chemical in Catalyst MC. The notified chemical is intended to be
used as part of a catalyst formulation for the production of polypropylene. Less than one
tonne of the notified chemical will be imported per annum for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified chemical was of low toxicity in rats by the dermal and oral routes, and was at
most a slight irritant to rabbit skin and eyes. It was not sensitising to the skin of guinea pigs.
In a 28-day feeding study in rats, the No Observed Effect Level (NOEL) was established to
be 253 mg/kg bw/day for males and 266 mg/kg bw/day for females.
A number of in vitro and in vivo mutagenicity tests were performed using the notified
chemical. In an in vitro chromosome aberration study, clear and significant increases in the
incidence of chromosome aberrations were seen in the presence of metabolic activation. The
remainder of the tests gave results indicating that the notified chemical was not genotoxic
under the conditions of the test.
The notified chemical would not be classified as a hazardous substance in accordance with
the NOHSC Approved Criteria for Classifying Hazardous Substances based on the results of
the toxicological studies submitted. The notified chemical has structural alerts giving rise to
potential concerns about genotoxicity. Based on the clear positive result in one of
genotoxicity studies submitted by the notifier, it is recommended that strict precautions be
taken to avoid dermal or other contact with the notified chemical.
Occupational Heath and Safety
The notified chemical will be imported as part of a formulated catalyst slurry for the
preparation of polypropylene. The slurry is a hazardous substance and a dangerous good,
primarily due to the presence of titanium tetrachloride, which is corrosive and produces
hazardous fumes of hydrogen chloride on contact with moist air.
Due to the air-sensitivity of the catalyst slurry, and the health hazards associated with
exposure of the slurry to air, use of the notified chemical involves transfer under nitrogen,
minimising the risk of worker exposure. The enclosed process minimises the risk of spills of
the notified chemical, however there is the possibility of drips of decomposed catalyst
mixture, containing the notified chemical at > 10 %, near the transfer hose connections.
Protection including overalls, impervious gloves, eye goggles and safety boots should be used
where contact with the notified chemical is possible.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
35
During polypropylene manufacture, the notified chemical is incorporated in the polymer
matrix at very low levels, and is completely consumed. Negligible risk is expected for
workers handling the finished polypropylene.
Public Health
Since the notified chemical is consumed in the industrial process for which it is intended, the
only likely method of public exposure to the notified chemical is through transport or
industrial accidents. Such contact is most unlikely. If contact occurs it is most likely to be
dermal, infrequent and transient. The low likelihood of contact and the toxicological profile
of the notified chemical suggest that it will not pose a significant hazard to public health
when used as proposed.
Environmental Effects
The majority of the notified chemical will share the fate of the polypropylene products in
which it is bound. The notifier indicates that the notified chemical is bound within the
polymer matrix during the polypropylene polymerisation process. Once incorporated into the
polypropylene polymer, the notified chemical is consumed and poses little risk to the
environment.
Polypropylene products containing the notified chemical will be disposed of in landfill or
incinerated, as to will wastes from spills during manufacture. In landfill, based on the low
water solubility and estimated Koc of the notified chemical, it will associate with the soil
matrix and not leach into the aquatic environment. The incineration of polypropylene
products containing the notified chemical would yield water vapour and oxides of carbon.
The ecotoxicity data indicates the notified chemical is moderately toxic to algae up to the
limit of its water solubility, but appears to be less toxic to fish and daphnia, based on
measured concentrations. However, exposure of the notified chemical to the aquatic
compartment should be low.
The polymer is not expected to cross biological membranes due to its low water solubility
and should not bioaccumulate.
Given the above considerations, the overall environmental risk is expected to be low.
RECOMMENDATIONS
Regulatory controls
? Use the following safety phrases for the notified chemical:
- S24: Avoid contact with skin
- S36/37: Wear suitable protective clothing and gloves
Control Measures
Occupational Health and Safety
? Employers should implement the following isolation and engineering controls to
minimise occupational exposure to the notified chemical in the product Catalyst MC:
- The product should be used only in enclosed systems
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
36
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical:
- Overalls, impervious gloves, eye goggles and safety boots
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.
? As the product containing the notified chemical is 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(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 11, 6 November 2001
37
11 PUBLICATION SUMMARY REPORT
Speedcure PBZ
Summary Report
Reference No: NA/959
Coates Brothers Australia Pty Ltd (ACN 000 079 550) of 323 Chisholm Road, Auburn NSW
2144 has submitted a limited notification statement in support of their application for an
assessment certificate for Speedcure PBZ. The notified chemical is intended to be used as a
component of printing ink. 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
The Material Safety Data Sheet for Speedcure PBZ suggests that the notified chemical is of
very low acute oral toxicity in rats (LD50 = 4700 mg/kg) is not a skin irritant and is not
mutagenic in bacteria. Toxicity reports were not available to confirm these observations.
The MSDS for a typical printing ink lists the health effects as harmful by ingestion, irritant to
skin, severely irritating to eyes and the vapour as irritating to the nose, throat and respiratory
tract. The MSDS states that the ink is hazardous according to the NOHSC Approved Criteria
for Classifying Hazardous Substances although no toxicological data are listed.
Occupational Health and Safety
Transport and storage of the sturdy plastic containers (capacity up to 20 kg) containing ink
formulations with the notified chemical at a concentration of less than 5% should result in
minimal worker exposure and consequent health effects even in the event of accidental
container rupture.
Workers may be involved in some blending of colours (about 20% of the imported volume)
in which small volumes are tested for colour matching prior to pumping inks to enclosed
blending vessels. Small samples are taken for colour determination and adjustment if
necessary. Initially inks will be blended by hand until recipes are established. The final batch
is then pumped into vessels of 25 kg capacity. The blend tanks, pumps and lines and flushed
with short chain alcohols or water 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 chemical in the imported inks suggests that the risk to workers of
adverse health effects from exposure to the notified chemical should be minimal. 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.
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 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 chemical in the inks should result in minimal exposure.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
38
Therefore, the risk to printers of adverse health effects from exposure to the notified chemical
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.
Public Health
The risk to the public of adverse health effects from exposure to the notified chemical is
minimal. There is virtually no exposure expected during transport, storage, use or disposal of
the inks containing the notified chemical and it is not bioavailable in the cured ink on the
packaging to which the public is exposed.
Environmental Effects
The majority of the notified chemical will be incorporated in printed food packaging material.
However, prior to leaving the printers, the ink in the printed material is irradiated with UV
light to form a high molecular weight, crosslinked compound. Therefore, once incorporated
into the printed material, the notified chemical is consumed and poses little risk to the
environment.
The wastes containing the notified chemical generated during the reformulation process will
be cured and disposed of in landfill. The notified chemical has a log partition coefficient of
approximately 4.6 and the notifier expects it to have relatively low water solubility. Therefore
in landfill, any uncured notified chemical will associate with the soil matrix and not leach
into the aquatic environment.
Liquid wastes containing the notified polymer will be incinerated by licensed waste disposal
contractors and are expected to produce water vapour and oxides of carbon.
The notified chemical has the potential to bioaccumulate, but this is not expected due to its
low water solubility.
The low environmental exposure of the notified chemical as a result of the proposed use
indicates the overall environmental hazard should be low.
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 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. Exposure standards for the adjuvant, 4-methoxyphenol and the pigment
carbon black (TWA 3 mg/m3) should be adhered to.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
39
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the printing inks containing the notified
chemical:
?coveralls, nitrile gloves and eye goggles
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
40
12 PUBLICATION SUMMARY REPORT
Sensiva SC 50
Summary Report
Reference No: NA/966
Schwarzkopf Pty Ltd of 20 Rodborough Road, Frenchs Forest, NSW 2068 (ABN 21 000 076
782) and Chemiplas Australia Pty Ltd of Lot 1, Canley Vale Road, Wetherill Park, NSW
2164 (ABN 29 003 056 808) have submitted a standard notification statement in support of
their application for an assessment certificate for Sensiva SC 50. The notified chemical is
intended to be used as a bacteriocidal agent in the manufacture of aerosol deodorants. Three
hundred kilograms will be imported in the first year increasing to 1500 kg by the fifth year.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
The notified chemical was shown to be of very low and low rat acute oral and dermal toxicity
respectively. Low to moderate acute inhalation toxicity was noted also in rats.
In a skin irritation study in rabbits, the notified chemical was shown to be mildly irritating. In
an eye irritation study in rabbits, neat notified chemical induced severe eye damage due to
persistent corneal effects and moderate to severe conjunctival irritation. In a separate rabbit
eye irritation study a 5% solution induced only mild irritation.
The notified chemical was shown to be non-sensitising in a guinea pig maximisation study.
In a 13 week repeat dose oral toxicity study in rats, a LOAEL of 50mg/kg/day was
established on the basis of increased liver weights at all doses. At the top dose
(800mg/kg/day), hepatic hypertrophy and an increased incidence of renal mineralisation was
observed in male and female animals respectively.
The notified chemical was non-mutagenic and non-clastogenic in an in vivo bacterial reverse
mutation assay and in vivo bone marrow micronucleus assay respectively.
According to the NOHSC Approved Criteria for Classifying Hazardous Substances the
notified chemical should be classified Harmful (Xn) and Irritant (Xi) with the risk phrases
R20 ?Harmful by Inhalation and R41 ?Risk of Serious Damage to Eyes.
Aerosol products containing the notified chemical are classified Class 2.1 dangerous goods in
accordance with the Australian Dangerous Goods Code.
Occupational Health and Safety
During the manufacture of deodorant aerosol products containing 0.3% notified chemical,
exposure to the notified chemical is incidental as the process is largely enclosed and
automated. However, reformulation personnel may experience dermal and ocular exposure to
the notified chemical following spillage during pouring from import containers. At this stage,
inhalation exposure is unlikely due to the low vapour pressure of the notified chemical.
However, inhalation exposure, in addition to dermal and ocular exposure, may occur for
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
41
reformulation workers involved in servicing the multi-head filling machine where fugitive
aerosols may be encountered.
Ocular exposure to the notified chemical is likely to be accompanied by irritation, or in the
case of neat chemical, possible serious, permanent eye damage. Local irritation is likely if
skin exposure occurs. If inhalation exposure to neat notified chemical occurs, respiratory
irritation is likely, depending on the dose.
The results of toxicological testing indicate that possible system toxicity may result from
repeated exposure to the notified chemical. However, given the enclosed nature of the
formulation process and incidental exposure, the risk of such adverse health effects is low.
The health hazards of the notified chemical underlines the importance of exposure controls
consisting of a combination of personal protective equipment and engineering controls such
as exhaust ventilation at sites of potential aerosol formation. In particular, safety goggles are
essential to prevent eye damage.
Because exposure would only occur in the result of an accident, exposure of transport and
warehouse workers who will move and store both neat notified chemical and reformulated
deodorant is unlikely. Similarly, the risk to retail workers is low.
Public Health
The aerosol product containing the notified chemical is intended to be applied to the
underarm area on a daily basis. The notified chemical is at a very low concentration in the
aerosol product and provided it is used as intended only a very small amount of the notified
chemical will be applied to restricted areas of the skin at any one application.
The notified chemical may accumulate at the site of application if it is not removed by regular
washing. However, the notified chemical is not a skin sensitiser and prolonged accumulation
to the point where skin irritation can occur is unlikely. On this basis and noting the toxicity
profile of the notified chemical, it is considered that the notified chemical will not pose a
significant hazard to public health when used as intended.
Environmental Effects
The notified chemical is intended to be used as a bacteriocide in a commercial deodorant
formulation. Initially, the deodorant will be imported into Australia in its final formulation in
ready-for-use containers. After marketing, it is expected that the notified chemical will be
imported as a raw material to be used in the manufacture of the deodorant in Australia.
Almost all of the notified chemical contained in the deodorant product would be released to
the sewage system, predominantly when it is washed off the skin during bathing, and to a
much lesser extent during the formulation process. Release into the sewer is expected to be
diffuse, as a consequence of the nationwide usage pattern of the product. Only small amounts
will be released to landfill during disposal of residuals in empty containers.
The physical and chemical properties of the notified chemical suggest some potential to cross
biological membrane and to bioaccumulate. In the static toxicity tests, the notified chemical
showed slight toxicity to fish, daphnia, and algae. Despite these results, safety margins
towards aquatic organisms are expected to be high. A worst case scenario Predicted
Environmental Concentration of the notified chemical, based on a 1500 kg per annum import
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
42
volume, was found to be several orders of magnitude lower than the concentrations found to
be toxic to aquatic organisms.
The chemical is not expected to pose any hazard to aquatic organisms because of the low
import volumes and anticipated diffuse release of low levels of the chemical to the aquatic
environment.
RECOMMENDATIONS
Regulatory controls
? The NOHSC Chemicals Standards Sub-committee should consider the following
health hazard classification for the notified chemical:
- R20 ?Harmful by Inhalation
- R41 ?Risk of Serious Damage to Eyes
- S39 ?Wear eye protection
? Use the following risk/safety phrases for products/mixtures containing the notified
chemical at the following cutoff concentrations:
- 25%: R20 ?Harmful by Inhalation, R41 ?Risk of Serious Damage to Eyes
- 10 - < 25%: R41 - Risk of Serious Damage to Eyes
- 5 - <10%: R36 ?Irritating to Eyes
- 5%: S39 - Wear eye protection
Control Measures
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical:
- Avoid generation of aerosols
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced:
- Safety goggles when handling large quantities; safety glasses when handling small
quantities
- Impermeable clothing and footwear
- Impermeable gloves
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
43
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
- conditions of use are varied from use as a component of aerosol body deodorant or
the concentration in products is increased to more than 1%;
or
Under Subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
44
13 PUBLICATION SUMMARY REPORT
Lexmark Acrylic Terpolymer
Summary Report
Reference No: NA/968
Lexmark International Inc. of 12A Rodborough Rd, Frenches Forest NSW 2086 has
submitted a limited notification statement in support of their application for an assessment
certificate for Lexmark acrylic terpolymer. The notified polymer is intended to be used in
aqueous ink formulations. Less than five 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 polymer 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 a skin irritant but could be a slight to moderate eye irritant. Upon repeated exposure, organ
or systemic effects are not expected. The notified polymer 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
Exposure to printing inks containing the notified polymer during transport of pre-filled
cartridges should not result in exposure except in the event of accidental spillage.
The notified polymer will be in imported inkjet cartridges at a maximum of 2%. Dermal
exposure of office workers to the notified polymer will potentially occur when replacing
spent cartridges and clearing paper jams from the printer. However, the design of the
cartridges is such that exposure to the notified polymer should be negligible.
Dermal exposure of maintenance workers to the notified polymer is possible during routine
maintenance but is expected to be low due to the low concentration of the notified polymer in
the ink. Inhalation exposure of maintenance workers to the notified polymer is also possible
during routine maintenance. Again the exposure is expected to be low due to the particle size
distribution for this polymer being greater than 100 祄 and the low concentration of the
notified chemical in the ink.
It is concluded that the risk of eye irritation in workers involved in transport, storage, use and
disposal of the notified polymer in this application is low.
Due to their frequent exposure to inks and toners, maintenance and printer personnel should
wear cotton or disposable gloves and ensure adequate ventilation is present during routine
maintenance and repairs.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
45
In the event that the notified polymer will be handled as a raw ingredient at high
concentrations, workers should be protected from skin contamination because it has staining
properties.
Public Health
At most stages in the acquisition and use of the ink jet cartridges containing the notified
polymer, human contact with the notified polymer is minimised. It is imported as a
component of ink at a very low concentration in an ink jet cartridge and remains there in an
inaccessible state until its imprinting on paper. Public exposure will be most likely limited to
transient and infrequent dermal contact which may occur with attempts to insert or remove a
damaged cartridge or to remove a paper jam. The notified polymer is itself of very low
toxicity. On the basis of the above information, it is considered that the notified polymer will
not pose a significant hazard to public health when used in the proposed manner.
Environmental Effects
The notified polymer will not be manufactured in Australia, but will be imported in an ink
blend. 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 the water or soil compartments indirectly during
disposal or recycling of the printed paper onto which the polymer is fixed. In aquatic
environments, most of the polymer will be dispersed in water owing to its high water
solubility and low octanol-water partition coefficient, although some of the polymer may
precipitate and partition into sludge.
The worst case scenario PEC of the notified polymer in aquatic environments is several
orders of magnitude below the highest concentrations to which aquatic organisms were
exposed during toxicity testing, and which had no adverse effects. Hence safety margins
toward aquatic organisms are expected to be high.
The new polymer is not readily biodegradable. However, in soil environments, it is expected
to either remain in the upper soil horizons, where it would undergo slow degradation, or enter
the aquatic compartment via surface runoff or percolating groundwater, depending on the pH
conditions in the environment.
Given the anticipated nationwide use of the new polymer, and the low concentration of the
chemical in the ink blend, release of the chemical to the environment will be diffuse. As such,
the overall environmental risk of the notified polymer is expected to be low.
RECOMMENDATIONS
To minimise occupational exposure to Lexmark acrylic terpolymer the following guidelines
and precautions should be observed:
Protective eyewear, clothing and gloves should be worn when handling the notified
?br>
polymer;
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
46
Spillage of the notified polymer 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>
No special precautions are required for the notified polymer when used at low quantities in
printer cartridges. However, in the interests of good occupational health and safety, the
following guidelines and precautions should be observed:
Service personnel should wear cotton or disposable gloves and ensure adequate
?br>
ventilation is present when removing spent printer cartridges containing the notified
polymer and during routine maintenance and repairs.
If products containing the notified polymer 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 11, 6 November 2001
47
14 PUBLICATION SUMMARY REPORT
Z-34
Summary Report
Reference No: PLC/244
Lubrizol International Inc of 28 River Street Silverwater NSW 2128 (ACN 002 747 944) has
submitted a synthetic polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for Z-34. The notified polymer is intended to be used
as a metalworking additive. Up to 50 tonnes of the notified polymer will be imported per
annum for the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
An Ames test using the notified polymer showed that it was not mutagenic in bacterial
strains. Irritation studies on a product, OS135262 containing 10% the notified polymer
indicated the product was a slight skin and eye irritant in rabbits. The notified polymer cannot
be classified as a hazardous substance according to the NOHSC Approved Criteria for
Classifying Hazardous Substances for the endpoints tested.
Occupational Health and Safety
Transport and Storage
Under normal working conditions, waterside, transport and storage workers are unlikely to be
exposed to the notified polymer and the occupational health risk posed to these workers is
considered low.
End use
The notified polymer is imported at 10% in Lubrizol 0805.2. At metalworking plants,
Lubrizol 0805.2 will be directly added to the metalworking fluid reservoir at a final
concentration of 500 ppm and sprayed onto the cutting edge during the machining operation.
Occupational exposure to the 10% notified polymer product may occur during filling,
spraying and cleaning up containers. Inhalation exposure is expected to be low as the
generation of mist is suppressed during metalworking. Skin and eye contact will be the main
routes of exposure. Significant dermal absorption of the notified polymer through intact skin
is not expected because of the high molecular weight and low concentration of the notified
polymer in metalworking fluid. The potential for mild skin/eye irritation exists for workers
exposed to the product. Workers will need to wear overalls, nitrile or neoprene gloves, and
safety glasses or goggles.
Conclusion
Risk of adverse health effects due to the notified polymer is low due its expected low toxicity
and low exposure potential. However, due to the presence of other components in the
formulated products control measures are required to minimize skin and eye contact.
Public Health
The notified polymer and the product containing the notified polymer are not available for
sale to the general public. The product containing the notified polymer will be used in
metalworking fluids for industrial use. The notified polymer is not likely to be a risk to public
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
48
health since the potential for public exposure to the notified polymer is negligible.
Environmental Effects
The environmental hazard from the notified polymer is considered to be low provided that the
material is used as indicated, and that disposal of waste metalworking fluid follows approved
practices. Apart from transport accidents or accidental spills or leaks, minimal release of the
notified polymer is expected as a result of transfer to metalworking fluid reservoirs. The
notifier has indicated that spent fluid will be treated similarly to waste engine oils and will be
recycled or incinerated. However, inappropriate disposal by smaller operators could mean
that up to 30 tonnes of the polymer may be disposed to landfill and other land, and up to 31
tonnes of the polymer may be disposed of to sewer. The Predicted Environmental
Concentration based on an Australia-wide use pattern is estimated to be 30 礸/L.
Exposure levels of this magnitude are of little ecotoxicological concern for poly(aliphatic
acid) polymers, such as the notified polymer, which typically have LC50 values >100 mg/L.
If deposited on soil or into landfill, the notified polymer will be mobile with the potential to
leach, while if released into waterways it would become associated with the aqueous phase.
However, release is expected to be diffuse, thus limiting the potential for adverse
environmental effects. Incineration of waste oil containing the notified chemical would
destroy the substance with evolution of water vapour and oxides of carbon, nitrogen and
sulphur, and sodium compounds that would be assimilated with the ash. Sludges from oil
recycling facilities could also be incinerated.
The high water solubility and high molecular weight of the notified polymer indicate little
potential for bioaccumulation.
Overall, the environmental risk presented by the introduction of the notified chemical is
predicted to be low.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer:
- Spillage of the notified polymer should be avoided. Spillages should be cleaned
up promptly with absorbents which should then be put into containers for
disposal.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer:
- Protective eyewear, chemical resistant industrial clothing and footwear and nitrile
or neoprene impermeable gloves should be used during occupational use of the
products containing the notified polymer; where engineering controls and work
practices do not reduce vapour and particulate exposure to safe levels, an air fed
respirator should also be used.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
49
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 11, 6 November 2001
50
15 PUBLICATION SUMMARY REPORT
Polymer in Uralac SE901 S2G3-55
Summary Report
Reference No: PLC/248
PPG Industries Australia Pty Ltd of McNaughton Road, Clayton Victoria 3168 (ABN 82 055
500 939) has submitted a notification statement in support of their application for an
assessment certificate for the synthetic polymer of low concern (PLC) `Polymer in Uralac
SE901 S2G3-55'. The notified polymer is intended to be used as a component of packaging
coatings (aerosol can). Up to 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
No toxicological data was provided and the notified polymer cannot be assessed against the
NOHSC Approved Criteria for Classifying Hazardous Substances. Polymers of high
molecular weight do not readily cross the skin or other biological membranes, and the overall
toxicity is expected to be low.
MSDS for the imported end use product 709-Z8726 HOBA 8726 Overprint Varnish indicates
that it is a possible skin, eye and a respiratory irritant. The MSDS lists a number of potential
health effects due to inhalation, or repeated skin contact namely breathing problems, cardiac
arrest and irritant contact dermatitis. These relate mainly to the solvents present in the
product rather than the notified polymer. The imported product 709-Z8726 HOBA 8726
Overprint Varnish is classed as a Class 3 dangerous good (flammable liquid) and a Schedule
Poison (S6) because of the solvent content. Three of the solvents in the end use product have
NOHSC exposure standards.
Occupational Health and Safety
There is little potential for significant occupational exposure to the notified polymer during
transport and storage of the imported end use product.
Coating applicators may be exposed to the notified polymer during application of the varnish.
There is some opportunity for exposure during adhesive stirring and thinning with solvent.
Personal protective equipment will be employed to reduce exposure. The coating process is a
closed system, therefore is not expected to result in worker exposure.
Exposure to the polymer during and following coating may occur due to spillage during
maintenance work. As these operations involve small volumes, exposure is expected to be
limited. The notifier states that personal protective equipment such as protective clothing,
gloves, goggles and respirators is used. Maintenance workers also rely on personal protective
equipment to limit exposure. The use of engineering controls and protective equipment is
necessary to prevent exposure to solvent components via dermal, inhalation and ocular
routes. The coating room should be equipped with adequate air extraction. The employer
must ensure that a respirator is used if any aerosols are likely to be formed during mixing,
thinning or application of the varnish and impervious gloves, goggles and protective clothing
worn.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
51
A number of ingredients in the varnish containing the notified polymer (solvent naphtha
heavy aromatic, 2-butoxyethanol, formaldehyde, 2-butoxyethyl acetate) may present health
hazards to workers. They are listed as appropriate in the relevant MSDS, together with the
NOHSC exposure standards. For the use of varnish, employers are responsible for ensuring
that the relevant NOHSC exposure standards are not exceeded in the workplace.
The solutions containing the notified polymer are flammable due to their solvent content.
Precautions must be taken to avoid sources of ignition, e.g. use of earthing leads. Operators
should wear antistatic overalls and footwear.
Once the applied coating has hardened, the polymer will not be separately available for
exposure or absorption. The wastes containing the notified polymer may be hazardous
substances on the basis of the solvent content and the precautions used for the additional
materials should be adequate for protection from the notified polymer. In addition, much of
the polymer will be crosslinked and hardened, and therefore immobile, by the time of
disposal.
The polymer size, mode of use, use of personal protective gear and in situ engineering
controls indicate that significant risks to human health through occupational exposure to the
notified polymer are unlikely. No specific control measures are required to reduce the risk of
skin, eye and respiratory irritation due to the notified polymer.
Overall, the polymer is of low concern to human health although controls indicated by the
notifier should be adhered to reduce risk of adverse health effects due to other ingredients in
the final varnish products.
Public Health
The public will only come into contact with the coating, after the notified polymer has
become an integral part of a hard durable coating on the surface of packaging articles.
Therefore, the potential risk for public exposure to the notified polymer is considered to be
low.
Environmental Risk Assessment
The majority of the notified polymer will be released into the environment through disposal
of end products containing the polymer in the coating to landfill. The notified polymer in
these products will slowly degrade through abiotic and biotic processes.
The notifier estimates that less then 500 kg per annum will be released to the environment
from the importation, and use of the notified polymer. This will be from spills, equipment
cleaning and residues in import containers where the majority will be disposed of to landfill.
Release to the sewer is expected to be insignificant. In landfill the polymer is expected to be
immobile due to its low water solubility and will become part of the soil matrix.
In the event of the polymer entering waterways, it would be expected to associate with the
sediments. The polymer is not expected to cross biological membranes due to its high
molecular weight and is therefore not expected to bioaccumulate.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
52
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer as introduced in the product 709-Z8726
HOBA 8726 Overprint Varnish:
- NOHSC exposure standards for all components of the polymer solution are not
exceeded in the workplace.
- Local exhaust ventilation and enclosed cabinet for coating operations.
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer as introduced in the
product 709-Z8726 HOBA 8726 Overprint Varnish:
- Workers should receive regular instruction on good occupational hygiene
practices in order to minimise personal contact, contamination of the work
environment with products, including those containing the notified polymer.
- Avoid contact with sources of ignition.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced in
the product 709-Z8726 HOBA 8726 Overprint Varnish:
- Respiratory protection, protective eyewear, impermeable clothing and gloves, and
occupational footwear are required for coating applicators.
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.
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
53
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
54
16 PUBLICATION SUMMARY REPORT
Evcote P56-100
Summary Report
Reference No: PLC/252
Asia Pacific Specialty Chemicals of 15 Park Road, Seven Hills, NSW (ABN 32 000 316 138)
has submitted a synthetic polymer of low concern (PLC) notification statement in support of
their application for an assessment certificate for EvCote P56-100. The notified polymer is
intended to be used as a strength enhancer and moisture barrier coating for paper and paper
products. Less than 10 000 tonnes of the notified polymer will be manufactured per annum
for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological data were provided for the notified polymer. The polymer meets the criteria
for a synthetic polymer of low concern and is therefore not classified as a hazardous
substance in accordance with the NOHSC Approved Criteria For Classifying Hazardous
Substances.
The MSDS for the notified polymer lists a number of potential health effects based on
products of similar composition, namely irritation of the gastrointestinal tract with upper
abdominal pain, nausea, vomiting and diarrhoea if swallowed, irritation of the eye with
discomfort or blurring (resulting in eye damage if exposure is prolonged), irritation of the
skin following prolonged exposure and irritation of the upper respiratory passages following
overexposure by inhalation. These effects are related to the physical characteristics of
polymer particles. The MSDS for the aqueous polymer dispersion lists similar potential
health effects.
Occupational Health and Safety
There is little potential for significant occupational exposure during transport and storage of
the notified polymer and its dispersion except in the event of accidental spillage. It is not
anticipated that workers involved in transport and storage of the notified polymer would be
exposed during normal operations.
During crushing of the solid polymer and blending of the crushed polymer into an aqueous
dispersion in the reactor, there is potential for respiratory and ocular exposure. There is no
NOHSC exposure standard for the notified polymer itself, however the NOHSC exposure
standard for dust not otherwise specified is 10 mg/m3. As the crushing and blending
processes occur under local exhaust ventilation, respiratory exposure is unlikely and the level
of 10 mg/m3 is unlikely to be attained. Standard personal protective measures used during
plant operation including the use of overalls, safety glasses, gloves and safety footwear. The
health risk of workers during crushing and blending is expected to be low.
During packing off of the polymer into drums and packing off of the dispersion into tanks,
there is the potential for dermal and respiratory exposure to the notified polymer in the event
of accidental spillage at the filling station. Given the expected low hazard of the notified
polymer and that exposure will be controlled through the standard protective measures
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
55
including overalls, safety glasses, gloves and safety footwear, the health risk to workers
during the packing off of the polymer and its dispersion is low.
During quality control testing of samples of the polymer during manufacture and application
of the dispersion to paper the main route of exposure will be dermal. Exposure to the notified
polymer and its dispersion will be controlled through the use of laboratory coats (during
quality control), overalls (during application of the dispersion to paper), safety glasses, safety
footwear and gloves. Given the expected low hazard of the notified polymer, the health risk
to workers during these processes will be low.
Conclusion
The notified polymer is of low concern to human health and safety. The standard control
measures used during plant operation and protective measures during quality control and
application of the dispersion to paper will ensure sufficient protection against the notified
polymer.
Public Health
The notified polymer is intended for use by paper manufacturers and will not be sold to the
public. Following application, the notified polymer will form a durable coating that is not
expected to be easily removable. Therefore, the health risk to the public from exposure to the
notified polymer is considered to be low.
Environmental Effects
The majority of the notified polymer will share the fate of the paper substrates to which it is
bound. Waste paper products containing the notified polymer will be disposed of in landfill,
recycled or incinerated. During recycling, the notified polymer is expected to associate with
sludge and will be disposed of in landfill or incinerated. The notifier indicates that aqueous
wastes will be treated with a polyacrylamide surfactant to remove suspended solids, which
will be disposed of in landfill, prior to the water being discharge into sewer.
In landfill, it is expected that the polymer will slowly break down and become part of the soil
matrix and is unlikely to leach due to its low water solubility. Any of the ammonium salt of
the notified polymer that passes through the treatment process and enters the sewer is
expected to dilute and disperse and eventually partition to the sediments through conversion
to the acid form. The incineration of polymer wastes would yield water vapour and oxides of
carbon.
The polymer's high molecular weight and expected low water solubility should prevent
bioaccumulation.
Given the above considerations, the overall environmental risk 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:
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
56
? Employers should implement the following engineering controls to minimise
occupational exposure:
- Exhaust ventilation during manufacture, blending, crushing and filling process
- Enclosed and automated manufacture process
? Employers should implement the following safe work practices to minimise
occupational exposure:
- During manual transfer of notified polymer and polymer dispersion into reaction
tanks and coating bath, avoid spills and splashing
- Avoid generation of dust clouds when handling the polymer in powder form
? 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 when splashes are generated
- A dust mask when dusts are generated
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 11, 6 November 2001
57
17 PUBLICATION SUMMARY REPORT
Polymer in Afranil SLO
Summary Report
Reference No: PLC/254
BASF Australia Ltd of 500 Princes Highway, Noble Park, Victoria 3174 (ABN 62 008 437
867) has submitted a synthetic polymer of low concern (PLC) notification statement in
support of their application for an assessment certificate for Polymer in Afranil SLO. The
notified polymer is intended to be used as a foam inhibitor and pulp deaerator for paper
manufacture. Between 1 and 10 tonnes of the notified polymer will be imported per annum
for each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information has been provided for the notified polymer. However, due to its
high molecular weight and presence of only low concern reactive functional groups, it is
unlikely to be a hazardous substance in accordance with the NOHSC Approved Criteria for
Classifying Hazardous Substances. The notified polymer meets the criteria for a Polymer of
Low Concern and thus is unlikely to represent a health hazard.
Occupational Health and Safety
Exposure to the notified polymer is not expected during import and storage of the polymer
suspension which contains 1.6% notified polymer. Import containers of polymer are not
opened prior to end-use and so occupational exposure of import/storage workers to the
polymer would only be envisaged in the case of accidental puncture of containers.
For paper plant operators and personnel involved in quality analysis, the main exposure
routes will be dermal and ocular from splashes and spills. Exposure is only likely to occur
during connection and disconnection of pump lines to import containers and during manual
sampling of imported polymer for quality analysis. The low likelihood of vapour or aerosol
formation during transfer and the use of exhaust ventilation at the dryer sections of the paper
plant make inhalation exposure to the notified polymer unlikely.
Since wash water is recycled, the notified polymer will be present in the final manufactured
paper only at very low levels. Therefore the possibility of exposure of workers involved in
any manual handling of finished paper is very low. Drum recyclers may be exposed to the
polymer residue via mainly the dermal route when reconditioning import containers.
A combination of personal protective equipment worn by workers and engineering controls in
the form of enclosed transfer lines and general and local ventilation will control exposure to
the polymer during end use. These controls will be adequate also to limit exposure to other
potentially hazardous components of the imported polymer solution such as formaldehyde, a
carcinogen and skin sensitiser, present in the imported solution at < 0.05%. Formaldehyde
has a NOHSC exposure standard of 1.2 mg/m3 TWA, 2.5 mg/m3 STEL. Where exposure
control measures have not been specified and exposure is likely eg. for container
reconditioners, personal protective equipment should be worn to limit exposure to the
polymer and other potentially hazardous components of the imported solution.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
58
Given these controls, the low possibility of exposure and the low health hazard associated
with the notified polymer the health risk for these workers would be assessed as low.
Public Health
The product containing the notified chemical is used by industrial users at very low
concentrations and is not available to the public. Hence the risk to public health is not
expected to be significant.
Environmental Effects
When used in the manner prescribed, the polymer is unlikely to lead to adverse effects in the
environment. Release estimates indicate the notified polymer will be present in mill effluent
at a concentration in the sub parts per billion range and assumes that 1% of the notified
polymer is released with mill effluent.
The notified polymer makes up 1.6% of the end use product, which is stated as miscible with
water in the MSDS. Even assuming a worst case scenario that all notified polymer used
during a daily production is released with effluent, the concentration in effluent would be less
than 1 part per billion which would be further diluted on release to receiving waters.
While no ecotoxicological data are available for the notified polymer, releases of this
concentration are not expected to lead to adverse environmental impacts.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No special precautions are required for the notified polymer. However, in the interests
of good occupational hygiene practice, employers should ensure that the following
personal protective equipment is used by workers to minimise occupational exposure
to the notified polymer in the product Afranil SLO:
- Impervious coveralls and footwear
- PVC, rubber or nitrile gloves
- 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 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 11, 6 November 2001
59
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) 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
(2) Under Subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
60
18 PUBLICATION SUMMARY REPORT
MVA 2453L
Summary Report
Reference No: PLC/255
MBT (Australia) Pty Ltd of 11 Stanton Rd Seven Hills NSW 2147 (ACN 000 450 288) has
submitted a synthetic polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for MVA 2453L. The notified polymer is intended to
be used as a concrete additive. Up to 100 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 polymer meets the criteria for a synthetic polymer of low concern and is unlikely
to be a human health hazard. According to the MSDS, the imported aqueous solution is not
hazardous according to the NOHSC Approved Criteria for Classifying Hazardous
Substances.
Occupational Health and Safety
Transport workers are only likely to be exposed to the notified polymer in the event of a
breach of bulk containers or drums in which the 44% polymer solution is imported.
The notified polymer solution is transferred to a holding tank in which the solution is
adjusted with water and to which other additions may be made. The finished solution is
pumped out into tanker trucks for transport to plants followed by transfer to a holding tank
and addition to concrete. The concrete is then transported to work sites for use in
construction. The notifier has stated that there is virtually nil handling of the polymer solution
or finished product as closed systems for pumping and electronic dispensation are employed.
This is reflected in the maximum estimated release of 10 g/day. For the low exposure to
workers gloves and goggles will be used for personal protection. The MSDS for the imported
polymer solutions suggests the use of nitrile rubber or PVC gauntlets, chemical worker's
goggles and overalls. Given the low level of polymer released coupled with its low hazard,
the risk of adverse health effects to workers involved in formulation of the concrete additive,
its transport, storage and addition to the wet concrete is considered to be low. Worker
exposure (mainly dermal) to concrete used in construction is potentially high unless gloves
are employed. However, the concentration of the notified polymer in finished concrete is
0.05% and there is negligible risk of adverse health effects to workers from exposure to the
polymer.
Public Health
The product containing the notified chemical is not available to the public. Dermal exposure
to the chemical through contact with wet concrete is not expected to pose a significant health
risk due to the low concentration and low irritancy of the chemical/product. Also the
chemical will be bound within the cement matrix of the concrete and will not be bioavailable.
The risk to public health is not expected to be significant.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
61
Environmental Effects
The majority of the notified polymer will be incorporated into a matrix of concrete. Once
the concrete is solidified, the notified polymer is expected to pose minimum risk to the
environment.
There is little potential for the notified polymer to be released into the environment from
spillage, drum residues and equipment washing as these processes take place within closed
systems and residues are overwhelmingly likely to be reused. Spillages are expected to be
dispersed and not restricted to a single site. This would minimise the degree of risk to the
environment at any given time. If the spilt imported material or raw product cannot be
recycled then it is likely it will end up in landfill adsorbed to the inert material used for the
spill clean-up (such as sand), where it is likely to leach out in a diffuse manner at low
concentrations.
The main environmental hazard would arise from release of the notified polymer during
storage or transport. The use of bunded containment minimises the risk of release at storage
sites. The MSDS appears to adequately address spills and disposal.
A further environmental hazard could arise from release of untreated polymer-contaminated
water into the aquatic compartment. However, this risk is greatly reduced by the likely
recycling of major volumes of truck wash water for subsequent batches of cement.
The low expected environmental exposure of the notified polymer, when integrated into
concrete, suggests the overall environmental risk should be limited.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
No specific precautions are required to control exposure to the notified polymer. However, in
the interest of good OHS practice the following measures should be implemented:
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer as introduced and as diluted for use:
- automated pumping
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer as introduced or
as diluted for use:
- nitrile rubber or PVC gauntlets, chemical worker's goggles and overalls
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.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
62
? 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:
(1) 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
(2) 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 11, 6 November 2001
63
19 PUBLICATION SUMMARY REPORT
Evcote PWRH-100
Summary Report
Reference No: PLC/256
Asia Pacific Specialty Chemicals Limited (APS) of 15 Park Road Seven Hills NSW 2147
(ABN 32 000 316 138) has submitted a synthetic polymer of low concern (PLC) notification
statement in support of their application for an assessment certificate for EvCote PWRH-100.
The notified polymer is intended to be used as a strength enhancer and moisture barrier
coating for paper and paper products. Greater than 10000 tonnes of the notified chemical will
be manufactured over the first five years and <100 tonnes of the solid notified polymer may
be imported during the first year.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information was provided for the notified polymer. The notified polymer
has a high molecular weight and is unlikely to penetrate biological membranes. It contains
carboxylic acid groups and very low concentrations of residual monomers. The polymer
meets the PLC criteria and is unlikely to be a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances.
The notified polymer is not a dangerous good for road and rail transport.
The Material Safety Data Sheet (MSDS) for the notified polymer lists a number of potential
health effects based on products of similar composition, namely irritation of the
gastrointestinal tract with upper abdominal pain, nausea, vomiting and diarrhoea if
swallowed, irritation of the eye with discomfort or blurring resulting in eye damage if
exposure is prolonged, irritation of the skin following prolonged exposure and irritation of the
upper respiratory passages following overexposure by inhalation. The MSDS for the aqueous
polymer dispersion lists potential health effects as irritation of the gastrointestinal tract,
nausea, vomiting and diarrhoea if the liquid is swallowed, irritation to the eye causing redness
and pain following eye exposure, skin irritation following prolonged exposure of the skin to
the liquid and irritation of the upper respiratory tract following mist inhalation. The adverse
health effects relate to the physical characteristics of the solid polymer particles rather than its
toxicological effects.
Occupational Health and Safety
During polymer manufacture, crushing of the solid polymer and blending of the crushed
polymer into an aqueous dispersion there is potential for respiratory, ocular and dermal
exposure to the coarse particles of the notified polymer. There is no NOHSC exposure
standard for the notified polymer itself, however the NOHSC exposure standard for nuisance
dust is 10 mg/m3. The manufacturing, crushing and blending processes are largely enclosed,
with local exhaust ventilation provided. Workers handling the notified polymer will wear
personal protective equipment including overalls, safety glasses, gloves, safety footwear and
respiratory protection. These controls will also provide protection against exposure to other
constituents of the polymer dispersion. These controls and the low toxicological impact
render the health risk from the notified polymer during manufacture, crushing and blending
of polymer low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
64
Inhalation exposure to airborne particulates and skin contamination from drips and spills is
possible when packing off the polymer and the dispersion into containers. The expected low
hazard of the notified polymer and the use protective equipment to mitigate exposure render
the health risk to workers during the packing off of the polymer and its dispersion low.
During quality control testing of samples of the polymer, intermittent dermal contact can
occur. Laboratory workers are protected by wearing laboratory coats, safety glasses and
gloves. The health risk to workers during this process is low.
Dermal exposure to spills when adding the dispersion into coating systems can occur during
the paper treatment process, which is largely enclosed and automated. Plant operators are
protected from dermal exposure by wearing overalls, safety glasses and gloves. Once the
notified polymer is impregnated onto the paper and has dried, it becomes unavailable for
exposure. Therefore, due to the low potential for exposure and the low health hazard of the
notified polymer, the health risk to paper treatment workers is low.
There is no occupational exposure expected for transport and storage workers except in the
event of accidental spillage.
The notified polymer is of low hazard to human health and safety. The standard control
measures in place during plant operation and protective measures during quality control and
application of the dispersion to paper will ensure sufficient protection against the notified
polymer. Therefore, the notified polymer is of low concern to human health and safety and no
additional risk reduction measures are necessary.
Public Health
The notified polymer is not available for sale to the general public. Although members of the
public will make dermal contact with the dried form of the notified polymer when handling
treated paper items, the risk to public health from the notified polymer is likely to be low
because the notified polymer is unlikely to be bioavailable.
Environmental Effects
The aqueous dispersion containing up to 25% of the notified polymer will be sold to paper
manufacturers who will apply it as a coating or impregnate it into a range of paper products.
These paper products will then be distributed to the general public. Once applied and dried,
the polymer is expected to be durable and not easily removed from the paper to which it has
applied. Therefore, little release of the `free' polymer is anticipated and the great majority of
environmental release of the polymer will be as a result of disposal to landfill, incineration or
recycling of waste paper products. Additionally, there may be some minor release to the
aquatic compartment from the paper/carton recycling processes.
In landfill, the polymer will exist as a stable polyester and is unlikely to be mobile in the soil
environment and would be expected to very slowly degrade to gas such as carbon dioxide
through abiotic and biotic processes. The environmental risk of the notified polymer in
landfill is expected to be low. Incineration of the polymer would yield water and oxides of
carbon. In the case of aquatic discharge, the polymer is likely to associate with sediments.
The high molecular weight and expected low water solubility of the polymer should prevent
bioaccumulation.
Given the above considerations, the overall environmental risk is expected to be low.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
65
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:
? Employers should implement the following engineering controls to minimise
occupational exposure:
- Exhaust ventilation during manufacture, blending, crushing and filling process
- Enclosed and automated manufacture process
? Employers should implement the following safe work practices to minimise
occupational exposure:
- During manual transfer of notified polymer and polymer dispersion into reaction
tanks and coating bath, avoid spills and splashing
- Avoid generation of dust clouds when handling the polymer in powder form
? 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 when splashes are generated
- A dust mask when dusts are generated
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.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) 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
(2) Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
66
20 PUBLICATION SUMMARY REPORT
Evcote PWR-100
Summary Report
Reference No: PLC/257
Asia Pacific Specialty Chemicals Limited (APS) of 15 Park Road Seven Hills NSW 2147
(ABN 32 000 316 138) has submitted a synthetic polymer of low concern (PLC) notification
statement in support of their application for an assessment certificate for Ev Cote PWR-100.
The notified polymer is intended to be used as a strength enhancer and moisture barrier
coating for paper and paper products. Greater than 10000 tonnes of the notified chemical will
be manufactured over the first five years and <100 tonnes of the solid notified polymer may
be imported during the first year.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Hazard Assessment
No toxicological information was provided for the notified polymer. The notified polymer
has a high molecular weight and is unlikely to penetrate biological membranes. It contains
carboxylic acid groups and very low concentrations of residual monomers. The polymer
meets the PLC criteria and is unlikely to be a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances.
The notified polymer is not a dangerous good for road and rail transport.
The Material Safety Data Sheet (MSDS) for the notified polymer lists a number of potential
health effects based on products of similar composition, namely irritation of the
gastrointestinal tract with upper abdominal pain, nausea, vomiting and diarrhoea if
swallowed, irritation of the eye with discomfort or blurring resulting in eye damage if
exposure is prolonged, irritation of the skin following prolonged exposure and irritation of the
upper respiratory passages following overexposure by inhalation. The MSDS for the aqueous
polymer dispersion lists potential health effects as irritation of the gastrointestinal tract,
nausea, vomiting and diarrhoea if the liquid is swallowed, irritation to the eye causing redness
and pain following eye exposure, skin irritation following prolonged exposure of the skin to
the liquid and irritation of the upper respiratory tract following mist inhalation. The adverse
health effects relate to the physical characteristics of the solid polymer particles rather than its
toxicological effects.
Occupational Health and Safety
During polymer manufacture, crushing of the solid polymer and blending of the crushed
polymer into an aqueous dispersion there is potential for respiratory, ocular and dermal
exposure to the coarse particles of the notified polymer. There is no NOHSC exposure
standard for the notified polymer itself, however the NOHSC exposure standard for nuisance
dust is 10 mg/m3. The manufacturing, crushing and blending processes are largely enclosed,
with local exhaust ventilation provided. Workers handling the notified polymer will wear
personal protective equipment including overalls, safety glasses, gloves, safety footwear and
respiratory protection. These controls will also provide protection against exposure to other
constituents of the polymer dispersion. These controls and the low toxicological impact
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
67
render the health risk from the notified polymer during manufacture, crushing and blending
of polymer low.
Inhalation exposure to airborne particulates and skin contamination from drips and spills is
possible when packing off the polymer and the dispersion into containers. The expected low
hazard of the notified polymer and the use protective equipment to mitigate exposure render
the health risk to workers during the packing off of the polymer and its dispersion low.
During quality control testing of samples of the polymer, intermittent dermal contact can
occur. Laboratory workers are protected by wearing laboratory coats, safety glasses and
gloves. The health risk to workers during this process is low.
Dermal exposure to spills when adding the dispersion into coating systems can occur during
the paper treatment process, which is largely enclosed and automated. Plant operators are
protected from dermal exposure by wearing overalls, safety glasses and gloves. Once the
notified polymer is impregnated onto the paper and has dried, it becomes unavailable for
exposure. Therefore, due to the low potential for exposure and the low health hazard of the
notified polymer, the health risk to paper treatment workers is low.
There is no occupational exposure expected for transport and storage workers except in the
event of accidental spillage.
The notified polymer is of low hazard to human health and safety. The standard control
measures in place during plant operation and protective measures during quality control and
application of the dispersion to paper will ensure sufficient protection against the notified
polymer. Therefore, the notified polymer is of low concern to human health and safety and no
additional risk reduction measures are necessary.
Public Health
The notified polymer is not available for sale to the general public. Although members of the
public will make dermal contact with the dried form of the notified polymer when handling
treated paper items, the risk to public health from the notified polymer is likely to be low
because the notified polymer is unlikely to be bioavailable.
Environmental Effects
The aqueous dispersion containing up to 25% of the notified polymer will be sold to paper
manufacturers who will apply it as a coating or impregnate it into a range of paper products.
These paper products will then be distributed to the general public. Once applied and dried,
the polymer is expected to be durable and not easily removed from the paper to which it has
applied. Therefore, little release of the `free' polymer is anticipated and the great majority of
environmental release of the polymer will be as a result of disposal to landfill, incineration or
recycling of waste paper products. Additionally, there may be some minor release to the
aquatic compartment from the paper/carton recycling processes.
In landfill, the polymer will exist as a stable polyester and is unlikely to be mobile in the soil
environment and would be expected to very slowly degrade to gas such as carbon dioxide
through abiotic and biotic processes. The environmental risk of the notified polymer in
landfill is expected to be low. Incineration of the polymer would yield water and oxides of
carbon. In the case of aquatic discharge, the polymer is likely to associate with sediments.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
68
The high molecular weight and expected low water solubility of the polymer should prevent
bioaccumulation.
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:
? Employers should implement the following engineering controls to minimise
occupational exposure:
- Exhaust ventilation during manufacture, blending, crushing and filling process
- Enclosed and automated manufacture process
? Employers should implement the following safe work practices to minimise
occupational exposure:
- During manual transfer of notified polymer and polymer dispersion into reaction
tanks and coating bath, avoid spills and splashing
- Avoid generation of dust clouds when handling the polymer in powder form
? 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 when splashes are generated
- A dust mask when dusts are generated
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.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) 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
(2) Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
69
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
70
21 PUBLICATION SUMMARY REPORT
1h-pyrazole-1-ethanol, 4, 5-diamino-, sulfate (1:1) salt (Pyrazole DHE)
Summary Report
Reference No: EX/30 (NA/755)
Schwarzkopf Pty Ltd. of 20 Rodborough Road, Frenchs Forest NSW 2086 has submitted a
notification statement in support of their application for an extension of the Assessment
Certificate for 1H-pyrazole-1-ethanol, 4,5-diamino-, sulfate (1:1) salt (Pyrazole DHE). The
notified chemical will be used in the formulation of hair dye products. Approximately 200
kg/year will be imported over the nest five years.
The original assessment certificate is held by Cosmetic Products (Wella) Pty Ltd of 1 Wella
Way, Somersby NSW, who has agreed to this extension.
The new information in this current application supplied by Schwarzkopf Pty Ltd affects
primarily the occupational exposure, public exposure and environmental sections of NA/755.
The chemical will be imported as a final product in 50mL heavy wall glass containers. The
concentration of the notified chemical in the hair dye products will be 0.9%. There is a
decrease in the import volume of the notified chemical in the application for an extension of
the original certificate.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
The notified chemical was of very low acute oral toxicity in rats. It was a slight skin irritant
in rabbits but non-irritant in human volunteers. In its pure form, the notified chemical caused
severe damage to the eyes of the rabbit, but was non-irritant when applied as a 5% aqueous
solution. The notified chemical was extremely sensitising to the skin of guinea pigs in the
Maximisation test but non-sensitising in the B黣hler test.
The notified chemical was considered non-mutagenic to the bacterial strains tested and non-
genotoxic in an in vivo mouse micronucleus assay. However, it was clastogenic in vitro in a
chromosomal aberration assay only in the absence of metabolic activation.
The notified chemical is classified as a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances based on the findings of the
persistent conjunctival effects in an eye irritation study, and the potential for skin
sensitisation observed in an adjuvant type test. The overall classification is Irritant (Xi) and
the risk phrase R41- Risk of Serious Damage to Eyes and R43- May Cause Sensitisation by
Skin Contact, are assigned.
The imported product and formulated end-use products will require the appropriate risk
phrases under hazardous substances regulations.
Occupational Health and Safety
Transport and Storage
Exposure to the notified chemical is not expected during transport or storage as long as the
packaging remains intact. Exposure after a spill would be controlled by use of the
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
71
recommended practices for spillage clean up given in the MSDS supplied by the notifier.
The risk of adverse health effects for transport and storage workers is considered low.
Formulation
The greatest potential for exposure to the notified chemical is during opening, emptying and
mixing of the powdered chemical and during disposal of empty used bags. There exists
potential for exposure by inhalation and/or skin and eye contact with dust particles with the
associated health effects of skin sensitisation and eye irritation. The notified chemical
comprises up to 80% of the imported dye powder for dark dye shades. At concentrations of >
1% chemical, Pyrazole DHE is a hazardous substance. There may also be potential for
genotoxic effects as revealed in a chromosome aberration study. Given the low molecular
weight (240) of the notified chemical, significant absorption through the skin cannot be
excluded.
Given this risk of adverse health effects during this stage of the formulation process, local
exhaust ventilation and dust extraction need to be maintained over mixing areas to capture
dust and aerosols at source, and minimise exposure to airborne particulates generated from
the notified chemical and any other ingredients. The wearing of an air purifying dust
respirator (with P3 particulate filter) and other protective equipment throughout the
formulation process, such as impervious gloves, overalls and eye protection, is needed. The
NOHSC exposure standard for inspirable dust will need to be adhered to in the workplace.
Exposure to the chemical at 0-4.5% may occur after dilution, when mixing with other hair
dye ingredients, during connection/disconnection of containers to transfer lines and during
cleaning and maintenance of equipment. Inhalation exposure is not expected as any aerosols
would be within enclosed automated operation systems. Skin and/or eye contact will be the
main routes of exposure. As the notified chemical is hazardous at > 1%, a risk of skin
sensitisation, and possibly eye irritation, exists during formulation and packaging,
particularly with the darker shades which contain the higher concentrations. The prompt
clean up of spills and the wearing of impervious gloves, overalls and chemical splash goggles
are needed to reduce these risks when handling the dye solutions.
Exposure to dusts and aerosols may also occur during laboratory testing, however, given the
smaller quantities handled, the potential for skin sensitisation and eye irritancy is reduced.
Local exhaust ventilation and the routine wearing of laboratory coats, impervious gloves and
safety glasses would be expected to further reduce these risks.
Measures should also be implemented in the disposal of the notified chemical to ensure that
exposure is avoided.
End use
Workers in hairdressing salons could handle this chemical on a frequent basis. The product
concentration of 0-4.5% is diluted in use, to a maximum of 0-2.25%. At 2.25%, the chemical
is still a hazardous substance (skin sensitiser) and hairdressers will need to wear gloves when
making up, applying and rinsing off this chemical.
Public Health
The public will be exposed to the notified chemical at up to 4.5% in hair dye products. At
this concentration, it is expected that the products will not cause skin or eye irritation, but
may cause skin sensitisation in certain susceptible individuals. Exposure of individuals, in
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
72
the at home use, to the notified chemical should be controlled by following the instructions
supplied on product labels. Exposure is expected to be low and for short periods only; thus, it
is considered that Pyrazole DHE will not pose a significant hazard to public health when used
in the proposed manner.
Variations to this assessment specific to the Schwarzkopf Pty Ltd extension
Public exposure to hair dye products containing the notified chemical is likely to be
intermittent (based on the use pattern), and widespread (sold to the public and limited only by
the commercial success of the products). When used, the colour gel containing the notified
chemical (1.0%) will be diluted 4:5 with developer, leading to maximal exposure
concentrations of 0.5%. At these concentrations, it is expected that the products will not
cause skin or eye irritation, but may cause skin sensitisation in certain susceptible individuals.
Use of hair dye products strictly in accordance with the product information, should minimise
the potential skin sensitisation hazard. There will be minimal public exposure from transport
and storage.
Environmental Effects
The notified chemical is expected to pose a low environmental hazard if used as specified by
the notifier.
The annual amount of waste notified chemical produced during the reformulation is 19.0 kg.
The majority of this waste will enter the sewer. The remainder will likely be disposed of to
landfill (ie in bags/containers), where is likely to leach out. The empty end-use containers
will generally go to landfill, equating to about 10 kg of unreacted notified chemical waste
annually. All these inputs into the environment are likely to be at very low concentrations
and in a very diffuse manner.
As the notifier has not provided the percentage uptake of the dye by the hair it has been
presumed that all the dye (containing the notified chemical) will end up in the sewer. The use
of the hair dye would be dispersed over Australia, so a PEC for the notified chemical could
be calculated as follows:
Amount of notified chemical imported per year,
subsequently entering sewer 500 kg
Population of Australia 18 million
Amount of water used per person per day 150 L
Number of days in a year 365
Estimated PEC 0.00005 mg/L (0.05 ppb)
The scenario where a whole formulation batch is dropped and subsequently enters the sewer
would represent a worst case PEC. The resultant PEC is:
Quantity of notified chemical entering the on-site
treatment plant 4.5 kg
Volume of water handled by the treatment plant 40 000 L
Sewer concentration 112.5 mg/L
Amount of effluent handled daily by MTP 250 ML
Dilution in receiving water 1:10
Worst case daily PEC 0.045 mg/L (0.045 ppm)
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
73
The ecotoxicity studies indicated that the most sensitive species to the notified chemical is
algae (EbC50 = 5.33 mg/L). All of the PECs calculated are several orders of magnitude below
the calculated EbC50 level for algae, therefore the use as proposed poses a low hazard.
Variation to this assessment specific to the Schwarzkopf Pty Ltd extension
The following calculations assume that the new chemical will be used nationwide and that it
is released to the sewer system. It is also assumed that 150 L of sewerage are generated each
day by each person.
Import rate 200kg/annum
Release rate 200kg/annum
19 x 106
Population (national)
1 x 1012 L/annum
Volume of sewerage per annum
0.2 礸 /L (0.2ppb)
Mean concentration of sewerage
On release to receiving waters (after treatment at the sewage treatment plant), it is usually
assumed that the effluent is diluted by a factor of 10. This gives a final PEC in receiving of
0.02 礸 /L (0.02 ppb).
However, it should be noted that no removal through other mechanisms has been considered
in the above calculations. Biodegradation of the chemical or adsorption to sediment will
lower the above PEC estimates to the extent these processes occur.
Conclusion
The notified chemical is not likely to present a hazard to the environment when it is stored,
transported and used in the proposed manner.
RECOMMENDATIONS
Pyrazole DHE is a skin sensitiser; workers handling it or products containing it will need to
be strictly protected against skin contact. To minimise occupational exposure to Pyrazole
DHE the following guidelines and precautions should be observed:
Safety goggles should be selected and fitted in accordance with Australian Standard
?br>
(AS) 1336 to comply with Australian/New Zealand Standard (AS/NZS) 1337;
industrial clothing should conform to the specifications detailed in AS 2919 and AS
3765.1; impermeable gloves or mittens should conform to AS 2161.2; all
occupational footwear should conform to AS/NZS 2210; respiratory protection should
conform to AS/NZS 1715, and AS 1716;
Local exhaust ventilation should conform to AS 1668.2;
?br>
Dust levels in the workplace should be maintained below the NOHSC exposure
?br>
standard for nuisance dusts, 10 mg/m3 (TWA) measured as inspirable fraction.
Employers are responsible for ensuring the exposure standard is not exceeded;
Spillage of the notified chemical should be avoided. Spillages should be cleaned up
?br>
promptly and put into containers for disposal;
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
74
Good personal hygiene should be practised to minimise the potential for ingestion;
?br>
and
A copy of the MSDS should be easily accessible to employees.
?br>
If the conditions of use are varied, then greater exposure to the public may occur. In such
circumstances, further information may be required to assess the hazards to public health.
The notified chemical may be recommended to the National Occupational Health and Safety
Commission for consideration for inclusion in the NOHSC List of Designated Hazardous
Substances.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
75
22 ACCESS TO FULL PUBLIC REPORT
NICNAS publishes a Full Public Report for each new chemical assessed. These reports are
available for public inspection at the library of the National Occupational Health & Safety
Commission at their Canberra office by appointment only. Please call the library on (02)
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 11, 6 November 2001
76
23 COMMERCIAL EVALUATION 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
19/09/01
Binder in
2086 No Less than
Rioch RSE-825
492
photocoping
1500kg per
Australia Pty
toner
year
Ltd
2086 No Less than Binder in 19/09/01
Rioch
493 RSE-801
Australia Pty 500kg per photocopying
Ltd year toner
Rioch 2086 No Less than Charge 19/09/01
494 RCR-8
Australia Pty 60kg per control in
Ltd year toner
BASF Akzo
495
Nobel
Chemical in
Automotive
No 1800kg Car primer 26/10/01
3020 RX 3211
OEM Pty Ltd
& Akzo
Nobel Pty Ltd
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
77
24 LOW VOLUME CHEMICAL 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 HAZARDOUS USE DATE
NUMBER NAME POSTCODE OR TRADE SUBSTANCE
NAME
398 Kodak 3058 CIN Yes Component of 19/01/01
Australasia 10090712 ink
Pty Ltd formulations
403 Canon 2113 NT-9 No Developer 04/10/01
Australia component
Pty Ltd for electro-
photocopying
machine
404 Konica 2113 H-9605 No Component of 04/10/01
Australia photo-
processing
chemicals
405 3M 1790 Polyurethane No Component of 05/10/01
Australia a foam used
Pty Ltd in OEM
applications
406 Lord 3043 Polymer in No Rubber 05/10/01
Chemical Ty-Ply ?RC bonding agent
Products
Pty Ltd
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
78
25 EARLY INTRODUCTION PERMITS FOR NON-HAZARDOUS INDUSTRIAL
CHEMICALS
The permits listed in Table 3 were issued to import or manufacture the following chemicals
prior to the issue of their respective assessment certificates under section 30A of the Act.
Table 3
Early Introduction Permits
PERMIT COMPANY CHEMICAL OR TRADE USE
NUMBER NAME NAME
180 3M Australia Pty Urethane Polymer Component of a
Ltd fabric/fibre stain
protector
181 Degussa Australia Dynapol H 700 Paint component
Pty Ltd
182 DuPont (Australia) RC 25433 Paint component
Ltd
183 ISP (Australasia) Pty Allianz LT120 Hair fixture resin for hair
Ltd styling products
184 BASF Akzo Nobel Polymer in RW 3210 Paint component
Automotive OEM
Coatings Pty Ltd &
185 Akzo Nobel Pty Ltd Polymer in RW 3210 Paint component
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
79
26 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES UNDER AN AMNESTY
Notice is given in accordance with section 20E of the Industrial Chemicals (Notification and
Assessment) Amendment Act (No. 2), 1992, that the following chemicals have been added to
the Australian Inventory of Chemical Substances.
Table 4
Chemicals Eligible For Listing On The Australian Inventory Of Chemical Substances
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
1-Propanaminium, 3-butoxy-2-hydroxy-N- (2-
C12H27NO6S
108797-84-8
hydroxy-3-sulfopropyl)-N, N-dimethyl-, inner salt
1-Propanaminium, 3-[(2-ethylhexyl) oxy]-2-
108797-85-9 C16H35NO6S
hydroxy-N- (2-hydroxy-3-sulfopropyl)-N, N-
dimethyl-, inner salt
1-Butanol, 2,2-bis [(2-propenyloxy) methyl]-,
71486-80-1 C12H22O3.C12H18N2O2.C3H6O
reaction products with allyl alc. and 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane
Poly [imino(1,2-dioxo-1,2-ethanediyl)imino-1,2-
36812-63-2 (C4H6N2O2) n
ethanediyl]
Ethanethiol, 2,2'-thiobis-, reaction products with
(C5H10Cl2O2.C4H10S3.C3H5Cl3.Unspecif
109159-22-0
reduced 1,1'-[methylenebis(oxy)]bis[2- ied ) x
chloroethane]-sodium sulfide
(Na2 (Sx)-1,2,3-trichloropropane polymer
Hexane, 1,6-diisocyanato-, homopolymer, 2-ethyl-1-
Unspecified
199745-10-3
hexanol- and 2-oxepanone homopolymer 2-[(1-oxo-
2-propenyl) oxy] ethyl ester-blocked
1,2-Ethanediamine, polymer with 2,2'-[(1-
27615-34-5 (C21H24O4.C2H8N2) x
methylethylidene) bis (4,1-
phenyleneoxymethylene)] bis [oxirane]
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
80
27 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 5
Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
(C8H14O2.C7H12O2.C4H6O2) x
32409-51-1
2-Propenoic acid, 2-methyl-, polymer with butyl 2-
propenoate and 2-methylpropyl 2-methyl-2-propenoate
162568-28-7 Unspecified
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, reaction
products with 1H-imidazole-1-propanamine, 2-
oxepanone homopolymer decy ester, polyethylene-
polypropylene glycol and poly-TDI
(C6H12N4.CH4N2O.CH2O) x
69898-35-7
Urea, polymer with formaldehyde and 1,3,5,7-
tetraazatricyclo[3.3.1.13,7]decane, butylated
99869-40-6
1,6-Hexanediol, polymer with 1,1'-methylenebis[4- (C15H10N2O2.C6H14O2.C3H8O3.3 (C3H6O.C2H4O)
x)x
isocyanatobenzene] and methyloxirane polymer with
oxirane ether with 1,2,3-propanetriol (3:1)
C28H34O8S2
92761-26-7
Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 3,3'-
(1,4-phenylenedimethylidyne)bis[7,7-dimethyl-2-oxo-
(C21H28O4.C16H26O3.C8H6O4) x
173659-63-7
1,3-Benzenedicarboxylic acid, polymer with 3-
(dodecenyl)dihydro-2,5-furandione and 1,1'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[2-
propanol]
C28H52N2O4.C8H18.C4H10O2
129757-67-1
Decanedioic acid, bis(2,2,6,6-tetramethyl-4-
piperidinyl) ester, reaction products with tert-Bu
hydroperoxide and octane
C30H25FN8O16S5.4Na
130201-56-8
2,7-Naphthalenedisulfonic acid, 3-[(2,5-
disulfophenyl)azo]-5-[[4-[[3-[[[2-
(ethenylsulfonyl)ethyl]amino]carbonyl]phenyl]amino]-
6-fluoro-1,3,5-triazin-2-yl]amino]-4-hydroxy
tetrasodium salt
C56H46F2N18O20S6.xK.xLi.xNa
149850-34-0
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-[[2-sulfo-4-[(4-
sulfophenyl)azo]phenyl]azo]-, lithium potassium
sodium salt
C30H25Br2ClN8O11S3.xNa
155522-14-8
2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-
(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-3-[[5-
[(2,3-dibromo-1-oxopropyl)amino]-2-
sulfophenyl]azo]-4-hydroxy-, sodium salt
153519-44-9 Unspecified
1,3-Benzenediol, 4-[4,6-bis(2,4-dimethylphenyl)-1,3,5-
triazin-2-yl]-, reaction products with
[(dodecyloxy)methyl]oxirane and oxirane mono[(C10-
16-alkyloxy)methyl] derivs.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
81
C18H11ClN2O2
88949-37-5
Pyrrolo[3,4-c]pyrrole-1,4-dione, 3-(4-chlorophenyl)-
2,5-dihydro-6-phenyl-
C27H27N3O2
147315-50-2
2-(4,6-Diphenyl-1,3,5-triazine-2-yl)-5-
[(hexyl)oxy]phenol
C20H16N2O2
84632-66-6
2,5-Dihydro-3,6-bis(4-methylphenyl)pyrrolo[3,4-
c]pyrrole-1,4-dione
C35H34N12O9S2.2Na
130201-55-7
Disodium 4,4'-(6-morpholino-1,3,5-triazine-2,4-
diyldiimino)bis[m-(2-
acetamidophenylazo)benzenesulfonate]
C18H14N4O6S.xNa
156738-27-1
Benzenesulfonic acid, 4-[[4-[(4-
hydroxyphenyl)azo]phenyl]amino]-3-nitro-, sodium
salt
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
82
28 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY OF
CHEMICAL SUBSTANCES
Notice is given in accordance with section 20 of the Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act) that the following amendment have been made to the
Australian Inventory of Chemical Substances (AICS).
1. The following chemical has been added to AICS.
Table 6 Amendment to AICS
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
Rosin, maleated, polymer with branched 4-
185765-80-4 Unspecified
nonylphenol, formaldehyde and
pentaerythritol
2. Some chemicals were listed in AICS under valid and invalid CAS numbers. Invalid CAS
numbers are now deleted from AICS. Table 5 lists the invalid CAS Numbers against the valid
CAS numbers.
Table 7 Invalid CAS numbers, now deleted from AICS, and the corresponding valid
CAS numbers
INVALID CAS NUMBER VALID CAS NUMBER
1338-46-1 67701-03-5
1406-70-8 58-95-7
5893-66-3 55671-32-4
8051-63-6 68155-24-8
10535-02-1 5280-66-0
12225-04-6 3905-19-9
12238-65-2 3068-39-1
12262-18-9 3251-84-1
12389-15-0 6047-12-7
12619-52-2 31455-16-0
12710-07-5 14117-96-5
12769-01-6 5045-40-9
22374-99-8 150-88-9
22886-75-5 12503-89-8
25776-41-4 52625-13-5
26793-72-6 68584-99-6
26857-24-9 25232-42-2
28068-35-1 38945-70-9
29754-80-1 7023-61-2
30373-82-1 25498-49-1
30496-13-0 79-94-7
31830-07-6 56449-05-9
31957-38-7 25119-99-7
32075-38-0 137-20-2
32917-01-4 12225-86-4
33115-06-9 37280-83-4
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
83
35885-17-7 9004-99-3
36443-64-8 57671-19-9
36655-14-8 73507-68-3
37332-31-3 123465-33-8
37359-39-0 30351-73-6
39355-08-3 8012-95-1
39355-58-3 61791-14-8
51176-98-8 26898-17-9
51750-73-3 7783-13-3
52238-52-5 5280-66-0
52309-41-8 25322-69-4
53523-20-9 9003-35-4
54173-86-3 56011-02-0
54990-32-8 68584-99-6
55599-33-2 7631-86-9
56731-19-2 30125-47-4
56802-99-4 11084-85-8
57485-98-0 82338-76-9
57851-91-9 9003-35-4
58517-33-2 25155-30-0
58660-13-2 9086-52-6
61180-55-0 12174-11-7
61512-60-5 109414-04-2
61512-64-9 21405-81-2
61931-54-2 15958-61-9
63172-75-8 65307-72-4
63690-56-2 5743-47-5
64945-73-9 37337-65-8
66105-29-1 68553-03-7
67953-88-2 54579-44-1
68345-29-9 26761-25-1
68412-30-6 58944-89-1
68412-90-8 69331-40-4
68412-91-9 59419-62-4
68609-75-6 68133-63-1
68610-03-7 62503-58-6
68859-51-8 29204-84-0
68859-68-7 36888-99-0
68916-24-5 9000-24-2
68988-66-9 8005-52-5
69771-45-5 15993-42-7
70865-24-6 12237-01-3
70992-41-5 27136-15-8
75497-74-4 3618-72-2
76168-74-6 40716-47-0
79331-93-4 9011-15-8
89591-46-8 68110-24-7
94351-85-6 15233-33-7
97143-76-5 33918-18-2
98073-10-0 119831-19-5
102979-97-5 100208-47-7
102979-98-6 97660-74-7
102980-36-9 102980-18-7
103513-11-7 9049-71-2
103819-01-8 68439-50-9
104133-13-3 60892-41-3
104133-20-2 102980-22-3
104339-47-1 57629-28-4
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
84
111977-68-5 67989-30-4
118658-97-2 68030-74-0
120145-59-7 110053-35-5
159339-88-5 146126-21-8
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
85
29 NICNAS MOVES - NEW CONTACT DETAILS
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is
moving from Camperdown to Marrickville during the week of 5 November 2001.
Our new contact details follow ?please note that our GPO Box and freecall numbers, as well
as our web site, remain unchanged.
Street address:
334-336 Illawarra Road
Marrickville NSW 2204
Postal address:
GPO BOX 58
Sydney NSW 2001
Australia
tel +61 2 8577 8800
fax +61 2 8577 8888
freecall 1800 638 528
email info@nicnas.gov.au
web www.nicnas.gov.au
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
86
30 OZONE PROTECTION PROGRAM, ENVIRONMENT AUSTRALIA,
REQUEST FOR INFORMATION ON OZONE-DEPLETING SUBSTANCES USED
AS PROCESS AGENTS
Under the Montreal Protocol on Substances that Deplete the Ozone Layer, the import, export
and manufacture of certain ozone depleting substances (ODS) has been prohibited. An
exception to this prohibition is the import, export or manufacture of ODS as process agents,
under certain circumstances.
Process agents are chemicals that are used, because of their unique chemical and/or physical
properties, to facilitate an intended chemical reaction and/or inhibit an unintended chemical
reaction. ODS are typically used as process agents in the production of chlorine, chlorinated
rubber, pharmaceuticals and agricultural and veterinary chemicals. To date, the Montreal
Protocol's panel of experts have verified that the ODS carbon tetrachloride (CTC),
chlorobromomethane (CBM) and chlorofluorocarbons 11, 12 and 113 (CFC 11, CFC 12,
CFC 113) are currently used internationally as process agents.
In accordance with industry and government consultation undertaken in 1998, the
Commonwealth Government reported internationally that Australia does not use ODS as
process agents. The 10th Meeting of the Parties to the Montreal Protocol in December 1998
agreed: a list of process agent applications of ODS; country-specific limits on the level of
"make-up quantity" (quantity of ODS needed annually in the process agent application to
maintain operations) and emissions allowable from ODS used in those process agent
applications; and annual reporting obligations. Australia's annual "make-up quantity" and
emission limits are currently zero.
Environment Australia is the Commonwealth agency responsible for implementing
Australia's international obligations under the Montreal Protocol, and as such would
appreciate any information relating to the use of these substances as process agents in
Australia. All information received by Environment Australia will be used to: fulfil
Australia's international reporting obligations; determine whether there are legitimate process
agent uses of ozone depleting substances within Australia; register these uses with the
Secretariat of the Montreal Protocol; and determine whether Australia needs to seek
amendment to its Protocol limits on "make-up quantity" and emission.
Users of these substances who believe that they may have relevant information should
contact Mr Ben Stapley of Environment Australia on (02) 6274 1601 by 1 December 2001.
Environment Australia has prepared a questionnaire to assist Australian industry in providing
the relevant information. This will be provided on request.
If you would like further information or wish to discuss any aspect of this request, please
contact Mr Stapley.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
87
31 CHANGES TO THE INDUSTRIAL CHEMICALS (NOTIFICATION AND
ASSESSMENT) ACT 1989
Changes have been made within legislation administered by the Minister for Employment,
Workplace Relations and Small Business to reflect the application of the Criminal Code Act
1995. These include changes to the Industrial Chemicals (Notification and Assessment) Act
1989. The Criminal Code contains a standard approach to the formulation of criminal
offences. Changes are found in the Employment, Workplace Relations and Small Business
Legislation Amendment (Application of Criminal Code) Act 2001, which commenced on 2
October 2001.
The Department of Employment, Workplace Relations and Small Business provides the
following explanation.
Outline of Amendments and Rationale
The Employment, Workplace Relations and Small Business Legislation Amendment
(Application of Criminal Code) Act 2001 (the EWRSB Act) commenced on 2 October 2001.
A copy of the Bill as introduced (there were no amendments made to the Bill as introduced)
and the Explanatory Memorandum can be found at:
http://www.dewrsb.gov.au/workplacerelations/legislation/EWRSBLA(ACC)/default.asp
The Act was one of a series proposed across portfolios to align Commonwealth offences in
general with Chapter 2 of the Criminal Code Act 1995. Chapter 2 of the Criminal Code sets
out the general principles of criminal responsibility and applies to the portfolio Acts it
amends from its commencement.
The amendments were made to ensure that the relevant offences continued to have much the
same meaning and to operate in much the same manner as they did before Chapter 2 applied.
The Criminal Code contains a standard approach to the formulation of criminal offences.
The following is a link to the Criminal Code Act 1995 (Note - it is over 160 pages to print
out, but Chapter 2 of the Code is the most relevant):
http://www.austlii.edu.au/au/legis/cth/consol_act/cca1995115/
The major forms of amendment effected to the Industrial Chemicals (Notification and
Assessment) Act 1989 by the EWRSB Act are:
? applying Chapter 2 of the Criminal Code. One consequence of this is that the provisions
of Part 2.5 of Chapter 2 which deal with the vicarious liability of corporations will apply
rather than the provisions of subsection 109(1) and 109(2);
?better identifying exceptions and defences. For example `reasonable excuse' has been
removed from the body of offences and restated as a defence for which the defendant
bears an evidential burden (see ss 13.3(3) of the Criminal Code);
?deleting references to sections 7, 7A, and 86 of the Crimes Act 1914 (which deal with
attempt, incitement and conspiracy) and replacing these with references to equivalent
Criminal Code provisions where appropriate;
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
88
? applying strict liability to individual offences or specified physical elements of offences
where appropriate. This means that the prosecution does not have to prove a mental
element in relation to the offence or element of the offence (such as intention to do
something). The defence of reasonable mistake of fact is available for strict liability
offences (see section 9.2 of the Criminal Code);
?reconstructing provisions in order to clarify physical elements of conduct, circumstance
and result. For example subsections 21L(4) and 21W(5) relating to breaching conditions
of a permit have been restructured to better identify the physical elements of conduct (in
this case doing or omitting to do an act) and result (the act or omission contravenes a
permit); and
?removing or replacing inappropriate fault elements. For example, omitting `knowingly or
recklessly' from provisions such as ss. 21(1); 30C(4); section 56; ss 67(2); and section
80B. This is because under the Criminal Code it will not be possible to apply a fault
element of knowledge or recklessness to a physical element of conduct. Only intention
can apply to conduct.
Contact Megan Smith, Innovation and Compliance, NICNAS on Freecall 1800 638 528 if
clarification is needed.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
89
32 NEW TRANSITIONAL ARRANGEMENTS TOWARDS APPROVAL OF
APPROVED FOREIGN SCHEME
The Transitional Arrangements Towards Approval of Approved Foreign Schemes
(Transitional Arrangements) were first published in the Chemical Gazette No. C 4, 7 April
1998.
NICNAS experience gained to date within the Transitional Arrangements and by
participating in international activity, namely within the OECD New Chemicals Task Force,
suggests benefits to NICNAS and industry by expanding the Transitional Arrangements. For
example, NICNAS has established firm links with Canada and European Union member
states on information sharing which will make it easier for industry to obtain assessment
reports from these sources. In addition, there are potential benefits for industry and NICNAS
by expanding the Transitional Arrangements to include the Limited Notification Category.
Finally, Canada and Australia share similar criteria for defining a Synthetic Polymer of Low
Concern (PLC). Consequently, we can introduce resource savings for both industry and
NICNAS where the applicant provides evidence to NICNAS that a polymer has been notified
and assessed in Canada under the Canadian Environment Protection Act (CEPA) as a Low
Concern Polymer. In this circumstance, NICNAS could waive the application fee for an Early
Introduction Permit (EIP).
The Minister has approved the New Transitional Arrangements Towards Approval of
Approved Foreign Schemes (New Transitional Arrangements). The new arrangements
provide industry with increased opportunities to either access an assessment rebate by
submitting assessment reports prepared by national authorities or be eligible for a waiver in
EIP fee.
New Transitional Arrangements
The New Transitional Arrangements supersede all previous notices with respect to
Transitional Arrangements Towards Approval of Approved Foreign Schemes.
The following options are now available to applicants notifying new industrial chemicals to
NICNAS.
Option 1 Up to 40% Rebate in Notification Fee for Provision of an Acceptable
Assessment Report issued by a National Authority
Option 1 applies to chemicals or polymers for notification under subsections 23(4) to 23(9) of
the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) that is,
notification under the Standard or Limited Notification category.
Criteria for an Acceptable Assessment Report
The assessment report must:
date from post-1994. Preferably, the report should be in English, however, authorised
translations are acceptable. Electronic reports are also acceptable;
originate from the national authority of an OECD Member country, preferably Canada or any
European Union Member State;
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
90
include confidential information, for example, chemical identity. Sanitised documents are not
acceptable;
include a summary and assessment of physicochemical properties;
include a summary and assessment of toxicological and environmental effects data, as
appropriate;
include a health and environmental risk assessment; and
be accompanied by a letter of validation from the overseas authority that the report is the full
and final report issued for that chemical.
Conditions
In all instances, acceptance of an assessment report is subject to the approval of the Director
of Chemicals Notification and Assessment.
Applicants are still required to follow the notification procedures as described in Section 23
of the Act and submit a notification statement about the chemical or polymer that contains the
information required as per the Schedule. Where not already covered by the notification
requirements of section 23, the following information should also be submitted to the
Director of Chemicals Notification and Assessment.
Details of the overseas authority, that is, when and where notified;
A copy of all the particulars about the chemical that were given under the foreign scheme and
are available to the applicant; and
Any other information about the chemical available to the applicant, that is, assessment
information or was given under another foreign scheme.
NICNAS statutory timeframes for assessment remain unchanged.
Rebate
NICNAS will decide the level of rebate on a case-by-case basis. The maximum rebate is 40%
of the notification fee, however the fee rebate will be less than 40% if data on toxicological
and environmental effects is absent or incomplete.
Method of Application and Fees
Applications for Assessment Certificates under the New Transitional Arrangements are to be
made on FORM 1-FS. Notification fees must be paid in full. The rebate is determined at the
end of the assessment period.
Obtaining Assessment Reports from the Canadian Authority
Applicants should first contact NICNAS to obtain a proforma authorising Environment
Canada to transmit the Canadian assessment report to NICNAS. This will expedite the
process of obtaining the Canadian assessment report.
Option 2: A Free Early Introduction Permit (EIP) for Synthetic Polymers of Low
Concern (PLC) Assessed as Low Concern Polymers in Canada.
Option 2 applies to polymers notified and assessed as a Low Concern Polymer under CEPA.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
91
Eligibility Criteria
The polymer has been assessed as a Low Concern Polymer under CEPA. The PLC
notification statement and EIP application to NICNAS includes a Validation Letter from
Environment Canada to this effect.
The PLC notified to NICNAS meets the requisite criteria for early introduction described
under section 30A of the Act.
Conditions
In all instances, recognition of the Validation Letter from Environment Canada is subject to
the approval of the Director of Chemicals Notification and Assessment. NICNAS and
Environment Canada will assume that the presence of a copy of the letter indicates that the
applicant is entitled to use it.
In all instances, the granting of an EIP is subject to the approval of the Director of Chemicals
Notification and Assessment.
Polymers that have had conditions or restrictions imposed by CEPA are ineligible to access
Option 2.
Applicants are still required to follow the notification procedures as described in Section 23
of the Act and submit a notification statement about the PLC that contains the information
required as per the Schedule.
NICNAS statutory timeframes for both assessment of the EIP application and PLC
assessment certificate remain unchanged.
Method of Application and Fees
Application for an EIP under the Transitional Arrangements is to be made on FORM 1-EIP.
The $500 fee need not be provided, as long as the Eligibility Criteria and Conditions are met.
Accessing the CEPA `No Suspicion of Toxic' Validation Letter
Applicants need to contact their Canadian company counterpart to obtain a copy of the
Environment Canada Validation Letter. This letter states that:
? the Schedule VI information on the polymer completes the applicant's obligations
under the CEPA New Substances Notification Regulations (that is, meets Low
Concern Polymer criteria);
? the assessment outcome is `No Suspicion of Toxic'; and
? depending on trigger threshold volumes, the polymer is eligible for addition to the
Domestic Substances List.
For further details on the New Transitional Arrangements please contact Bob Graf or Roshini
Jayewardene in NICNAS New Chemicals on freecall 1800 638 528.
Chemical Gazette Commonwealth of Australia Gazette
No. C 11, 6 November 2001
|