Gazette
Commonwealth
of Australia
No. C 1, Tuesday, 6 January 2004
CHEMICAL
Published by the Commonwealth of Australia
ISSN 1035-9877
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 EX/46 POLYMER IN NUOSPERSE FX 600 5
2 STD/1054 1,2-BENZENDICARBOXYLIC ACID BIC(2- 8
PROPYLHEPTYL) ESTER
3 LTD/1114 MIRAPOL FB2 10
4 PLC/381 ZK56-3843 12
5 PLC/382 ZK56-3804 14
6 PLC/409 DCA 229 16
7 PLC/419 TEMPO MAX SHEETFED VARNISH 802578X 18
11200960
8 PLC/420 11201212 VBC (PLAST) VARNISH 802282 20
9 ACCESS TO FULL PUBLIC REPORT 22
PERMITS ISSUED
10 LOW VOLUME CHEMICAL PERMITS 23
11 COMMERCIAL EVALUATION CATEGORY PERMITS 24
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES
25
12 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES FIVE
YEARS AFTER ISSUING OF ASSESSMENT CERTIFICATES
13 NOTICE OF AMENDMENTS TO THE AUSTRALIAN INVENTORY 27
OF CHEMICAL SUBSTANCES
SPECIAL NOTICES
14 APPLICATIONS FOR AN ASSESSMENT CERTIFICATE-DATA 28
REQUIREMENTS
15 DRAFT ENVIRONMENTAL EXPOSURE ASSESSMENT REPORT 30
ON SCCPS FOR COMMENT
16 POLICY ON TOXICOLOGY TESTING FOR SKIN SENSITISATION 31
IN HEALTH RISK ASSESSMENTS
5
1 PUBLICATION SUMMARY REPORT
Polymer in Nuosperse FX 600
Summary Report
Reference No: EX/46
Degussa Coatings and Colorants Pty Ltd of 30 Commercial Drive, Dandenong VIC 3175 has
submitted a limited notification statement in support of their application for an assessment
certificate for Polymer in Nuosperse FX 600. The notified polymer is intended to be used as a
dispersing agent for use in water-based paints and coatings, printing inks and pigment
dispersions. Less than one tonne of the notified polymer will be imported per annum for the
first five years.
Chem-Hawk Pty Ltd (ABN No. 55 006 503 475) of Suite 12B, Brookwood House, 424-426
Nepean Highway, Frankston, VIC 3199 has applied for an Extension of the Original
Assessment Certificate. The notified polymer is intended to be used in leather finishes,
textiles, plastics and inks. Approximately 10 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
Based on the available data, SER-AD FX 600, containing 25% notified polymer is not
classified as hazardous under the NOHSC Approved Criteria for Classifying Hazardous
Substances.
The notified polymer may be a hazardous substance due to its irritancy, in particular, eye
irritation effects.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health under the conditions of the occupational
settings described.
Environmental Effects
The notified polymer is not likely to present a risk to the environment when it is stored,
transported and used in the proposed manner.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
6
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer:
- Exhaust ventilation at the formulation site.
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer:
- The application of spray painting should follow 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 the notified polymer:
- Protective clothing
- Gloves
- Eye protection
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
? The following control measures should be implemented by end users to minimise
environmental exposure during use of the notified polymer:
- Do not pour leftover paint down the drain. Unwanted paint should be brushed out on
newspaper, allowed to dry and then disposed of via domestic waste collections.
Empty paint containers should be left open in a well ventilated area to dry out. When
dry, recycle steel containers via steel can recycling programs. Disposal of empty paint
containers via domestic recycling programs may differ between local authorities.
Check with your local council first.
Disposal
? Once dry, solid waste containing the notified polymer should be disposed of in
landfill or by incineration.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
7
Emergency procedures
Spills/release of the notified polymer should be contained as described in the MSDS (ie.
Collect spilled material with an inert absorbent) and the resulting waste disposed to an
authorised landfill.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
8
2 PUBLICATION SUMMARY REPORT
1,2-benzenedicarboxylic acid, bis(2-propylheptyl) ester (Palatinol 10-P)
Summary Report
Reference No: STD/1054
BASF Australia Limited of 500 Princes Highway Noble Park VIC 3174 and Orica Australia
Pty Ltd of 1 Nicholson Street Melbourne VIC 3000 have submitted a standard notification
statement in support of their application for an assessment certificate for 1,2-
benzenedicarboxylic acid, bis(2-propylheptyl) ester (Palatinol 10-P). The notified chemical is
intended to be used as a plasticiser for polyvinyl chloride (PVC) and vinyl chloride
copolymers in automobile undercoating, building materials, wires, cables, shoes, carpet
backing, pool liners and gloves. Up to 1000 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
Based on the available data, the notified chemical is not classified as a hazardous substance
under the NOHSC Approved Criteria for Classifying Hazardous Substances.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is No Significant Concern to public health under the end-use conditions described.
Environmental Effects
The chemical is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Regulatory Controls
Use
? The notified chemical is not to be used in toys or food and medical contact materials.
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified chemical:
- Enclosure of formulation processes as much as possible
- Local exhaust ventilation where process not enclosed
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
9
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical:
- Avoid generation of vapours and aerosols during transfer and mixing operations
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical:
- Overalls
- Chemical-resistant gloves (nitrile rubber or neoprene)
- Goggles or safety spectacles
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous
to health in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances, workplace practices and control procedures consistent with
provisions of State and Territory hazardous substances legislation must be in
operation.
Environment
? The following control measures should be implemented by end users to minimise
environmental exposure during use of the notified chemical:
- Do not allow material or contaminated packaging to enter drains, sewers or water
courses.
Disposal
? The notified chemical should be disposed of by either incinerating liquid wastes
containing the notified chemical or landfill for PVC articles containing the notified
chemical.
Emergency procedures
Spills/release of the notified chemical should be handled by containment to prevent run-off
and sorbed onto a absorbent material (soil, sand or other inert material). Collect and seal in
properly labelled containers for disposal.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
10
3 PUBLICATION SUMMARY REPORT
Mirapol FB2
Summary Report
Reference No: LTD/1114
Procter Gamble Australia Pty Ltd (ABN: 91 008 396 245) of 320 Victoria Road Rydalmere
NSW 2116 has submitted a limited notification statement in support of their application for
an assessment certificate for Mirapol FB2. The notified polymer is intended to be used as a
suds stabliser in an imported finished dishwashing liquid. Two 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
Limited toxicological testing has been carried out on the notified polymer. The notified
polymer was found to have low acute oral toxicity. Due to its large molecular weight, the
notified polymer is not expected to be absorbed and cause systemic toxicity. The applicant
has stated that the notified polymer was found be non mutagenic in a bacterial reversion
mutation study. The study was not provided, as the English translation was not available.
The analogue toxicity data indicates that the notified polymer is not likely to cause eye
irritation, and skin sensitisation. The analogue data suggests that the notified polymer may
cause slight skin irritation. Overall, the analogue data demonstrates that the notified polymer
is not likely to be mutagenic. The results of a repeated dose inhalation study using an
analogue indicates that the notified polymer, if inhaled, as component of a product is not
likely cause adverse effects.
The applicant has stated that the use of alternative counterions is not expected to alter the
hazard the properties of the notified polymer.
Based on the available data the notified chemical is not classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999).
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described
Public Health
There is Negligible Concern to public health when used as described in the notification.
Environmental Effects
On the basis of the PEC/PNEC ratio; the chemical is not considered to pose a risk to the
environment based on its reported use pattern.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
11
RECOMMENDATIONS
Control Measures
? 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.
Environment
Disposal
? The notified chemical should be disposed of to landfill.
Emergency procedures
? Spills/release of the notified chemical should be recovered as much as possible.
Absorb non-recoverable liquid with sand or inert absorbent. Wash contaminated area
with large amount of water.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under Section 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
12
4 PUBLICATION SUMMARY REPORT
ZK56-3843
Summary Report
Reference No: PLC/381
Akzo Nobel Pty Ltd (ABN 59 000 119 424) of 51 McIntyre Road Sunshine VIC 3020 and
BASF Akzo Nobel Automotive OEM Coatings Pty Ltd (ABN 092 127 501) of 51 McIntyre
Road Sunshine VIC 3020 have jointly submitted a synthetic polymer of low concern (PLC)
notification statement in support of their application for an assessment certificate for ZK56-
3843. The notified polymer is intended to be used as a coating in original equipment
manufacture (OEM). It will initially be imported in formulated paints but may be
manufactured in Australia in future. The imported coating and the manufactured polymer
solution and coating will be stored and transported by road in 200 kg steel drums. Less than
30 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 PLC criteria and can therefore be considered to be of low
hazard. Based on the available data the notified polymer is not classified as hazardous under
the NOHSC Approved Criteria for Classifying Hazardous Substances.
Public Health
There is Negligible Concern to public health when used as a component of coating in OEM
applications.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Environmental Assessment
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer:
- Exhaust ventilation during mixing and spray application
- Enclosed and automated spray paint application
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
13
? Employers should implement the following safe work practices to minimise occupational
exposure during handling of the notified polymer:
- During transfer operations and cleaning of equipment, avoid spills and splashing
- Spray application should be conducted in a down draft spray booth.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer during polymer
manufacture, paint manufacture and spray application:
- Chemical resistant gloves
- Protective clothing which protects the body, arms and legs
- Goggles or face shield
- Half mask combination filter or air fed respirator, during spray application
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? Wastes generated during industrial application should be disposed of through a
licensed waste contractor.
Emergency procedures
? Spills/release of the notified polymer should be contained with absorbent material
such as sand, earth or vermiculite and sealed in properly labelled containers for
disposal. Spills should be prevented from entering stormwater drains and waterways.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
14
5 PUBLICATION SUMMARY REPORT
ZK56-3804
Summary Report
Reference No: PLC/382
Akzo Nobel Pty Ltd (ABN 59 000 119 424) of 51 McIntyre Road Sunshine VIC 3020 and
BASF Akzo Nobel Automotive OEM Coatings Pty Ltd (ABN 092 127 501) 51 McIntyre
Road Sunshine VIC 3020 have submitted a synthetic polymer of low concern (PLC)
notification statement in support of their application for an assessment certificate for ZK56-
3804. The notified polymer is intended to be used as a coating for components of OEM car
bodies. It will initially be imported in formulated paints but may be manufactured in
Australia in future. Less than thirty 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 PLC criteria and can therefore be considered to be of low
hazard. Based on the available data the notified polymer is not classified as hazardous under
the NOHSC Approved Criteria for Classifying Hazardous Substances.
Public Health
There is negligible concern to public health when used in the manner described.
Occupational Health and Safety
There is low concern to occupational health and safety under the conditions of the
occupational settings described.
Environmental Assessment
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? Employers should implement the following engineering controls to minimise
occupational exposure to the notified polymer:
- Exhaust ventilation during mixing and spray application
- Enclosed and automated spray paint application
? Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified polymer:
- During transfer operations and cleaning of equipment, avoid spills and splashing
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
15
- Spray application should be conducted in a down draft spray booth.
? Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified polymer during polymer
manufacture, paint manufacture and spray application:
- Chemical resistant gloves
- Protective clothing which protects the body, arms and legs
- Goggles or face shield
- Half mask combination filter or air fed respirator, during spray application
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Disposal
? Wastes generated during industrial application should be disposed of through a
licensed waste contractor.
Emergency procedures
? Spills/release of the notified polymer should be contained with absorbent material
such as sand, earth or vermiculite and sealed in properly labelled containers for
disposal. Spills should be prevented from entering stormwater drains and waterways.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
16
6 PUBLICATION SUMMARY REPORT
DCA 229
Summary Report
Reference No: PLC/409
GE Betz Pty Ltd (ABN 84 001 221 941) of 69-77 Williamson Road Ingleburn NSW 2565
has submitted a polymer of low concern (PLC) notification statement in support of their
application for an assessment certificate for DCA 229. The notified polymer is intended to be
used as a scale inhibitor in cooling tower water treatment and a super plasticiser in concrete
Up to 22 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 PLC criteria and can therefore be considered to be of low
hazard. The result for acute oral toxicity supports the conclusion of low hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used as described in the submission
Environmental Effects
The polymer is not considered to pose a risk to the environment based on its proposed use
pattern.
RECOMMENDATIONS
Control Measures
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
17
Disposal
? The notified polymer should be disposed of to landfill or a liquid waste treatment
facility by a licensed waste contractor.
Storage
? The following precautions should be taken regarding storage of the notified polymer:
- Keep containers closed when not in use.
- Store in cool ventilated area away from oxidizers.
Emergency procedures
? Spills/release of the notified polymer should be absorbed or contained with a suitable
absorbent material (eg. tissues, cloth, dry sand or vermiculite). Shovel into labelled
sealable containers for subsequent safe disposal. Contaminated surfaces should be
washed with a detergent solution with washings retained as waste.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
18
7 PUBLICATION SUMMARY REPORT
Temp max sheetfed varnish 802578X 11200960
Summary Report
Reference No: PLC/419
SICPA Australia Pty Ltd of 3 Millers Road Brooklyn VIC 3025 (ABN: 86 007 114 338),
have submitted a synthetic polymer of low concern (PLC) notification statement in support of
their application for an assessment certificate for Temp max sheetfed varnish 802578X
11200960. The notified polymer will be imported as a component of a varnish used to
manufacture of oil-based inks used for the packaging, labelling, and packaging. Up to 100
tonnes of the notified polymer will be imported in each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Health Assessment
The notified polymer meets the PLC criteria and can therefore be considered to be of low
hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used as described in the notification.
Environmental Assessment
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
19
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
? The following control measures should be implemented to minimise environmental
exposure during (manufacture, formulation, use) of the notified polymer:
- Do not pour residues down the drain. Empty import/product containers should be
recycled/reconditioned. Disposal of varnish containers via domestic recycling
programs may differ between local authorities. Check with your local council first
Disposal
? The notified polymer should be disposed of by landfill.
Emergency procedures
? Spills/release of the notified polymer should be handled by collecting with non-
combustible absorbent materials and placing in a suitable container for disposal
according to Local, State and Federal Government waste regulations.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
20
8 PUBLICATION SUMMARY REPORT
11201212 VBC (Plast) Varnish 802282
Summary Report
Reference No: PLC/420
SICPA Australia Pty Ltd of 3 Millers Road Brooklyn VIC 3025 (ABN: 86 007 114 338),
have submitted a synthetic polymer of low concern (PLC) notification statement in support of
their application for an assessment certificate for 11201212 VBC (Plast) Varnish 802282.
The notified polymer will be imported as a component of a varnish used to manufacture of
oil-based inks used for the packaging, labelling, and packaging. Up to 300 tonnes of the
notified polymer will be imported in each of the first five years.
ASSESSMENT OF PUBLIC, OCCUPATIONAL HEALTH AND SAFETY AND
ENVIRONMENTAL EFFECTS
Health Assessment
The notified polymer meets the PLC criteria and can therefore be considered to be of low
hazard.
Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
Public Health
There is Negligible Concern to public health when used as described in the notification.
Environmental Assessment
The polymer is not considered to pose a risk to the environment based on its reported use
pattern.
RECOMMENDATIONS
Control Measures
Occupational Health and Safety
? No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be
selected on the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
21
? If products and mixtures containing the notified polymer are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
? The following control measures should be implemented to minimise environmental
exposure during (manufacture, formulation, use) of the notified polymer:
- Do not pour residues down the drain. Empty import/product containers should be
recycled/reconditioned. Disposal of varnish containers via domestic recycling
programs may differ between local authorities. Check with your local council first
Disposal
? The notified polymer should be disposed of by landfill.
Emergency procedures
? Spills/release of the notified polymer should be handled by collecting with non-
combustible absorbent materials and placing in a suitable container for disposal
according to Local, State and Federal Government waste regulations.
Secondary Notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
Under subsection 64(1) of the Act; if
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
22
9 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) 8577 8816 or fax: (02)
8577 8888.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
23
10 LOW VOLUME CATEGORY PERMITS
The permits listed in Table 2 were issued to import or manufacture the following chemicals
under section 21U of the Industrial Chemicals (Notification and Assessment) Act 1989. Low
Volume Category Permits are approved for 36 months.
Table 1
Low Volume Category Permits
PERMIT COMPANY COMPANY CHEMICAL OR TRADE HAZARDOUS USE DATE
NUMBER NAME POSTCODE NAME SUBSTANCE
585 Trimex Pty 2018 12- ND Cosmetics 20/11/03
Ltd hydroxyoctadecanoic
acid ester with 2,2'-
[oxybis(methylene)]
bis[2-
(hydroxymethyl)-1,3-
propanediol] and
isooctadecanoic acid
586 International 3175 3-cyclopentene-1- No Cosmetics 02/12/03
Flavours & butanal, alpha,2,2,3-
Fragrances tetramethyl-
(Aust) Ltd (Santafleur)
587 Unilever 2151 Docosanoic acid, ND Cosmetics 11/12/03
Australia isohexadecyl ester
LTD
588 Chemiplas 3002
Australia Pty
Ltd 16/12/03
Thiocyanic acid, 3- Yes Rubber
(triethoxysilyl)propyl component
ester
589 Degussa 3175
Australia Pty
Ltd
N.D.: not determined; insufficient data available to effect a health effects classification under
Approved Criteria [NOHSC:1008(1999)]
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
24
11 COMMERCIAL EVALUATION CATEGORY PERMIT
The permits listed in Table 1 were issued to import or manufacture the following chemicals
for commercial evaluation under section 21G of the Industrial Chemicals (Notification and
Assessment) Act 1989.
Table 2
Commercial Evaluation Category Permits
PERMIT COMPANY COMPANY CHEMICAL HAZARDOUS QUANTITY USE PERIOD
NUMBER NAME POSTCODE OR TRADE SUBSTANCE APPROVED
NAME
3175 Yes 900 kg Laminating 1 year
HB Fuller WD4120
538
adhesive
Company
(revised)
Australia Pty
Ltd
Yes 4000 kg Tissue paper 6 mths
Polymer in
Hercules 3171
577
production
Crepetrol
Chemicals
A3025
Australia
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
25
12 NOTICE OF CHEMICALS ELIGIBLE FOR LISTING ON THE AUSTRALIAN
INVENTORY OF CHEMICAL SUBSTANCES FIVE YEARS AFTER ISSUING OF
ASSESSMENT CERTIFICATES
Notice is given in accordance with section 14(1) of the Industrial Chemicals (Notification
and Assessment) Act 1989, that the following chemicals have been added to the Australian
Inventory of Chemical Substances.
Table 3
Chemicals Eligible for Listing on the Australian Inventory of Chemical Substances
CHEMICAL NAME CAS MOLECULA
NUMBER R FORMULA
Formaldehyde, polymer with benzenamine, 135108-88-2 Unspecified
hydrogenated
Cerium sulfide 12014-93-6 Ce2S3
208945-12-4 C9H20O.x(C6H10
Hexanedioic acid, polymer with 1,4-
butanediol and 2,2-dimethyl-1,3-propanediol, O4.C5H12O2.C4
isononyl ester H10O2)x
143683-23-2 C54H46F2N14O16
2-Anthracenesulfonic acid, 4,4'-[1,2-
ethanediylbis[imino(6-fluoro-1,3,5-triazine- S4.xNa
4,2-diyl)imino(2,4,6-trimethyl-5-sulfo-3,1-
phenylene)imino]]bis[1-amino-9,10-dihydro-
9,10-dioxo-, sodium salt
171599-85-2 C46H38Cl2N14O1
2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-
6-[[2-[[4-chloro-6-[[7-[[4- 9S6.xNa
(ethenylsulfonyl)phenyl]azo]-8-hydroxy-3,6-
disulfo-1-naphthalenyl]amino]-1,3,5-triazin-
2-yl]amino]ethyl](2-hydroxyethyl)amino]-
1,3,5-triazin-2-yl]amino]-3-[[4-
(ethenylsulfonyl)phenyl]azo]-4-hydroxy-,
sodium salt
191877-09-5 Unspecified
4,11-Triphenodioxazinedisulfonic acid, 3,10-
bis[(2-aminopropyl)amino]-6,13-dichloro-,
reaction products with 2-amino-1,4-
benzenedisulfonic acid, 2-[(4-
aminophenyl)sulfonyl]ethyl hydrogen sulfate
and 2,4,6-trifluoro-1,3,5-triazine, sodium
salts
171599-84-1 C34H29ClN12O19
1,3,6-Naphthalenetrisulfonic acid, 7-[[2-
[(aminocarbonyl)amino]-4-[[4-[[5-amino-4- S6.xNa
sulfo-2-[[4-[[2-
(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenyl]
amino]-6-chloro-1,3,5-triazin-2-
yl]amino]phenyl]azo]-, sodium salt
181314-48-7 Unspecified
2(3H)-Benzofuranone, 5,7-(1,1-
dimethylethyl)-3-hydroxy-, reaction products
with o-xylene
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
26
159317-31-4 (C5H8O2.C5H8O
2-Propenoic acid, 2-methyl-, telomer with
ethyl 2-propenoate, 2-mercaptoethanol and 2.C4H6O2)x.C2H
methyl 2-methyl-2-propenoate 6OS
6,10-Dioxaspiro[4.5]decane, 8,8-dimethyl-7- 62406-73-9 C13H24O2
(1-methylethyl)-
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
27
13 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).
The following chemical has been added to AICS.
Table 4 Amendment to AICS
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
Benzenesulfonic acid, mono-C11-13- Unspecified
68608-89-9
branched alkyl derivs., sodium salts
Polysulfides, bis[3-(triethoxysilyl)propyl] 211519-85-6 Unspecified
2-Oxepanone, polymer with 2-ethyl-2- Unspecified
230302-77-9
(hydroxymethyl)-1,3-propanediol, 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and 2,2'-
oxybis[ethanol], 2-hydroxyethyl acrylate-
blocked
The following chemical is being deleted from AICS.
Table 5 Amendment to AICS
CHEMICAL NAME CAS NUMBER MOLECULAR FORMULA
85338-68-7 (C12H18N2O2.C6H14O3.C6H10O2.C
2-Oxepanone, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, a-hydro- 5H8O3.(C2H4O)nH2O)x
w-hydroxypoly(oxy-1,2-ethanediyl) and 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, 2-hydroxyethyl
acrylate-blocked
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
28
14 APPLICATIONS FOR AN ASSESSMENT CERTIFICATE
Data Requirements for New Chemicals with POPS Characteristics
Australia, together with 90 other countries, signed the Stockholm Convention on Persistent
Organic Pollutants (POPS) at a diplomatic conference on 16 May 2001, with the Convention
to come into force when 50 countries have ratified it. To date, 151 countries have signed the
Convention and 41 have ratified it.
The objective of the Stockholm Convention is to protect human health and the environment
from the effects of POPS, which are toxic, persistent in the environment and accumulate in
the food chain. The Convention sets out a range of control measures to reduce and eliminate
POPS releases, including emissions of by-product POPS, and to ensure the sound
management of stockpiles and wastes containing POPS.
Initially, the Convention will cover control measures on 12 POPS, including the industrial
chemicals polychlorinated biphenyls (PCBs), hexachlorobenzene and the by-products dioxins
and furans. However, Article 3 of the Stockholm Convention requires parties to the
Convention to take into account POPS characteristics when conducting assessments on new
and existing chemicals. The POPS characteristics are persistence, bioaccumulation, potential
for long-range environmental transport and adverse effects on human health and the
environment.
Consequently, from the beginning of 2004, NICNAS will undertake the screening of new
industrial chemicals to identify potential POPS chemicals. Additional data in accordance
with the Information Requirements and Screening Criteria of Annex D of the Convention
may be requested, in particular, information relating to persistence, bioaccumulation and
toxicity (PBT). The Criteria for persistence and bioaccumulation in Annex D are as follows:
Persistence
(i) Evidence that the half-life of the chemical in water is greater than two months,
or that its half-life in soil is greater than six months, or that its half-life in sediment is greater
than six months; or
(ii) Evidence that the chemical is otherwise sufficiently persistent to justify its
consideration within the scope of the Convention.
Bioaccumulation
(i) Evidence that the bioconcentration factor or bioaccumulation factor in aquatic
species for the chemical is greater than 5000 or, in the absence of such data, that the log Kow
(n-octanol/water partition coefficient) is greater than 5;
(ii) Evidence that the chemical presents other reasons for concern, such as high
bioaccumulation in other species, high toxicity or ecotoxicity; or
(iii) Monitoring data in biota indicating that the bioaccumulation potential of the
chemical is sufficient to justify its consideration within the scope of the Convention.
Toxicity and ecotoxicity data requirements will be in accordance with Part C of the Schedule
to the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act). The Schedule
to the Act will be amended in 2004 to accommodate the other POPS data requirements.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
29
This notice applies to applications for an assessment certificate. In the interim period, before
amendment of the Schedule, NICNAS will request additional information under section 27 of
the Act when required, for example, if POPS characteristics are identified in the prescreening
phase of the assessment. Alternatively, applicants can submit additional data under section
28 of the Act when notifying possible POPS chemicals.
Further information on this matter can be obtained from Bob Graf, Team Leader, New
Chemicals on (02) 8577 8850.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
30
15 DRAFT ENVIRONMENTAL EXPOSURE ASSESSMENT REPORT ON
SCCPS FOR COMMENT
Short Chain Chlorinated Paraffins (SCCPs) were assessed as Priority Existing Chemicals and
a preliminary assessment report published in June 2001. A recommendation in the report was
that a full risk assessment for the environment be carried out unless information on sewer
release comes forward which indicated acceptable releases. This was based on the
conclusion that these substances may be a risk to sediment dwelling organisms due to
improper disposal of extreme pressure lubricants used in metal working fluids.
A scoping exercise to determine the extent of use was undertaken in 2002. Following this
exercise it was determined that, prior to undertaking a full risk assessment, a more
comprehensive exposure assessment should be conducted in the areas flagged as being of
concern, namely, metal working industries.
The draft SCCPs Environmental Exposure Assessment report is now available for comment.
Please provide comments by 3 February 2004.
If you would like a copy of the report or should you require an electronic read-only copy of
the report or further information please contact Jun Zhang by phone on (02) 8577 8882 or by
email: jun.zhang@nicnas.gov.au.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
31
16 POLICY ON TOXICOLOGY TESTING FOR SKIN SENSITISATION IN
HEALTH RISK ASSESSMENTS
Historically, the species of choice for assessment of skin sensitisation has been the guinea
pig, which was reflected in the regulatory guidelines that were available until recently, the
OECD Test Guideline 406 incorporating the guinea pig maximisation test (GPMT) and
Buehler test. On 24 April 2002 a test in mice, the Local Lymph Node Assay (LLNA) was
promoted from a positive screening assay for the detection of skin sensitisation hazard to full
status as a regulatory test guideline; OECD TG 429.
To date, Australia has not declared a preferred guinea pig test and notifiers can submit either
a Buehler test or GPMT.
Within the notification procedure for new chemicals in the European Union, the preferred
guinea pig test for skin sensitisation has been the GPMT. In May 2002 the UK c.a. (Health
and Safety Executive) announced that it will accept the LLNA, conducted in the mouse, as a
stand-alone test and method of first choice for skin sensitisation as part of a notification under
the Notification of New Substances Regulations, 1993 (NONS). Negative results in the
LLNA would no longer require further confirmation by testing for skin sensitisation in the
guinea pig. The use of alternative tests, such as those using guinea pigs, require full
justification on a case-by-case basis.
The US EPA accepts both the GPMT and Buehler tests. The US EPA Federal Register
Notice of 26 March 2003 announced the availability of the revised final test guideline for
Series 870璈ealth Effects Test Guidelines, OPPTS 870.2600 Skin Sensitization, the LLNA,
which stated that the LLNA is a preferred alternative method, where applicable. The Federal
Register Notice stated that certain testing situations may necessitate the use of traditional
guinea pig tests, such as certain metallic compounds, high molecular weight proteins, strong
dermal irritants and materials that do not sufficiently adhere to the ear for an acceptable
period of time during treatment. In situations where the LLNA is not applicable or may
provide unreliable or problematic results, the GPMT or Buehler tests are recommended.
Australian Government agencies responsible for the regulation of chemicals have considered
the mouse LLNA and its acceptability for determining the skin sensitisation potential of
chemicals.
The LLNA has been more fully evaluated than the Buehler test and GPMT and demonstrates
an equivalent prediction of human sensitisation potential as compared to currently accepted
guinea pig tests. In addition, the LLNA offers a number of advantages over the Buehler test
and GPMT, including:
?straightforward and objective interpretation of results that can be analysed to evaluate
a dose-response;
?animal welfare benefits, namely reduction in stress and suffering to test animals and a
potential to offer a reduction in the number of animals required;
?clear guidance on the choice of test concentrations;
?is a relatively robust assay as indicated by test method transferability between
laboratories;
?requires a significantly shorter time to conduct and a potential to be less costly than
the guinea pig tests; and
?can be used to test coloured substances.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
32
Decision
Agencies within the Health portfolio support the declaration of the LLNA as an acceptable
test (when conducted in accordance with OECD TG 429 or equivalent guidelines) and will
encourage industry to conduct the LLNA when commissioning new toxicity testing.
While the Health and Ageing portfolio agencies support the acceptance of the LLNA and will
encourage the conduct of this test, all other OECD and equivalent testing guidelines for skin
sensitisation remain acceptable as well. In addition, in situations where it is demonstrated
that the LLNA is not applicable or may provide unreliable results, the GPMT or Buehler tests
are recommended.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) and its policy
department have provided in-principle agreement to this position. The APVMA is currently
consulting stakeholders prior to making a formal policy statement in relation to pesticides and
veterinary medicines.
The National Occupational Health and Safety Commission (NOHSC) Office supports this
position, confirms the suitability of the LLNA for hazard classification purposes under the
NOHSC hazardous substances framework and has committed to revising the NOHSC
Approved Criteria for Classifying Hazardous Substances at the next update to provide
specific guidance on the LLNA for classification purposes.
NICNAS encourages its industry sector to consider the LLNA test when developing safety
testing programs. The GPMT and Buehler test remain acceptable tests.
Chemical Gazette Commonwealth of Australia Gazette
No. C 1, 6 January 2004
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