File No PLC/652
11 September 2006
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Polyacrylate-13
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and
Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia.
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department
of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The
assessment of environmental risk is conducted by the Department of the Environment and Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
Australian Safety and Compensation Council
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email ascc.library@dewr.gov.au
This Full Public Report is available for viewing and downloading from the NICNAS website or available on request,
free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration
Coordinator at:
Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL: + 61 2 8577 8800
FAX + 61 2 8577 8888.
Website: www.nicnas.gov.au
Director
NICNAS
TABLE OF CONTENTS
FULL PUBLIC REPORT....................................................................................................................................... 3
1. APPLICANT AND NOTIFICATION DETAILS ................................................................................... 3
2. IDENTITY OF CHEMICAL ................................................................................................................... 3
3. PLC CRITERIA JUSTIFICATION ......................................................................................................... 3
4. PHYSICAL AND CHEMICAL PROPERTIES ...................................................................................... 4
5. INTRODUCTION AND USE INFORMATION..................................................................................... 4
6. HUMAN HEALTH IMPLICATIONS..................................................................................................... 5
6.1. Exposure Assessment ..................................................................................................................... 5
6.2. Toxicological Hazard Characterisation .......................................................................................... 5
6.3. Human Health Risk Assessment..................................................................................................... 6
7. ENVIRONMENTAL IMPLICATIONS .................................................................................................. 6
7.1. Exposure Assessment ..................................................................................................................... 6
7.2. Environmental Hazard Characterisation ......................................................................................... 7
7.3. Environmental Risk Assessment .................................................................................................... 7
8. CONCLUSIONS...................................................................................................................................... 7
8.1. Level of Concern for Occupational Health and Safety................................................................... 7
8.2. Level of Concern for Public Health................................................................................................ 7
8.3. Level of Concern for the Environment ........................................................................................... 7
9. MATERIAL SAFETY DATA SHEET.................................................................................................... 8
9.1. Material Safety Data Sheet ............................................................................................................. 8
10. RECOMMENDATIONS .................................................................................................................... 8
10.1. Secondary Notification ................................................................................................................... 8
Created on 11/09/2006 2:39 PM Last Saved 11/09/2006 2:46 PM
11 September 2006 NICNAS
FULL PUBLIC REPORT
Polyacrylate-13
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Bronson & Jacobs Pty Ltd (ABN 81 000 063 249)
5 Parkview Drive
Australia Centre
Olympic Park NSW 2127
NOTIFICATION CATEGORY
Polymer of Low Concern
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
Data items and details claimed exempt from publication:
Chemical Name, Other Names, CAS Number, Molecular and Structural Formulae, Molecular Weight,
Polymer Constituents, Residual Monomers/Impurities, Concentration of polymer in product.
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
No variation to the schedule of data requirements is claimed.
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None
NOTIFICATION IN OTHER COUNTRIES
Canada (2005)
2. IDENTITY OF CHEMICAL
MARKETING NAME(S)
Polyacrylate-13
SEPIPLUS 400 (aqueous mixture of polyacrylate-13, polyisobutene and polysorbate-20)
MOLECULAR WEIGHT (MW)
Number Average Molecular Weight (Mn) >10000
REACTIVE FUNCTIONAL GROUPS
The notified polymer contains only low concern functional groups.
3. PLC CRITERIA JUSTIFICATION
Criterion Criterion met
(yes/no/not applicable)
Molecular Weight Requirements Yes
Functional Group Equivalent Weight (FGEW) Requirements Yes
Low Charge Density Yes
Approved Elements Only Yes
Stable Under Normal Conditions of Use Yes
Not Water Absorbing Yes
Not a Hazard Substance or Dangerous Good Yes
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11 September 2006 NICNAS
The notified polymer meets the PLC criteria.
4. PHYSICAL AND CHEMICAL PROPERTIES
Viscous, translucent to opaque, white to
Appearance at 20°C and 101.3 kPa
pale yellow, emulsion (SEPIPLUS 400)
> 200°C.
Glass Transition Temp
No glass transition temperature was
observed below the decomposition
temperature of 200°C.
100 kg/m3 at 20°C (SEPIPLUS 400)
Density
Stated to be insoluble. Polymer is
Water Solubility
dispersible in water and forms a gel.
The notified polymer contains a salt of a
Dissociation Constant
very strong acid, and therefore it is
expected to remain dissociated throughout
the environmental pH range of 4-9.
Stable under normal environmental
Reactivity
conditions.
None under normal conditions of use.
Degradation Products
5. INTRODUCTION AND USE INFORMATION
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year 1 2 3 4 5
Tonnes 0.5 1 1 1 1
USE AND MODE OF INTRODUCTION AND DISPOSAL
Mode of Introduction
The notified polymer will be imported as a component of the product SEPIPLUS 400 in up to 70%
concentration. This polymer emulsion will be transported in 30 kg polyethylene drums from the dock
to a holding warehouse, and then to the customer by road.
Reformulation/manufacture processes
The notified polymer will not be manufactured in Australia. Reformulation will be carried out at
several cosmetic manufacturing sites.
In a typical process, a compounder will weigh out the notified polymer manually into a separate
container. This will then be manually added to a mixing tank, along with other ingredients. During the
blending a chemist may take samples of the product containing the notified polymer using a dip tube.
After the blending is complete a packer will supervise the use of a line filler and capper to transfer the
finished product into the retail bottles. The packaged cosmetic products will then be stored and
handled by a store person.
Use
The notified polymer (as a component of SEPIPLUS 400) is used as a thickener for cosmetic gels,
creams and lotions at levels of up to 2%. Typical applications are:
-in skin gel-creams at levels of 1.0-1.5% notified polymer;
-in self-tanning light emulsions at levels of 0.5-1.0% notified polymer.
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11 September 2006 NICNAS
6. HUMAN HEALTH IMPLICATIONS
6.1. Exposure Assessment
OCCUPATIONAL EXPOSURE
Transport and storage
Transport and warehousing workers are expected to have dermal and ocular contact with the notified
polymer solution and products containing the notified polymer only in the event of accidental
spillages.
Reformulation
Dermal and ocular exposure to the notified polymer solution (up to 70% polymer) may occur due to
drips, spills and splashes during weighing out and manual addition to the blending tank. The
compounder is expected to wear personal protective equipment such as glasses, gloves and coveralls.
Dermal and ocular exposure to the polymer solutions may potentially occur during other processes
involving the notified polymer such as sampling, cleaning, maintenance, or by accidental spills during
the packing process. However, exposure to significant amounts of the notified polymer is limited
because of the largely automated processes, and the engineering controls and personal protective
equipment worn by workers.
Beauty Industry
Intermittent, wide-dispersive use with direct handling is expected to occur among cosmeticians and
beauticians. According to EASE (1997) modelling of this work environment, dermal exposure in the
range of 1-5 mg/cm2/day of products containing up to 2% of the notified polymer could result.
PUBLIC EXPOSURE
Since the notified polymer will be in products sold to the general public, widespread public exposure
to the notified polymer at up to 2% concentration is expected. Exposure to the notified polymer will
vary depending on individual use patterns. Typical use patterns for potential applications:
- 1.2 g of skin cream containing 1.0-1.5% notified polymer is applied to the hands/face once or twice
a day;
- 8.0 g of self-tanning lotion containing 0.5-1.0% notified polymer is applied to the body once a day.
6.2. Toxicological Hazard Characterisation
The notified polymer meets the PLC criteria and can therefore be considered to be of low hazard. This
is supported by toxicological endpoints observed in testing conducted on SEPIPLUS 400 (up to 70%
notified polymer).
Endpoint Result Classified? Effects Test Guideline
Observed?
1. Rat, acute oral LD50 > 2000 mg/kg no no OECD TG 423
bw
2. Genotoxicity - bacterial non mutagenic no no OECD TG 471
reverse mutation
3. Dermal irritation human 48- non irritating at 3% no yes In house procedure
hour occlusive single patch test
4. Eye irritation in vitro HET- non irritating at 3% no no In house procedure
CAM* test
5. Eye irritation in vitro non irritating at 5% no no In house procedure
RBCA** method
6. Skin sensitisation human no evidence of no yes In house procedure
repeat insult patch test sensitisation at 5%
* HET-CAM: Hen's egg test-chorio allantoic membrane.
** RBCA: Red blood cell aggregation
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11 September 2006 NICNAS
Dermal irritation
Very slight to slight erythema was observed in 2/20 human subjects following 48 hour exposure to the
notified chemical. All effects had reversed by 48 hours after patch removal. Therefore SEPIPLUS 400
is not classified as an irritant.
Skin sensitisation
One subject (out of 49) showed slight erythema on days 5,8 and 10 of the induction phase and at the
induction site immediately after challenge. No reactions were observed at the challenge site, therefore
SEPIPLUS 400 did not induce any skin sensitisation; it was well tolerated.
Although the in vitro eye irritation tests and human patch tests are not validated for classification, the
negative results in all tests indicate low hazard of the notified polymer solution.
6.3. Human Health Risk Assessment
OCCUPATIONAL HEALTH AND SAFETY
Although exposure to the notified polymer could occur during reformulation processes such as
weighing out, sampling or cleaning and maintenance, the risk to workers is considered to be low due to
the intrinsic low hazard of the notified polymer.
PUBLIC HEALTH
Although the public will be exposed to the notified polymer during use of cosmetic products such as
creams and lotions, the risk to public health is considered to be low due to the predicted low hazard of
the notified polymer and the low concentration of the notified polymer in the products.
7. ENVIRONMENTAL IMPLICATIONS
7.1. Exposure Assessment
ENVIRONMENTAL RELEASE
Release to the environment may be considered at several stages:
1. Transport of the notified polymer prior to formulation. This is not likely to constitute a major
hazard, as the material is likely to be containerised, or in packaging designed to withstand impact.
Accidental spills during transportation should be relatively easily recovered and disposed of, as
described under Environmental Emergency Procedures.
2. Storage and product formulation. With the relatively low level use proposed for this product and
with its formulation and dispensing in closed systems, it is unlikely that there will be any significant
release to the environment. Formulation of the product is a batch process with a batch typically 6 tonne
with each batch containing up to 120 kg of the notified chemical being produced in 4 hours, 16 batches
per year. Emissions to waste water are possible while cleaning the equipment. It is estimated that 2-3%
final product are rinsed into the waste water collection which then goes to a biological treatment plant.
The treatment plant will be managed according to the requirements of Sydney Water or their
equivalent.
3. End Use. Given the use pattern of the notified chemical, release is entirely expected to occur to the
aquatic compartment. This release is expected to be relatively diffuse. A small amount of the notified
polymer (<1.0%) will remain in containers and will be disposed of to land-fill via normal household
rubbish collection.
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11 September 2006 NICNAS
ENVIRONMENTAL FATE
The majority of the total volume of notified polymer will be disposed of to sewer. In the sewage
treatment plant, the notified polymer may end up in receiving waters or it may associate with sludge
where it could be incinerated or be applied to agricultural land. The nature of creams and lotions
indicates they could associate with sludge due to hydrophobic moieties or remain in solution due to
hydrophilic moieties. Notified polymer that remains in the aquatic compartment is expected to
eventually degrade via biotic and abiotic means. Similarly, notified polymer that is disposed of to
agricultural land or to landfill is also expected to eventually degrade via biotic and abiotic means. The
notified polymer should be relatively immobile and associate with soil and sediment, due to its very
large molecular weight and net anionic charge. Notified polymer that is disposed of by incineration is
expected to thermally degrade to form simple oxides of carbon, nitrogen, sulphur and sodium as well
as water vapour.
7.2. Environmental Hazard Characterisation
No ecotoxicological data were submitted. Anionic polymers are known to be moderately toxic to
algae. The mode of toxic action is overchelation of nutrient elements needed by algae for growth. The
highest toxicity is when the acid is on alternating carbons of the polymer backbone. This is unlikely to
apply to the notified polymer. However, the toxicity to algae is likely to be further reduced due to the
presence of calcium ions, which will bind to the functional groups.
7.3. Environmental Risk Assessment
Since most of the polymer will be washed into the sewer, under a worst case scenario with no removal
of the notified polymer in the sewerage treatment plant, the resultant predicted environmental
concentration in sewerage effluent on a nationwide basis is calculated as follows:
Predicted Environmental Concentration (PEC) for the Aquatic Compartment
Annual quantity of chemical released to sewer 1,000 kg/year
Days per year where release occurs 365 days/year
Daily chemical release: 2.74 kg/day
Water use 200.0 L/person/day
Population of Australia (Millions) 20.496 million
Daily effluent production: 4,099 ML
Dilution Factor - River 1.0
Dilution Factor - Ocean 10.0
PEC - River: 0.67 g/L
PEC - Ocean: 0.07 g/L
As ecotoxicity data were not provided, it is not possible to determine a Predicted No-Effect
Concentration nor subsequently a Risk Quotient. However, given the diffuse release pattern, the
notified polymer is not expected to pose an unacceptable risk to the environment, given the qualitative
aquatic toxicity discussed above.
8. CONCLUSIONS
8.1. Level of Concern for Occupational Health and Safety
There is Low Concern to occupational health and safety under the conditions of the occupational
settings described.
8.2. Level of Concern for Public Health
There is No Significant Concern to public health when used in the proposed manner.
8.3. Level of Concern for the Environment
The polymer is not considered to pose a risk to the environment based on its reported use pattern.
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11 September 2006 NICNAS
9. MATERIAL SAFETY DATA SHEET
9.1. Material Safety Data Sheet
The notifier has provided MSDS as part of the notification statement. The accuracy of the information
on the MSDS remains the responsibility of the applicant.
10. RECOMMENDATIONS
CONTROL MEASURES
Occupational Health and Safety
· No specific engineering controls, work practices or personal protective equipment are
required for the safe use of the notified polymer itself, however, these should be selected on
the basis of all ingredients in the formulation.
Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.
· A copy of the MSDS should be easily accessible to employees.
· If products and mixtures containing the notified polymer are classified as hazardous to health
in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances,
workplace practices and control procedures consistent with provisions of State and Territory
hazardous substances legislation must be in operation.
Disposal
· The notified polymer should be disposed of by thermal decomposition in an incinerator or to
landfill.
Emergency procedures
· Spills and/or accidental release of the notified polymer should be handled by physical
containment, collection and subsequent safe disposal.
10.1. 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
(1)
- the notified polymer is introduced in a chemical form that does not meet the PLC
criteria.
or
Under subsection 64(2) of the Act:
(2)
- if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
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