File No PLC/804
March 2009
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Castor Isostearate Succinate
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, Water, Heritage and the Arts.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by
appointment only at 334-336 Illawarra Road, Marrickville NSW 2204.
This Full Public Report is also 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 ......................................................................................................... 5
4. PHYSICAL AND CHEMICAL PROPERTIES ...................................................................................... 5
5. INTRODUCTION AND USE INFORMATION..................................................................................... 5
6. HUMAN HEALTH IMPLICATIONS..................................................................................................... 5
7. ENVIRONMENTAL IMPLICATIONS .................................................................................................. 6
8. CONCLUSIONS AND RECOMMENDATIONS................................................................................... 6
Created 29/06/07 Last Saved: 11:24 AM 30/03/2009
March 2009 NICNAS
FULL PUBLIC REPORT
Castor Isostearate Succinate
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Cee Chem Australia Pty Ltd (ABN 61 081 398 192)
227A Belmore Road
Riverwood, NSW 2210
NOTIFICATION CATEGORY
Polymer of Low Concern
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
No details are claimed exempt from publication.
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
2. IDENTITY OF CHEMICAL
MARKETING NAME(S)
Zenigloss
Zenigloss UP
Zenigloss UPH (90% notified polymer with 10% hydrogenated castor oil)
Zenigloss S (90% notified polymer with 10% beeswax)
CHEMICAL NAME
Castor oil, polymer with succinic acid, isostearates
CAS NUMBER
321573-76-6
OTHER NAME(S)
INCI name: Castor Isostearate Succinate
MOLECULAR FORMULA
Unspecified
FULL PUBLIC REPORT: PLC/804 Page 3 of 7
March 2009 NICNAS
STRUCTURAL FORMULA
O R
O
O R
O
O R
O
Where R = or or
OH
O C CH2 CH2 C O O (C17H35 -iso)
O O O
Typical structure with only the main triglyceride (i.e. ricinoleic acid derivatives) depicted.
Castor oil is a triglyceride containing the following fatty acids:
Ricinoleic acid (141-22-0) 87-91%
Stearic acid (57-11-4) and palmitic acid (57-10-3) 2%
Oleic acid (112-80-1) 4-5%
Linoleic acid (60-33-3) 4-5%
Dihydroxystearic acid (26248-43-1, 120-87-6) 1%
The castor oil is covalently bonded to the other monomers in the notified polymer to form a polyester.
The polyester is formed by a condensation reaction between the carboxylic acid functional groups on
the isooctadecanoic and butanedioic acids and the secondary alcohols on the dihydroxystearic and
ricinoleic acids.
The approximate concentrations of the fatty acids were sourced from Ullmann's Encyclopedia of
Industrial Chemistry (7th Ed, 2007).
MOLECULAR WEIGHT
Number Average Molecular Weight (Mn) 3814 Da
Weight Average Molecular Weight (Mw) 8457 Da
Polydispersity Index (Mw/Mn) 2.2
% of Low MW Species < 1000 Da 1%
% of Low MW Species < 500 Da 0%
POLYMER CONSTITUENTS
Weight % Weight %
Chemical Name CAS No.
starting residual
Isooctadecanoic acid 30399-84-9 3 0
Butanedioic acid 110-15-6 8.5 0
Castor oil 8001-79-4 88.5 0
REACTIVE FUNCTIONAL GROUPS
The notified polymer contains only low concern functional groups.
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March 2009 NICNAS
3. PLC CRITERIA JUSTIFICATION
Criterion Criterion met
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
The notified polymer meets the PLC criteria.
4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20癈 and 101.3 kPa: Transparent amber viscous liquid
Melting Point/Glass Transition Temp Not conducted as the notified polymer is a liquid.
990 kg/m3
Density
Water Solubility The notifier states that the notified polymer forms a separate phase
when added to water, and cannot be measured in the aqueous phase.
Water solubility is expected to be very low (in the low mg/L range)
because the notified polymer is a polyester with limited hydrophilic
functionality.
Reactivity Stable under normal environmental conditions
Degradation Products None under normal conditions of use
5. INTRODUCTION AND USE INFORMATION
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year 1 2 3 4 5
Tonnes 1 1.5 2 3 5
Use
The notified polymer will be used as a component in personal care products at concentrations up to 50%.
The notified polymer is used to provide gloss and will be used in products such as shampoos, conditioner, skin
creams, lipsticks and lip-glosses and will be reformulated into such products within Australia.
Mode of Introduction and Disposal
The neat notified polymer will be imported in 16 kg containers or 100 kg drums by air or sea freight through
Sydney or Melbourne.
6. HUMAN HEALTH IMPLICATIONS
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 the notified polymer.
Endpoint Result Effects Observed? Test Guideline
Eye irritation ?The MatTek Corporation non-irritating at a no In house
EpiOcular Tissue Model In Vitro Toxicity Testing concentration of method
System 10%
Skin sensitisation ?Human repeat insult patch no evidence of yes In house
test. sensitisation and method
irritation
Genotoxicity ?bacterial reverse mutation non mutagenic no In house
method
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March 2009 NICNAS
One subject out of the 53 that completed the human repeat insult patch test showed barely perceptible erythema
after the first of 9 applications. No further signs of irritation were seen in this or any other of the test subjects.
Only 53 subjects were tested, which makes it unlikely that a sensitisation reaction would be detected.
However, given the size of the polymer and the lack of structural alerts sensitisation would not be expected.
All results were indicative of low hazard.
Occupational Health and Safety Risk Assessment
Reformulation
Dermal and ocular exposure can occur during the reformulation of the notified polymer into cosmetic products.
However, exposure to significant amounts of the notified polymer will be limited by engineering controls and
the use of personal protective equipment, including impermeable gloves, eye protection and coveralls.
End use
Exposure of beauticians and hairdressers to the notified polymer at concentrations up to 50% could occur
during final application of the cosmetic products to their clients. The main route of exposure is expected to be
dermal, although ocular exposure to splashes is possible. PPE is not expected to be worn, however good
hygiene practices are expected to be in place.
Although exposure to the notified polymer could occur during reformulation and end use, the risk to workers is
not considered to be unacceptable due to the intrinsic low hazard of the notified polymer.
Public Health Risk Assessment
The general public will be repeatedly exposed to the notified polymer at concentrations up to 50% via a
number of different consumer products. Exposure to the notified polymer will vary depending on individual
use patterns.
Although the public will be exposed to the notified polymer during use of personal care products, the risk to
public health is not considered to be unacceptable due to the intrinsic low hazard of the notified polymer.
7. ENVIRONMENTAL IMPLICATIONS
Hazard Characterisation
No ecotoxicological data were submitted. PLCs without significant ionic functionality are of low concern to
the aquatic environment.
Environmental Risk Assessment
The notified polymer is expected to be washed to sewer as an inescapable consequence of its use in personal
care products. Based on its structure, significant removal can be expected during sewage treatment through
sorption to sludge, with some biodegradation also likely to occur. The notified polymer would be expected to
partition to sediment and biodegrade if released to receiving waters in treated effluent. Bioaccumulation
would be precluded by the molecular weight. If released to aquatic environments, the notified polymer is
expected to remain well below concentrations that could be harmful to aquatic life as polymers of this nature
are of low concern to the aquatic environment. Therefore, the notified polymer is not considered to pose a
risk to the environment.
8. CONCLUSIONS AND RECOMMENDATIONS
Human health risk assessment
Under the conditions of the occupational settings described, the notified polymer is not considered to pose an
unacceptable risk to the health of workers.
When used in the proposed manner, the notified polymer is not considered to pose an unacceptable risk to
public health.
Environmental risk assessment
Based on its low water solubility and the reported use pattern, the notified polymer is not considered to pose a
risk to the environment.
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March 2009 NICNAS
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 Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)],
workplace practices and control procedures consistent with provisions of State and Territory hazardous
substances legislation must be in operation.
Disposal
? The notified polymer should be disposed of by landfill.
Emergency procedures
? Spills and/or accidental release of the notified polymer should be handled by containment, collection
and subsequent safe disposal.
Regulatory Obligations
Secondary Notification
This risk assessment is based on the information available at the time of notification. The Director may call for
the reassessment of the polymer under secondary notification provisions based on changes in certain
circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the
notifier, as well as any other importer or manufacturer of the notified polymer, have post-assessment regulatory
obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the
notified polymer is listed on the Australian Inventory of Chemical Substances (AICS).
Therefore, the Director of NICNAS 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
- the function or use of the notified polymer has changed from as a component in personal care
products, or is likely to change significantly;
- the amount of notified polymer being introduced has increased, or is likely to increase,
significantly;
- the notified polymer has begun to be manufactured in Australia;
- additional information has become available to the person as to an adverse effect of the chemical
on occupational health and safety, public health, or the environment.
The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required.
Material Safety Data Sheet
The MSDS of the notified polymer provided by the notifier was reviewed by NICNAS. The accuracy of the
information on the MSDS remains the responsibility of the applicant.
FULL PUBLIC REPORT: PLC/804 Page 7 of 7
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