File No PLC/674
February 2007
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethers with polyethylene-
polypropylene glycol monobenzoate
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 ......................................................................................................... 4
4. PHYSICAL AND CHEMICAL PROPERTIES ...................................................................................... 4
5. INTRODUCTION AND USE INFORMATION..................................................................................... 5
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 ......................................................................................... 6
7.3. Environmental Risk Assessment .................................................................................................... 6
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.................................................................................................... 7
9.1. Material Safety Data Sheet ............................................................................................................. 7
10. RECOMMENDATIONS .................................................................................................................... 7
10.1. Secondary Notification ................................................................................................................... 7
Created on 4/03/2004 10:41 AM Last Saved 16/02/2007 3:52 PM
2007 NICNAS
FULL PUBLIC REPORT
Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethers with polyethylene-
polypropylene glycol monobenzoate
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
A.S. Harrison & Co. Pty Ltd (ABN 89 000 030 437)
75 Old Pittwater Road
Brookvale NSW 2100
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
None
2. IDENTITY OF CHEMICAL
CHEMICAL NAME
Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethers with polyethylene-polypropylene glycol
monobenzoate
OTHER NAME(S)
Dimethicone PEG/PPG-20/23 Benzoate
MARKETING NAME(S)
Finsolv SLB-101
CAS NUMBER
337966-38-8
MOLECULAR FORMULA
C3H9SiO(C2H6OSi)n[C4H9SiO2(C2H4O)y(C3H6O)zC7O]mC3H9Si
STRUCTURAL FORMULA
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2007 NICNAS
CH3 CH3 CH3
H3C Si O Si O Si O Si(CH3)3 O
m
n
CH3 CH3 (CH2)3 O (C2H4O)y (C3H6O)z C
MOLECULAR WEIGHT (MW)
Number Average Molecular Weight (Mn) 6449
Weight Average Molecular Weight (Mw) 14048
Polydispersity Index (Mw/Mn) 2.18
% of Low MW Species < 1000 0
% of Low MW Species < 500 0
POLYMER CONSTITUENTS
Chemical Name CAS No. Weight % Weight %
starting residual
Poly(oxy-1,2-ethanediyl), -hydro--hydroxy- 25322-68-3 6 0
Poly[oxy(methyl-1,2-ethanediyl)], -hydro--hydroxy- 25322-69-4 9 0
Benzoic acid 65-85-0 1 0
Dimethicone 9006-65-9 84 0
Oxirane 75-21-8 < 0.01
Oxirane, methyl- 75-56-9 < 0.10
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
The notified polymer meets the PLC criteria.
4. PHYSICAL AND CHEMICAL PROPERTIES
Clear to hazy liquid
Appearance at 20癈 and 101.3 kPa
Freezing point < -10 癈
Melting Point/Glass Transition Temp
~1000 kg/m3 at 25 癈
Density
> 400 g/L at 20癈. A clear solution was
Water Solubility
observed, after incremental amounts of test
substance were added to deionised water.
However, silicones are generally insoluble
so the polymer may actually be present as a
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micro-emulsion rather than in solution.
No acid or base groups are present
Dissociation Constant
Stable under normal environmental
Reactivity
conditions. Contains hydrolysable groups
but unlikely to undergo hydrolysis except
under extreme pH and temperature
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 0.6 0.8 1.0 1.5 3.0
USE AND MODE OF INTRODUCTION AND DISPOSAL
Mode of Introduction
Imported in sealed 204.15 kg drums at approximately 100%.
Reformulation/manufacture processes
This product will be reformulated in a batch process with other ingredients. It is added at the end of the
process at a maximum temperature of 35oC. It will be then filled into aerosol cans, pressurised and
distributed to the consumer market. The end use will be into a range of shaving foams.
Use
To improve skin feel in a shaving cream formulation. Used at ~0.1% by weight.
6. HUMAN HEALTH IMPLICATIONS
6.1. Exposure Assessment
OCCUPATIONAL EXPOSURE
Dermal and ocular exposure can occur during certain formulation processes. However, exposure to
significant amounts of the notified polymer is limited because of the engineering controls (local
exhaust ventilation) and personal protective equipment worn by workers.
PUBLIC EXPOSURE
The general public is not exposed to the neat notified polymer. Personal care products containing the
notified polymer are for sale to the general public. Members of the public make dermal contact and
possibly accidental ocular contact with products containing the notified polymer. However, exposure
is low because the notified polymer is present at low concentrations (appropriately 0.1% by weight).
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 the notified polymer.
Endpoint Result Classified? Effects
Observed?
Non irritating no no
MatTek Corporation EpiDerm Skin
Model In Vitro Toxicity Testing System,
skin irritation
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2007 NICNAS
Non irritating no no
MatTek Corporation EpiOcular Tissue
Model In Vitro Toxicity Testing System,
eye irritation
All results were indicative of low hazard.
6.3. Human Health Risk Assessment
OCCUPATIONAL HEALTH AND SAFETY
The OHS risk presented by the notified polymer is expected to be low given its likely low hazard and
predicted low exposure to workers involved in formulating personal care products due to a mostly
automated system coupled with the use of PPE. The notified polymer may be present in formulations
containing hazardous ingredients. If these formulations 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.
PUBLIC HEALTH
The notified polymer as imported is not available to the public. Members of the public may make
dermal contact with products containing the notified polymer. However, the risk to public health is
negligible because the notified polymer meets the PLC criteria and the concentration of the polymer in
personal care products is low (~ 0.1%).
7. ENVIRONMENTAL IMPLICATIONS
7.1. Exposure Assessment
ENVIRONMENTAL RELEASE
The notified polymer is not manufactured in Australia but is reformulated and packaged into aerosol
cans for personal care products. It is estimated that a maximum of 1% (< 30 kg per annum) of the
notified polymer will remain in the import packaging. Currently approximately 50% of this packaging
(tin plate cans) undergoes metal recycling. The remaining packaging is likely to be disposed of to
landfill. A small amount (< 1%; < 30 kg per annum) may require disposal from cleaning of equipment
and spills. This is likely to be disposed of to landfill. Approximately 3-5% (< 150 kg per annum) of the
notified polymer is expected to remain in the empty aerosol cans. These are likely to be disposed of as
domestic waste. The remainder is likely to enter the sewer during use (e.g. from washing of skin and
razor after shaving and washing of towels used to dry skin).
ENVIRONMENTAL FATE
Most of the notified polymer (~95%; < 2850 kg per annum) is expected to enter the sewer during use.
The remainder as residue in packaging will share the fate of the packaging. Most of this will be
landfilled with the polymer eventually undergoing abiotic and biotic degradation to landfill gases
including methane and oxides of carbon and silicon and water vapour. During metal recycling the
notified polymer is expected to undergo thermal decomposition to oxides of carbon, silicon and water
vapour.
7.2. Environmental Hazard Characterisation
No ecotoxicological data were submitted. PLCs without significant ionic functionality are of low
concern to the aquatic environment.
7.3. Environmental Risk Assessment
Most of the notified polymer will be disposed of to sewer throughout Australia during use. A worst
case predicted environmental concentration (PEC) assuming no adsorption of the polymer in the
sewage treatment plant (STP) may therefore be calculated as 1.9 礸/L at sewage outfall (2850 kg per
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annum ?(20.5 million persons ?200 L per day per person ?365 days).
As no toxicity data were provided a predicted no effect concentration (PNEC) and risk quotient (RQ)
cannot be calculated. However, non-toxic PLCs are of low concern to the aquatic environment.
Therefore the notified polymer is likely to pose an acceptable risk to the environment.
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.
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 authorised landfill.
Emergency procedures
? Spills and/or accidental release of the notified polymer should be handled by physical
containment with subsequent adsorption with compatible material (sand, vermiculite etc).
Transfer to suitable containers for disposal or reclamation.
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:
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(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.
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