Cyclooctene Homopolymer
File No: PLC/121
October 1999
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
Cyclooctene Homopolymer
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals
(Notification and Assessment) Act 1989 (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 National Occupational Health and Safety Commission
which also conducts the occupational health & safety assessment. The assessment of environmental
hazard is conducted by the Department of the Environment and the assessment of public health is
conducted by the Department of Health and Aged Care.
For the purposes of subsection 78(1) of the Act, copies of this full public report may be inspected by
the public at the Library, National Occupational Health and Safety Commission, 92-94 Parramatta
Road, Camperdown NSW 2050, between the following hours:
Monday ?Wednesday 8.30 am - 5.00 pm
Thursday 8.30 am - 8.00 pm
Friday 8.30 am - 5.00 pm
Copies of the full public report may also be requested, free of charge, by contacting the
Administration Coordinator.
Please direct enquiries or requests for full public reports to the Administration Coordinator at:
Street Address: 92 Parramatta Road, CAMPERDOWN NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA
Telephone: (61) (02) 9577 9514
Facsimile: (61) (02) 9577 9465
Director
Chemicals Notification and Assessment
FULL PUBLIC REPORT
PLC/121
FULL PUBLIC REPORT
Cyclooctene Homopolymer
1. APPLICANT
Process Chemicals Australia Pty Ltd. of 105/10 Edgeworth David Avenue, HORNSBY
NSW 2077 has submitted a Polymer of Low Concern notification statement in support of
their application for an assessment certificate for Cyclooctene Homopolymer.
No claims for exempt information were made by the notifier.
2. IDENTITY OF THE CHEMICAL
The polymer meets the criteria for assessment as a Synthetic Polymer of Low Concern
under Regulation 4A of the Industrial Chemicals (Notification and Assessment) Act
(1989).
Cyclooctene homopolymer
Chemical Name:
25267-51-0
Chemical Abstracts Service
(CAS) Registry No.:
Trans-polyoctenamer;
Other Names:
Polyoctenylene;
Polyoctenamer Rubber.
Vestenamer 8012;
Marketing Names:
Vestenamer 6213
(See Comments below)
-(C4H7=C4H7)-n
Molecular Formula:
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Structural Formula:
(CH2)6 (CH2)6
(CH2)n (CH2)6 n
n
(CH2)6 (CH2)6
(CH2)6 (CH2)6
n
n
(CH2)6 (CH2)6
+
n
n=30-10000
Vestenamer 8012: 14 400 (see Comments below);
Number-Average
Vestenamer 6213: Not determined
Molecular Weight (NAMW):
Vestenamer 8012: 75 000 (see Comments below);
Weight-Average
Vestenamer 6213: 95 000
Molecular Weight (WAMW):
Vestenamer 8012: 5.21 Calculated (see Comments
Polydispersity:
below)
Maximum Percentage of Low
Molecular Weight Species
No data
Molecular Weight < 500:
0.5%
Molecular Weight < 1 000:
Weight Percentage of
Ingredients:
Chemical Name Cyclooctene , homopolymer (99.5%)
CAS No. 25267-51-0
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Gel Permeation Chromatography (GPC) for the NAMW
Method of Detection
and percentage of species with NAWM < 1 000.
and Determination:
A GPC trace and printout and a reflectance Fourier
Spectral Data:
Transform Infra-Red (IR) spectrum were supplied.
Comments on Chemical Identity
The notified polymer consists of linear and cyclic macromolecules in a 75% to 25% ratio
that cannot be separated or distinguished. It is produced by polymerisation of
cyclooctene, which is in turn synthesised from 1,3-butadiene.
Vestenamer is available in two grades of crystallinity, Vestenamer 8012 and Vestenamer
6213. The degree of crystallinity is dependent on the cis/trans ratio of double bonds,
which is controlled by polymerisation conditions. Crystallinity increases as the trans
content increases.
The structures within the notified polymer were able to be determined from the
information supplied by the notifier. A slight variation to the cyclic structure as provided
in the Vestenamer product bulletin (Degussa-Huls Engineering Plastics (undated)) was
made, noting that the cyclic structure has a molecular weight of less than 1 000.
The GPC trace for Vestenamer 8012 was used to determine the NAMW, percentage
of low, molecular weight species and polydispersity. From the GPC trace, the NAMW
14 400 and the WAMW was 67 100. However, following further information supplied
by the notifier the WAMW was 75 000. Polydispersity calculated for Vestenamer 8012
was 5.21.
3. PHYSICAL AND CHEMICAL PROPERTIES
Vestenamer 8012 Vestenamer 6213
Light, opaque pellets
Appearance at 20癈 & 101.3 kPa:
54 + 4oC < 36oC
Melting Point:
-65 oC -75 oC
Glass Transition Temperature:
Crystallinity at 23oC: 30% 10%
20:80 40:60
Cis/Trans ratio of double bonds:
Specific Gravity at 20oC: 0.91 0.89
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Not applicable
Vapour Pressure:
Not determined (see comments below)
Water Solubility:
Partition Co-efficient
Not determined
(n-octanol/water):
Not determined
Hydrolysis as a Function of pH:
Cylindrical or lenticular granules < 6 mm
Particle Size
Not applicable (no charged group)
Charge Density
Not determined
Adsorption/Desorption:
Not determined
Dissociation Constant:
Not applicable
Flash Point:
Not determined
Flammability Limits:
> 400 癈 (from Material Safety Data Sheet (MSDS)
Autoignition Temperature:
Not explosive (from MSDS)
Explosive Properties:
Decomposition begins at Decomposition begins at
Reactivity/Stability:
275 癈; at 250癈;
No hazardous reactions. No hazardous reactions.
Comments on Physico-Chemical Properties
Water solubility was not determined. The notifier claims that the notified polymer is very
hydrophobic, therefore insoluble in water. No polar groups are present.
The notifier claims that the polymer will be chemically and environmentally inert when
incorporated as a constituent of rubber compounds. While the polymer contains double bonds
which may cause oxidation reactions, it does not contain charged groups or functionality
capable of being readily ionised.
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4. PURITY OF THE CHEMICAL
>99.5%
Degree of Purity:
None
Hazardous Impurities:
Non-hazardous Impurities
None
(> 1% by weight):
Maximum Content
of Residual Monomers:
Chemical Name CAS No. Weight %
Cyclooctene 931-88-4 80 ppm
Cyclooctane 292-64-8 0.3
Aliphatic hydrocarbons unknown 0.2
5. USE, VOLUME AND FORMULATION
The notified substance will not be manufactured in Australia but will be imported by sea as
granules in 25 kg plastic bags, palletized and shrink-wrapped into Australia in containers.
The polymer is to be used as a processing aid in the manufacture of a wide range of rubber
compounds and products such as tyres, conveyor belts, recycled rubber, shoe soling and
rubber rollers.
The estimated import volume of the notified polymer will be up to 20 tonnes during the first
year increasing by approximately 5 tonnes per year thereafter.
The notifier indicated that the material will be used at no more than ten sites in Australia.
Rubber processing involves: weighing and mixing of raw materials, including the notified
polymer; shaping by moulding, extrusion or calendering; vulcanisation; finishing; and
packaging and shipping of the final rubber product. The notified polymer is formulated with
other raw materials and rubber products at a final concentration of 2 to 5% of the total
weight.
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6. OCCUPATIONAL EXPOSURE
Number of Workers
The notifier estimated that approximately 10 to 20 workers will be involved in transport and
storage of the notified polymer, and in rubber manufacturing operations.
Dockside and Transport
The packaged, palletized and shrink-wrapped polymer, will be removed from the import
containers and delivered to the notifier's warehouse(s) for storage until required by and
delivered to customer sites. No repackaging or reformulation will occur at the warehouse(s).
Transport and storage workers would only be exposed to the notified polymer in the event of
a spill.
Rubber manufacture
At the customer site, the import bags are opened, the required quantities of polymer are
weighed and added to a mixer. These processes are not described in the submission,
however, if manual methods are involved then skin contact with the pellets is possible. Dust
exposure is unlikely given both the low glass transition temperature and crystallinity of the
notified polymer. Since rubber manufacturing involves thermal processing with generation
of hazardous fumes and dusts, all subsequent stages of rubber manufacture would be in
enclosed systems and skin and inhalation exposure to volatiles of the notified polymer is not
expected. Additionally, local exhaust ventilation would be positioned to capture at point of
source volatiles and aerosols originating from extrusion, calendering and vulcanisation.
Following vulcanisation, the notified polymer is fixed within the rubber matrix and therefore
not available for separate exposure during handling of rubber products. Therefore, no worker
exposure to the notified polymer from handling of finished products is expected.
7. PUBLIC EXPOSURE
In the event of a transport accident any spillage of polymer pellets could be readily recovered
by sweeping. Significant public exposure in this circumstance is considered unlikely.
Public contact with the products containing the notified polymer may be widespread and
frequent if the notified polymer is commercially successful. As the notified polymer is
chemically bound into the matrix of rubber products however, exposure is likely to be
negligible.
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8. ENVIRONMENTAL EXPOSURE
Release
Release to the environment may occur during reformulation when the bags are opened,
required quantities are weighed and added to mixing machinery. The notifier estimates that
0.01-0.05% of the notified polymer would remain as residues in the bags. The notifier did
not estimate the amount of residue obtained from cleaning equipment, spills or wastage but
this assessment estimates residue of 1 to 2%. The notifier has indicated that all residues
would be disposed of by recycling into other rubber compound products or sent to landfill.
Except in the case of accident, it is not expected that either the polymer or the rubber
formulation containing the polymer would be released to the environment during storage and
transportation. The MSDS contains adequate instructions for handling a spill.
Fate
If any of the uncured polymer formulation was released by spills, it would be expected to
associate with the organic component of soils and sediments because of its predominantly
hydrophobic nature and assimilate into these materials. Biological membranes are not
permeable to polymers of very large molecular size and as such, bioaccumulation of the
notified polymer would not be expected if quantities of the uncured polymer were to be
released into the water compartment.
Any of the notified polymer released to the sewer within the cured and insoluble polymer
matrix (rubber) is expected to associate with the sewer plant sludge, to be either deposited
into landfill or incinerated.
When deposited into landfill either as residues or discarded rubber products, the organic
components of the cured rubber including the notified polymer would be inert and immobile,
but could nevertheless be expected to be very slowly degraded through the biological and
abiotic processes operative in these facilities. The polymer also contains double bonds,
which would undergo oxidation reactions.
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9. EVALUATION OF TOXICOLOGICAL DATA
Only summary reports were available for the following studies.
9.1 Acute Toxicity (Degussa-Huls Engineering Plastics (undated))
Summary of the acute toxicity of Vestenamer 8012 and Vestenamer 6213
Test Species Outcome
acute oral toxicity rat LD 50 > 12 500 mg/kg
skin irritation rabbit Non-irritant
eye irritation rabbit Non-irritant
9.2 Repeated Dose Toxicity (Huls 1990a)
Species/strain: Rats/Wistar
Number/sex of animals: 10/sex/group (treatment and control groups)
Method of administration: Vestenamer 8012 or 6213 ad libitum for 90 consecutive days
Dose/Study duration: 0, 1 000, 2 000, 4 000 mg/kg bw/day (Vestenamer 8012);
4 000 mg/kg bw/day (Vestenamer 6213);
Test method: OECD TG 407
Clinical observations:
Animals from all treatment groups, except for males treated with 2 000 mg/kg bw/day of
Vestenamer 8012, revealed a slight increase in food consumption, which did not lead to
increased food conversion or body weight gain. A significant decrease in body weight gain
was detected at the end of the 90-day exposure period in the group (males) treated with
4 000 mg/kg bw/day of Vestenamer 8012.
No mortalities occurred during the study period and no treatment related changes in general
body health or ophthalmoscopic changes were detected in any of the animals.
Clinical chemistry/Haematology
Minor decreases, with only a few animals exceeding the normal range, in inorganic
phosphate, calcium and potassium in the blood were detected in treatment groups. Slight
changes in organ weight were observed in treatment groups.
Histopathology:
No treatment related gross pathological or histological effects could be detected in the
animals at the end of the 90-day treatment period.
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Comment:
The significant decrease in body weight gain observed in the males treated with 4 000
mg/kg bw/day of the test substance as well as the marginal decrease in certain blood
parameters are not taken to be toxic effects of Vestenamer but secondary effects of the high
dosages (greater than 7% Vestenamer) in the food, resulting in malsorption.
Under the test conditions, treatment with Vestenamer did not result in systemic toxicity and
no target organs could be identified.
Result:
Based on the observations reported for Vestenamer 8012 and 6213, the No Observed
Adverse Effect Level (NOAEL) was determined to be 4 000 mg/kg bw/day.
9.3 Genotoxicity
9.3.1 Salmonella typhimurium Reverse Mutation Assay-Ames Test (Huls 1990b)
Strains: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
up to 5 000 礸/plate
Concentration range:
Metabolic activation: S9 mix
Test method: Guideline 87/449/EEC, method B.14
Comment: No detectable mutagenic effects when tested at
concentrations up to 5 000 礸/plate.
Result: The notified polymer was considered non-mutagenic under
the conditions of the assay.
9.3.2 HGPRT test in Chinese Hamster Ovary Cells (Huls 1991a)
Cell line: Chinese Hamster Ovary cells
Up to 30 礸/mL, without metabolic activation;
Doses:
Up to 125礸/mL, with metabolic activation
Metabolic activation: S9
Test method: OECD TG 476
Comment: Treatment with the test substance in two independent assays
did not result in a reproducible statistically or biologically
significant increase in the mutation frequency of the HGPRT
locus.
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Result: The notified polymer was considered non-mutagenic under
the conditions of the assay
9.3.3 Metaphase Analysis in V79 cells in vitro (Huls 1991b)
Cell line: Chinese Hamster Lung (V79) cells
up to 500 礸/mL tested in the absence and presence of
Doses:
metabolic activation;
harvest times of 12, 17 and 24 hours after the beginning of
treatment.
Metabolic activation: S9
Test method: OECD TG 473
Comment: The test substance did not induce chromosomal aberrations
in V79 cells either in the presence or absence of metabolic
activation.
Result: The notified polymer was considered non-clastogenic under
the conditions of the assay
9.3.4 Micronucleus Assay in the Bone Marrow Cells of the Mouse (Volkner 1989a;
Volkner 1989b)
Species/strain: Mice/strain not specified
Number and sex of animals: 5/sex/ test group each for Vestenamer 8012 and Vestenamer
6213
24 hour exposure: 500, 1 670, 5 000 礸/kg bw;
Doses:
48 hour exposure: 5 000 礸/kg bw;
72 hour exposure: 5 000 礸/kg bw
vehicle control: 1% carboxymethylcellulose
positive control: not specified.
Method of administration: Oral; single dose of 20 mL/kg bw
Test method: OECD TG 474
In a series of pre-experiments, 5 000 礸/kg bw was
Comment:
estimated to be the maximum attainable dose. Slight toxic
reactions were observed in the animals. However, no
cytotoxic effects were observed following treatment with the
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test substance.
No substantial enhancement in the frequency of the detected
micronuclei was observed following treatment with the test
substance at all exposure periods.
The positive control, not specified, induced a distinct
increase in micronucleus frequency.
Result: Vestenamer 8012 and Vestenamer 6213, were considered
non-clastogenic under the conditions of the assay.
9.4 Overall Assessment of Toxicological Data
The toxicological assessment is based on summary data provided by the notifier.
The notified polymer was of very low acute oral toxicity in rats with an LD50 of greater than
12 500 mg/kg bw. The notified polymer was reported as non irritating to rabbit eye or skin.
Oral administration of the notified polymer to rats in a 90-day subchronic toxicity study
resulted in minor haematological and body weight effects, which were likely to be a result of
secondary effect resulting in malsorption. Based on these findings, an NOAEL of 4 000
mg/kg bw was established.
The notified polymer was non genotoxic in vitro or in vivo.
The notified polymer is not considered a hazardous substance according to the NOHSC
Approved Criteria for Classifying hazardous Substances (NOHSC 1999).
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
No ecotoxicological data were submitted.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
It is difficult to predict the amount of notified polymer that would be released to the
environment as the notifier has not supplied estimates of the amount of material expected to
be released from the reformulation process or the likely percentages of polymer that would be
disposed of to landfill rather than recycling. However, the release is likely to be small
(approximately 2%) and dispersed, hence, not significant at any one site. The majority of the
material would be encapsulated in a cured polymer matrix and is expected to be insoluble and
inert. Most of this solid waste would be deposited into landfill.
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However, some of the polymer may be released into sewers as a consequence of cleaning
equipment, where it would become incorporated into sewerage treatment plant sludge which
would eventually be either incinerated or placed into landfill.
The polymer is unlikely to present a hazard to the environment when it is incorporated into
the rubber compound and cured. There will be some release from the end products in a
dispersed fashion as products such as tyres and belts wear with time and use. Such rubber
objects will be consigned to either recycling plants or landfill at the end of their useful lives
and the notified substance will share their fate.
The main environmental hazard would arise through spillage in transport accidents that may
release small quantities of the polymer to drains and waterways. However, the polymer
should quickly become immobile on association with the soil/sediment layer.
The low environmental exposure of the polymer as a result of the proposed use indicates the
overall environmental hazard should be low
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND
SAFETY EFFECTS
The notified polymer is of very low acute oral toxicity and is non irritating to rabbit eye or
skin. An NOAEL of 4 000 mg/kg/day was determined in a 90 day oral study. Genotoxicity
was not observed in vitro or in vivo.
On the data supplied, the notified polymer is not determined to be a hazardous substance
according to the NOHSC Approved Criteria for Classifying hazardous Substances (NOHSC
1999).
Occupational Health and Safety
Transport and Storage
Exposure to the notified polymer is not expected during transport or storage as long as the
packaging remains intact. Exposure after a spill would be controlled by use of the
recommended practices for spillage clean-up given in the MSDS supplied by the notifier. The
notified polymer is not considered a hazardous substance and both its crystallinity and glass
transition temperature precludes the formation of dusts when handled. Therefore, no
significant risk is posed to workers who may make contact with the polymer pellets (6 mm).
Occupational Exposure
During rubber processing, skin contact with the polymer pellets is possible during weighing
and charging of mixing vessels with the polymer: the polymer is incorporated at 2 to 5% by
weight in rubber compounds. The notified polymer is not considered a hazardous substance
and in its pellet form unlikely to generate dust when handled. Therefore, no significant risk is
posed to workers who may make contact with the polymer in pellet form.
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The rubber processing industry is an environment in which hazardous fumes and dusts are
generated. Existing ventilation control measures will control exposure to volatiles arising
from the notified polymer during processing. Therefore, the risk of adverse health effects
from the notified polymer during thermal processing is considered minimal. After
vulcanisation, the notified polymer is chemically fixed within the rubber matrix and not
available for separate exposure during handling of finished rubber products. Therefore, no
significant risk is posed to workers handling finished rubber products.
Public Health
Despite possible widespread and frequent contact with rubber products containing the
notified polymer, public exposure is likely to be minimal due to the notified polymer being
chemically bound into the matrix of the rubber. Any exposure which does occur is unlikely
to lead to adverse effects given the low toxicity of the notified polymer in animal studies and
the high NAMW and the water insolubility which are likely to preclude absorption across
biological membranes. Based on its toxicology and physico chemical characteristics and the
proposed use pattern, Cyclooctene Homopolymer is not considered to pose a significant
hazard to public health.
13. RECOMMENDATIONS
To minimise occupational exposure to Cyclooctene Homopolymer the following
guidelines and precautions should be observed:
Safety goggles should be selected and fitted in accordance with Australian
?br>
Standard (AS) 1336 (Standards Australia 1994) to comply with Australian/New
Zealand Standard (AS/NZS) 1337 (Standards Australia/Standards New Zealand
1992); industrial clothing should conform to the specifications detailed in AS
2919 (Standards Australia 1987) and AS 3765.2 (Standards Australia 1990);
impermeable gloves or mittens should conform to AS 2161 (Standards Australia
1978); all occupational footwear should conform to AS/NZS 2210 (Standards
Australia/Standards New Zealand 1994);
Spillage of the notified chemical should be avoided. Spillages should be swept up
?br>
promptly and stored in containers for disposal;
Good personal hygiene should be practised to minimise the potential for
?br>
ingestion; and
A copy of the MSDS should be easily accessible to employees.
?br>
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14. MATERIAL SAFETY DATA SHEET
The MSDS for the notified polymer was provided in accordance with the National Code of
Practice for the Preparation of Material Safety Data Sheets (NOHSC 1994).
This MSDS was provided by the applicant as part of the notification statement. It is
reproduced here as a matter of public record. The accuracy of this information remains the
responsibility of the applicant.
15. REQUIREMENTS FOR SECONDARY NOTIFICATION
Under subsection 64(1) of the Act, secondary notification will be required if the polymer
characteristics cease to satisfy the criteria under which it has been accepted as a Synthetic
Polymer of Low Concern. Secondary notification of the notified polymer shall be required if
any of the circumstances stipulated under subsection 64(2) of the Act arise. No other specific
conditions are prescribed.
16. REFERENCES
Degussa-Huls Engineering Plastics (undated). VESTENAMER The Rubber with
Unique Properties, Degussa-Huls.
Huls, A. (1990a). Vestenamer - Subchronic oral toxicity in the rat.
Huls, A. (1990b). Cyclooctene: Ames test.
Huls, A. (1991a). Cyclooctene: HPRT test in CHO cells.
Huls, A. (1991b). Cyclooctene: Metaphase analysis in V79 cells in vitro.
NOHSC (1994). National Code of Practice for the Preparation of Material Safety Data
Sheets [NOHSC:2011(1994)]. Canberra, Australian Government Publishing Service.
NOHSC (1999). Approved Criteria for Classifying Hazardous Substances
[NOHSC:1008(1999)]. Canberra, Australian Government Publishing Service, In press.
Standards Australia (1978). Australian/New Zealand Standard 2161.2-1998,
Occupational protective gloves, Part 2: General requirements. Sydney, Standards
Association of Australia.
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Standards Australia (1987). Australian Standard 2919-1987, Industrial Clothing. Sydney,
Standards Association of Australia.
Standards Australia (1990). Australian Standard 3765.2-1990, Clothing for Protection
against Hazardous Chemicals Part 2 Limited protection against specific chemicals.
Sydney, Standards Association of Australia.
Standards Australia (1994). Australian Standard 1336-1994, Eye protection in the
Industrial Environment. Sydney, Standards Association of Australia.
Standards Australia/Standards New Zealand (1992). Australian/New Zealand Standard
1337-1992, Eye Protectors for Industrial Applications. Sydney/Wellington, Standards
Association of Australia/Standards Association of New Zealand.
Standards Australia/Standards New Zealand (1994). Australian/New Zealand Standard
2210-1994, Occupational Protective Footwear. Sydney/Wellington, Standards
Association of Australia/Standards Association of New Zealand.
Volkner, W. (1989a). Micronucleus assay in bone marrow cells of the mouse with
Vestenamer 8012, CCR, Cytotest Cell Research GMBH & Co. KG.
Volkner, W. (1989b). Micronucleus assay in bone marrow cells of the mouse with
Vestenamer 6213, CCR, Cytotest Cell Research GMBH & Co. KG.
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