DETERMINATION ON WHETHER A SUBSTANCE IS A HAZARDOUS
SUBSTANCE PURSUANT TO SECTION 26 OF THE HSNO ACT
Application Code
HAZ03006
Application Type
Section 26 – determine whether a substance is hazardous
under the HSNO Act.
Applicant
Plastics New Zealand (Inc)
Date Application Received
2 April 2003
To be considered by
The Hazardous Substances Standing Committee of the
Authority.
Purpose of the Application
To determine whether specific vinyl polymers are hazardous
Applications Advisor (Operations
Group)
Noel McCardle
Scientific Advisor (Science &
Analysis Group)
Tania van Maanen
Identification of the substances
Vinyl polymers are a generic class of polymers formed from the polymerisation of vinyl
monomers, ie substances containing a carbon-carbon double bond (vinyl or vinylidene group)
with a functional group. The constituent monomers may contain a range of functional groups and
as such, vinyl polymers make up the largest family of polymers, including vinyl chlorides, vinyl
acetates, styrenics, and acrylates. The presence of the double bond enables polymerisation (and
copolymerisation) of various monomers in any combination. As such, there is a wide variety of
copolymers available, each with different physical properties dependant on the types and ratios of
monomers used, and on the conditions of polymerisation. This section 26 determination is
limited to a specific subset of vinyl polymers as defined below.
No polymer manufacture is currently undertaken in New Zealand. Plastics are imported into the
country in the form of granules from which a range of products are manufactured. Manufactured
articles are exempt from the HSNO approval process but polymer granules fall within the HSNO
definition of a substance and as such, a HSNO approval is required if any of the HSNO hazardous
property thresholds are exceeded.
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Substance Definition
This section 26 determination is limited to a specific subset of vinyl polymers (either
homopolymers or co-polymers) made from the following monomers:
Monomer name
CAS number
Structure
Vinyl chloride
75-01-4
H2C
Cl
Vinylidene chloride
Cl
75-35-4
H2C
Cl
Esters of acrylic or
methacrylic acid
CH3
various
H2C
H2C
O
O
O
R
Styrene
100-42-5
Vinyl acetate (and its
vinyl alcohol hydrolysis
product)
108-05-4
Acrylonitrile
107-13-1
O
R
CH2
O
H2C
O
CH3
H2C
N
Butadiene
106-99-0
H2C
CH2
Ethene
75-85-10
H2C CH2
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Further, this definition is limited to those vinyl polymers (not containing additives) with a number
average molecular weight greater than 10 000 amu and with residual monomer, catalyst and
solvent impurities present at levels less than 0.1%. In addition, polymers that are cationic (or
potentially cationic) or those that are water absorbing, are specifically excluded from this
definition.
Examples of vinyl polymers covered by this definition are listed in the application form HS7
provided as Appendix 1 to this document.
Hazardous Property Assessment
An assessment of vinyl polymers (as defined above) against the HSNO thresholds was provided
in the application form HAZ03006 (attached as Appendix 1 to this document). It is noted that
often limited or no information was available on these types of substances for a number of
endpoints, especially data on vinyl polymers as a group. Where information was available on
specific vinyl polymers, this has been provided.
However, it is recognised that this s26 determination is limited to vinyl polymers of very high
molecular weight (i.e. greater than10 000 amu) and as discussed in the application form, such
substances are not likely to be bioavailable and therefore highly unlikely to adversely affect either
human health or the environment.
A summary of the hazardous property assessment of those vinyl polymers as defined for this s26
determination is provided below.
Class / Sub-class
Detail
Threshold
Class 1 – Explosiveness
Vinyl polymers are not considered explosive. They do
not meet the HSNO criteria for an explosive substance
and are not listed in the UN Recommendations on the
Transport of Dangerous Goods.
Not triggered
Class 2,3,4 – Flammability
Vinyl polymers are not considered flammable. They do
not meet the HSNO criteria for a flammable substance
and are not listed in the UN Recommendations on the
Transport of Dangerous Goods.
Not triggered
Sub-class 5.1 – Oxidisers
Vinyl polymers do not meet the HSNO definition/criteria
for an oxidising substance.
Not triggered
Subclass 5.2 – Organic
peroxides
Vinyl polymers do not meet the HSNO definition/criteria
for an organic peroxide.
Not triggered
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Class / Sub-class
Detail
Threshold
Sub-class 6.1 – Acute toxicity
Vinyl polymers are not considered to be acutely toxic as
defined by the HSNO criteria.
Not triggered
Data for specific vinyl polymers is as follows:
Powdered PVC fed to rats at a dose of 2500 mg/kg had
no effects.
A single 50000 mg/kg dose of polybutyl methacrylate
administered to rabbits did not result in any signs of
toxicity.
A rat feeding study of polystyrene at 5000 mg/kg showed
no abnormal effects.
Rats and mice survived an acute oral dose of 25000
mg/kg bw of polyvinyl acetate (PVAc).
A dispersion of ethylene vinyl acetate (EVA) was nontoxic in acute experiments with mice and rats.
The LD50 for polyvinyl alcohol (PVOH) in mice is 14700
mg/kg, for rats is 23800 mg/kg and for guinea pigs is
18700 mg/kg.
Sub-class 6.3 – Skin irritancy
No information was located to indicate that vinyl
polymers would be skin irritants as defined by the HSNO
criteria.
Not triggered
Data for specific vinyl polymers is as follows:
No dermal effects of PVC have been linked to the
polymer alone.
Human subjects exposed to PVAc film reported no
irritation.
Sub-class 6.4 – Eye irritancy
No information was located to indicate that vinyl
polymers would be eye irritants as defined by the HSNO
criteria.
Not triggered
Sub-class 6.5A – Respiratory
sensitisation
No information was located to indicate that vinyl
polymers would be respiratory sensitisers as defined by
the HSNO criteria.
Not triggered
Sub-class 6.5B – Contact
sensitisation
No information was located to indicate that vinyl
polymers would be contact sensitisers as defined by the
HSNO criteria.
Not triggered
Data for specific vinyl polymers is as follows:
Polymethyl methacrylate (PMMA) is not recognised as a
contact allergen.
PVAc film tested on human subjects showed no
sensitising properties.
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Class / Sub-class
Detail
Threshold
Sub-class 6.6 – Mutagenicity
No information was located to indicate that vinyl
polymers would be mutagenic as defined by the HSNO
criteria.
Not triggered
Data for specific vinyl polymers is as follows:
PMMA is reported to be an anti-mutagenic agent.
An acrylonitrile-butadiene-styrene (ABS) copolymer
tested showed no mutagenic effect.
Cosmetic grade PVAc it not mutagenic. PVOH was not
mutagenic when tested on five strains of Salmonella
typhimuarium.
The vinyl acetate-polyvinyl alcohol copolymer was not
mutagenic to Drosophila melanogaster.
Sub-class 6.7 –
Carcinogenicity
No information was located to indicate that vinyl
polymers would be carcinogenic as defined by the HSNO
criteria.
Not triggered
The International Agency for Research on Cancer
(IARC) has classified a number of vinyl polymers as
class 3 substances [unclassifiable as to carcinogenicity to
humans] i.e. not unclassifiable as a carcinogen under
HSNO. Such polymers include PVC, PMMA,
polystyrene, styrene-acrylonitrile copolymers, styrenebutadiene copolymers, acrylonitrile-butadiene-styrene
copolymers, PVOH and PVAc.
In addition, the following data has been reported from
carcinogenicity studies on specific vinyl polymers:
Animal and human exposure data indicate no evidence of
metastatic cancer being caused by PMMA.
In a two year study of PVOH administered intravaginally
to mice there was no evidence of carcinogenic activity.
Cosmetic grade PVAc was found not to be carcinogenic
in animal testing.
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Class / Sub-class
Detail
Threshold
Sub-class 6.8 – Reproductive
/ developmental effects
No information was located to indicate that vinyl
polymers would be reproductive /developmental
toxicants as defined by the HSNO criteria.
Not triggered
Data for specific vinyl polymers is as follows:
An epidemiological study of women in the plastics
industry reported no association between PVC contact
and the incidence of spontaneous abortion.
No teratogenic effects were reported in mice exposed to
PVC.
An EVA dispersion had no effect on the reproductive
function or on offspring development.
Sub-class 6.9 – Target organ
systemic effects
No information was located to indicate that vinyl
polymers would be target organ systemic toxicants as
defined by the HSNO criteria.
Not triggered
Data for specific vinyl polymers is as follows:
Rats and dogs receiving the vinyl chloride-vinylidene
chloride copolymer in their diet for 2 years showed no
signs of any toxicity.
Much effort has gone into studying potential adverse
pulmonary effects of PVC dust. The weight of evidence
from inhalation and intratracheal exposure data in
animals indicates PVC itself possesses little or no
biological activity. At elevated dust concentrations its
physical presence may produce benign pneumoconiosis
which does not trigger any HSNO thresholds.
Repeated doses of 5000 mg/kg bw polybutyl
methacrylate to rats did not produce any toxic effects.
In a two-year feeding study, rats fed polystyrene at doses
up to 5000 mg/kg showed no abnormal effects.
Long term feeding studies with PVAc (rats at 20000
mg/kg bw/day and mice at 40000 mg/kg bw/day)
revealed no toxic effects. An EVA dispersion was nontoxic in chronic experiments with rats and mice.
A repeat dose study with PVOH administered
intravaginally to mice revealed no adverse effects.
Some chronic effects for PVOH are reported in the
literature, but these are only apparent at doses much
higher than the standard toxicology testing thresholds (ie
above the HSNO threshold for classification in this
endpoint) and at levels much higher than any feasible
human exposure.
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Class / Sub-class
Detail
Threshold
Class 8 – Corrosivity
Vinyl polymers are not considered to be corrosive to
metals (sub-class 8.1), to skin (sub-class 8.2) or to the
eye (sub-class 8.3). Vinyl polymers are not listed in the
UN Recommendations on the Transport of Dangerous
Goods.
Not triggered
Class 9 - Ecotoxicity
Vinyl polymers are not considered to be ecotoxic due to
their low solubility, low reactivity and high molecular
weight. As such, they will not be bioavailable and
therefore highly unlikely to adversely affect aquatic life
(sub-class 9.1), soil organisms (sub-class 9.2) terrestrial
vertebrates (subclass 9.3) or terrestrial invertebrates (subclass 9.4). Although vinyl polymers may not be rapidly
biodegradable, they will not bioaccumulate due to their
low bioavailablitiy.
Not triggered
Other information
As discussed in the application form (attached as Appendix 1 to this document), vinyl polymers
(as defined for this s26 determination) of molecular weight > 10,000 meet the USEPA polymer
exemption rule and the NICNAS polymers of low concern criteria.
Furthermore, various vinyl polymers are permitted by the US Food and Drug Administration
(USFDA) “as articles or components of articles intended for use in contact with food” – for
example CFR Title 21 paragraphs177.1960, 177.1980, 177.1990, 177.2000 (specific vinyl
chloride polymers, vinylidine chloride polymers); CFR Title 21 paragraph177.1010 (specific
acrylic polymers); CFR Title 21 paragraphs 177.1020, 177.1030, 177.1040, 177.1640, 177.1810,
177.1830 (specific styrenic polymers); and CFR Title 21 paragraphs177.1350, 177.1360,
177.1620 (specific vinyl acetate polymers).
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Recommended Determination
If the Authority is of the view that specific vinyl polymers (as defined above) are not
hazardous under the HSNO Act, then the Authority may:
a) determine that specific vinyl polymers (as defined above) are not hazardous pursuant to
section 26 of the HSNO Act 1996; and
b) direct the Chief Executive to arrange for notice of this determination to be placed in
the Gazette.
Dr Donald Hannah, Manager, Science and Analysis
Date: 10 July 2003
Determination by the Authority
The recommended determination is approved.
Mr Tony Haggerty, Chair Hazardous Substances Standing Committee
Date: 30 July 2003
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Appendix 1
Application form HAZ03006 (attached)
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