hexanediamine tetramethyl piperidinyl polymer with trichloro triazine, reaction products with bromo propene butyl butanamine and piperidinamine, oxidised, hydrogenated (Tinuvin NOR 371 FF)
File No.: NA/910
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT
SCHEME
FULL PUBLIC REPORT
1,6-hexanediamine, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4,6-
trichloro-1,3,5-triazine, reaction products with 3-bromo-1-propene, N-butyl-1-
butanamine and N-butyl-2,2,6,6-tetramethyl-4-piperidinamine, oxidised, hydrogenated
(Tinuvin NOR 371 FF)
Under subsection 38(5) of the Industrial Chemicals (Notification and Assessment) Act 1989
(the Act), the Director of Chemicals Notification and Assessment publishes this assessment
report by giving a copy of it to the:
Chief Executive Officer of the National Occupational Health and Safety Commission;
?br>
Secretary of the Department of Environment and Heritage; and
?br>
Secretary of the Department of Health and Aged Care.
?br>
This assessment report will not be available for inspection by the public.
Director
Chemicals Notification and Assessment
August 2001
FULL PUBLIC REPORT
NA/910
FULL PUBLIC REPORT
1,6-Hexanediamine, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymer with 2,4,6-
trichloro-1,3,5-triazine, reaction products with 3-bromo-1-propene, N-butyl-1-
butanamine and N-butyl-2,2,6,6-tetramethyl-4-piperidinamine, oxidised, hydrogenated
(Tinuvin NOR 371 FF)
1. APPLICANT
Ciba Speciality Chemicals of 235 Settlement Road, THOMASTOWN, VIC 3082 (ABN 97
005 061 469) has submitted a limited notification statement in support of their application for
an assessment certificate for "1,6-Hexanediamine, N,N'-bis(2,2,6,6-tetramethyl-4-
piperidinyl)-, polymer with 2,4,6-trichloro-1,3,5-triazine, reaction products with 3-bromo-1-
propene, N-butyl-1-butanamine and N-butyl-2,2,6,6-tetramethyl-4-piperidinamine, oxidised,
hydrogenated (Tinuvin NOR 371 FF)".
2. IDENTITY OF THE CHEMICAL
The notifier did not apply for any information on the notified polymer to be exempted from
publication in the Full Public Report and the Summary Report.
1,6-Hexanediamine, N,N'-bis(2,2,6,6-tetramethyl-4-
Chemical Name:
piperidinyl)-, polymer with 2,4,6-trichloro-1,3,5-
triazine, reaction products with 3-bromo-1-propene, N-
butyl-1-butanamine and N-butyl-2,2,6,6-tetramethyl-4-
piperidinamine, oxidised, hydrogenated.
Chemical Abstracts Service
Not assigned
(CAS) Registry No.:
Tinuvin NOR 371 FF;
Other Names:
TKA 45023;
Chimassorb 371.
CGL 371
Marketing Name:
C166H318N32O8
Molecular Formula:
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Structural Formula:
R
N
C4H9
C4H9
N
C4H9
N
C4H9 N N N
(CH2)4 N (CH2)4 N N
N
N
N N N N n
C4H9
N
C4H9 N C4H9
N C4H9
N N N
C4H9
R R R
N
R
Where, n = 0, 2, 4, 6, 8.........
R = OC3H7 (Minor variations can be found in these molecules with one or more of the N-OC3H7 groups substituted with
N-H. N=OH, N-O-Allyl and N-O moieties)
Number-Average
3 200
Molecular Weight (NAMW):
Weight-Average
4 050
Molecular Weight:
Maximum Percentage of Low
Molecular Weight Species
Molecular Weight < 500: < 0.1%
Molecular Weight < 1 000: < 0.6%
Weight Percentage of
Ingredients:
Chem ical Nam e CAS No. W eight % Residual %
1,6-Hexanediamine, N,N'-bis(2,2,6,6- 192268-64-7 83.9 None
tetramethyl-4-piperidinyl)-, polymer with
2,4,6-trichloro-1,3,5-triazine, reaction
products with, N-butyl-1-butanamine and
N-butyl-2,2,6,6-tetramethyl-4-
piperidinamine (Chimassorb 2020)
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Allyl bromide 106-95-6 11.1 <0.1
Peracetic acid 71-29-0 4.4 None
Hydrogen 1333-74-0 0.6 None
UV/Vis, NMR, IR and Matrix-Assisted Laser
Method of Detection and
Desorption Ionisation Mass Spectrometry (MALDI MS)
Determination:
were used to confirm the structure of the notified
polymer.
The polymer profile was characterised by GPC and
MALDI MS analysis.
Spectra provided by the notifier
Spectral Data:
3. PHYSICAL AND CHEMICAL PROPERTIES
Off-white to pink or yellow odourless granules.
Appearance at 20癈 & 101.3 kPa:
91-104癈 (glass transition)
Melting Point:
1.026 at 24癈
Density:
<10 kPa at 225癈;
Vapour Pressure:
<6x10-5 kPa at 20癈 (calculated).
3.3x10-5 g/L
Water Solubility:
>100 g/L in THF;
Solubility in Organic Solvents:
10-100 g/L in dichloromethrane;
0.1-2.2 g/L in n-octanol;
<0.1 g/L in isopropanol.
Partition Co-efficient
Not determined.
(n-octanol/water):
Not expected to hydrolyse.
Hydrolysis as a Function of pH:
Not determined.
Adsorption/Desorption:
Not expected to dissociate.
Dissociation Constant:
99% by weight >45 祄
Particle Size:
Not determined.
Flash Point:
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NA/910 4/19
Not determined
Flammability Limits:
>400癈
Autoignition Temperature:
The notified polymer is not explosive by thermal or
Explosive Properties:
mechanical (by shock or friction) sensitivity.
Dust explosions may be possible.
The notified polymer is a non-oxidising agent and is
Reactivity/Stability:
thermally stable at room temperature.
3.1 Comments on Physico-Chemical Properties
The water solubility was determined using OECD TG 105 (Ruberto, 2000a). A preliminary
visual test was conducted and then a flask test was conducted. Six replicas were done with
88.5?8.7 mg of the notified polymer being added to 500 mL of water in Erlenmeyer flasks.
The flasks were stirred for up to 3 days then allowed to come to equilibrium for 24 hours. The
solution was then analysed with a spectrophotometer and the solubility determined. With a
water solubility of 3.3X10-5 mg/L, this polymer would be considered to be very slightly
soluble in water.
No information has been supplied indicating the possibility of hydrolysis. It is very unlikely
that the polymer would hydrolyse, as it contains no groups generally recognised as
hydrolysing.
The notified polymer's solubility in organic solvents was also determined (Ruberto, 2000b).
For each solvent 4 solutions of varying concentration of the notified polymer were tested. It
was determined that the solubilities for the solvents were > 100 g/L for THF, 10 ?100 g/L for
dichloromethane, 0.1 ?2.2 g/L for n-octanol and <0.1 g/L for isopropanol. This would
indicate that the notified polymer is readily soluble in n-octanol.
Thereby, an estimate of the partition coefficient (P) would be 30303?6666 (log P = 4.48-
4.8). From the information provided it appears that the notified polymer is likely to be
hydrophobic and immobile in soils/sediments.
The company indicates it is also not expected to dissociate due to its low water solubility, as
the formation of N+ will not occur due to the polymer's solubility. However, it does contain a
number of aromatic and tertiary aliphatic amine groups. Due to possible steric hinderance the
tertiary aliphatic amine groups may not be very basic.
4. PURITY OF THE CHEMICAL
High
Degree of Purity:
Hazardous Impurities:
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Chemical name: Toluene
CAS N o.: 108-88-3
Weight percentage: <1
Harmful by inhalation at concentrations>12.5%
Toxic properties:
(NOHSC, 1999a). NOHSC has exposure standard of
100 ppm or 377 mg/m3 (TWA) and 150 ppm or 565
mg/m3 (STEL) (NOHSC, 1995).
Non-hazardous Impurities and
byproducts:
Chemical name: Water
Weight percentage: <1.5
CAS N o.: 7732-18-5
Chemical name: Sodium bromide
Weight percentage: <0.01
CAS N o.: 7647-15-6
Chemical name: Sodium acetate
Weight percentage: <0.05
CAS N o.: 127-09-3
The notifier indicated in the submission that the notified polymer also contains ash (<0.1%)
and volatiles (0.4%).
None.
Additives/Adjuvants:
5. USE, VOLUME AND FORMULATION
Tinuvin NOR 371 FF is used as a light stabiliser to prolong the useful life of polymers. It will
be used predominately for polyolefines and blends of polyolefines with elastomers. Products
would include fibre, tape, film and articles. The notified polymer will partially replace nickel-
based stabiliser on the current market.
Tinuvin NOR 371 FF is not manufactured in Australia but will be imported at high
percentage as granules in 25 kg antistatic polyethylene lined cardboard boxes. Less than 10
tonnes will be imported annually in the first 5 years.
Year 1 2 3 4 5
Volume (tonne) 1-2 2-3 3-5 5-8 5-10
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The final concentrations of the notified polymer in plastic products will be at 0.1-1%.
6. OCCUPATIONAL EXPOSURE
Transport and storage
The boxed bags of notified polymer arrive at marine terminals and are transferred unopened
to the notifier's warehouses for storage for later use by the notifier. The notified polymer will
be stored in a cool dry area with adequate ventilation. Exposure to marine terminal, transport
and warehouse workers is expected to occur only in the event of accidental spillage.
Pellet formulation
At the formulation site, workers will scoop the granules from the bags and add the notified
polymer to a tin bucket on the weigher. After weighing, the notified polymer will be added
into the hopper through a loading port on a tumbler blender, where it is mixed with other
ingredients. After blending, the mixture is fed automatically via a metering device to a
heating machine to be extruded into masterbatch pellets. The resulting plastic pellets are
weighted and bagged in 25 or 500 kg antistatic polyethylene lined fibreboard boxed, ready for
distribution. The concentrations of the notified polymer in the masterbatch pellets will be at
0.1-1%. The notified polymer is encapsulated in the compounded plastic pellets and unable
for absorption.
Vapour pressure of the notified polymer is low. As the notified polymer is in granular form
and end encapsulated within the polymer matrix, there would be negligible dust generated at
the workplaces. General and local ventilation of the weighing area and local ventilation at the
blending vessel site will remove a build up of the fumes. The main route of occupational
exposure to the notified polymer would be dermal contact during weighing and feeding of the
granules into the blending vessel. Eye exposure is also possible. Occupational exposure is not
expected during the automatic processes of transferring from the mix vessel to the heating
machine and extrusion. Fifteen workers are likely to be involved in formulation activities.
Data of duration of exposure and frequency of operations were not provided. The notifier
states that workers at the formulation site will wear overalls, gloves and safety glasses when
handling the notified polymer.
Injection moulding
There are 3-15 moulding facilities in Australia using the pellets containing the notified
polymer. Approximately two workers at each facility will carry out work involving the
notified polymer. Workers will remove the masterbatch pellets from packaging and add them
into a hopper of an injection moulding machine. The pellets are heated to about 250oC in the
machine and injected as a liquid, under pressure into moulds to form articles containing 0.1-
1% notified polymer.
Due to the low vapour pressure, inhalation of the notified polymer in vapour is not expected.
Dermal contact is possible but the exposure is low as the notified polymer is encapsulated
into the masterbatch pellets and unavailable for absorption. Local exhaust ventilation is fitted
at the hopper and exit areas to capture any fugitive emissions from the notified polymer when
heated. The operators of the injection mould machines will wear gloves and eye protection.
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End u se
Plastic ware containing the notified polymer will be used at workplace. However, as the
notified polymer is at 0.1-1% of articles and encapsulated into the plastic matrix, occupational
exposure is expected to be negligible.
7. PUBLIC EXPOSURE
Plastics containing the notified polymer will be used in commercial, agricultural, or
engineering operations, and will not usually be available to the public. Any articles that do
enter the public domain will contain 0.1 to 1% of the notified polymer, encapsulated within
the articles' plastic matrix.
8. ENVIRONMENTAL EXPOSURE
8.1 Release
The sources of release include accidental spills during transport and transfer, residues in
containers, processing waste and disposal of end product.
Since the notified polymer is in granular form if spilt it should be easily cleaned up. Spilt
granules will be re-used or disposed of to landfill. An estimation of percentage lost due to this
means has not been provided by the notifier, but it may account for less than 1% annually
(less than 100 kg annually).
It is estimated that less than 1% of the notified polymer will be lost during processing and as
residue in empty containers (bags). Annually this would equate to a maximum of 100 kg.
Some material lost during the processing may enter the wastewater stream but it will be
removed via screening and solids removal prior to the release of wastewater to the sewer. The
solids (including any waste notified polymer) will be disposed of to landfill. The amount of
out-of-specification masterbatch is expected to be very low and is likely to be reprocessed, or
if this is not possible, disposed of to landfill with the containers.
At the end product production plant there will be some minimal loss of the notified polymer
due to spills and `off-cuts'.
The majority (approximately 98%) of the notified polymer will ultimately suffer the same fate
as the end product and end up in landfill.
8.2 Fate
Any spilt imported material will be disposed of to landfill, where it is unlikely to leach out
due to the very low water solubility.
Once the notified polymer has been processed into masterbatch pellets or end-products, it will
be firmly incorporated into a polymer matrix. End-products will ultimately be disposed of
into landfill, or by incineration.
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In a landfill there is little possibility of significant leaching of the polymer, since it will be
firmly incorporated into the polymer matrix either in the masterbatch pellets or the end-
product. However, the polymer articles will be very slowly degraded through the agency of
biological and abiotic processes operative in landfills, and the notified polymer may be
destroyed. Incineration of the masterbatch pellets or the end-products containing the notified
polymer will result in its immediate combustion, with formation of water vapour and oxides
of carbon and nitrogen.
While the notified polymer is not expected to readily biodegrade, it should not bioaccumulate
since it is not expected to cross biological membranes due to its high molecular weight.
9. EVALUATION OF TOXICOLOGICAL DATA
All tests were performed according to OECD/EEC Guidelines and in facilities that comply
with GLP.
9.1 Acute Toxicity
Summary of the acute toxicity of Tinuvin NOR 371 FF
Test Species Outcome Reference
acute oral toxicity rat LD50 > 2000 mg/kg Covance, 1999a
acute dermal toxicity rabbit LD50 > 2000 mg/kg Covance, 2000
skin irritation rabbit Non-irritant Covance, 1999b
eye irritation rabbit Slight to moderate irritant Covance, 1999c
skin sensitisation guinea pig Non-sensitiser Covance, 1999d
9.1.1 Oral Toxicity (Covance, 1999a)
Species/strain: Rats / Crl:CD (SD)IGS BR
Number/sex of animals: 5 males and 5 females
Observation period: 14 days
Method of administration: 2000 mg/kg, in corn oil, orally by gavage.
Test method: OECD TG 401 (Limit test)
Mortality: None
Clinical observations: All males showed wet or dark-stained urogenital areas on the
day of treatment and/or on day 1. No other signs of toxicity
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were observed.
Morphological findings: No treatment-related macroscopic findings were observed.
LD50: > 2 000 mg/kg
Result: The notified polymer was of very low acute oral toxicity in
rats.
9.1.2 Dermal Toxicity (Covance, 2000)
Species/strain: Rabbit / Hra:(NZW)SPF
Number/sex of animals: 5 males and 5 females
Observation period: 14 days
Method of administration: 2 000 mg/kg, moistened with mineral oil, applied to shaven
skin under occlusive dressing for 24 hours.
Test method: OECD TG 402 (Limit test)
Mortality: None
Clinical observations: Slight to moderate erythema and slight oedema were
observed with local effects persisting until day 14. No signs
of systemic toxicity were observed.
Morphological findings: No treatment-related macroscopic findings were observed
Draize scores:
Time after Animal #
treatment
(days) 1 2 3 4 5 6 7 8 9 10
Erythema
1i
1 1 0 0 1 1 0 1 0 1
3 1 1 1 0 1 1 0 0 0 1
7 1 1 1 1 1 1 1 1 0 1
10 1 2 1 1 1 2 1 2 1 1
14 1 1 0 1 1 1 0 2 1 2
Oedema
1 0 0 0 1 1 0 0 1 0 0
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3 0 0 0 0 1 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0 0
10 0 0 0 0 0 0 0 0 0 0
14 0 0 0 0 0 0 0 0 0 0
i
see Attachment 1 for Draize scales
LD50: > 2 000 mg/kg
Result: The notified polymer was of low dermal toxicity in rabbits.
It was a moderate skin irritant in this acute dermal toxicity
study when applied to skin for 24 hours under occlusive
dressing.
9.1.3 Inhalation Toxicity
Study was not conducted.
9.1.4 Skin Irritation (Covance, 1999b)
Species/strain: Rabbit / Hra:(NZW)SPF
Number/sex of animals: 3 males
Observation period: 1, 24, 48 and 72 hours after patch removal.
Method of administration: 0.5 mg test substance, moistened with mineral oil, was
applied to shaven intact skin, under semi-occlusive dressing,
for 4 hours.
Test method: OECD TG 404
Draize scores: Grade 1 erythema was observed in one animal at the 1 hour
observation time. Zero scores were recorded for erythema
and oedema at all other observation times in all animals.
Result: The notified polymer was not irritating to the skin of rabbits.
9.1.5 Eye Irritation (Covance, 1999c)
Species/strain: Rabbit / Hra:(NZW)SPF
Number/sex of animals: 3 males
Observation period: 1, 24, 48, 72 and 96 hours
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Method of administration: 48 mg (0.1 mL) test substance dropped into conjunctival sac
of one eye in each rabbit.
Test method: OECD TG 405
Draize scores of unirrigated eyes:
Time after instillation
Anim al 1 hour 24 hours 48 hours 72 hours 96 hours
Cornea o a o a o a o a o a
1
1 0 0 0 0 0 0 0 0 0 0
2 0 0 1 1 0 0 0 0 0 0
3 0 0 0 0 0 0 0 0 0 0
Iris
Zero scores were recorded for iridial effects in all animals at all time points
Conjunctiva r c d r c d r c d r c d r c d
1 1 1 1 2 1 0 1 1 0 1 0 0 0 0 0
2 1 0 0 2 1 0 1 1 0 0 0 0 0 0 0
3 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0
1
see Attachment 1 for Draize scales
o = opacity a = area r = redness c = chemosis d = discharge
Comment: Average scores for each animal from scores recorded for the
24, 48 and 72 observations times were:
corneal effects = 0, 0.33, 0;
iridial effects = 0,0,0;
conjunctival redness = 1.33, 1, 0.33;
conjunctival chemosis = 0.66, 0.66, 0.
Result: The notified polymer was slight to moderately irritating to
the eyes of rabbits.
9.1.6 Skin S ensitisation (Covance, 1999d)
Species/strain: Guineapig / Crl:(HA)BR
Number of animals: 20 test and 10 control animals
Induction procedure:
test group:
day 1 Intradermal injections:
0.1 mL of 1% test substance in mineral oil,
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0.1 mL of 1% test substance in Freund's Complete
Adjuvant,
0.1 mL of Freund's Complete Adjuvant in sterile water
(1:1).
day 7 Injection sites were treated with 10% sodium lauryl sulphate
in petrolatum.
day 8 Topical application: 50% test substance in petrolatum, under
occlusive dressing for 48 hours.
control group:
day 1 Intradermal injections:
0.1 mL mineral oil,
0.1 mL mineral oil in Freund's Complete Adjuvant (1:1),
0.1 mL of Freund's Complete Adjuvant in sterile water
(1:1).
day 7
Injection sites were treated with 10% sodium lauryl sulphate
in petrolatum.
day 8
Topical application : petrolatum under occlusive dressing for
48 hours.
Challenge procedure:
Day 22 35% test substance in petrolatum, applied to test and control
animals, under occlusive dressing for 24 hours.
Test method: OECD TG 406
Challenge outcome:
Test anim als Control animals
Challenge
concentration 24 hours* 48 hours* 24 hours 48 hours
35% 0/20** 0/20 0/10 0/10
* time after patch removal
** number of animals exhibiting positive response
Comment: Mild to moderate erythema and oedema were observed in
test and control animals at induction.
Result: The notified polymer was not sensitising to the skin of
guinea pigs.
9.2 Genotoxicity
9.2.1 Salmonella typhimurium Reverse Mutation Assay (Covance, 1999e)
Strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537
and Escherichia coli WP2uvrA
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Metabolic activation: Aroclor-induced rat liver S9
10, 33.3, 100, 333, 1000, 5000 礸/plate
Concentration range:
Test method: OECD TG 471 (plate incorporation method)
Comment: There were no statistically significant, dose-related increases
in the number of revertants in any of the tester strains.
Toxicity was not observed either in the presence or absence
of exogenous metabolic activation. Moderate precipitation
was seen with 1000 礸/plate and above.
Result: The notified polymer was non mutagenic under the
conditions of the t est.
9.3 Overall Assessment of Toxicological Data
Tinuvin NOR 371 FF is of very low acute oral and low acute dermal toxicity with LD50
values greater than 2 000 mg/kg being obtained in animal studies.
Based on the results of a standard skin irritation study in rabbits, Tinuvin NOR 371 FF is not
considered to be a skin irritant following a 4 hour exposure. However moderate irritation,
non-reversible within 14 days was observed in the acute dermal toxicity study. Therefore the
potential for skin irritation exits particularly at higher doses and longer exposure periods. The
notified polymer produced slight to moderate eye irritation in rabbits.
Tinuvin NOR 371 FF was not a skin sensitiser and did not produce mutagenicity in bacterial
cells.
Based on available toxicological information, the notified polymer would not be classified as
a hazardous substance according to the Approved Criteria for Classifying Hazardous
Substances (NOHSC, 1999b).
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
No ecotoxicological data were provided for assessment.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The environmental hazard from the notified polymer is considered to be low when it is used
in the manner indicated in the notification. Very little should reach natural waters.
Most material will be used in the production of plastic articles where it is incorporated into a
polymer matrix giving little possibility for release. At the end of their serviceable lives the
plastic articles will be disposed of to landfill or incinerated. In a landfill it could be expected
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that the notified polymer will be very slowly degraded. Incineration would result in instant
and immediate destruction. In either case the polymer will decompose to water and harmless
gases.
Due to its low water solubility and its incorporation in an inert polymer matrix, the notified
polymer will not leach from the landfill.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
Toxicological Hazard
Tinuvin NOR 371 FF is of very low acute oral and low acute dermal toxicity. It can produce
slight to moderate skin, and moderate eye irritation. It is not a skin sensitiser and does not
produce mutagenicity in bacterial cells. Studies for other end-points were not available. For
the end points tested, the notified chemical would not be classified as a hazardous substance
according to the Approved Criteria for Classifying Hazardous Substances (NOHSC 1999b).
NOHSC has established an exposure standard of 100 ppm or 377 mg/m3 (TWA) and 150 ppm
or 565 mg/m3 (STEL) for the hazardous impurity, toluene (CAS No. 108-88-3) (NOHSC,
1995).
Occupational Health and Safety
Waterside, warehouse and transport workers are unlikely to be exposed to the notified
polymer, as they will be handling sealed packages containing the notified polymer.
Therefore, occupational risk for these workers is considered to be low.
During formulation, workers involved in scooping, weighing and manual adding of granules
of the notified polymer and other materials to form the compounded plastic pellets, can
experience dermal or eye exposure to the notified polymer. Workers involved in other
processes, such as extrusion, quality control and bagging of plastic pellets, will have limited
exposure, since after compounding, the notified polymer is present at lower concentrations
(between 0.1-1%) and it is encapsulated in the masterbatch pellets. The solid granular/pellet
form of the notified polymer and the masterbatch pellets will minimise the generation of dust.
The notifier states that workers involved in the production of the masterbatch pellets will
wear eye protection, gloves and overalls to minimise potential dermal and ocular exposure to
the notified polymer. General and local ventilation is employed at the weighing area to
minimise inhalation exposure to the notified polymer.
At the injection mould sites, the masterbatch pellets will be re-extruded to form plastic
products. Since the notified polymer is encapsulated within the masterbatch pellets, the
health risk to workers from exposure to the notified polymer during the extrusion process is
considered to be low. The use of protective equipment will further control exposure to the
notified polymer.
Similarly, health risk to workers from exposure to the plastic articles containing the notified
polymer is considered to be low since the notified polymer will be present at low
concentration (between 0.1?%) and bound within the plastic articles.
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Public health
Public exposure to articles containing the notified polymer is likely to be limited. Though the
notified polymer is a moderate eye irritant, it will comprise 0.1 to 1% of a plastic article and
will be encapsulated within a plastic matrix, restricting contact with the polymer.
Consequently the public risk from exposure to the notified polymer through all phases of its
life cycle is considered to be low.
13. RECOMMENDATIONS
Control measures (for manufacturer/formulator)
OHS
Employers should implement the following engineering controls to minimise occupational
exposure to the notified polymer:
- Enclosure of mixing tanks during formulation to prevent exposure to aerosols
- Local exhaust ventilation during transfer of notified polymer from boxes to mixing
tank.
- Ensure that the NOHSC Exposure Standard for toluene of 100 ppm (TWA) and
150 ppm (STEL) is not exceeded in the workplace.
Employers should implement the following safe work practices to minimise occupational
exposure during handling of the notified polymer:
- During transfer to mixing tank, avoid generation of dust
Formulation plant workers and workers involved in injection moulding should wear the
following personal protective equipment to minimise occupational exposure to the notified
polymer:
- safety goggles
- industrial clothing
- impermeable gloves
- occupational footwear.
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 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.
14. MATERIAL SAFETY DATA SHEET
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The MSDS for the notified polymer was provided in a format consistent 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 the Act, the director must be informed if any of the circumstances stipulated under
subsection 64(2) of the Act arise, and secondary notification of the notified chemical may be
required. No other specific conditions are prescribed.
16. REFERENCES
Covance, 1999a, Acute oral toxicity study of TKA 45023 in rats, Covance 90305930,
Covance laboratories Inc., USA.
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Attachment 1
The Draize Scale (Draize, 1959) for evaluation of skin reactions is as follows:
Erythema Formation Rating Oedema Formation Rating
No erythema 0 No oedema 0
Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1
Well-defined erythema 2 Slight oedema (edges of area well-defined 2
by definite raising
Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3
Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm 4
and extending beyond area of exposure)
The Draize scale (Draize et al., 1944) for evaluation of eye reactions is as follows:
CORNEA
Opacity Rating Area of Cornea involved Rating
No opacity 0 none 25% or less (not zero) 1
Diffuse area, details of iris clearly 1 slight 25% to 50% 2
visible
Easily visible translucent areas, details 2 mild 50% to 75% 3
of iris slightly obscure
Opalescent areas, no details of iris 3 Greater than 75% 4
visible, size of pupil barely discernible moderate
Opaque, iris invisible 4 severe
CONJUNCTIVAE
Redness Rating Chemosis Rating Discharge Rating
Vessels normal 0 none No swelling 0 none No discharge 0 none
Vessels definitely 1 Any swelling above 1 slight Any amount different 1 slight
injected above normal slight normal from normal
More diffuse, deeper 2 mod. Obvious swelling with 2 mild Discharge with 2 mod.
crimson red with partial eversion of lids moistening of lids and
individual vessels not adjacent hairs
Swelling with lids half-
easily discernible
closed 3 mod. Discharge with 3 severe
Diffuse beefy red 3 severe moistening of lids and
Swelling with lids half- hairs and considerable
closed to completely 4 severe area around eye
closed
IRIS
Values Rating
Normal 0 none
Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight
No reaction to light, haemorrhage, gross destruction 2 severe
Draize, J. H., Woodward, G., Calvery, H. O. (1944) Methods for the Study of Irritation and Toxicity of
Substances Applied Topically to the Skin and Mucous Membranes, J. Pharmacol. Exp. Ther. 82 : 377-390.
Draize J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food
and Drug Officials of the US, 49 : 2-56.
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