HIMER EP-208
File No: NA/824
February 2001
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
1,4-Benzenedicarboxylic acid, polymer with 1,3-dihydro-1,3-dioxo-5-
isobenzofurancarboxylic acid, dimethyl 1,4-benzenedicarboxylate, formaldehyde, 2,5-
furandione, , '-[(1-methylethylidene) di-4,1-phenylene] bis[-hydroxypoly
(oxy-
, '-[(1-methylethyldiene)
1,2-ethanediyl)], di-4,1-phenylene] bis[-
hydroxypoly[oxy(methyl-1,2-ethanediyl)]], oxirane and phenol
(HIMER EP-208)
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 this full public report may also be requested, free of charge, by contacting the
Administration Coordinator on the fax number below.
For enquiries please contact the Administration Coordinator at:
Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA
Telephone: (61) (02) 9577 9514 FAX (61) (02) 9577 9465
Director
Chemicals Notification and Assessment
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NA/824 1/18
NA/824
FULL PUBLIC REPORT
1,4-Benzenedicarboxylic acid, polymer with 1,3-dihydro-1,3-dioxo-5-
isobenzofurancarboxylic acid, dimethyl 1,4-benzenedicarboxylate, formaldehyde,
2,5-furandione, , '-[(1-methylethylidene) di-4,1-phenylene] bis[-hydroxypoly
, '-[(1-methylethyldiene)
(oxy-1,2-ethanediyl)], di-4,1-phenylene] bis[-
hydroxypoly[oxy(methyl-1,2-ethanediyl)]], oxirane and phenol
(HIMER EP-208)
1. APPLICANT
Sharp Corporation of Australia Pty Ltd of 1 Huntingwood Drive, Huntingwood NSW 2148
(ACN: 003039 405) has submitted a limited notification statement in support of their
application for an assessment certificate for `HIMER EP-208'. No application for information
relating to `HIMER EP-208' to be exempt from publication in the Full Public Report and
Summary Report was received.
2. IDENTITY OF THE POLYMER
1,4-Benzenedicarboxylic acid, polymer with 1,3-
Polymer Name:
dihydro-1,3-dioxo-5-isobenzofurancarboxylic acid,
dimethyl 1,4-benzenedicarboxylate, formaldehyde,
2,5-furandione, , '-[(1-methylethylidene)di-4,1-
phenylene] bis[-hydroxypoly (oxy-1,2-ethanediyl)], ,
'-[(1-methylethyldiene) di-4,1-phenylene] bis[-
hydroxypoly [oxy (methyl-1,2-ethanediyl)]], oxirane
and phenol
213077-22-6
Polymer Abstracts Service
(CAS) Registry No.:
Terephthalic acid, polymer with trimellitic anhydride,
Other Names:
,'-[(1-methylethylidene) di-4,1-phenylene]bis[-
, '-[(1-
hydroxypoly (oxy-1,2-ethanediyl)],
methylethylidene) di-4,1-phenylene] bis[-hydroxypoly
[oxy (methyl-1,2-ethanediyl]], dimethyl terephthalate,
maleic anhydride, formaldehyde, ethylene oxide and
phenol
HIMER EP-208
Marketing Name:
((C3H6O)x(C3H6O)xC15H16O2.(C2H4O)z(C2H4O)z
Molecular Formula:
C15H16O2.(C6H6O.C2H4O.CH2O)y.C9H4O5.C8H6O4 .
C4H2O3.C10H10O4)n
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Structural Formula:
H2 O
H2 O
O C C OCH(CH3 )CH2 O
CH2 OCH2CH2O
H2C x
y y
H2C O O
O CH2 CH2
O O CH2 CH2 H3C CH3
O O
HO
O O H
O
O O CH2 CH(CH3O)
O x
H
O
z
O H2C
OC H3
OCH(CH3 )CH2 O
x OH
O
H3C CH3
H3C CH3
O
H
z
O
H
x
n
4 300 (GPC Method)
Number-Average
Molecular Weight (NAMW):
740 000 (GPC Method)
Weight-Average
Molecular Weight:
Maximum Percentage of Low
Molecular Weight Species
Molecular Weight < 500: 1.6 %
Molecular Weight < 1 000: 5.0 %
Weight Percentage of
Ingredients:
Polymer Name CAS No. Weight %
Poly(oxy-1,2-ethanediyl), , '-[(1- 32492-61-8 8.2
methylethylidene)di-4,1-phenylene]bis[-hydroxy-
1,4-Benzenedicarboxylic acid 100-21-0 18.4
Poly[oxy(methyl-1,2-ethanediyl)], , '-[(1- 37353-75-6 55.3
methylethylidene) di-4,1-phenylene]bis[-hydroxy-
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Formaldehyde, polymer with oxirane and phenol 25134-84-3 3.8
5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3- 552-30-7 5.2
dioxo-
2,5-furandione 108-31-6 2.7
1,4-Benzenedicarboxylic acid, dimethyl ester 120-61-6 6.4
1
H NMR, UV spectrum and IR spectrum
Method of Detection and
Determination:
1
H NMR polymer group shifts at: 8.2, 7.2, 6.8, 5.5, 4.7,
Spectral Data:
4.0, 3.8, 1.5 to 1.3 ppm. UV; broad band at 280 nm.
3. PHYSICAL AND POLYMER PROPERTIES
The following are for the notified polymer, unless otherwise specified.
The notified polymer is a lightly yellow, granular solid
Appearance at 20 癈 & 101.3 kPa:
with no specific odour.
The toner product containing the notified polymer is a
fine, black odourless powder.
approximately 170癈
Softening Point:
Approximately 1.2 x 103 kg/m3 at 20癈
Specific Gravity:
Not provided: the notified polymer is a solid at 25癈
Vapour Pressure:
approximately 1 mg/L
Water Solubility:
Not determined
Partition Co-efficient
(n-octanol/water):
Stable
Hydrolysis as a Function of pH:
Not determined
Adsorption/Desorption:
Not determined
Dissociation Constant:
Polymer = 93.4 % > 45 祄; 4.3% > 500 祄; Average
Particle Size:
= 180 祄.
Toner = 8.7 祄.
Carrier = 100 祄.
> 200 癈 (Cleveland open cup method)
Flash Point:
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Not provided: Not expected to be flammable.
Flammability Limits:
Not provided: Not expected to autoignite.
Autoignition Temperature:
Not provided: Not expected to be explosive.
Explosive Properties:
Not provided: Expected to be stable.
Reactivity/Stability:
Comments on Physico-Polymer Properties
The vapour pressure was not determined as the notified polymer has a high molecular weight
and is solid at room temperature. Thus, the vapour pressure is expected to be negligible.
Water solubility was determined using a modified flask method where the polymer was added
to water and the remaining solid material was filtered, dried and weighed. This method
indicated that the solubility of the notified polymer is ~1 mg/L.
Hydrolysis as a function of pH was determined using a modified flask method. The polymer
was placed in buffered solutions at pH 1.2, 4.0, 7.0 and 9.0 at 40癈 (prepared according to
OECD TG 111) and the solubility was determined as described above. After two weeks there
was no significant change compared with the water solubility. The polymer is believed to be
stable in the environmental pH range.
While the partition coefficient was not determined due to the low water and octanol solubility
of the polymer at 25癈, the octanol solubility was measured as 1 mg/L, suggesting that the
notified polymer will not partition significantly between the aqueous and organic phases.
Adsoption/desorption was not determined due to the low water solubility of the notified
polymer. It is thought that the polymer will become associated with soil and sediments.
No dissociation constant data was provided. The polymer contains a very small amount of
aromatic carboxylic acid functional groups, which are expected to have typical acidity and
dissociate. However, the insoluble nature of the polymer should prevent extensive
dissociation.
4. PURITY OF THE POLYMER
> 99 wt %
Degree of Purity:
None
Hazardous Impurities:
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Non-hazardous Impurities (> 1% by weight):
Chemica l name: Stannane, dibutyloxo-
Synonyms:
Weight percentage: <1.6%
CAS No.: 818-08-6
Chemical name: Water
Synonyms:
CAS No.: 7732-18-5
Weight percentage: 0.2%
Maximum Content of Residual Monomers:
Polymer Name CAS No. Weight %
Poly(oxy-1,2-ethanediyl), , '-[(1- 32492-61-8
methylethylidene)di-4,1-phenylene]bis[-hydroxy-
1,4-Benzenedicarboxylic acid 100-21-0
Poly[oxy(methyl-1,2-ethanediyl)], , '-[(1- 37353-75-6
methylethylidene) di-4,1-phenylene]bis[-hydroxy-
<1.6
Formaldehyde, polymer with oxirane and phenol 25134-84-3
5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3- 552-30-7
dioxo-
2,5-furandione 108-31-6
1,4-Benzenedicarboxylic acid, dimethyl ester 120-61-6
None
Additives/Adjuvants:
5. USE, VOLUME AND FORMULATION
The notified polymer will be imported in 100 g sealed toner cartridges or 700 and 800 g
bottles as a component of toners (AR-400NT, AR-400ST and AR-400T) and developers (AR-
400ND, AR-400SD and AR-400DV) used in photocopiers, laser printers and fax machines.
The notified polymer is used as a toner binding agent for fixing electrophotographic images
onto a sheet of paper. The notified polymer is present in the toners at 85-89% and in the
developers at 3.55%. Both the toners and developers are imported as a fine black powder.
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The notified polymer will be imported at a projected rate of 2.77 tonnes/year for the first five
years.
All manufacturing, formulation and packaging of the toners and developers will be performed
prior to importation.
At the time of this assessment the notified polymer was in use in Australia under a NICNAS
Commercial Evaluation permit (Permit No.:427) granted under section 21G of the Act.
6. OCCUPATIONAL EXPOSURE
Transport and Storage
The notified polymer will be imported as a component of toners and developers. The toners
and developers will be transported by road in bottles or cartridges sealed in plastic bags for
distribution to customers in the printing industry. Waterside, warehouse and transport
workers are unlikely to be exposed to the notified polymer during transportation and storage
except in the event of an accident.
Service Personnel
Duties of the service personnel will include cleaning the inside of the machine and servicing
the machine (particularly the exterior of the processing unit), and replacement of copier
developer. The notifier estimated total exposure time for an individual to be 47 hours per
year, based on 187 services and 0.25 hours per service. Both inhalation and dermal exposure
to the toner powder may occur during these activities.
Office Workers
Printing and/or office staff would add copier toner to the hopper once a month and replace the
toner cartridge every four months (160 000 copies) for a total anticipated exposure of 12
minutes/year. As the pre-packaged toner bottles and cartridges are sealed, the likelihood of
dermal or inhalation exposure to the notified polymer during toner replacement should be
low. Spent toner cartridges are disposed of through general office waste. During printing,
less than 50 mg of toner is transferred to each paper sheet and heat-cured, limiting the
potential for dermal exposure to the notified polymer from printed material.
If toner is spilt while changing cartridges or bottles, exposure may occur. In the event of a
spill, dermal and inhalation exposure to the notified polymer is expected to be high for the
toner (85-89% notified polymer) and low for the developer (3.55% notified polymer).
However, as the binder product has a large mean particulate size of 180 祄 (95 % > 45 祄),
the risk of respirability is low. Dermal exposure may also occur when clearing paper jams and
other minor fax, printer and photocopier mechanical failures.
Control of Exposure
No personal protective equipment has been recommended by the notifier. The Material Safety
Data Sheet (MSDS) states that a dust mask should be used while handling a large quantity of
toner or during long term exposure to the notified polymer.
Health Conditions and Adverse Effect Reporting
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The notifier advised that the notified substance is not known to cause any health conditions or
to affect any existing health conditions.
7. PUBLIC EXPOSURE
Public exposure to the notified polymer will occur during the filling of toner or developer
bottles and the changing of toner cartridges in photocopiers/printers/faxes. There will also be
contact with printed media containing the notified polymer. Consequently, any exposure is
likely to be dermal and/or by inhalation, with the possibility of ocular and oral exposure.
8. ENVIRONMENTAL EXPOSURE
Release
Under normal use the toner/developer containing the notified polymer is transferred onto a
sheet of paper where it is firmly fixed to the surface by heat. Release to the environment will
be negligible. Waste paper containing the toner/developer will eventually be sent to landfill,
recycled or incinerated.
Release of the notified polymer will also occur through the disposal of bottles containing
residues of the toner/developer. Though the notifier has indicated that 1 g of residue is left in
a toner/developer container (~0.15% of original contents), experience suggests that,
depending on the design of the bottles, residual toner levels of up to 1% are more realistic.
The expected volume of residue remaining in cartridges may be up to 7 g. However, as the
toner contains 89% of the notified polymer, the maximum quantity of polymer released in this
fashion would be 6.3 g per bottle. This represents a maximum of up to 28 kg of the notified
polymer per year on current import volume projections. The spent bottles will be disposed of
to landfill, a process which would be widespread across Australia.
Additional release to the environment will result from disposal of the used toner container
from the photocopy machine. This will amount to up to 123 kg per year, approximately 5%
of the import quantity. The used toner would be disposed of through general office waste,
with most going to landfill.
Fate
Some waste paper may be disposed of directly to landfill with the notified polymer strongly
bound to the paper. It is anticipated that prolonged residence in an active landfill environment
would eventually degrade the notified polymer. Incineration of waste paper will destroy the
polymer with the generation of water vapours and oxides of carbon.
Printed paper may also be recycled. The notifier has provided no data on the likely behaviour
of the polymer during the paper recycling process. During such processes, waste paper is
repulped and de-inked. De-inking wastes are expected to go to trade waste sewers.
The low water solubility of the notified polymer suggests that any released to the aquatic
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compartment will associate with sediments and soils. Polymer disposed of to landfill is
unlikely to leach or contaminate surface water.
Due to the large molecular weight of the notified polymer, it is not expected to cross
biological membranes or bioaccumulate.
9. EVALUATION OF TOXICOLOGICAL DATA
The notifier has not submitted toxicity studies using the notified polymer. Instead the notifier
has submitted toxicity studies using the Toner product AR-ST17-B, which contains the
notified polymer at >85%. The studies are accepted as providing a reasonable indication of
the toxicity of the polymer.
9.1 Acute Toxicity
Summary of the acute toxicity of AR-ST17-B
Test Species Outcome Reference
Acute oral toxicity rat >2000 mg/kg Environmental Biological Life
Science Research Centre, 1998a
Skin irritation rabbit Non irritating Environmental Biological Life
Science Research Centre, 1998b
Eye irritation rabbit Non irritating Environmental Biological Life
Science Research Centre, 1998c
9.1.1 Oral Toxicity (Environmental Biological Life Science Research Centre, 1998a)
Species/strain: Rat/Sprague-Dawley
Number/sex of animals: 5/sex
Observation period: 14 days
Method of administration: Oral (gavage) of 2 000 mg/kg of body weight in female and
male rats.
Test method: OECD TG 401
Mortality: No deaths occurred during the observation period.
Clinical observations: Black staining of the hair around the anus on day one after
dosing was observed in all animals.
Morphological findings: No morphological abnormalities were detected in all animals
sacrificed at day 14.
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Comment: Normal bodyweight gains were observed for all animals.
LD50: >2000 mg/kg bodyweight.
Result: The notified polymer was of very low acute oral toxicity in
rats.
9.1.2 Skin Irritation (Environmental Biological Life Science Research Centre, 1998b)
Species/strain: Rabbit/New Zealand Albino
Number/sex of animals: 3
Observation period: 3 days
Method of administration: A semi-occlusive application of 0.1 g test substance
moistened with a little water was made on the dorsal skin.
After 4 hours, the substance was carefully removed with
70% ethanol.
Test method: OECD TG 404
Draize scores:
Time after Animal #
treatment 1 2 3
(days)
Erythema
all scores were zero
Oedema
all scores were zero
a
see Attachment 1 for Draize scales
Result: The notified polymer was not irritating to the skin of rabbits.
9.1.3 Eye Irritation (Environmental Biological Life Science Research Centre, 1998c)
Species/strain: Rabbit/New Zealand Albino
Number/sex of animals: 3
Observation period: 3 days
Method of administration: A single dose of 0.1 g of test substance was applied to the
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conjunctival sac of the right eye of each animal, with the left
untreated eye serving as control.
Test method: OECD TG 405
Draize scores of unirrigated eyes:
Time after instillation
Animal 1 day 2 days 3 days
Cornea
all scores were zero
Iris
all scores were zero
Conjunctiva
all scores were zero
Comment: Eye irritation was not observed in all animals tested.
Result: The notified polymer was not irritating to the eyes of rabbits.
9.2 Genotoxicity
9.2.1 Salmonella typhimurium Reverse Mutation Assay (Environmental Biological Life
Science Research Centre, 1998d)
Strains: Salmonella typhimurium strains TA 1535, TA 1537, TA 98
and TA 100 and Escherichia coli strain WP2 uvrA
Metabolic activation: Liver fraction (S9 mix) from rats pretreated with
phenobarbital and -benzoflavone
Concentration range: Dose ranging study;
0, 0.3, 1.2, 4.9, 19.5, 78.1, 312.5, 1 250 and 5 000 礸/plate.
Main Study;
0, 156.3, 312.5, 625, 1 250, 2 500 and 5 000 礸/plate.
Each concentration was tested with and without the presence
of metabolic activator.
Each data point was tested in duplicate.
Appropriate strain specific control reference substances were
used.
Test method: OECD TG 471
Comment: A stock solution of the test article at 100 mg/mL was
prepared in acetone.
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In the dose ranging study the test article was found to
precipitate at 78.1 礸/plate in the absence of metabolic
activator and 312.5 礸/plate in the presence of metabolic
activator. In the main study the test article was found to
precipitate at all concentrations in the absence of metabolic
activator and 312.5 礸/plate in the presence of metabolic
activator.
Bacterial growth was not inhibited by precipitation of the
test article.
Result: The notified polymer was non mutagenic under the
conditions of the test.
9.3 Overall Assessment of Toxicological Data
The notifier submitted toxicity studies using the Toner product AR-ST17-B, which contains
the notified polymer at >85%.
The product AR-ST17-B has very low acute oral toxicity (LD50 > 2 000 mg/kg) in rats.
Acute dermal toxicity and acute inhalation studies have not been conducted for the notified
polymer or the product AR-ST17-B. In rabbits, the product AR-ST17-B was not a skin or eye
irritant. No sensitisation or repeat dose toxicity studies have been conducted using the
notified polymer or the product AR-ST17-B.
As indicated in the MSDS for the notified polymer and the product AR-400NT, mechanical
irritation of the eyes and inflammation and irritation of the respiratory tract may result from
exposure to the notified polymer in dust form as well as the toner or developer containing the
notified polymer.
Although the toner product AR-ST-17B revealed no mutagenic activity in a bacterial test
system, it should be noted that the test substance was found to precipitate at all concentrations
in the absence of metabolic activator and at concentrations above 312.5 礸/plate in the
presence of metabolic activator. It is noted that the MSDS for the product AR-400NT states
that a two-year cancer study using a typical toner preparation containing carbon black
demonstrated no association between toner exposure and tumour development in rats.
Based on the data submitted the notified polymer could not be classified as a hazardous
substance against the Approved Criteria for Classifying Hazardous Substances (National
Occupational Health and Safety Commission, 1999).
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10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
No ecotoxicology data were provided.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The notified polymer will enter environmental compartments indirectly via disposal of waste
paper for recycling, to landfill or for incineration, and directly from release from discarded
spent bottles at landfill sites and sludge from paper recycling processes. Release of the
notified polymer to the environment is expected to be low and widespread.
Following accidental spillage of the toner, either during filling of toner hoppers or during
transport, powder wastes should be sent to either landfill or incineration facilities.
The notified polymer is expected to be immobile in soils, sediments and landfill sites and
should not partition to the aquatic environment because of its low water solubility.
On the basis of the available information the overall environmental hazard of the notified
polymer is expected to be low.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
Hazard Assessment
The notified polymer is a powder of mean particulate size of 180 祄 (95 % > 45 祄), ie it is
possibly inspirable but not respirable.
The toner product AR-ST17-B, which contains the notified polymer at >85%, is of very low
acute oral toxicity in rats (LD50 > 2 000 mg/kg), was not a skin or eye irritant and did not
result in mutagenic activity in an Ames test.
Acute dermal and acute inhalation toxicity studies, skin or respiratory sensitisation studies,
and chromosome aberration studies have not been conducted for the notified polymer or the
product AR-ST17-B.
Based on the limited toxicological data supplied for the notified polymer the substance cannot
be classified as a hazardous substance against the Approved Criteria for Classifying
Hazardous Substances (National Occupational Health and Safety Commission 1999).
Occupational Health and Safety
There is little potential for significant occupational exposure to the notified polymer in the
transport and storage of the toner and developer products that contain the notified polymer.
Service personnel may experience inhalation and dermal exposure to toner and developer
powders while cleaning and servicing the inside of photocopies, printers and fax machines
(particularly the exterior of the processing unit). As there may be a low level of toner and
developer dust inside photocopies, printers and fax machines, service personnel should wear
personal protective equipment, such as a dust mask, to limit inhalation exposure to the
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notified polymer. The high molecular weight of the notified polymer indicates that dermal
absorption would be minimal.
Office workers may experience infrequent dermal exposure when changing the toner or
developer, while clearing paper jams or cleaning up small spills. Due to the enclosed design
of toner cartridges and the short duration required to perform these functions, exposure to the
notified polymer should be minimal. The instructions on the cartridge label and instruction
sheet on how to insert a new cartridge should be followed. The high molecular weight of the
notified polymer indicates that dermal absorption would be minimal. As there may be a low
level of toner and developer dust in the immediate vicinity of photocopies, faxes and printers
when they are operating, the area around them should be well ventilated.
Based on the low toxicological hazard presented by the polymer and the expected low
exposures, the health risk posed to service personnel and office workers by the notified
polymer is low.
However, it should be noted that the toners and developers, which contain the notified
polymer, also contain potentially hazardous ingredients such as carbon black, iron oxide and
magnesium oxide. It is important that appropriate measures are taken to control any
occupational exposure to these components. Employers should ensure that the exposure
standards for these agents are adhered to in the workplace.
Public Health
Public exposure to the notified polymer will predominantly occur from dermal contact with
printed media. Once printed, the notified polymer is heat-cured onto paper making it
biologically unavailable. Occasional exposure will also occur from the filling of toner or
developer bottles and changing of toner cartridges. A mean particle size of 180 祄 (95% >45
祄) greatly reduces the potential inhalation hazard; consequently the main toxicological
hazard is likely to be mechanical irritation by inert particulate material to the eye or the
respiratory system. Therefore, the potential hazard to the public throughout of the life of the
notified polymer is considered to be low.
13. RECOMMENDATIONS
To minimise occupational exposure to HIMER EP-208 the following guidelines and
precautions should be observed:
Service personnel should wear a disposable dust mask to minimise inhalation
?br>
exposure to the toner or developer;
Photocopies, faxes and printers utilising toners and developers containing the notified
?br>
polymer should be located in a well ventilated area when operating to minimise the
concentration of airborne particles;
Employers should ensure that the exposure standards for ingredients in the toners and
?br>
developers are adhered to in the workplace;
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Spillage of the notified polymer should be avoided. Spillages should be swept or
?br>
wiped promptly and put into containers for disposal;
A copy of the MSDS should be easily accessible to employees.
?br>
If products containing the notified polymer are hazardous to health in accordance with the
National Occupational Health and Safety Commission Approved Criteria for Classifying
Hazardous Substances (National Occupational Health and Safety Commission, 1999),
workplace practices and control procedures consistent with State and Territory hazardous
substances regulations must be in operation.
14. MATERIAL SAFETY DATA SHEET
The MSDS for HIMER EP-208 and the toner and developer products containing HIMER EP-
208 were provided in a format consistent with the National Code of Practice for the
Preparation of Material Safety Data Sheets (National Occupational Health and Safety
Commission, 1994).
A sample MSDS for a toner product containing HIMER EP-208 is published in the
assessment report. The accuracy of the information remains the responsibility of the
applicant.
15. REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, secondary notification of HIMER EP-208 may be required if any of the
circumstances stipulated under subsection 64(2) of the Act arise. No other specific conditions
are prescribed.
16. REFERENCES
Connell D W, 1989. `General characteristics of organic compounds which exhibit
bioaccumulation'. In Connell D W, (Ed) Bioaccumulation of Xenobiotic Compounds. CRC
Press, Boca Raton, USA.
Environmental Biological Life Science Research Centre, Inc. (1998a) Acute oral toxicity of
Toner (AR-ST17-B, AR-330CT, AR-330LT) for AR-330MT series in Rat. Report No. 2731,
(English Translation) Japan.
Environmental Biological Life Science Research Centre, Inc. (1998b) Primary dermal
irritation test of Toner (AR-ST17-B, AR-330CT, AR-330LT) for AR-330MT series in
Rabbits. Report No. 2732, (English Translation) Japan.
Environmental Biological Life Science Research Centre, Inc. (1998c) Primary ocular
irritation test of Toner (AR-ST17-B, AR-330CT, AR-330LT) for AR-330MT series in
Rabbits. Report No. 2733, (English Translation) Japan.
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Environmental Biological Life Science Research Centre, Inc. (1998d) Bacterial reverse
mutation test of Toner (AR-ST17-B, AR-330CT, AR-330LT) for AR-330MT series. Report
No. 2734, (English Translation) Japan.
National Occupational Health and Safety Commission (1999) Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(1999)]. Australian Government Publishing
Service, Canberra.
National Occupational Health and Safety Commission (1994) National Code of Practice for
the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)]. Canberra, Australian
Government Publishing Service.
7 February 2001
FULL PUBLIC REPORT
NA/824 16/18
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 oedema (raised approx. 1 mm) 3
Moderate to severe erythema 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
50% to 75% 3
Easily visible translucent areas, details 2 mild
of iris slightly obscure
Greater than 75% 4
Opalescent areas, no details of iris 3
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
07 February 2001
FULL PUBLIC REPORT
NA/824 17/18
MSDS
07 February 2001
FULL PUBLIC REPORT
NA/824 18/18
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