Dehymuls PGPH
File No: PLC/96
February 1999
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
Dehymuls PGPH
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 Family Services.
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
PLC/96
FULL PUBLIC REPORT 3 November, 2000
PLC/96 1/17
FULL PUBLIC REPORT
Dehymuls PGPH
1. APPLICANT
Henkel Australia Pty Ltd of 83 Maffra Street BROADMEADOWS VIC 3047 has submitted a
notification statement in support of their application for an assessment certificate for a
synthetic polymer of low concern, Dehymuls PGPH.
2. IDENTITY OF THE CHEMICAL
The chemical name, CAS number, molecular and structural formulae and spectral data have
been exempted from publication in the Full Public Report.
SAT 940669
Other Name:
Dehymuls PGPH or Dehymuls KE 3190
Trade Name:
2 400 (visual estimate from mass spectrogram).
Number-Average
Molecular Weight (NAMW):
It is stated a GPC analysis could not be carried out due
to the nature of the notified substance. However the
Number Average Molecular Weight and low weight
fractions were established from a mass spectrum of the
substance.
Maximum Percentage of Low
Molecular Weight Species
Molecular Weight < 500: 0.5%
Molecular Weight < 1 000: 1.5%
Weight Percentage of
Ingredients:
Chemical Name CAS No. Weight %
polyglycerine 25618-55-7 66.7
poly(12-hydroxystearic acid) 27924-99-8 33.3
Method of Detection
IR, MS
and Determination:
3. PHYSICAL AND CHEMICAL PROPERTIES
FULL PUBLIC REPORT 3 November, 2000
PLC/96 2/17
Appearance at 20癈
cloudy viscous liquid
and 101.3 kPa:
23-32癈
Melting Point:
939 kg/m3 at 25癈
Specific Gravity:
<0.1 kPa at 25癈
Vapour Pressure:
< 1 g/L (see comments below)
Water Solubility:
Partition Co-efficient
not determined
(n-octanol/water):
Hydrolysis as a Function
may hydrolyse under extreme conditions
of pH:
not determined
Adsorption/Desorption:
the polymer does not have any group that undergoes
Dissociation Constant:
dissociation
292癈
Flash Point:
combustible
Flammability:
>390癈
Autoignition Temperature:
no explosive properties
Explosive Properties:
aliphatic hydroxyl (low concern)
Reactive Functional Groups:
expected to be stable under normal use conditions (see
Reactivity/Stability:
comments below)
Comments on Physico-Chemical Properties
Tests were performed according to test guidelines at facilities complying with OECD
Principles of Good Laboratory Practice.
The water solubility has been determined at less than 1 g/L. A mix at 1 g/L produced a
solution that was cloudy. It could not be shown that this was the solubility limit for the
polymer. An analysis of the Dissolved Organic Carbon (DOC) in test solutions used for fish
ecotoxicity tests was made to confirm the expected "low" solubility. Part of the DOC (of
7.7 mg per gram of product) is probably 0.5% residual 12-hydroxystearic acid.
The substance contains an ester functionality that may undergo hydrolysis under extreme
FULL PUBLIC REPORT 3 November, 2000
PLC/96 3/17
conditions of temperature and pH.
4. PURITY OF THE CHEMICAL
99.45%
Degree of Purity:
Toxic or Hazardous
not stated
Impurities:
Non-hazardous Impurities
not stated
(> 1% by weight):
Maximum Content of Residual
Monomers/Other Reactants:
Chemical Name CAS No. Weight %
Polyglycerine 25618-55-7 0.0
12-hydroxystearic acid 106-14-9 0.3-0.5
not stated
Additives/Adjuvants:
5. USE, VOLUME AND FORMULATION
The notified polymer is to be used as an emulsifier in skin care lotions at concentrations up to
5%. The notified polymer will not be manufactured in Australia. It will be imported in 200
kg steel drums and reformulated in Australia. The estimated import volumes are:
Year 1 2 3 4 5
tonnes 6 10 10 10 10
6. OCCUPATIONAL EXPOSURE
The main route for occupational exposure will be dermal contamination as the vapour
pressure for the notified polymer is low. Mists are unlikely to be generated as the polymer is
viscous.
Transport and Storage
The notified polymer will be imported as a 100% viscous liquid in 200 kg steel drums. It is
estimated that 10 workers will be involved in the transport and storage of the polymer,
including waterside workers, transport drivers and warehouse operators. They will handle the
notified polymer 2-3 hours per day and 10-15 days per year.
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PLC/96 4/17
Occupational exposure for transport and storage workers is unlikely unless the drums were
breached in the event of an accident. The transport and warehouse workers will wear overalls
and safety boots.
Formulation-Mixing
At the formulation site, the notified polymer, 50 L per batch, is transferred to 1 000 L sealed
mixing tanks by metered dosing pumps. During the process, the oil and water phases will be
heated to 80癈, blended together and cooled to approximately 30癈 before filling. As the
formulation is an enclosed and automatic process, formulators may be contaminated with the
notified polymer only during connecting and disconnecting the transfer lines to the mixer.
The formulation will be carried out about 2 batches per day. It is estimated that there will be
8 workers at the formulation site. They will work 8 hours per day and 60-100 days per year.
During formulation processes, workers will wear PVC gloves, safety glasses, uniforms and
safety shoes. General and local ventilation is used.
Formulation-Filling
The final concentration of the notified polymer in the products is up to 5%. The formulated
product is piped directly by metered dosing pumps to the filling machines, which are sealed
and automated. The final product is filled into 250 mL moulded plastic bottles ready for
distribution to retail outlets. There will be 25 packaging workers handling the products 8
hours per day and 60-100 days per year. They will operate and clean the automated guarded
filling equipment. Skin contamination may occur due to overfilling or spills during filling
process. Workers also could be exposed to the notified polymer during cleaning up through
skin or eye contact.
R&D and Quality Control
There will be 3 R&D workers handling the notified polymer 6 hours per day and 15 days per
year. They will disperse the notified polymer with other components by laboratory mixers to
prepare trial batches. R&D workers will wear laboratory coats and safety glasses.
In addition, there will be 5 quality control workers who will handle the notified polymer on 4
hours per day and 30 days per year basis. Quality control workers will use laboratory
equipment to test the raw material and the final formulations containing the notified polymer.
The notifier has not specified the personal protective equipment for quality control workers,
however, they would be expected to wear laboratory coats and safety glasses.
Both R&D and quality control workers will handle small amounts of the notified polymer and
operate at a small scale in the laboratory.
End use
Beauty salon workers and beauticians will use the products containing the notified polymer.
The maximum concentration of the notified polymer in the products will be 5%. Dermal
would be the main route of exposure. The duration of handling the products containing the
notified polymer among beauty salon workers and beauticians is expected to be short.
7. PUBLIC EXPOSURE
FULL PUBLIC REPORT 3 November, 2000
PLC/96 5/17
Public exposure from reformulation and disposal is expected to be minimal. Since the
notified chemical is to be used as a cosmetic ingredient in body lotions, primary public
exposure to the notified polymer will be by dermal contact, and possibly ocular contact.
8. ENVIRONMENTAL EXPOSURE
Release
Although the production activity takes place in a purpose-constructed facility with standard
controls for capture of accidental releases, some release to the environment through spillage is
possible during product formulation. The notifier estimates that a maximum of 5% (annually
300-500 kg) of the imported volume may be lost in this manner. The material released in the
plant as a result of spills and cleaning activities is sent with other waste to an on-site
treatment facility consisting of a solids and oil interceptor followed by chemical/biological
treatment. The effluent from this treatment is released to sewer. The residual solids and
liquids from the interception processes are disposed of by licensed waste contractors.
The notifier indicates that each empty drum is likely to contain 4 kg of the chemical. Drums
are cleaned on site and the rinsings treated at the on-site effluent neutralisation plant.
The notifier also estimates that around 2% of the skin care products is likely to remain in the
depleted consumer packages. These would be discarded with household garbage and
ultimately placed into landfill or incinerated. This would account for 195 kg of the chemical
per annum.
The new chemical is a component of cosmetic products, which would consequently be
expected to be released into the environment through the sewerage system. The notifier has
estimated that the release of the notified substance from an individual application would be
50 mg (10% of that applied), which would be washed off during showering. The usual
volume of water used in showering is 60 litres, resulting in an influent concentration of 0.83
mg/L and a predicted environmental concentration (PEC) in metropolitan receiving waters of
0.00083 ppm. Country treatment works could be expected to release a concentration of 0.021
ppm.
Fate
The notifier provided a laboratory report on the assessment of the biodegradation of the
notified substance conducted in accordance with the guidelines for the Modified OECD
Screening Test [OECD TG 301E]. The results of the test indicated 44% loss of initial
chemical oxygen demand (COD) of the notified substance after 7 days, and 88% loss of COD
after 28 days. This was interpreted in the report as indicating that the material was readily
biodegradable under the conditions of this test. Strictly however, for a compound to be
classified as readily biodegradable under TG 301E, > 70 % reduction in DOC should be
attained after 28 days and this level of degradation should be achieved within 10 days of
attainment of 10% degradation. In this case, it was 14 days. Sodium acetate, used as the
standard in this test, had lost 86% of the initial COD after 28 days, but had been 70%
degraded after 7 days from start of the test.
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PLC/96 6/17
Residual chemical disposed of to landfill within empty drums or together with residual solids
derived from water treatment at the production facility would be subject to the biological and
abiotic processes operative in these situations. The notified chemical is expected to degrade
to water, methane and carbon dioxide. Similarly, incineration of the material would produce
water vapour and oxides of carbon.
Most of the new chemical is expected to be released into the sewerage system. The
hydrophobic and surface active nature of the chemical indicates that it would become
associated with the organic component of the particulate matter present in the raw sewage,
and eventually become incorporated into sediments where it would be expected to undergo
biological degradation.
9. EVALUATION OF TOXICOLOGICAL DATA
9.1 Toxicity Studies
Summary of the acute toxicity of Dehymuls PGPH.
Test Species Outcome Reference
acute oral toxicity rat LD50 > 18 500 mg/kg (FAO/WHO, 1969)
(analogue)
skin irritation rabbit a slight skin irritant (Pels Rijcken, 1994)
eye irritation rabbit a slight eye irritant (Pels Rijcken, 1995)
skin sensitisation guinea pig a weak skin sensitiser (Pittermann, 1994)
9.1.1 Oral Toxicity on Interesterified Ricinoleic Acid (Unilever Research Labs, 1966
cited in FAO/WHO, 1969)
The acute oral LD50 in rat for the analogue substance interesterified ricinoleic acid was
reported as > 18 500 mg/kg.
9.1.2 Skin Irritation (Pels Rijcken, 1994)
Species/strain: rabbit/New Zealand White
Number/sex of animals: 3 males
Observation period: 7 days
Method of administration: the notified chemical (0.5 mL) was applied to the
intact skin for 4 hours under a semi-occlusive
dressing
FULL PUBLIC REPORT 3 November, 2000
PLC/96 7/17
Draize scores (Draize, 1959):
Animal Time after after treatment
1 hour 1 day 2 days 3 days 7 days
Erythema
a
1 0 2 2 1 0
2 1 1 1 0 0
3 1 2 1 0 0
Oedema
1 1 1 0 0 0
2 0 1 0 0 0
3 0 1 0 0 0
a
see Attachment 1 for Draize scales
Test method: OECD TG 404 (Organisation for Economic Co-
operation and Development, 1995-1996)
Result: the notified chemical was slightly irritating to the
skin of rabbits
9.1.3 Dermatological Evaluation in Humans (Matthies & Molitor, 1995)
A brief report entitled "Dehymuls PGPH, RIS-No: 51Z1200325000, Dermatological
Evaluation" from Department of Dermatology, Henkel KgaA was provided.
A 20% ethanolic dilution of the substance was applied to the skin of 20 volunteers over a 24
hour period. The application was performed using Finn Chambers to create conditions for a
higher penetration of the test substance. The application site was not described.
Three individuals developed slight to moderate erythema and slight squamation. The authors
concluded that "Dehymuls PGPH can be recommended as good skin compatible for the use as
emulsifier up to 10% in cosmetic and pharmaceutic products".
9.1.4 Eye Irritation (Pels Rijcken, 1995)
Species/strain: rabbit/New Zealand White
Number/sex of animals: 3 males
Observation period: 72 hours
Method of administration: the notified chemical (0.1 mL) was instilled in the
conjunctival sac of one eye of each animal
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PLC/96 8/17
Draize scores (Draize, 1959):
Time after instillation
Animal 1 hour 1 day 2 days 3 days
Conjunctiva r r r r
1 2 1 0 0
2 2 1 0 0
3 2 1 0 0
1
see Attachment 1 for Draize scales
r - redness
The Draize scores for cornea (opacity and area), iris and conjunctiva (chemosis and
discharge) were zero for all animals up to 72 hours. No corneal epithelial damage was
revealed, under fluorescein staining.
Test method: OECD TG 405 (Organisation for Economic Co-
operation and Development, 1995-1996)
Result: the notified chemical was a slight irritant to the
eyes of rabbits
9.1.5 Skin Sensitisation (Pittermann, 1994)
Species/strain: guinea pig/Dunkin Hartley
Number of animals: 20 females (treatment), 10 females (control)
Induction procedure: 0.5 mL of the notified chemical (12.5% in peanut
oil) was applied 3 times (day 1, 8, 15) to the left
flank under an occlusive dressing for 6 hours.
Challenge procedure: 14 days after the third induction, 0.5 mL of the
notified chemical (10% in peanut oil) was applied
to both flanks under an occlusive dressing for 6
hours
Challenge outcome:
Challenge Test animals Control animals
concentration 24 h* 48 h 24 h 48 h
72 h 72 h
10% (left flank) **1/20 5/20 0/20 0/10 1/10 0/10
10% (right flank) 0/20 1/20 0/20 0/10 2/10 0/10
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PLC/96 9/17
* time after patch removal
** number of animals exhibiting positive response
Test method: Buehler test, similar to OECD TG 406
(Organisation for Economic Co-operation and
Development, 1995-1996)
Result: the notified chemical was a weak skin sensitiser in
guinea pigs
9.1.6 Photo-Irritation-Cytotoxicity in Mouse Fibroblasts in vitro (Schroder, 1997)
Cell culture: mouse fibroblast (Balb/c)
preliminary test: 3 ?10 000 礸/mL;
Concentration range:
main test: 1 ?2 000 礸/mL as either an emulsion or
as a solution in 1-propanol
Test method: cell viability was determined after cell cultures
incubated with the notified chemical were
irradiated with a UV dose of approximately 5
J/cm2. Chlorpromazine and Texapon ASV were
used as the positive and negative controls.
Result: the notified polymer did not show any phototoxic
potential in the in vitro test while both positive and
negative controls demonstrated the appropriate
responses.
9.1.7 Salmonella typhimurium Reverse Mutation Assay (Banduhn, 1994)
Strains: S. typhimurium TA 1535, TA 1537, TA 1538, TA
98 and TA 100
8.0 ?5 000 礸/plate in the absence or presence of
Concentration range:
metabolic activation by S9-mix
Test method: OECD TG 471 (Organisation for Economic Co-
operation and Development, 1995-1996)
Remarks: No cytotoxicity or precipitation was observed at the
test concentrations. The positive and negative
controls tested accordingly.
Result: Dehymuls Ke 3190 (Dehymuls PGPH) did not
induce gene mutations in this bacterial
mutagenicity test, with or without S9 metabolic
FULL PUBLIC REPORT 3 November, 2000
PLC/96 10/17
activation.
9.1.8 Repeated Dose Toxicity (Unilever Research Labs, 1966 cited in FAO/WHO,
1969)
Some short-term and long-term studies for the analogue substance interesterified ricinoleic
acid in animals and humans were included in the FAO/WHO report. The treated animals
essentially did not show any adverse effects apart from an increase in liver and kidney
weights after more than 45 weeks treatment.
9.2 Overall Assessment of Toxicological Data
The notifier provided published FAO/WHO literature on the acute toxicity of polyglycerol
esters of interesterified ricinoleic acid, which has a similar structure to the notified polymer.
The level of reporting in this paper is basic and it cites an earlier study for the oral LD50. As
cited, the acute oral LD50 for polyglycerol esters of interesterified ricinoleic acid in rats is
>18 500 mg/kg. Thus, the notified polymer is expected to be of very low acute oral toxicity.
The notifier provided a published paper on a validation study of hen's egg chorioallantoic
membrane (HET-CAM) test (Spielmann et al., 1993), which is an in vitro screening test for
eye irritation. Dehymuls PGPH has been tested and found to produce slight reactions in the
vascular system of the chorioallantoic membrane. The report is unpublished and was
unavailable for assessment. However, based on the slight positive findings, an eye irritation
study was conducted in rabbits and this study was provided for assessment. It showed that
the notified polymer was a slight eye irritant, but would not warrant a health hazard
classification as an eye irritant.
The notified polymer was a slight skin irritant in rabbits and a weak skin sensitiser in guinea
pigs. A skin irritation study in humans revealed that the notified polymer was a slight skin
irritant in humans (3/20 volunteers). The notified polymer did not show any phototoxic
potential in mouse fibroblast cell cultures in vitro suggesting that the chemical in skin
products does not increase danger from the sun.
Dehymuls PGPH was not mutagenic in bacteria with and without metabolic activation.
Dehymuls PGPH could not be classified as a hazardous substance according to NOHSC
Approved Criteria for Classifying Hazardous Substances (National Occupational Health and
Safety Commission, 1994a) based on the available data.
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
Although not required by the Act for new chemicals assessed as Synthetic Polymers of Low
Concern, the notifier supplied the following ecotoxicity data - specifically laboratory reports
on the acute toxicity of the notified substance to zebra fish and on the inhibition of bacteria.
FULL PUBLIC REPORT 3 November, 2000
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Test Species Results (Nominal)
LC50(96 h) > 10 000 mg/L
Acute Toxicity (semi static) Brachydanio rerio
LC0 (96 h) = 10 000 mg/L
[EU TG 92/96 EWG] (Zebra fish)
Bacterial inhibition Pseudomonas putida EC10 > 10 000 mg/L
EC0 = 10 000 mg/L
[DIN 38412, Part 27]
The tests results indicate that the notified substance is non toxic to the zebra fish, with a 96
hour LC0 of 10 000 mg/L. Nominal concentrations were used because of the lack of solubility
of the substance even with the aid of a dispersant (ultraturrax). The measured concentrations
of dissolved organic carbon (DOC) were around the average of 7.7 mg per gram of product for
the duration of the test showing that the substance was present at low levels. Values did not
alter over the period of the test. No fish died or were affected at any concentration tested.
The acute bacterial toxicity test assesses the ability of a bacteria to continue normal respiration
in the presence of the test substance over a period of 30 minutes. The notified substance is
shown to be non toxic to bacteria at the maximum nominal rate tested of 10 000 mg/L.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
Release to the environment from formulation and packaging of the notified substance at the
factory site is expected to be captured by the on-site collection and treatment systems.
Effluent released after this treatment to the municipal sewage stream will be further fixed to
sludge or reduced by micro-organisms in the digesters.
Packaging into individual 250 mL containers and packaging in boxes for distribution to retail
point of sale will reduce potential exposure from transport accident.
Domestic use across Australia is expected and low levels of the notified substance in effluent
would be quickly diluted in the receiving waters or degraded by micro-organisms. The worst
case dilution figures provided by the notifier show limited release at concentrations of 0.021
mg/L, below the level of concern for harm to the most sensitive ecotoxicity test of
10 000 mg/L for fish and bacteria.
Calculations based on 100% discharge of the new chemical into Australian domestic sewers
(of 10 000 kg per year, or 27 kg per day), and assuming an average of 150 L of water released
to sewer per person per day and a national population of 18 000 000, show the mean
nationwide PEC in sewage treatment plant effluent is 0.01 mg/L. This confirms the expected
low hazard from the proposed use.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
The notified polymer is expected to be of very low acute toxicity, based on acute rat data for a
similar chemical, polyglycerol esters of interesterified ricinoleic acid. Slight skin and eye
irritation was observed in animals with the notified polymer. A 20% solution in ethanol
placed under occlusive dressing for 24 h caused slight to moderate erythema and slight
squamation of the skin in 3/24 human volunteers. The polymer was a slight skin sensitiser in
FULL PUBLIC REPORT 3 November, 2000
PLC/96 12/17
guinea pigs by the Buehler method. No cytotoxicity to mouse fibroblast cells was
demonstrated following culture with the polymer under UV irradiation. The polymer was not
mutagenic in the Ames test. No repeat dose study was available for the notified polymer, but
the high molecular weight would limit absorption through biological membranes. Based on
the available data, the notified polymer is not classified as a hazardous substance according to
NOHSC Approved Criteria for Classifying Hazardous Substances (National Occupational
Health and Safety Commission, 1994a).
As the notified polymer is viscous and has a low vapour pressure, dermal contamination is
considered to be the main route for occupational exposure rather than inhalation.
Transport and Storage
The health risk for transport and storage workers arising from potential contact with the
notified polymer is expected to be low due to the low toxicity of the polymer and the
expected nil exposure except in the case of accidental spillage.
Formulation
Formulation is an automatic process and taken place in sealed mixers. Formulators will
handle the undiluted polymer and could be contaminated with the notified polymer during
connecting and disconnecting the pumps. Both skin and eye contamination is possible.
Workers wear PVC gloves, safety glasses, uniform and safety shoes. General and local
ventilation will be provided. The potential health risk for mixing workers is considered to be
low due to anticipated low exposure.
Filling workers could be exposed to the notified polymer during cleaning up through skin or
eye contact. The concentrations of the notified polymer in the final products are low (up to
5%). Workers will wear gloves, safety glasses, overalls and safety shoes. The health risk for
filling workers is expected to be low.
R&D and Quality Control
Both R&D and quality control workers will handle small amounts of the notified polymer and
operate on a small scale in the laboratory. R&D and quality control workers will wear
laboratory coats and safety glasses. The anticipated health risk will be low.
End Use
Beauty salon workers and beauticians may use the products containing the notified polymer in
their work. Dermal contact is the primary route in end uses. However, adverse health risk is
considered to be low for beauty salon workers and beauticians because of the low toxicity of
the notified polymer, low amount of the notified polymer in products and short duration of
occupational exposure. The skin sensitisation label warning statement proposed for skin
lotions for public health (see below) will serve as a warning for occupational users also.
Public Health
Since the notified chemical will be used as a cosmetic ingredient in body lotions, primary
public exposure will be by dermal contact, and possibly ocular contact. The notified polymer
was a slight skin and eye irritant in rabbits. At the use level in skin lotions (around 5%), it is
unlikely to be a skin or eye irritant. However, 10% of the notified polymer caused slight skin
sensitisation in a guinea pig study. Skin sensitisation could occur in some individuals at the
intended use level in skin lotions. A warning on the skin sensitisation potential is
FULL PUBLIC REPORT 3 November, 2000
PLC/96 13/17
recommended.
13. RECOMMENDATIONS
Skin lotions containing the notified polymer should carry the following warning on the labels:
"Sensitive persons may experience allergic reactions".
To minimise occupational exposure to Dehymuls PGPH prior to end use the following
guidelines and precautions should be observed:
Safety goggles should be selected and fitted in accordance with Australian Standard
?br>
(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
?br>
(Standards Australia, 1987) and AS 3765.1 (Standards Australia, 1990);
Impermeable gloves or mittens should conform to AS 2161 (Standards
?br>
Australia/Standards New Zealand, 1998);
All occupational footwear should conform to AS/NZS 2210 (Standards
?br>
Australia/Standards New Zealand, 1994);
Spillage of the notified chemical should be avoided. Spillages should be cleaned up
?br>
promptly with absorbents which should be put into containers for disposal;
Good personal hygiene should be practised to minimise the potential for ingestion;
?br>
A copy of the MSDS should be easily accessible to employees.
?br>
14. MATERIAL SAFETY DATA SHEET
The MSDS for the notified chemical was provided in accordance with the National Code of
Practice for the Preparation of Material Safety Data Sheets (National Occupational Health
and Safety Commission, 1994b).
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, secondary notification of the notified chemical shall be required if any of the
circumstances stipulated under subsection 64(2) of the Act arise. No other specific conditions
are prescribed.
FULL PUBLIC REPORT 3 November, 2000
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16. REFERENCES
Banduhn N (1994) Dehymuls Ke 3190, Salmonella/mammalian-microsome mutagenicity test
(Ames Test), Project No. R 9400821, Henkel KGaA, Germany.
Draize JH (1959) Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.
Association of Food and Drug Officials of the US, 49: 2-56.
FAO/WHO (1969) Toxicological evaluation of some food colours, emulsifiers, stabilisers,
anti-caking agents and certain other sustances, FAO Nutrition Meetings Report Series No
46A, WHO/FAO ADD/70-36.
Matthies W & Molitor C (1995) Dehymuls PGPH, RIS-No: 51Z1200325000,
Dermatological Evaluation, Project No. R 9400795, Henkel KGaA.
National Occupational Health and Safety Commission (1994a) Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(1994)]. Canberra, Australian Government
Publishing Service.
National Occupational Health and Safety Commission (1994b) National Code of Practice for
the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)]. Canberra, Australian
Government Publishing Service.
Organisation for Economic Co-operation and Development (1995-1996) OECD Guidelines
for the Testing of Chemicals on CD-Rom. Paris, OECD.
Pels Rijcken W (1994) Primary skin irritation/corrosion study with SAT 940669 in the
rabbit, Project No. R 9400993, NOTOX B.V., The Netherlands.
Pels Rijcken W (1995) Acute eye irritation/corrosion study with SAT 940669 in the rabbit,
Project No. R 9500265, NOTOX B.V., The Netherlands.
Pittermann W (1994) Dehymuls Ke 3190, Skin sensitization (Buehler Test) on guinea pig,
Project No. R 9400843, Henkel KGaA, Germany.
Schroder K (1997) Dehymuls PGPH Ke 3190, In-vitro test: photo-irritation-cytotoxicity in
mouse fibroblasts (Balb/c 3T3), Project No. R 9700261, Henkel KGaA, Germany.
Spielmann Hea (1993) Validation study of alternatives to the Draize eye irritation test in
Germany: cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxic in
Vitro, 7(4): 505-510.
Standards Australia (1987) Australian Standard 2919-1987, Industrial Clothing. Sydney,
Standards Association of Australia.
Standards Australia (1990) Australian Standard 3765.1-1990, Clothing for Protection against
Hazardous Chemicals Part 1 Protection against General or Specific Chemicals. Sydney,
Standards Association of Australia.
FULL PUBLIC REPORT 3 November, 2000
PLC/96 15/17
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.
Standards Australia/Standards New Zealand (1998) AS/NZS 2161.2:1998 Occupational
protective gloves, Part 2: General requirements, Standards Australia/Standards New Zealand.
FULL PUBLIC REPORT 3 November, 2000
PLC/96 16/17
Attachment 1
The Draize Scale 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 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
FULL PUBLIC REPORT 3 November, 2000
PLC/96 17/17
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