File No: NA/355
Date: June 1996
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
DYMSOL UWB COMPONENT
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 Worksafe Australia which also conducts the occupational health &
safety assessment. The assessment of environmental hazard is conducted by the
Department of the Environment, Sport, and Territories 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, Worksafe Australia, 92-94 Parramatta
Road, Camperdown NSW 2050, between the hours of 10.00 am and 12.00 noon
and 2.00 pm and 4.00 pm each week day except on public holidays.
For Enquiries please contact the Administration Coordinator at:
Street Address: 92 Parramatta Rd Camperdown, NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, Sydney 2001, AUSTRALIA
Telephone: (61) (02) 577-9466 FAX (61) (02) 577-9465
Director
Chemicals Notification and Assessment
NA/355
FULL PUBLIC REPORT
DYMSOL UWB COMPONENT
1. APPLICANT
Henkel Australia Pty Ltd of 83 Maffra St BROADMEADOWS VIC 3047 has submitted
a standard notification statement in support of their application for an assessment
certificate for Dymsol UWB Component.
2. IDENTITY OF THE CHEMICAL
For commercial reasons, the identity of the notified chemical has been granted
exemption from publication in the Full Public Report and the Summary Report.
Dymsol UWB Component is considered to be an eye irritant when classified in
accordance with Worksafe Australia's Approved Criteria for Classifying Hazardous
Substances [NOHSC:1008(1994)]. According to Regulation 7 of the National
Model Regulations for the Control of Workplace Hazardous Substances
[NOHSC:1005(1994)] (Model Regulations), substances which are classified as
eye irritants can be identified by a generic name if the identity of the substance is
commercially confidential. Therefore the identity of the notified chemical has been
exempted from publication in the Full Public Report and the Summary Report. The
conditions of this being permitted are:
? A descriptive generic name be used to identify the substance in public reports,
labels and Material Safety Data Sheet (MSDS) where its concentration exceeds
20% in a formulation,
? The full chemical name shall be provided to any health professionals in the
case of a legitimate need where exposure to the chemical may involve a health
risk,
? The full chemical name shall be provided to those on site who are using the
chemical and to those who are involved in planning for safe use, etc in the case
of a legitimate need,
? The Director of NICNAS will release the full chemical name etc in the case of a
request from a medical practitioner,
? The chemical be identified as a irritant in the Health Effects section of the
MSDS, and that reference to assessment by NICNAS be made on the MSDS
under circumstances where the level of the notified chemical exceeds 20%.
FULL PUBLIC REPORT 2
3. PHYSICAL AND CHEMICAL PROPERTIES
The notified chemical is manufactured in a 50% aqueous formulation and is never
isolated. The following physico-chemical data are for the formulation.
Appearance at 20癈
and 101.3 kPa: light yellow, viscous liquid
Melting Point: 25癈 (at 101.3 kPa)
1130 kg/m3
Density:
Vapour Pressure: not determined
Water Solubility: soluble in water in any proportion at 20癈
Partition Co-efficient
(n-octanol/water): log K ow = 1.77
Hydrolysis as a Function
of pH: the notified chemical is used in alkaline
detergent formulations in the USA and is stated
to be stable between pH 4-14
Flash Point: > 93癈 (closed cup)
Flammability Limits: not flammable
Explosive Properties: not explosive
Reactivity/Stability: stated to be stable and non-reactive but can
decompose to oxides of carbon when mixed with
strong acids and oxidising agents or when
exposed to fire
Comments on Physico-Chemical Properties
The value given by the notifier for melting point corresponds to point at which the
product is able to be poured (pour point). The value of the partition coefficient given
by the notifier was determined for the product. This is not a pure compound. It
contains the notified substance as a mixture of compounds. The product also
contained organic and inorganic salts. The value was estimated by measuring the
concentrations of only one component of the mixture.
The stability range (pH range 4-14) quoted for the notified chemical is based on a
claim of caustic stability in the Technical Data Sheet for APG Glycoside Surfactants.
Based on the known stability of this class of compounds a pH range of 3-12 is
more realistic (1).
FULL PUBLIC REPORT 3
No information was provided on the adsorption/desorption properties of the
chemical. Given the polymer's high water solubility and low partition coefficient it is
anticipated that it will not strongly adsorb.
The notified chemical contains no dissociable hydrogens or basic functionalities.
4. PURITY OF THE CHEMICAL
Degree of purity: approximately 80%
Toxic or hazardous
impurities: none
Non-hazardous impurities see table below
(> 1% by weight):
Chemical Name CAS No. Weight %
N-butyl glucoside 31387-97-0
} 15%
oligo saccharides n/a
sodium p-toluene sulfonate n/a 1.0%
sodium sulfate 7727-73-3 1.0%
sodium chloride 7647-14-5 1.0%
Additives/Adjuvants: the imported formulation contains 0.012%
glutaraldehyde (CAS No. 111-30-8)
5. USE, VOLUME AND FORMULATION
The notified chemical is intended to be used as a surfactant in waterborne
architectural coatings and will be imported at a rate of 5 tonne per year for the first
year rising to 10 tonne per year by the fifth year. The notified chemical will be
imported as a 50% aqueous solution.
6. OCCUPATIONAL EXPOSURE
The notified chemical in its aqueous imported formulation will be transported in
200 L plastic lined drums and 20 L plastic pails to a single site for blending into
paint. At the reformulation site, reformulation may be carried out by either research
and development or paint makeup personnel. In the former case only small
amounts of the imported formulation would be tested. Quality control personnel
may
also test small amounts for viscosity and pH. Research and development and
quality control is estimated to have a duration of 6 hours per day, 10 days per year.
FULL PUBLIC REPORT 4
The paint makeup, conducted for 4 hours per day, 20 days per year, involves
insertion of a spear into a drum and pumping the contents into a high speed
disperser. Following dispersion, other ingredients are added and the contents
blended at low speed followed by filtering and drumming off into 1 L to 20 L tins.
Exposure is possible when removing drum bungs and coupling and uncoupling
lines for pumping. Spillage is possible during pumping, batch adjusting and
testing and during drum filling although the system is largely enclosed and fitted
with fume extraction. Exposure from drips, splashes and spills is expected to be
infrequent and the amounts involved relatively small.
The notified chemical is at 1% in the final paint formulation and may be used by a
large number of trade and DIY painters. Exposure to the paint may be frequent, is
expected to be via the skin and may be prolonged.
7. PUBLIC EXPOSURE
There is negligible potential for public exposure to the notified substance arising
from importation, transportation and formulation into paint products. Similarly, the
potential for public exposure to the chemical during transport and disposal of
process waste and clean up waste after a spill is very minor. This is minimised by
the recommended practices during storage, transportation and waste disposal.
There is likely public exposure from the end use application of the chemical as a
water based surface coating, particularly during domestic application, but the
notified substance is at a low concentration (1%) in these coatings. The chemical
will finally be immobilised as part of a cross linked hardened paint film and while
there will be significant public contact with the notified chemical in this inert form,
there seems no likely route of exposure and absorption.
8. ENVIRONMENTAL EXPOSURE
Release
Environmental release during transportation will result only in the event of
accidental spill or mishandling. All clean up of spills and disposal should be
carried out according to the MSDS.
The notifier states that chemical released into the factory environment during paint
manufacture will be trapped by the standard engineering controls in place. The
release of chemical into the factory comes from two sources: (a) accidental
spillage; (b) cleaning of mixers and mills. The notifier has estimated that 60 kg of
the notified chemical will be lost annually as a result of the reformulation process.
Aqueous waste will be handled by the site waste treatment plant, and solid waste
is disposed of in approved landfill.
The architectural coatings containing the notified chemical will be stored and
transported in epoxy lined paint cans, probably in 1, 2, 4, 10 and 20 litre sizes. The
architectural coatings are water-based air drying formulations. They will be
FULL PUBLIC REPORT 5
applied using a brush, roller or spray gun. The coatings will be applied by both
tradesmen and "do-it-yourself" painters.
Release to the environment resulting from the use of the architectural coatings
may occur to the sewer (washing of tools used to apply formulations containing the
notified chemical), or to landfill (disposal of residual quantities of the formulations
within used containers). The notifier has estimated that a maximum 140 mg
(~1.5%) of the notified chemical will be lost in washing equipment. Empty
containers may contain up to 5% of the contents.
Losses from spray application of the coatings may be up to 5% for well ventilated
confined spaces, 5-10% for outdoor applications in static air and over 20% in
windy conditions. This is likely to remain where it falls, mainly on the ground.
Fate
The substance was examined for biodegradation potential using the modified
Screening test (OECD Test Guideline 301C)(2). The substance exhibited a 90-
93% loss of Dissolved Organic Carbon after 28 days, indicating that it is readily
biodegradable under the conditions of the test. The test solution became cloudy
after seven days suggesting the formation of a water insoluble degradation
product(s). The cloudiness of the solution faded toward the end of the test
indicating biodegradation of intermediate product(s) formed. These intermediate
product(s) are likely to be oligo saccharides and fatty acids.
No testing of the bioaccumulation potential was conducted. The low partition
coefficient and high water solubility of the notified chemical would indicate it is not
be likely to bioaccumulate.
The fate of the majority of the notified chemical will share that of the architectural
coatings into which it is formulated, which when cured will share the fate of the
building materials to which they are applied. The final environmental fate will be
mostly landfill with some incineration. Any incineration of the notified chemical is
expected to produce water and oxides of carbon.
FULL PUBLIC REPORT 6
9. EVALUATION OF TOXICOLOGICAL DATA
9.1 Acute Toxicity
The acute toxicity tests, except for skin sensitisation, were conducted with
the formulation designated APG 325, which contains the notified chemical.
The skin sensitisation test was conducted with APG 600 which differs
slightly from the notified chemical.
Summary of the acute toxicity of Dymsol UWB Component
Test Species Outcome Reference
acute oral toxicity rat LD 50 > 5000 mg/kg (3)
acute dermal toxicity rabbit LD 50 > 2000 mg/kg (4)
skin irritation rabbit slight irritant (5)
eye irritation rabbit moderate irritant (6)
skin sensitisation guinea pig non-sensitiser (7)
9.1.1 Oral Toxicity (3)
Species/strain: rat, Sprague-Dawley
Number/sex of animals: 5 males, 5 females
Observation period: 14 days
Method of administration: gavage
Clinical observations: no toxicologically significant observations
Mortality: one death unrelated to treatment
Morphological findings: none
Test method: in accordance with OECD Guidelines (2)
LD 50: > 5000 mg/kg
Result: the notified chemical was of low oral toxicity
in rats
FULL PUBLIC REPORT 7
9.1.2 Dermal Toxicity (4)
Species/strain: rabbit, New Zealand White
Number/sex of animals: 5 males, 5 females
Observation period: 14 days
Method of administration: occlusive gauze dressing, 24 hours duration
Clinical observations: no effects of toxicological concern; essentially
non-irritating
Mortality: no deaths
Morphological findings: none
Test method: in accordance with OECD Guidelines (2)
LD 50: > 2000 mg/kg
Result: the notified chemical was of low dermal
toxicity in rabbits
9.1.4 Skin Irritation (5)
Species/strain: rabbit, New Zealand White
Number/sex of animals: 3 males, 3 females
Observation period: 7 days
Method of administration: 0.5 mL of undiluted test material under an
occlusive gauze patch for 4 hours
FULL PUBLIC REPORT 8
Draize scores (8):
Time after Animal #
treatment 1 2 3 4 5 6
(hrs)
Erythema
1i
_ -1 2 2 2 2 2
24 1 1 2 1 2 1
48 0 1 1 1 1 1
72 0 1 0 1 1 1
Day 7 0 0 0 0 0 0
Oedema
_ -1 0 1 1 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
Day 7 0 0 0 0 0 0
i
see Attachment 1 for Draize scales
Test method: in accordance with OECD Guidelines (2)
Result: slight skin irritant in rabbits
9.1.5 Eye Irritation (6)
Species/strain: rabbit, New Zealand White
Number/sex of animals: 3 males, 3 females
Observation period: 21 days
Method of administration: 0.1 mL undiluted test material into the
conjunctival sac of one eye; eye not rinsed
FULL PUBLIC REPORT 9
Draize scores (8) of unirrigated eyes:
Time after instillation
Animal 1 day 2 days 3 days 4 days 7 days
a b a b a b a b
oa ab
Cornea o a o a o a o a
2i
1 4 2 4 2 4 2 4 2 3
2 1 4 1 4 2 3 2 3 2 4
3 2 4 2 4 2 4 2 4 2 4
4 2 4 2 3 2 3 2 3 2 3
5 2 4 2 3 2 3 2 4 3 4
6 2 4 2 4 2 4 2 4 3 4
Iris
1 1 1 1 1 0
2 1 1 0 0 0
3 1 1 0 0 0
4 1 1 0 0 1
5 1 1 1 0 0
6 0 0 0 0 0
rc cd de rc cd de rc cd de rc cd de rc cd de
Conjunctiv
a
1 2 3 2 2 3 2 3 3 2 3 3 2 2 3 0
2 2 3 2 2 3 1 3 3 2 3 3 2 3 4 2
3 2 4 2 2 3 2 3 3 1 3 2 2 2 2 2
4 2 3 2 2 2 1 2 2 1 2 2 0 2 3 1
5 2 3 2 2 2 2 3 2 1 3 2 1 2 2 1
6 2 3 2 3 3 1 3 2 1 3 2 0 2 2 0
i
see Attachment 1 for Draize scales
a b c d e
opacity area redness chemosis discharge
Test method: in accordance with OECD Guidelines (2)
Result: the notified chemical is a moderate eye
irritant in rabbits
9.1.6 Skin Sensitisation (7)
Species/strain: Pirbright white guinea pig
Number of animals: 36 ( 2x3 pre-experiments, 20 test, 10 control)
Induction procedure: three pairs of injections of Freunds Complete
FULL PUBLIC REPORT 10
Adjuvant (FCA) in distilled water (1:1); 1% test
substance in distilled water; 1% test
substance, 50% FCA in distilled water;
topical induction: at day 7 60% test
substance for 48 hours (occlusive)
Challenge procedure: 10% test substance, 24 hour, occlusive
dressing
Challenge outcome:
Test animals Control animals
Challenge
concentratio 24 hrs* 48 hrs* 24 hrs 48 hrs
n
10% **0/20 0/20 0/10 0/10
* time after patch removal
** number of animals exhibiting positive response
Test method: Magnusson and Kligman (1969) (9)
Result: not a skin sensitiser in guinea pigs
9.2 Repeated Dose Toxicity (10)
The following study was conducted with HL-BE-9, a close analogue of the
notified chemical.
Species/strain: rat, Sprague-Dawley
Number/sex of animals: 50 males, 50 females
Method of administration: orally by gavage
Dose/Study duration:: 10 females/10 males dosed at 0, 250, 500 or
1000 mg/kg/day for 90 days; in addition 5
males and 5 females dosed at 0 and 1000
mg/kg/day for 90 days given a recovery period
(in total 106-133 days)
Clinical observations: 2 mortalities were observed, 1 male in the
low dose group and 1 female in the mid dose
group; there were no treatment-related
variations in body weight
Clinical high dose males at the sixth week had
chemistry/Haematology increased numbers of thrombocytes
FULL PUBLIC REPORT 11
Histopathology: decreased gonad weight in all test group
males exposed to the test substance was in
concert with body weight and therefore not
significant; high dose group had ulceration
and oedema restricted to the forestomach
Test method: in accordance with "Ermittlung der
toxicologischen Eigenschaften von
Chemikalen empfohlen" (11)
Result: NOEL 250 mg/kg/day; effects at higher doses
were not systemic apart from increased
thrombocytes in males and this was
considered not to be compound-related
9.3 Genotoxicity
9.3.1 Salmonella typhimurium Reverse Mutation Assay (12)
The test substance was HL-BE-9, a close analogue of the notified chemical.
Strains: TA 98, TA 100, TA 1535, TA 1537 and
TA 1538
8 - 5000 礸/plate
Concentration range:
Test method: in accordance with OECD Guidelines (2)
toxic effects seen above 200 礸/plate; no
Result:
increases in mutation frequency above
background in any strain in the presence or
absence of metabolic activation provided by
rat liver S9
FULL PUBLIC REPORT 12
9.3.2 In vitro Mammalian Cytogenetic Test in Chinese Hamster V79 Cells (13)
This test was conducted with Plantaren-1200 UP, a close analogue of the
notified chemical.
Cell line: chinese hamster V79
Doses: without metabolic activation (rat liver S9): 16
礸/mL at each of the time points -
chromosomes prepared at 7, 20 and 28
hours after the start of treatment with the
treatment interval 4 hours; in addition at the
20 hours time cells were treated with 2 and 8
礸/mL; with metabolic activation at 7 hours
the dose was 40 礸/mL; at 20 hours, 10, 40
and 80 礸/mL and at 28 hours, 80 礸/mL
Test method: in accordance with OECD Guidelines (2)
Result: no induction of chromosomal aberrations by
the test substance; in the absence of
metabolic activation no reduction in mitotic
index was observed; in the presence of
metabolic activation at the highest
concentration nearly no mitoses were
observed
9.4 Overall Assessment of Toxicological Data
A close analogue of the notified chemical was found to have low acute oral
toxicity in rats (LD50 > 5000 mg/kg) and low acute dermal toxicity in rabbits
(LD 50 > 2000 mg/kg). The analogue was a slight skin irritant and a
moderate eye irritant in rabbits. A second close analogue of the notified
chemical was not a skin sensitiser in guinea pigs and was not clastogenic
in chinese hamster V79 cells in vitro. A third close analogue of the notified
chemical did not exhibit organ toxicity in a 90-day oral repeat dose study
except for irritation at the site of application. This third analogue was not
found to be mutagenic in bacteria.
On the basis of the analogue data, the notified chemical would not be
classified as hazardous according to Worksafe Australia's Approved
Criteria for Classifying Hazardous Substances (Approved Criteria) (14) in
relation to acute lethal effects (oral, dermal), irritant effects (skin),
sensitising effects (skin) or severe effects after repeated or prolonged
exposure (oral route). However, the notified chemical would be classified
as hazardous in relation to eye irritant effects.
FULL PUBLIC REPORT 13
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
The notifier has provided ecotoxicological data for a structurally related
product Glucopon 600 UP. It is expected that the notified chemical should
have similar properties, with marginally higher water solubility.
Species Test Result Ref
Zebra fish Acute Toxicity (96 h), 2 mg/L < LC50 < 8 mg/L (15)
(Brachydanio OECD Guideline 203 (2)
rerio)
Daphnia magna Daphnia Reproduction NOEC (reprod) = 2 mg/L (16)
Test (21 d)
OECD Guideline 202 (2) NOEC (mort) = 1 mg/L
(21 d)
LOEC (mort) > 2 mg/L
(21 d)
Daphnia magna Acute Daphnia Toxicity 2 mg/L < LC50 < 16 mg/L (17)
(48 h),
EU Guideline 92/69/EWG
OECD Guideline 202, part
1 (2)
Scenedesmus Algal, Growth Inhibition NOEC (growth) = 4 mg/L (18)
subspicatus (72 h), (72 h)
OECD Guideline 201 (2) EbC50 = 12 mg/L (72 h)
Er C50 = 38 mg/L (0-72 h)
Micro-organisms Acute Bacterial Toxicity, 500 mg/L < 10% effect (19)
from activated OECD Guideline 209 (2) (30 min)
sludge
(Pseudomonas
putida)
* NOEC - no observable effect concentration
Reports were provided and these indicate the above tests were satisfactorily
conducted according to OECD Guidelines. The test reports indicate the notified
chemical is moderately toxic to fish, Daphnia and algae, and practically non-toxic to
sewerage micro-organisms.
In the semistatic Acute Fish Toxicity test (OECD Guideline 203) (2) the effect of
Glucopon 600 UP was investigated at only three concentrations of the active
ingredients (2, 4 and 8 mg/L), these data were used to calculate an LC50 (2.9 mg/L)
reported by the notifier. The lowest concentration resulted in no fish mortality,
while in the highest concentration all the fish died. Hence, these data cannot be
used to calculate the LC50 for fish and the true LC50 value most likely lies between
the two extremes (ie 2 mg/L < LC50 < 8 mg/L). At 4 mg/L of the active ingredient
20% mortality was observed along with sublethal effects (balance disturbances).
Concentrations ranging from 0-16 mg/L were examined in the Acute Daphnia
Toxicity test (OECD Guideline 202, part 1)(2). The LC 50 value of 7 mg/L provided by
the notifier, was based on only three concentrations (2, 8 and 16 mg/L), and like
the Acute Fish Toxicity test the true LC50 value most likely lies between the two
FULL PUBLIC REPORT 14
extremes (ie. 2 mg/L < LC50 < 16 mg/L).
The algal species tested (Scenedesmus subspicatus) is considered to be
relatively insensitive (20).
In the Acute Bacterial Toxicity test (OECD Guideline 209)(2) the effect on the
bacteria was quantified by measuring the difference between the oxygen
consumption of bacterial suspensions containing the test substance and a control
(glucose). The notifier quotes an EC0 of 500 mg/L, which they define as the highest
measured substance concentration with an effect below 10%.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The hazard posed by the use of the end product appears to be small in that it will
be incorporated at a small percentage (~1%) in a range of architectural coatings
the use of which might be expected to be widespread across Australia. The total
quantity estimated by the notifier to be released through the sewer system annually
Australia wide through washing of equipment is 150 kg (1.5% of 10 tonnes
imported).
Taking the worst case assumption that 10% of the chemical imported reaches the
aquatic compartment, remains dissolved and is thus discharged to receiving
waters, a predicted environmental concentration (PEC) for the substance in
sewage water across Australia can be estimated from the following assumptions:
1 tonne maximum annual use an Australian population of 18 million and a daily
per capita waste water discharge (a conservative estimate) of 150 L. This provides
a PEC of approximately 1 ppb in sewage water. At 1 ppb the PEC is three orders of
magnitude below the concentrations of the notified chemical at which toxic effects
are observed. Assuming only 150 kg is released into effluent the level would be
reduced by an order of magnitude.
Normal use of the end products appear to be unlikely to cause undue load on
water and sewage treatment plants that treat and biodegrade effluent. Leaching of
the chemical from landfills is not expected to be significant as the chemical will be
trapped in the matrix of the solidified architectural coating.
The overall environmental hazard posed by the notified chemical can be rated as
negligible when incorporated into architectural coatings.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
On the basis of analogue data, the notified chemical would not be classified as
hazardous according to the Approved Criteria (14) in relation to acute lethality, skin
irritation, skin sensitisation and severe effects after repeated or prolonged
exposure. The notified chemical is also not expected to be genotoxic. However,
the notified chemical would be classified as an eye irritant.
FULL PUBLIC REPORT 15
The imported formulation, containing 50% of the notified chemical in an aqueous
solution is reformulated into paint at a final concentration of 1%. The reformulation
and drumming off of the paint is largely automatic and enclosed with the use of
fume extraction to control exposure to vapours and aerosols. Dermal exposure to
spills, drips and splashes is possible during transfer operations but is likely to be
infrequent.
During use of the formulated paint there is potential for widespread exposure to
the skin and the paint may remain on the skin for long periods until it is removed by
washing.
The occupational health risk posed by the notified chemical is expected to be
limited to eye irritation and is most likely to occur during transfer of the imported
aqueous solution from the drums in which it is imported to the paint mixing
apparatus. The health risk in other operations and during use of the paint is
expected to be minimal.
There is negligible potential for public exposure to the notified substance arising
from importation, transportation and formulation into paint products. There is likely
public exposure from the end use application of the chemical as a water based
surface coating, particularly during domestic application, but the notified substance
is at a low concentration (1%) in these coatings. The chemical will finally be
immobilised as part of a cross linked hardened paint film and while there will be
significant public contact with the notified chemical in this inert form, there seems
no likely route of exposure and absorption.
Based on the available information, it is unlikely that the Dymsol UWB aqueous
formulation containing 50% of the notified chemical will pose a significant hazard
to public health when used in the proposed manner.
13. RECOMMENDATIONS
To minimise occupational exposure to the notified chemical the following
guidelines and precautions should be observed:
If engineering controls and work practices are insufficient to reduce
?br>
exposure to a safe level, then the following personal protective equipment
which conforms to Australian Standards (AS) or Australian/New Zealand
Standards (AS/NZS) should be worn;
safety goggles should be selected and fitted in accordance with AS
1336 (21) to comply with AS/NZS 1337 (22),
industrial clothing should conform to the specifications detailed in AS
2919 (23),
impermeable gloves or mittens should conform to AS 2161 (24),
FULL PUBLIC REPORT 16
all occupational footwear should conform to AS/NZS 2210 (25);
Spillage of the notified chemical should be avoided, spillages should be
?br>
cleaned up promptly with absorbents which should then be put into
containers for disposal;
Good personal hygiene should be practised to minimise the potential for
?br>
ingestion;
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 (26).
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.
16. REFERENCES
1. Greek, B F 1990, Detergent Industry Ponders Products for New Decade,
Chemical and Engineering News, January 29
2. Organisation for Economic Co-operation and Development, OECD
Guidelines for Testing of Chemicals, OECD, Paris.
3. Kreuzmann J J 1990, Acute Oral Toxicity in Rats - Limit Test. Project
number: 89-3981-21 (A), data on file, Henkel Corporation, USA
4. Kreuzmann J J 1990, Acute Dermal Toxicity Study in Rabbits - Limit Test.
Project number: 89-3981-21 (B), data on file, Henkel Corporation, USA.
5. Kreuzmann J J 1989, Primary Skin Irritation Study in Rabbits. Project
number: 89-3981-21 (C), data on file, Henkel Corporation, USA.
6. Kreuzmann J J 1990, Primary Eye Irritation Study Without Rinsing In
Rabbits. Project number: 89-3981-21 (D), data on file, Henkel Corporation,
USA.
FULL PUBLIC REPORT 17
7. Steiling 1990, Skin Sensitisation Study. Project number: TBD900290, data
on file, Henkel, Dusseldorf.
8. 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.
9. Magnusson B and Kligman A M 1969 J. Invest. Dermatol. 52 268-276.
10. Potokar M Sterzal W and Pittermann W 1989 90 day repeat dose toxicity test
Report number 890161, data on file, Henkel, Dusseldorf.
11. Ermittlung der toxicologischen Eigenschaften von Chemikalen empfohlen.
12. Banduhn 1990, Salmonella/Mammalian-Microsome Mutagenicity Test.
Project number: TBD900467, data on file, Henkel, Dusseldorf.
13. Banduhn 1995, In Vitro Mammalian Cytogenic Test (For the Detection of
Chromosomal Aberrations in Chinese Hamster V79 Cells), Project number:
R 9400243, data on file, Henkel, Dusseldorf
14. National Occupational Health and Safety Commission 1994, Approved
Criteria for Classifying Hazardous Substances [NOHSC:1008(1994)],
Australian Government Publishing Service, Canberra.
15. Scholz J 1995, Acute Fish Toxicity Test, Project number: R 9400701, data on
file, Henkel, Dusseldorf.
16. Kirsch A 1995, Daphnia Reproduction Test, Project number: R9500594,
data on file, Henkel, Dusseldorf
17. Scholz J 1995, Acute Daphnia Toxicity, Project number: R9500085, data on
file, Henkel, Dusseldorf.
18. Rieche H-W 1994, Algal Growth Inhibition Test, Project number: R9400738,
data on file, Henkel, Dusseldorf.
19. Henkel Acute bacterial toxicity test, Project number: R9500541, data on file,
Henkel, Dusseldorf.
20. USEPA 1982 Environmental Effects Test Guidelines, Algal acute toxicity test,
EG-8.
21. Standards Australia 1994, Australian Standard 1336-1994, Eye protection in
the Industrial Environment, Standards Association of Australia Publ.,
Sydney.
22. Standards Australia/Standards New Zealand 1992, Australian/New Zealand
Standard 1337-1992, Eye Protectors for Industrial Applications, Standards
Association of Australia Publ., Sydney, Standards Association of New
Zealand Publ, Wellington.
FULL PUBLIC REPORT 18
23. Standards Australia 1987, Australian Standard 2919-1987, Industrial
Clothing, Standards Association of Australian Publ., Sydney.
24. Standards Australia 1978, Australian Standard 2161-1978, Industrial Safety
Gloves and Mittens (excluding electrical and medical gloves), Standards
Association of Australia Publ., Sydney.
25. Standards Australia/Standards New Zealand 1994, Australian/New Zealand
Standard 2210-1994, Occupational Protective Footwear, Standards
Association of Australia Publ., Sydney, Standards Association of New
Zealand Publ, Wellington.
26. National Occupational Health and Safety Commission 1994, National Code
of Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(1994)], Australian Government Publishing Service, Canberra.
FULL PUBLIC REPORT 19
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 1 Very slight oedema (barely 1
perceptible) perceptible)
Well-defined erythema 2 Slight oedema (edges of area well- 2
defined by definite raising
Moderate to severe erythema 3 Moderate oedema (raised approx. 1 3
mm)
Severe erythema (beet redness) 4 Severe oedema (raised more than 1 4
mm 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
Easily visible translucent areas, 2 mild 50% to 75% 3
details of iris slightly obscure
Opalescent areas, no details of iris 3 Greater than 75% 4
visible, size of pupil barely moderate
discernible
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 2 mild Discharge with 2 mod.
crimson red with with partial eversion moistening of lids
individual vessels not of lids and adjacent hairs
easily discernible
Swelling with lids 3 mod. Discharge with 3
Diffuse beefy red 3 half-closed moistening of lids severe
severe and hairs and
Swelling with lids 4 considerable area
half-closed to severe around eye
completely 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 20
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