Search    ENTER KEYWORD
MSDS Material Safety Data Sheet
CAS

62406-73-9

File Name: 62406-73.asp





Opalal











File No: NA/641

December 1998


NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME

FULL PUBLIC REPORT

Opalal




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.

F o r 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

NA/641


FULL PUBLIC REPORT

Opalal




1. APPLICANT

Quest International Australia Pty Ltd of 6 Britton St, SMITHFIELD NSW 2164 has
submitted a standard notification statement in support of their application for an assessment
certificate for Opalal.


2. IDENTITY OF THE CHEMICAL

Chemical Name: 3,3-Dimethyl-4-isopropyl-1,5-dioxaspiro(4,5)decane

Chemical Abstracts Service 62406-73-9
(CAS) Registry No.:

Other Names: 6,10-Dioxaspiro(4,5)decane,8,8-dimethyl-7-(1-methyl
ethyl)

Trade Name: Opalal

Molecular Formula: C13H24O2

Structural Formula:
CH3

H3 C CH3
CH3



O O




Molecular Weight: 212

FULL PUBLIC REPORT 2
NA/641

Method of Detection The notifier provided comprehensive spectroscopic
data - infra red, UV/visible, NMR (1H and 13C) and
and Determination:
mass spectroscopy - on the new chemical which may be
used to identify the material. A Gas Liquid
Chromatogram also accompanied the notification.

Spectral Data: IR: no distinctive functional group peaks; strong peaks
in the range 2850-2950 cm-1 and 900-1500 cm-1 only
UV/Vis: no peaks in the range 200-900 nm
1
H nmr: 0.8 (singlet), 1.0 (complex), 1.1 (singlet), 1.7
(complex), 1.9 (complex), 3.1, 3.3, 3.5 (doublets) ppm
13
C nmr: 18.917, 19.329, 22.081, 22.621, 23.215,
24.193, 29.241, 30.539, 34.014, 39.903, 74.650, 83.373,
110.403 ppm
mass spectrum: m/e 212 (m+ ), 197, 183, 169, 157, 140,
129, 127, 113, 111, 97, 85, 83, 69, 67, 56, 55, 43, 41


3. PHYSICAL AND CHEMICAL PROPERTIES


Appearance at 20癈 clear colourless liquid
and 101.3 kPa:

Boiling Point: 233癈

Specific Gravity: 0.949 at 21癈

9.5_10-3 kPa at 20癈
Vapour Pressure:
1.4_10-2 kPa at 25癈

Water Solubility: 63.5 mg/L at 25癈

Partition Co-efficient log Kow = 5.33
(n-octanol/water):

Hydrolysis as a Function T 1/2 < 1 day at pH 4.0
of pH: T 1/2 = 208 days at pH 7.0
T 1/2 > 1 year at pH 9.0

Adsorption/Desorption: log Koc = 2.49-2.71

Dissociation Constant: no acidic or basic functional groups

Flash Point: 97癈

FULL PUBLIC REPORT 3
NA/641

Flammability Limits: not determined

Autoignition Temperature: approximately 384癈

Explosive Properties: not expected to be explosive

Reactivity/Stability: not expected to be reactive


Comments on Physico-Chemical Properties

The notified chemical is a high boiling point organic liquid with no highly polar or reactive
functional groups. The vapour pressure is sufficiently low that it will not provide an unusual
flammability hazard except when heated.

It is evident from the proposed use of Opalal that it will most readily be identified by smell.

Water solubility was determined by stirring an excess of the test substance with 100 mL of
distilled water at 30篊, equilibrating for at least 24 hours at 20癈, then separating the aqueous
and non aqueous layers by centrifugation. The content of the new chemical in the aqueous
phase was then determined by gas chromatography. The average of three separate
determinations gave the water solubility as 63.5?2.2 mg/L at 20癈.

The Henry's law constant was calculated from the molecular weight, the measured water
solubility and vapour pressure through the equation:

H= MW(g/mole) ?Vapour Pressure (Pa)/Water solubility (g/L).

The compound contains an acetal linkage which is susceptible to hydrolysis under acidic
conditions, and more slowly under neutral conditions. The rate of hydrolytic degradation of
aqueous solutions containing measured concentrations of the test material (26.5-27.6 mg/L)
was determined in duplicate at pH 4, 7 and 9 at 50癈 over test periods of up to 10 days.
Samples were analysed for the undegraded Opalal at least twice after commencement of the
tests (2.4 h and 6 h at pH 4; 48, 120 and 288 h at pH 7; 48 h and 120 h at pH 9) by extraction
of organic material from the aqueous liquid with chloroform, and determination using gas
chromatography. A second study at pH 7 at temperatures of 50, 60 and 70癈 was used to
better define the temperature dependence of hydrolysis at this pH, and provided the value for
t 1/2 at 25癈 of 208 days.

This data is interpreted to indicate a half life of less than 1 day under acid conditions (pH 4)
to greater than 208 days at 25癈 at pH 9.

The n-octanol/water partition coefficient was determined using the HPLC method (European
Economic Community, 1992). In this method the retention time of the test compound on C18
columns is compared with those of eight reference compounds with known values for Log

FULL PUBLIC REPORT 4
NA/641

Kow ranging from 1.1 (benzyl alcohol) to 6.2 (DDT). The determined value of Log Kow = 5.33
indicates the new chemical has a high affinity for hydrocarbon-like environments.

The value of Log Koc was determined using the method of the OECD draft guideline:
Screening Method for the Determination the Adsorption Coefficient on Soil using High
Performance Liquid Chromatography. In this method the retention time of the test compound
on specially prepared columns is compared with those of eight reference compounds with
known values for Log Koc ranging from 1.81(atrazine) to 4.34 (pentachloronitrobenzene).
The determined value of Log Koc being close to 2.6 indicates the new chemical has only
moderate affinity for the organic component of soils, and would not be strongly associated
with these materials.

The compound contains no functionalities capable of dissociating or otherwise becoming
ionised in aqueous media, and the notifier indicates that dissociation constant data are not
applicable.

The surface tension of an aqueous solution containing approximately 46.7 mg/L (73%
saturation) of the test substance was 64.6 mN/m at 20?.5癈 (water = 72.2 mN/m),
indicating the material is not surface active.

Calculations based on the molecular structure using the quantitative structure activity
relationships (QSARs) of the US Environment Protection Agency ASTER database (US
Environment Protection Authority, 1998) furnished the following estimates for
environmentally relevant physico-chemical parameters. Comparison with the data supplied
by the notifier is not good, except for the water solubility.

ASTER data (all calculated using QSAR's)

Property QSAR estimate

256 癈
Boiling Point:

Vapour Pressure: 0.449 Pa

Water Solubility: 65.3 mg/L

1.44 Pa/m3/mole
Henry's Law Constant:

Log Kow: 3.50

Log Koc: 3.24

Hydrolysis: Hydrolytic degradation unlikely.




FULL PUBLIC REPORT 5
NA/641

4. PURITY OF THE CHEMICAL

Degree of Purity: >99 %

Toxic or Hazardous none
Impurities:

Non-hazardous Impurities none
(> 1% by weight):

Additives/Adjuvants: the notified chemical will be imported as a component,
0.1 % to 25 %, of a number of compounded fragrances;
the identity of the other components of the
compounded fragrances has not been disclosed


5. USE, VOLUME AND FORMULATION

The notified chemical will be used as an aroma chemical and will be blended with other such
chemicals to produce compounded fragrances for products such as soaps, detergents and air
fresheners. The notified chemical will comprise 0.1 % to 25 % of the compounded fragrances,
with a typical level being around 5 %. The end use products will reportedly commonly
contain 1-2 % of the fragrance mixture, therefore a maximum of 0.5 % of the notified chemical.
This maximum concentration is only likely to be approached in solid air fresheners.

The compounded fragrances will not be manufactured in Australia. The import volumes are
estimated to be 250 kg per annum in the first 3 years, possibly reaching 500 kg per annum
after this time. The import volumes are estimates for the volume of notified chemical in the
imported fragrance mixtures.


6. OCCUPATIONAL EXPOSURE

The compounded fragrances will be imported in 200 L polythene or lacquer lined steel drums.
No exposure of the compounded fragrances containing the notified chemical to waterside,
transport or warehouse workers is expected except in the case of an accident involving
spillage.

The notified chemical is likely to be used as a component of the fragrance for a wide variety
of products for household use. The fragrances will be blended into the consumer products by
a number of customers using a variety of mixing techniques. It is estimated that between 5 and
20 process workers will be exposed to the notified chemical at each production line where it is
used.

The notifier has provided a description of the type of operation which will be carried out in
the production of several types of product containing the notified chemical. The examples

FULL PUBLIC REPORT 6
NA/641

given are for production of air fresheners, soap bars and liquid soaps. The fragrance mixture
used in soap manufacture is expected to include a maximum of 2 % notified chemical; while
the fragrance mixture used in air fresheners will contain up to 25 % notified chemical.

All processes described will be carried out in closed systems, and therefore worker exposure
is most probable at the time when new drums of fragrance mixture are being connected to the
production system, and in the cleaning of milling and blending equipment. The most probable
routes of exposure are inhalation and dermal exposure to drips and spills.

The notifier indicates that adequate ventilation should be provided in the customer facilities,
including local exhaust ventilation during filling operations, and that gloves should be worn
during procedures involving a risk of dermal exposure. Overalls, safety goggles and
respiratory protection should be used where appropriate.

Exposure to the products containing the fragrances during packaging operations should
present a low hazard as this is the form which will be provided for sale to the general public.


7. PUBLIC EXPOSURE

As the notified chemical will be used in a wide range of household products (soaps, detergents
and air fresheners containing compounded fragrances) there will be widespread public
exposure. Routes of exposure will include inhalation (of air fresheners), ocular, and systemic
absorption across the skin (due to the molecular weight of 212 Daltons), which is likely to be
the main route of exposure.

Exposure of the general public to the concentrates of the compounded fragrances is unlikely
as these products are only used within an industrial environment.


8. ENVIRONMENTAL EXPOSURE

Release

The notifier indicated that production activities involving use of the new chemical would be
performed by a number of different companies at a number of sites, and it is expected that
production activities will take place in purpose constructed facilities.

The notifier indicates that around 1 % of the new chemical (annually 5 kg) may be lost as a
consequence of cleaning the blending and filling equipment, and this would be discharged to
the sewer system. No reference to the quantities of chemical likely to be lost and released as a
result of accidental spillage was made in the submission. However, it is reasonable to estimate
that a further 1 % of total import quantity could be lost through accident, which amounts to
an annual release of another 5 kg.

The empty steel and polythene drums of fragrance will be washed and reused. No estimates

FULL PUBLIC REPORT 7
NA/641

of the amount of residual chemical left in the drums was presented in the application, but a
r e a s o n a b l e estimate is that this could amount to 0.05 - 0.1 % of the import quantity, or
around 250-500 g per annum, and it is probable that this would also be washed into the
sewer.

Consequently it is estimated that annually around 10-11 kg of the imported chemical could be
discharged directly to the sewerage system.

However, the new chemical is a fragrance for use in domestic cleaning and personal care
products, and consequently all will be eventually released into the environment as a result of
normal product usage. It is expected that this release would be primarily to the sewage
system, although due to the reasonably high vapour pressure much would be expected to
volatilise and enter the atmosphere.
Empty containers of the consumer products are likely to contain some residual unused
product, and these packages would be discarded with domestic garbage and be disposed of
into landfill.

Fate

?Biodegradation

The notifier provided a laboratory report on the assessment of the biodegradation of Opalal
conducted in accordance with the OECD Test Guideline TG 301F (Manometric
Respirometry Test) (Organisation for Economic Cooperation and Development, 1992c). The
results of this test (performed in triplicate) indicated approximately 2 % loss of initial
Chemical Oxygen Demand (COD) of the test material after 28 days, and accordingly the
Opalal cannot be classed as either readily biodegradable or as inherently biodegradable.

?Models

All the new chemical will eventually be released into the environment, and the majority could
be expected to be discharged into sewerage systems. However, once released in this manner
the relatively high vapour pressure indicates significant partitioning into the atmospheric
compartment. For that proportion of the chemical which reaches sewage treatment plants (i.e.
is not volatilised or otherwise destroyed during passage to the plant), the notifier presented
the results of calculations from the SimpleTreat Model (European Commission, 1996). These
estimates were based on the chemical having a calculated Henry's constant of 46.7
Pa/m3/mole, a Log Kow = 5.33 and being not biodegradable, and indicated that the chemical
would be expected to partition into the air, water and sewer sludge compartments as follows

Air Water Sewer Plant Sludge

6% 12% 82%

Mackay Level 1 calculations from the ASTER database (US Environment Protection
Authority, 1998) indicate that the chemical would partition primarily to the atmosphere. The

FULL PUBLIC REPORT 8
NA/641

Mackay model assumes an equilibrium is established between all phases. In the environment
an equilibrium state will not be reached as chemical which reaches the atmosphere will be
effectively removed from the system by diffusion and destruction through reaction with
hydroxyl radicals - see further below. The partitioning into the various environmental
compartments resulting from this model is:

Atmospheric compartment 25.43%

Soil compartment 12.54%

Sediment compartment 11.71%

Water compartment 50.30%

Aquatic biota compartment 0.01%
Considering the assumptions and approximations inherent in both these estimation models,
the differences between the two sets of results cannot be considered surprising or
contradictory, and the differences can be primarily attributed to the difference between the
measured value of Log Kow (i.e. 5.33) and that calculated by QSAR (3.50). Both
methodologies indicate partitioning to the atmosphere, and while the Mackay calculations
indicate more partitioning to this compartment, it should be appreciated that as the
compound is destroyed in the atmosphere through reaction with hydroxyl radicals (see
below), it would be replenished from that in the water in order to maintain the equilibrium
distribution.

?Atmosphere

Once released to the atmosphere it is considered that the chemical would be quickly
decomposed through photolytically promoted free radical reactions. Hence, over time the
sediment/water and water/air partitioning will be driven toward the loss of the chemical to the
atmosphere. In the atmosphere it is likely that the substance will be degraded through reaction
with hydroxyl radicals (through hydrogen abstraction mechanisms), and a calculation
(Organisation for Economic Cooperation and Development, 1992d) indicates that in the
troposphere the new chemical would react in this manner with a rate constant estimated as
32.1 ?10 -12 cm3/molecule/s. Rate constants of this order are indicative of rapid degradation
(Organisation for Economic Cooperation and Development, 1992d), and the compound is not
expected to persist in the atmosphere.

?Sediment

The new chemical is hydrophobic in character with Log Kow = 5.33 and Log Koc = 2.6;
consequently when released into the sewer system some may remain associated with the
organic component of the particulate matter present in the raw sewage, and eventually
become incorporated into sediments. Here it would be slowly degraded through biological and
abiotic processes to water, carbon dioxide and methane.




FULL PUBLIC REPORT 9
NA/641

?Soil

Residual chemical disposed of to landfill via empty drums, discarded consumer packaging or
within residual solids derived from water treatment at the production facilities, would also be
expected to volatilise and enter the atmosphere. However, some chemical may remain
adsorbed to soil particles, and in this situation would be expected to be slowly destroyed by
similar mechanisms to those operating in sediments. Any waste material containing the
notified chemical placed into compost facilities could also be expected to be destroyed
through aerobic and anaerobic biological degradation processes. Incineration of the material
would produce water vapour and oxides of carbon.

?Bioaccumulation

The ASTER calculations (US Environment Protection Authority, 1998) also provide an
estimate of 231 for the bioaccumulation factor for the compound in fish (fathead minnow),
indicating the compound has some potential for bioaccumulation. While reasonably soluble,
the compound is also volatile and is therefore not expected to have prolonged residence times
in the aquatic compartment.

9. EVALUATION OF TOXICOLOGICAL DATA

All toxicity testing was conducted using Opalal.

9.1 Acute Toxicity

Summary of the acute toxicity of Opalal

Test Species Outcome Reference
acute oral toxicity rat LD50 > 2000 mg/kg (McRae,
1996b)
acute dermal toxicity rat LD50 > 2000 mg/kg (McRae, 1996a)
skin irritation rabbit moderate irritant (Parcell, 1996b)
eye irritation rabbit slight irritant (Parcell, 1996a)
skin sensitisation guinea pig non-sensitising (Selbie, 1996)

9.1.1 Oral Toxicity (McRae, 1996b)

Species/strain: rat/Hsd/Ola:Sprague-Dawley(CD)

Number/sex of animals: 5/sex

Observation period: 15 days

Method of administration: gavage, test material used as supplied; dose 2000 mg/kg

FULL PUBLIC REPORT 10
NA/641

Clinical observations: no deaths occurred during the study

Mortality: piloerection was observed in all animals within 5
minutes of dosing; in 4 males and 4 females this was
accompanied by increased salivation; the piloerection
persisted for two days while the increased salivation
was only observed on day 1

Morphological findings: no macroscopic findings were observed at necropsy

Test method: limit test, OECD TG 401 (Organisation for Economic
Cooperation and Development, 1987c)

LD 50: greater than 2000 mg/kg

Result: the notified chemical was of very low acute oral
toxicity in rats

9.1.2 Dermal Toxicity (McRae, 1996a)

Species/strain: rat/Sprague Dawley(Crl:CD BR VAF PLUS)

Number/sex of animals: 5/sex

Observation period: 15 days

Method of administration: semi-occluded patch; 24 hour exposure; at the end
of this time excess test material was removed with
warm water and paper towel
dose 2000 mg/kg; test material used as supplied

Mortality: no deaths occurred during the study

Clinical observations: no clinical signs of toxicity were observed during
the study

Morphological findings: no macroscopic findings were observed at necropsy

Test method: limit test, OECD TG 402 (Organisation for
Economic Cooperation and Development, 1987a)

LD 50: greater than 2000 mg/kg

Result: the notified chemical was of low dermal toxicity in
rats

FULL PUBLIC REPORT 11
NA/641

9.1.4 Skin Irritation (Parcell, 1996b)

Species/strain: rabbit/New Zealand White

Number/sex of animals: 3 male

Observation period: 14 days

Method of administration: 0 . 5 mL of test material was applied to a clipped
intact region of the dorsal skin and secured under a
gauze patch with a semi-occlusive dressing for 4
hours; at the end of this time residual material was
removed with lukewarm water and paper towel;
animals were examined for skin reaction 1, 24, 48
and 72 hours following application of the test
substance; additional observations were made on
days 5 to 14


Draize scores (Draize, 1959) :

Time after Animal #
treatment 1 2 3
(days)
Erythema
2a
1 2 2
2 2 2 1
3 2 2 1
Oedema
1 2 1 1
2 2 1 0
3 2 1 0
a
see Attachment 1 for Draize scales

Observations: very slight to well defined erythema was observed
for all animals for the entire 14 days of observation;
very slight to moderate oedema for all animals,
visible for 1 day for one animal, for 12 days for
another and throughout the study for the third
animal; cutaneous dryness and sloughing in all
animals evident from day 7 or 8 through to the
termination of the study

Test method: OECD TG 404 (Organisation for Economic
Cooperation and Development, 1992a)

FULL PUBLIC REPORT 12
NA/641

Result: the notified chemical was moderately irritating to
the skin of rabbits


9.1.5 Eye Irritation (Parcell, 1996a)

Species/strain: rabbit/New Zealand White

Number/sex of animals: 3 male

Observation period: 7 days

Method of administration: 0 . 1 mL of test material applied as supplied into
lower everted lid of one eye of each animal; the
contralateral eye served as the control; animals
were examined for eye lesions 1, 24, 48 and 72
hours after test substance application with further
observations after 4 and 7 days
Draize scores (Draize, 1959) of unirrigated eyes:

Time after instillation
Animal 1 day 2 days 3 days 4 days 7 days
Cornea
01
1 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0
Iris
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0
Conjunctiva r c r c r c r c r c
1 2 1 1 1 1 1 0 0 0 0
2 1 1 0 0 0 0 0 0 0 0
3 2 1 2 1 2 1 1 1 0 0
1
see Attachment 1 for Draize scales
r = redness c = chemosis

Test method: OECD TG 405 (Organisation for Economic
Cooperation and Development, 1987b)

Observations; diffuse crimson colouration of the conjunctiva one
hour after installation for all animals; this persisted

FULL PUBLIC REPORT 13
NA/641

for up to 4 days; considerable swelling and partial
eversion of the eyelid in one animal; chemosis
lasted for up to 4 days

no corneal or iridal inflammation was observed

Result: the notified chemical was slightly irritating to the
eyes of rabbits


9.1.6 Skin Sensitisation (Selbie, 1996)

Species/strain: guinea pig/Dunkin Hartley

Number of animals: test group 10/sex
control group 5/sex




Induction procedure:

test group:

day 1: to a clipped area of the scapular dorsal skin, each
animal received 3 pairs of 0.1 mL injections as
follows ?br>
? 1:1 (v/v) mixture of Freund's Complete
Adjuvant and 0.9 % (w/v) physiological saline

? the test material diluted to 1 % in corn oil

? the test material diluted to 2 % in corn oil,
mixed 1:1 (v/v) with Freund's Complete
Adjuvant; final test material concentration 1 %

day 7 the same skin area was clipped and shaved and a
filter paper patch saturated with 100 % test
material was held in place under a polythene patch
for 48 hours

control group:

day 1: to a clipped area of the scapular dorsal skin, each
animal received 3 pairs of 0.1 mL injections as
follows ?br>
FULL PUBLIC REPORT 14
NA/641

? 1:1 (v/v) mixture of Freund's Complete
Adjuvant and 0.9 % (w/v) physiological saline

? corn oil

? corn oil, mixed 1:1 (v/v) with Freund's
Complete Adjuvant

day 7 as for test group but with a plain filter paper patch

Challenge procedure:
day 20 a filter paper patch soaked in a 5 % solution of test
material in acetone/PEG 400 was applied to both
test and control animals; the patch was covered
with an aluminium patch test cup and held in place
for 24 hours; the animals were examined for skin
reactions 24 and 48 hours after removal of the
patches

Challenge outcome:

Test animals Control animals
Challenge
concentration 24 hours* 48 hours* 24 hours 48 hours
5% **0/20 0/20 0/10 0/10
* time after patch removal
** number of animals exhibiting positive response

Test method: OECD TG 406 (Organisation for Economic
Cooperation and Development, 1992e)

Result: the notified chemical was not sensitising to the skin
of guinea pigs


9.2 Repeated Dose Toxicity (Allan, 1996)

Species/strain: rat/Sprague Dawley(Crl:CD BR VAF PLUS)

Number/sex of animals: group 1: 10/sex
group 2: 5/sex
group 3: 5/sex
group 4: 10/sex

Method of administration: gavage, 5 mL/kg/day test substance in corn oil, 0, 3,
30, 100 mg/mL


FULL PUBLIC REPORT 15
NA/641

Dose/Study duration:: group 1: 0 mg/kg/day
group 2: 15 mg/kg/day (low dose)
group 3: 150 mg/kg/day (intermediate dose)
group 4: 500 mg/kg/day (high dose)

the study duration was 28 days; 5 animals per sex
in groups 1 and 4 were then allowed to recover for
28 treatment free days

Clinical observations: no clinical signs of toxicological importance in any
of the animals; increased salivation, wet fur and
subsequent fur loss and paddling of the forepaws
following dosing were stated to be related to the
unpalatability of the test substance and discomfort
following dosing

bodyweight gains in all treated females were lower
than controls; the effect was found in the 500
mg/kg/day group throughout the treatment period
and for the 150 and 15 mg/kg/day groups, for the
last two weeks of treatment; it was not seen in
males

Haematology packed cell volume, haemoglobin concentration and
red blood cell counts lower than control for 500
mg/kg/day females after treatment period; mean
corpuscular volume slightly higher than control for
the same group; reticulocyte counts statistically
significantly higher than control for 500 mg/kg/day
males and females and 150 mg/kg/day males after
treatment period

marginally higher than control mean corpuscular
haemoglobin concentration for 150 and 500
mg/kg/day males and higher than control levels of
neutrophils for 15, 150 and 500 mg/kg/day males
and levels of monocytes for 500 mg/kg/day males
were considered incidental

after 28 days recovery, higher than control
reticulocyte levels and lower than control packed
cell volume, haemoglobin concentration and mean
corpuscular haemoglobin concentration were
observed for treated males; no other differences
were observed



FULL PUBLIC REPORT 16
NA/641

Clinical chemistry after the treatment period, blood triglyceride and
cholesterol levels were higher than the controls for
150 and 500 mg/kg/day males and cholesterol levels
were also high for 500 mg/kg/day females; glucose
levels were lower than the controls for 500
mg/kg/day males and females; alkaline phosphatase
levels were lower than the controls for 500
mg/kg/day females; albumin levels for 500
mg/kg/day females and globulin levels for 500
mg/kg/day males and females (and thus total
protein levels) were statistically significantly higher
than the controls

statistically significant decreases in chloride levels
were observed for 500 mg/kg/day males and females
but the individual levels were all within the
historical range

no biochemical differences from the controls were
observed at the end of the recovery period

Gross pathology: no macroscopic changes were observed at the end
of the treatment phase or the recovery period

Organ weights
liver: relative liver weights for 500 mg/kg/day males and
females were higher than the controls

kidney: relative kidney weights for 500 mg/kg/day males
and females were higher than the controls but in the
absence of histopathological findings the study
authors did not consider this treatment related

spleen: relative spleen weights for 500 mg/kg/day females
were statistically significantly higher than the
controls

other: no other statistically significant differences from
controls were observed

recovery period: the relative liver weights for 500 mg/kg/day males
were higher than the controls after the recovery
period; the right epididymis weight for 500
mg/kg/day males was lower than the controls
although this was not considered treatment related



FULL PUBLIC REPORT 17
NA/641

Histopathology:
liver: centrilobular hepatocyte hypertrophy was seen in
the liver of all males and three females treated at
500 mg/kg/day and one male at 150 mg/kg/day
(minimal to trace)

kidney: an increase in incidence and degree of eosinophilic
inclusions was seen in the kidneys of the 150 and
500 mg/kg/day males

spleen: dose related incidence of haemosiderosis was seen
in the spleen of all 500 mg/kg/day females
(minimal), two of the 150 mg/kg/day females (trace)
and one of the 15 mg/kg/day females; the finding of
haemosiderosis in the low dose animal was
considered unlikely to be related to the treatment
by the study authors

other: follicular epithelial hypertrophy (minimal) was
seen in the thyroid of males and females treated at
150 and 500 mg/kg/day

recovery period after the recovery period no significant
histopathological differences between the treated
group and the controls were observed

Test method: OECD TG 407 (Organisation for Economic
Cooperation and Development, 1995)

Result: the authors established a NOAEL of 15 mg/kg/day,
based on the dose related incidence of
haemosiderosis seen in the spleen of female rats at
150 and 500 mg/kg/day; a NOEL could not be
established because treatment related effects on
bodyweight gain were found in female rats at all
doses




FULL PUBLIC REPORT 18
NA/641

9.3 Genotoxicity

9.3.1 Salmonella typhimurium Reverse Mutation Assay (Windebank, 1996)

Strains: Salmonella typhimurium: TA98, TA100, TA1535,
TA1537

5000, 1500, 500, 150, 50, 15 and 5 礸/plate (all
Concentration range:
strains, with metabolic activation)
5000, 1500, 500, 150, 50 and 15 礸/plate
(TA1535, without metabolic activation)
1500, 500, 150, 50, 15, 5, 1.5 and 0.5 礸/plate
(TA100 and TA98, without metabolic activation)
500, 150, 50, 15, 5, 1.5 and 0.5 礸/plate (TA1537,
without metabolic activation)

Metabolic Activation System: rat liver S9 fraction from animals pretreated with
Arochlor 1254

Test method: OECD TG 471 (Organisation for Economic
Cooperation and Development, 1983b)

2-aminoanthracene 2 礸/plate ?TA1535, TA1537
Positive controls
with metabolic activation
2-aminoanthracene 1 礸/plate ?TA100, TA98
with metabolic activation
sodium azide 2 礸/plate ?TA1535, TA100,
without metabolic activation
2-nitrofluorene 1 礸/plate ?TA 98 without
metabolic activation
9-aminoacridine 20 礸/plate ?TA 1537 without
metabolic activation

Comment: in the presence of metabolic activation, toxicity
was observed for all strains at 500 礸/plate; in the
absence of metabolic activation, all strains except
TA1535 showed toxicity at 50 礸/plate; for
TA1535, toxicity was observed at 5000 礸/plate

no substantial increase in the number of revertant
colonies or indication of clear dose response was
observed in any test

the positive controls produced clear positive
results indicating that the test system responded
appropriately

FULL PUBLIC REPORT 19
NA/641

Result: the notified chemical was not mutagenic in the
bacterial strains tested in the absence or presence of
metabolic activation provided by rat liver S9
fraction


9.3.2 Chromosomal Aberrations in Human Lymphocytes In Vitro (Ackhurst, 1996)


Cells: human lymphocytes treated with phytohaemag-
glutinin

Doses: test material
25-200 礸/mL (without metabolic activation)
50-250 礸/mL (with metabolic activation)

positive controls
mitomycin C 0.2-0.8 礸/mL (without metabolic
activation)
cyclophosphamide 15-25 礸/mL (with metabolic
activation)

Metabolic Activation System: rat liver S9 fraction from animals pretreated with
Arochlor 1254

Test method: OECD TG 473 (Organisation for Economic
Cooperation and Development, 1983a)

Treatment Regime: with metabolic activation:
test material (in ethanol) or positive control added
to cell cultures in medium, with 250 礚/mL S9 mix,
for 3 hours; the cells were then washed and
cultured in fresh medium for a total time of 21 or
45 hours

without metabolic activation:
test material (in ethanol) or positive control added
to cell cultures in medium and incubated for a total
of 21 or 45 hours without a change of medium

colcemid was added to all cultures 2 hours before
harvest to arrest cells in metaphase

Observations: toxic effects were observed between 100 and 200
?g/mL in the different studies; up to the highest

FULL PUBLIC REPORT 20
NA/641

doses used no statistically significant increase in
the proportion of aberrant cells was seen compared
with the solvent controls either in the presence or
absence of metabolic activation

statistically significant increases in cells showing
structural chromosome aberrations occurred for the
positive control substances, indicating that the test
system responded appropriately

Results: the notified substance did not induce structural
chromosome aberrations in the presence or absence
of metabolic activation




9.4 Overall Assessment of Toxicological Data

The acute oral toxicity in rats is very low (LD 50>2000 mg/kg) and the acute dermal toxicity in
rats is low (LD 50>2000 mg/kg).

The notified chemical is a moderate irritant to rabbit skin, producing erythema which
persisted for at least 14 days and oedema which persisted for up to 12 days. Opalal is
determined to be a hazardous substance according to the NOHSC Approved Criteria for
Classifying Hazardous Substances (Approved Criteria) (National Occupational Health and
Safety Commission, 1994a), because of (1) the erythema score over the first 72 hours of the
t e s t and (2) the persistence of skin irritation over the 14 days of the study. Opalal is
classified as irritant and warrants the risk phrase R38, `Irritating to the skin'.

The notified chemical did not elicit corneal or iris effects in rabbit eyes. Conjunctival redness
and chemosis both persisted for up to four days after application of the test material and
therefore Opalal must be considered to be a slight eye irritant. The mean scores for
conjunctival effects were below the threshold for classification as irritating to eyes according
to the Approved Criteria.

The notified chemical was not found to be a skin sensitiser in guinea pigs in an adjuvant skin
sensitisation study.

In a 28 day repeat dose oral toxicity study in rats, the animals were administered the notified
chemical by gavage at 0, 15, 150 or 500 mg/kg/day. The most significant findings related to
the liver and spleen of the treated animals when compared to controls. Treatment related
effects in the liver included increased liver weight plus centrilobular hepatocyte hypertrophy.
The study authors suggested that these effects, plus the biochemical findings, reflected an
adaptive change in the liver. Treatment related effects in the spleen included an increase in
spleen weight accompanied by haemosiderosis (considered an adverse effect in the high and
intermediate dose groups). This was possibly related to haemolysed red blood cells, as

FULL PUBLIC REPORT 21
NA/641

evidenced also by effects on red blood cell parameters in high dose females, and high
reticulocyte counts for high dose males and females.

Increased kidney weight accompanied by histopathological changes were observed in the
kidneys of male rats; however the study authors suggested this was indicative of light
hydrocarbon nephropathy syndrome (Alden, 1986) and that this is not considered predictive
of a similar effect in man (Halder, 1984; Hard, 1993). The effects were only partially
reversible. Treatment related thyroid hypertrophy was also observed in the high and
intermediate dose groups.

A NOEL could not be established because of the effects on bodyweight gain found at all
doses. The observed effects of treatment were found to be reversible after a 28 day recovery
period.

The notified chemical was not mutagenic in bacterial test systems nor did it induce
chromosomal aberrations in an in vitro human lymphocyte cytogenetic assay.


10. ASSESSMENT OF ENVIRONMENTAL EFFECTS

The notifier provided the following ecotoxicity data in support of their application. The
ecotoxicity tests were performed in accordance with OECD Test Guidelines 203
(Organisation for Economic Cooperation and Development, 1992b), 202 (Organisation for
Economic Cooperation and Development, 1984c), 201 (Organisation for Economic
Cooperation and Development, 1984b) and 209 (Organisation for Economic Cooperation and
Development, 1984a).

Test Species Results Reference
Brachydanio rerio LC50 (96 h) = 11.27 mg/L (Vaughan,
acute toxicity
(zebra fish) 0.98 < NOEC(96 h) < 2.26 1996)
mg/L

EC50 (48 h) > 11 mg/L (Flanagan,
acute immobilisation Daphnia magna
NOEC (48 h) = 3.4 mg/L 1996)

Scenedesmus subspicatus EbC50 (72 h) = 8.2 mg/L (Roebuck,
algal growth
NOEC (72 h) = 3.6 mg/L 1996)
inhibition

inhibition of bacterial sewage sludge bacteria Eb50 (3 h) > 1,000 mg/L (Mead, 1997)
respiration NOEC( 3 h) > 100 mg/L

* NOEC - no observable effect concentration

The tests on zebra fish were performed using solutions of the test material made up in carbon
filtered tap water at mean measured concentrations of 0 (control), 0.98, 2.26, 4.12, 5.6, and
22.69 mg/L. The tests were conducted in a semi-static (renewal) system over a 96 hour period

FULL PUBLIC REPORT 22
NA/641

at a controlled temperature of 26.5oC, with water removed daily and replaced with fresh water
containing the respective concentrations of the test material. Solution analysis was conducted
daily by gas chromatography for determination of the test chemical concentrations. Seven fish
were tested at each concentration. During these tests the pH of the test solutions remained
between 7.4 and 8.0, dissolved oxygen levels remained between 6.8 and 7.2 mg/L and water
hardness remained between 138 and 155 mg/L as CaCO3.

No fish mortality occurred over the duration of the test for concentrations less than or equal
to 5.6 mg/L, while at the highest concentration tested (22.7 mg/L) all fish died immediately.
Behavioural aberration, specifically erratic swimming activity, was observed at concentrations
greater than or equal to 2.26 mg/L. The tests results indicate that the material Opalal is
moderately toxic to zebra fish with a 96 hour LC 50 = 11.27 mg/L, and NOEC (96 h) between
0.98 and 2.26 mg/L.

The acute immobilisation tests on Daphnia were performed using solutions of the test
material in a static non renewal system over a 48 hour period at a controlled temperature of
20 ? 癈. Five solutions of the chemical with (geometric mean) measured concentrations of
0.69, 1.6, 3.4, 6.8 and 11 mg/L were tested, together with one control. Solution analysis (gas
chromatography) for the test compound was conducted daily on samples of both old and
fresh test media. Five juvenile Daphnia were tested at each concentration, with four replicate
tests conducted at each concentration. During these tests the pH of the test solutions
remained between 7.4 and 8.0, while dissolved oxygen levels remained between 7.8 and 9.0
mg/L and hardness was approximately 240 mg/L as CaCO3.

Significant reduction in Daphnia mobility was observed during the tests, and the results
indicate that the material Opalal is at most moderately toxic to Daphnia with a 48 hour
NOEC = 3.4 mg/L.

A test on the inhibition of algal growth was also conducted on the freshwater green algae
Scenedesmus subspicatus over a 72 hour incubation period at 21-24癈 with (geometric mean)
measured concentrations for the test material of 0.73, 1.1, 3.4, 3.6 and 8.5 mg/L, together with
a control containing no chemical. The solutions were made up in distilled water. The measured
test concentrations were significantly less than the nominal concentrations (up to 90 %
difference), indicating appreciable adsorption of the test material by the algal mass. Both rate
of growth and algal biomass were monitored over the 72 hour test duration, and the results
show the new chemical to be moderately toxic to this species of green algae, with an
approximate EC50 of 8.2 mg/L, and NOEC (72 h) = 3.6 mg/L based on the biomass data.

The new chemical was also studied for its effect on the respiration of sewage bacteria, and
was found to have some inhibitory effects at concentrations equal to or greater than 100 mg/L.
In contrast, the reference material used in these tests, 3,5-dichlorophenol, produced 89 %
inhibition of bacterial respiration at a concentration of 32 mg/L. The compound is therefore
considered to be practically non toxic to these bacteria.

The QASR calculations of the ASTER database (US Environment Protection Authority,
1998) also furnished predicted acute toxicity LC50 data for several fish species which included

FULL PUBLIC REPORT 23
NA/641

Rainbow trout (2.92 mg/L), Fathead minnow (7.38 mg/L), Bluegill (6.0 mg/L), and Channel
catfish (3.2 mg/L). These calculations also furnished an acute LC50 of 4.3 mg/L for
immobilisation of Daphnia, and a chronic MATC of 1.18 mg/L for Fathead minnow. These
results are in reasonable accord with the experimental data, and support the conclusion that
the new chemical can be considered to be moderately toxic to aquatic species.


11. ASSESSMENT OF ENVIRONMENTAL HAZARD

The majority of the new chemical is an ingredient of domestic cleaning formulations and most
of the material would eventually be released into domestic sewage systems as a consequence
of product use. However, due to the volatility of the material, a high proportion is likely to
enter the atmosphere where it is expected to be degraded through reactions with hydroxyl
radicals.

The ecotoxicity data indicates that the new chemical can be considered moderately toxic to
aquatic species. Based on annual imports of 0.5 tonne, all of which is eventually released to
sewer, the daily release on a nationwide basis is 1.36 kg/day. Assuming a national population
of 18,000,000 and that each person contributes an average 150 L/day to overall sewage flows,
the predicted concentration in sewage effluent on a nationwide basis is estimated as 0.5 礸/L.
When released to receiving waters the concentration is generally understood to be reduced by
a further factor of at least 10, and so the Predicted Environmental Concentration is around
0.05?g/L. This is several orders of magnitude less than the concentrations at which the
compound has demonstrated toxicity to aquatic species.

The chemical is hydrophobic with Log Kow = 5.33. This indicates high affinity for organic
material, although the measured value of Log Koc = 2.6 indicates only moderate affinity for
the organic component of soils and sediments. The Simple Treat and Level 1 Mackay
calculations also indicate that due to the relatively high vapour pressure, much of the chemical
would partition into the atmosphere and be destroyed by reactions with hydroxyl free
radicals. Nevertheless, it is likely that some of the chemical would become bound to soils and
sediments, and here it would be expected to be slowly degraded to water, carbon dioxide and
methane through biological processes. These mechanisms would operate to continuously
remove the chemical from the environmental compartments, and that overall environmental
concentrations would be unlikely to increase with prolonged release of the chemical.

The above considerations indicate a low hazard to the environment when the new chemical is
used as a component of domestic products in the manner indicated by the notifier.


12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS

The notified chemical is of low acute toxicity, but is a moderate skin irritant and a slight eye
irritant in rabbits. The main hazards associated with the public and occupational use of Opalal
will be associated with the irritant properties. A NOEL could not be established for the

FULL PUBLIC REPORT 24
NA/641

chemical.

The notified chemical will be imported in mixtures as compounded fragrances containing high
concentrations (up to 25 %) of the notified chemical. The fragrances will be used in the
manufacture of consumer products, where the final concentration of the notified chemical will
be much lower. Therefore the irritant effects will be of most concern in the industrial use of
the chemical.

The fragrance mixtures containing Opalal are to be sold on to a variety of customers; the
notifier was able to provide only basic information on the manufacturing processes whereby
the notified chemical will be incorporated into a variety of consumer products. All potential
product types are not determined, however. The notifier provided examples of the
manufacturing processes involved in the manufacture of air fresheners and solid and liquid
soaps, which are examples of the types of products in which these fragrances may be used.
The processes will generally be automated sealed systems. After formulation of the products,
the occupational exposure, for example for packaging workers, should be low.

Dermal exposure to spills and drips on the transfer of the compounded fragrances are likely to
be the main route of exposure for production workers. This is most likely to occur on
connecting and disconnecting the 200 L drums of fragrance, and when cleaning the production
equipment and empty drums. Inhalation exposure is also possible, although the vapour
pressure of the notified chemical is low (1.4 ?10 -2 kPa at 25 癈). Workers may also be
exposed to the notified chemical when using the retail products. Exposure and risk for these
workers would be similar to that for the general public.

The notifier recommends that impervious gloves and eye protection be worn when the
concentrated material is handled, and indicates that adequate ventilation should be provided at
all times, including local exhaust ventilation during filling operations. Workers involved in the
manufacture of consumer products will need to be protected against the topical and systemic
effects of repeated exposure. The chemical is a hazardous substance and warrants the risk
phrase R38 `Irritating to skin', as the chemical produced persistent skin irritation. This
information is provided on the label for the notified chemical. The imported fragrances
containing the chemical at up to 25 % will be hazardous substances in relation to the chemical
when it is present at 20 %. In addition, a no effect level could not be established for the
chemical. Consequently, workers repeatedly handling the imported fragrances, or end use
products containing high concentrations of the notified chemical, will require skin protection.

As the notified chemical will be used in a wide range of household products, there will be
widespread public exposure. However, the public health hazards associated with skin and eye
irritation are likely to be offset by the low concentration of 0.001 ?0.5 % of the notified
chemical in household products.

The notifier has supplied a risk assessment where typical exposures from cosmetic products,
soaps/shower gels, and household products have been calculated based on European usage
figures. Assuming a notified chemical concentration of 0.03 % in household products, and
0.006 % in cosmetic products and soaps/shower gels, 10 % absorption through the skin, and a

FULL PUBLIC REPORT 25
NA/641

60 kg body weight, a person applying 10 g of cosmetic cream, once daily, would receive a
systemic exposure of 0.001 mg/kg/day. A person using 5 g of soap/shower gel per day,
assuming 10 % remains on the skin, would receive a systemic exposure of 0.00005 mg/kg/day,
and a person using 10 g of a household product, 1 % of which is in direct contact with the
skin, would receive a systemic exposure of 0.00005 mg/kg/day. The total estimated exposure
is thus of the order of 0.001 mg/kg/day. Therefore public exposure from the proposed use is
likely to be low.

Based on the use pattern for the notified chemical it is considered that it is unlikely to pose a
significant hazard to public health.


13. RECOMMENDATIONS

To minimise occupational exposure to Opalal 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 3765.2 (Standards Australia, 1990);

Impermeable gloves should conform to AS/NZS 2161.2 (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>

Imported compounded fragrance products containing the notified chemical at 20 %
?br> will need to conform with the NOHSC National Code of Practice for the Labelling of
Workplace Substances.


14. MATERIAL SAFETY DATA SHEET

The MSDS for the notified chemical was provided in a format consistent with the National
Code of Practice for the Preparation of Material Safety Data Sheets (National Occupational

FULL PUBLIC REPORT 26
NA/641

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.


16. REFERENCES

Ackhurst, L. C. (1996) Opalal: Metaphase Chromosome Analysis of Human Lymphocytes
Cultured In vitro, Project No. ULR 615/952586, Unilever Research, Bedford, UK.

Alden, C. L. (1986) A Review of Unique Male Rat Hydrocarbon Nephropathy. Tox. Path.,
14 (1): 109-111.

Allan, S. A. (1996) Opalal: Four-Week Oral Toxicity Study in the Rat with Four-Week
Recovery Period, Project No. ULR 617/961846, Huntingdon Life Sciences Ltd., Huntingdon,
UK.

Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.
Association of Food and Drug Officials of the US, 49 : 2-56.

European Commission (1996) Technical Guidance Document in Support of Commission
Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission
Regulation (EC) No 1488/94 on Risk Assessment for Existing Substances. Part IV. ECSC-
EC-EAEC, Brussels.

European Economic Community (1992) EEC Directive 92/69/EEC on the Approximation of
the Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging
and Labeling of Dangerous Preparations.

Flanagan, J. M. (1996) The Acute Toxicity of Opalal to Daphnia Magna, Project No.
AT/Q063/01, Unilever Research, Merseyside, UK.

H a l d e r , C. A., Warne, J. M. and Harfoum, N. S. (1984) Renal Toxicity of Gasoline and
Related Petroleum Naphthas in Male Rats. In: M. A. Melham ed. Renal Effects of Petroleum
Hydrocarbons. Princeton Sci. Pub., Princeton, N. J.




FULL PUBLIC REPORT 27
NA/641

Hard, G. C., Rodgers, I. S., Baetke, K. P., Richards, W. L., McGaughy, R. E. and Valcovic, L.
R. (1993) Hazard Evaluation of Chemicals That Cause Accumulation of 2?globulin,
Hyaline Droplet Nephropathy and Tubal Neoplasia in the Kidney of Male Rats.
Environmental Health Perspectives, 99 : 313-349.

McRae, L. A. (1996a) Opalal: Acute Dermal Toxicity to the Rat, Project No. ULR
607/952630/AC, Huntingdon Life Sciences Ltd., Huntingdon, UK.

McRae, L. A. (1996b) Opalal: Acute Oral Toxicity to the Rat, Project No. ULR
606/952629/AC, Huntingdon Life Sciences Ltd., Huntingdon, UK.

Mead, C (1997) QRM 1734 (Opalal): Assessment of the Inhibitory Effect on the
Respiration of Activated Sewage Sludge, Project No. 766/027, Safepharm Laboratories Ltd.,
Derby, UK.

National Occupational Health and Safety Commission (1994a) Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(1994)]. Australian Government Publishing
Service, Canberra.

National Occupational Health and Safety Commission (1994b) National Code of Practice for
the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)]. Australian
Government Publishing Service, Canberra.

Organisation for Economic Cooperation and Development (1983a) Genetic Toxicology: In
vitro Mammalian Cytogenetic Test, Guideline 473. OECD Guidelines for Testing of
Chemicals. Section 4: Health Effects.

Organisation for Economic Cooperation and Development (1983b) Genetic Toxicology:
Salmonella typhimurium, Reverse Mutation Assay, Guideline 471. OECD Guidelines for
Testing of Chemicals. Section 4: Health Effects.

Organisation for Economic Cooperation and Development (1984a) Activated Sludge
Respiration Inhibition Test, Guideline 209. OECD Guidelines for Testing of Chemicals.
Section 2: Effects on Biotic Systems.

Organisation for Economic Cooperation and Development (1984b) Alga, Growth Inhibition
Test, Guideline 201. OECD Guidelines for Testing of Chemicals. Section 2: Effects on Biotic
Systems.

Organisation for Economic Cooperation and Development (1984c) Daphnia Sp. Acute
Immobilization Test, Guideline 202. OECD Guidelines for Testing of Chemicals. Section 2:
Effects on Biotic Systems.

Organisation for Economic Cooperation and Development (1987a) Acute Dermal Toxicity,
Guideline 402. OECD Guidelines for Testing of Chemicals. Section 4: Health Effects.



FULL PUBLIC REPORT 28
NA/641

Organisation for Economic Cooperation and Development (1987b) Acute Eye
Irritation/Corrosion, Guideline 405. OECD Guidelines for Testing of Chemicals. Section 4:
Health Effects.

Organisation for Economic Cooperation and Development (1987c) Acute Oral Toxicity,
Guideline 401. OECD Guidelines for Testing of Chemicals. Section 4: Health Effects.

Organisation for Economic Cooperation and Development (1992a) Acute Dermal
Irritation/Corrosion, Guideline 404. OECD Guidelines for Testing of Chemicals. Section 4:
Health Effects.

Organisation for Economic Cooperation and Development (1992b) Fish, Acute Toxicity Test,
Guideline 203. OECD Guidelines for Testing of Chemicals. Section 2: Effects on Biotic
Systems.

Organisation for Economic Cooperation and Development (1992c) Manometric Respirometry
Test, Guideline 301 F. OECD Guidelines for Testing of Chemicals, Section 3.

Organisation for Economic Cooperation and Development (1992d) The Rate of
Photochemical Transformation of Gaseous Organic Compounds in Air Under Tropospheric
Conditions. OECD, Paris.

Organisation for Economic Cooperation and Development (1992e) Skin Sensitisation,
Guideline 406. OECD Guidelines for Testing of Chemicals. Section 4: Health Effects.

Organisation for Economic Cooperation and Development (1995) Repeated Dose 28-day Oral
Toxicity Study in Rodents, Guideline 407. OECD Guidelines for Testing of Chemicals.
Section 4: Health Effects.

Parcell, B. I. (1996a) Opalal: Eye Irritation to the Rabbit, Project No. ULR 609/952960/SE,
Huntingdon Life Sciences Ltd., Huntingdon, UK.

Parcell, B. I. (1996b) Opalal: Skin Irritation to the Rabbit, Project No. ULR 608/952903/SE,
Huntingdon Life Sciences Ltd., Huntingdon, UK.

R o e b u c k , S. R. (1996) The Toxicity of Opalal to Scenedesmus Subspicatus, Project No.
AL/QO63/01, Unilever Research, Merseyside, UK.

Selbie, E. and Lea, L. (1996) Opalal: Skin Sensitization Study in Guinea Pigs, Project No.
SM950450, Unilever Research, Bedford, UK.

Standards Australia (1987) Australian Standard 2919-1987, Industrial Clothing. Standards
Association of Australia, Sydney.




FULL PUBLIC REPORT 29
NA/641

Standards Australia (1990) Australian Standard 3765.2-1990, Clothing for Protection against
Hazardous Chemicals Part 2 Limited protection against specific chemicals. Standards
Association of Australia, Sydney.

Standards Australia (1994) Australian Standard 1336-1994, Eye protection in the Industrial
Environment. Standards Association of Australia, Sydney.

Standards Australia/Standards New Zealand (1992) Australian/New Zealand Standard 1337-
1992, Eye Protectors for Industrial Applications. Standards Association of
Australia/Standards Association of New Zealand, Sydney/Wellington.

Standards Australia/Standards New Zealand (1994) Australian/New Zealand Standard 2210-
1994, Occupational Protective Footwear. Standards Association of Australia/Standards
Association of New Zealand, Sydney/Wellington.

Standards Australia/Standards New Zealand (1998) Australian/New Zealand Standard 2161.2-
1998, Occupational protective gloves, Part 2: General requirements. Standards Association of
Australia, Sydney.

US Environment Protection Authority (1998) ASTER Ecotoxicity Profile: 3,3-Dimethyl-4-
isopropyl-dioxaspiro(4,5)decane - [CAS No 62406-73-9]. United States Environment
Protection Agency, Office of Research and Development, National Health and Environmental
Effects Research Laboratory, Mid-Continent Ecology Division

Vaughan, M (1996) The Acute Toxicity of Opalal to Zebra Fish, Project No. AT/QO63/02,
Unilever Research, Merseyside, UK.

Windebank, S. and Fedyk, J. (1996) Opalal: Mutagenicity Study in Salmonella
Typhimurium, Project No. AT950449, Unilever Research, Bedford, UK.




FULL PUBLIC REPORT 30
NA/641

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 perceptible) 1
perceptible)
Well-defined erythema 2 Slight oedema (edges of area well- 2
de fine d by definite raising
Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3
Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm 4
and extending beyond area of
exposure)



The Draize scale 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
d e t a i l s 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. O b v i o u s swelling 2 mild Discharge with 2 mod.
crimson red with with partial eversion m o i s t e n i n g of lids and
i n d i v i d u a l vessels not o f lids adjacent hairs
e a s i l y discernible
Swelling with lids 3 mod. Discharge with 3 severe
Diffuse beefy red 3 severe half-closed m o i s t e n i n g of lids and
hairs and considerable
Swelling with lids 4 severe area around eye
half-closed to
c o m p l e t e l y 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 31
NA/641





Search    ENTER KEYWORD
ALL PAGES On Chemical Property IN THIS GROUP
NAMECAS
7732-18-5_57-55-6_9002-93-1_009002-93-1.asp 7732-18-5 57-55-6 9002-93-1 009002-93-1
57-55-6_75-28-5.asp 57-55-6 75-28-5
1130192759.asp N/A
7732-18-5_5989-27-5_1332-09-8_69227-21-0_68956-68-3_138-96.asp 7732-18-5 5989-27-5 1332-09-8 69227-21-0 68956-68-3 138-96-8 8001-97-6 8042-47-5 61789-91-1 8006-54-0 26172-55-4 58-95-7 102-71-6
n194658984.asp N/A
1669656993.asp N/A
n1404540820.asp N/A
75-74-1_78-00-2_1163-19-5_25637-99.asp 75-74-1 78-00-2 1163-19-5 25637-99-4
04-06.asp 04-06-1
n1751203592.asp N/A
598-62-9.asp 598-62-9
64742-48-9_5989-27-5_124-38.asp 64742-48-9 5989-27-5 124-38-9
n573754349.asp N/A
n1687332145.asp N/A
142-82-5_60-29-7_124-38-9_110-54-3.asp 142-82-5 60-29-7 124-38-9 110-54-3
112-80-1_60-33-3_463-40-1_79-11-8_107-41-5_79-14-1_128-37.asp 112-80-1 60-33-3 463-40-1 79-11-8 107-41-5 79-14-1 128-37-0 14332-09-3
60-35-5.asp 60-35-5
1763-23.asp 1763-23-1
142-82-5_6674-22.asp 142-82-5 6674-22-2
1358254874.asp N/A
1763283784.asp N/A
61-73-4.asp 61-73-4
286762516.asp N/A
n989274001.asp N/A
n379409109.asp N/A
25852-47-5_18268-70-7_80-15-9_9004-36-8_81-07-2_613-48-9.asp 25852-47-5 18268-70-7 80-15-9 9004-36-8 81-07-2 613-48-9
25852-47-5_868-77-9_63393-89-5_9003-42-3_80-15-9_81-07-2_613-48.asp 25852-47-5 868-77-9 63393-89-5 9003-42-3 80-15-9 81-07-2 613-48-9
24448-20-2_3006-93-7_80-15-9_27813-02-1_112945-52-5_114-83.asp 24448-20-2 3006-93-7 80-15-9 27813-02-1 112945-52-5 114-83-0 613-48-9 110-16-7 81-07-2
25852-47-5_39382-25-7_81-07-2_80-15-9_613-48-9.asp 25852-47-5 39382-25-7 81-07-2 80-15-9 613-48-9
5888-33-5_868-77-9_79-41-4_67762-90-7_614-45-9_110-16-7_81-07.asp 5888-33-5 868-77-9 79-41-4 67762-90-7 614-45-9 110-16-7 81-07-2
n17881534.asp N/A
115-96-8_13674-84-5_13674-87-8_6145-73-9_302346-65.asp 115-96-8 13674-84-5 13674-87-8 6145-73-9 302346-65-2
n839848978.asp N/A
n845233275.asp N/A
00617-48-1.asp 00617-48-1
70131-67-8_67762-90-7_63148-62-9_6175-45-7_17689-77-9_4253-34-3.asp 70131-67-8 67762-90-7 63148-62-9 6175-45-7 17689-77-9 4253-34-3 77-58-7
67762-90-7_6175-45-7_2768-02-7_546-68-9_107-46-0_67-56.asp 67762-90-7 6175-45-7 2768-02-7 546-68-9 107-46-0 67-56-1
00062-53-3.asp 00062-53-3
00062-56-6.asp 00062-56-6
n898420687.asp N/A
1237167040.asp N/A
62406-73.asp 62406-73-9
1492178500.asp N/A
108-05-4_27138-31-4_9003-20-7_1138-66-2.asp 108-05-4 27138-31-4 9003-20-7 1138-66-2
71-43.asp 71-43-2
106-97-8_74-98-6_75-28-5_7732-18-5_134-62-3_64-17.asp 106-97-8 74-98-6 75-28-5 7732-18-5 134-62-3 64-17-5
64742-89-8_108-88-3_110-54-3_64-17-5_14808-60.asp 64742-89-8 108-88-3 110-54-3 64-17-5 14808-60-7
1330-20-7_108-88-3_64-17-5_95-63-6_71-43-2_100-41-4_110-54.asp 1330-20-7 108-88-3 64-17-5 95-63-6 71-43-2 100-41-4 110-54-3 110-82-7 91-20-3
64-17-5_7664-41-7.asp 64-17-5 7664-41-7
4253-34-3_17689-77-9_64-19-7_7631-86-9_70131-67-8.asp 4253-34-3 17689-77-9 64-19-7 7631-86-9 70131-67-8


HBCChem,Inc

Chemical Information Net chemcas.orgCopyright Reserved

Trading Lead

Leputech HPLC Laboratory