Download STD/1106

File No: STD/1106
26 April 2006
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Chemical in Crodazosoft DBQ
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification
and Assessment) Act 1989 (Cwlth) (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 Department of Health and Ageing, and conducts the risk assessment for public health and occupational
health and safety. The assessment of environmental risk is conducted by the Department of the Environment and
Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
Australian Safety and Compensation Council
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email [email protected]
This Full Public Report is available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:
Street Address:
Postal Address:
TEL:
FAX
Website:
Director
NICNAS
334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
+ 61 2 8577 8800
+ 61 2 8577 8888
www.nicnas.gov.au
TABLE OF CONTENTS
FULL PUBLIC REPORT ....................................................................................................................................... 4
1.
APPLICANT AND NOTIFICATION DETAILS .................................................................................... 4
2.
IDENTITY OF CHEMICAL ................................................................................................................... 4
3.
COMPOSITION....................................................................................................................................... 4
4.
INTRODUCTION AND USE INFORMATION ..................................................................................... 5
5.
PROCESS AND RELEASE INFORMATION ........................................................................................ 5
5.1.
Distribution, transport and storage .................................................................................................. 5
5.2.
Operation description ...................................................................................................................... 5
5.3.
Occupational Exposure ................................................................................................................... 5
End use: ............................................................................................................................................................. 6
5.4.
Release ............................................................................................................................................ 6
5.5.
Disposal .......................................................................................................................................... 7
5.6.
Public exposure ............................................................................................................................... 7
6.
PHYSICAL AND CHEMICAL PROPERTIES ....................................................................................... 7
7.
TOXICOLOGICAL INVESTIGATIONS ............................................................................................. 10
7.1. Irritation – skin – in vitro ..................................................................................................................... 10
7.2 Irritation – Eye Irritancy Potential Utilizing the HET-CAM test. ......................................................... 10
7.3 Skin sensitisation – human volunteers – Repeated Insult Patch Test .................................................... 11
8.
ENVIRONMENT ................................................................................................................................... 13
8.1.
Environmental fate ........................................................................................................................ 13
8.1.1. Ready biodegradability ............................................................................................................ 13
8.1.2. Bioaccumulation ...................................................................................................................... 13
8.2.
Ecotoxicological investigations .................................................................................................... 13
8.2.1. Acute toxicity to fish ................................................................................................................ 13
8.2.2. Acute toxicity to aquatic invertebrates ..................................................................................... 13
8.2.3. Algal growth inhibition test ..................................................................................................... 14
9.
RISK ASSESSMENT ............................................................................................................................ 16
9.1.
Environment ................................................................................................................................. 16
9.1.1. Environment – exposure assessment ........................................................................................ 16
9.1.2. Environment – effects assessment ........................................................................................... 16
9.1.3. Environment – risk characterisation ......................................................................................... 16
9.2.
Human health ................................................................................................................................ 17
9.2.1. Occupational health and safety – exposure assessment ........................................................... 17
9.2.2. Public health – exposure assessment ........................................................................................ 17
9.2.3. Human health – effects assessment .......................................................................................... 17
9.2.4. Occupational health and safety – risk characterisation ............................................................ 19
9.2.5. Public health – risk characterisation......................................................................................... 19
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS ........................................................................................................................................................ 19
10.1.
Hazard classification ..................................................................................................................... 19
10.2.
Environmental risk assessment ..................................................................................................... 20
10.3.
Human health risk assessment ...................................................................................................... 20
10.3.1.
Occupational health and safety ............................................................................................ 20
10.3.2.
Public health ........................................................................................................................ 20
11.
MATERIAL SAFETY DATA SHEET ............................................................................................. 20
11.1.
Material Safety Data Sheet ........................................................................................................... 20
11.2.
Label ............................................................................................................................................. 20
12.
RECOMMENDATIONS................................................................................................................... 20
12.1.
Secondary notification .................................................................................................................. 22
13.
BIBLIOGRAPHY ............................................................................................................................. 22
Created on 6/26/2015 7:05:00 AM
Last Saved 6/29/2015 9:11:00 AM
File No: STD/1106
26 April 2006
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Chemical in Crodazosoft DBQ
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification
and Assessment) Act 1989 (Cwlth) (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 Department of Health and Ageing, and conducts the risk assessment for public health and occupational
health and safety. The assessment of environmental risk is conducted by the Department of the Environment and
Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
Australian Safety and Compensation Council
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email [email protected]
This Full Public Report is available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:
Street Address:
Postal Address:
TEL:
FAX
Website:
Director
NICNAS
334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
+ 61 2 8577 8800
+ 61 2 8577 8888
www.nicnas.gov.au
26 April 2006
NICNAS
FULL PUBLIC REPORT
Chemical in Crodazosoft DBQ
1.
APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Croda Singapore Pte Ltd (trading as Croda Australia) (ABN: 34 088 345 457)
Suite A1, Ground Floor,
44-46 Mandarin Street
Villawood NSW 2163
NOTIFICATION CATEGORY
Standard: Chemical other than polymer (more than 1 tonne per year).
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
Data items and details claimed exempt from publication:
 Import volumes
 Chemical name
 CAS number
 Molecular and structural formulae
 Molecular weight
 Spectral data
 Percentage of notified chemical in final products
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
Variation to the schedule of data requirements is claimed as follows:
All toxicological testing
All ecotoxicological testing
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None
NOTIFICATION IN OTHER COUNTRIES
Canada (low level notification under the Food and Drugs Act)
2.
IDENTITY OF CHEMICAL
OTHER NAME(S)
Quaternium 91 (INCI name)
MARKETING NAME(S)
Crodazosoft DBQ (notified chemical is component of this mixture)
METHODS OF DETECTION AND DETERMINATION
METHOD
Remarks
3.
IR, titration for free amine.
Copy of IR spectrum of Crodazosoft DBQ provided.
COMPOSITION
DEGREE OF PURITY
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NICNAS
> 80%
4.
INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
The notified chemical will be imported as 50% of Crodazosoft DBQ.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year
Tonnes
1
<1
2
<1
3
<1
4
<1
5
<1
USE
Ingredient in hair care products.
5.
PROCESS AND RELEASE INFORMATION
5.1.
Distribution, transport and storage
PORT OF ENTRY
Sydney
IDENTITY OF MANUFACTURER/RECIPIENTS
Manufacturers of hair care products
TRANSPORTATION AND PACKAGING
The notified chemical will be transported into Australia by ship in 75 kg heat-sealed plastic bags. The
notified chemical will be transported from the dockside to the manufacturing site at Hornsby, NSW,
where it will be stored and formulated into hair care products. The finished hair care product will be
packaged into 250 mL plastic bottles. These plastic bottled products are then packed in cardboard
cartons before being transported by truck or van to hairdressing salons or to a port for export.
5.2.
Operation description
At the formulation site the hair care products are formulated in batch sizes of 18,000 kg. Crodazosoft
DBQ containing 50% of the notified chemical is poured into stainless steel containers filled with
solvent for dissolution. The resulting mixture is transferred under vacuum into a second sealed
blending vessel where other components of the hair products are added. Prior to packaging, sampling
and quality testing of the preparation is carried out in the laboratory. The formulated hair care
products are then transferred to a hopper with a multiple head filler machine and automatically poured
into 250 mL plastic bottles. The finished hair care products will contain < 1% of the notified chemical.
The bottled products will be packed in cardboard cartons and will be exported or sent to distribution
centres for hairdressing outlets .
5.3.
Occupational Exposure
Number and Category of Workers
Category of Worker
Storage and transport
Transporting from dock to
Manufacturer’s site for
reformulation (loading/unloading
trucks)
FULL PUBLIC REPORT: STD/1106
Number
Exposure Duration
Exposure Frequency
2-4
2-3 hours/day
2 days/year
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NICNAS
Manufacture of hair care
products:
Formulation, filling containers,
cleaning and maintenance
6
8 hours/day
72 days/year
Quality control
1
4 hours/day
20 days/year
2-4
1-2 hours/day
150 days/year
~ 1000
8 hours/day
300 days/year
Transport and storage of
formulated hair care products to
end users (hair dressers)
End use:
Product application by
hairdressers
Exposure Details
Transport and storage
Warehousing and distribution of the notified chemical involves loading, unloading, moving and storing
of packaged notified chemical and packaged hair care products. No exposure is expected except in the
case of accident.
Manufacture of hair care products
The mixing vessels are enclosed and the filling machines are automated and fitted with local exhaust
ventilation to capture any volatile or aerosol materials at the source. However, dermal and limited
ocular exposure may occur when opening and closing the drums and when adding the notified
chemical manually into mixing vessel, and connecting and disconnecting transfer and filling lines.
Dermal exposure may also occur due to drips and spills and if containers are overfilled at the filling
station. Skin contamination may occur when maintenance workers are cleaning equipment and during
maintenance of equipment.
Workers involved in the above activities wear personal protective equipment such as, overalls, safety
glasses, safety shoes and PVC or disposable latex gloves.
Quality Control/Maintenance
Limited dermal exposure to small quantities may occur during sampling and testing or during machine
maintenance. To minimise exposure workers will wear laboratory coats, safety glasses and rubber
gloves.
End-use in hairdressing salons
The bottled products will be sent to distribution centres for storage until distribution to retail or
hairdressing outlets. Except in the case of accident, workers handling the finished product during
distribution and retail would not be exposed to the notified chemical because of the closed containers,
and even in the case of spills, the small packaging size and the low concentration of the notified
chemical in the finished products would limit exposure.
Intermittent dermal exposure to hairdressers is likely to occur when applying the hair care products to
the hair of customers in salons, as gloves will probably not be used for this process. Based on similar
products, the quantity used per application will be approximately 14 grams. Repeated exposure may
occur through use of the product on different customers. Some accidental ocular exposure may occur.
Inhalation exposure is not expected. The low concentration of the notified chemical in the hair care
products (< 1%) will reduce the exposure of hairdressers.
5.4.
Release
RELEASE OF CHEMICAL AT SITE
The notified chemical will not be manufactured in Australia. Local operations will include transport
and storage, formulation, filling and packaging.
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NICNAS
Release during transport
Release to the environment may occur in the unlikely event of an accident during transport or an
accidental spill. The notified chemical will be transported to Australia by ship in 75 kg heat-sealed
plastic bags and will be transported directly to the formulation site.
Release during formulation
During the formulation of the hair care products up to 10 kg per annum of the notified chemical will
be released into the environment as a result of residual in import containers, spills and equipment
cleaning. Subsequent water washes will pass to interceptor pits where the settled material will be
collected and disposed of to landfill. Wastewater will be used for gardening or recycled in the plant
for other processing activities. Import containers will be rinsed and disposed off to landfill. The
rinsate will be collected and disposed off to a liquid waste facility by licensed contractor.
RELEASE OF CHEMICAL FROM USE
Since the notified chemical will be used in hair care products, majority of the import volume is
expected to be released to sewer. However, the notifier has indicated that 90% of the formulated
products will be exported. Therefore, at the maximum rate of import rate ~100 kg per annum of the
notified chemical is expected to be disposed of to sewers Australia wide. It is expected that up to 5 kg
per annum of the notified polymer will be disposed of to landfill in empty product containers.
5.5.
Disposal
The plastic bags containing residual notified chemical will be disposed of to landfill. The plastic
bottles in which the hair product will be sold to consumers and the residues they contain will be
disposed of in domestic landfill or recycled.
The majority of the notified chemical used in hair care products domestically will ultimately be
disposed of to sewer. Spilt material will be contained by absorbent, placed into containers and disposed
in landfill.
5.6.
Public exposure
The notified chemical will be used in the manufacture of wash-off hair care products. Public exposure
will be widespread and will result through salon use of hair care products containing < 1% of notified
chemical. It is expected that approximately 14 grams will be used per application and that application
may occur up to once weekly. While deliberate dermal contact will occur and accidental eye contact
may also occur, inhalation exposure is not expected.
Public exposure during transport and storage is unlikely unless the packaging is breached.
6.
PHYSICAL AND CHEMICAL PROPERTIES
Physico-chemical properties are based on Crodazosoft DBQ, containing 50% of the notified chemical.
Appearance at 20oC and 101.3 kPa
Light yellow waxy solid with mild fatty amine odour.
Melting Point
60-70 oC
METHOD
Not provided
Boiling Point
Not determined.
Density
Not determined
Vapour Pressure
Not determined.
Remarks
Given the ionic nature (quaternary ammonium salt) of the notified substance and
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NICNAS
its high molecular weight it is anticipated that it will have a low vapour pressure.
Water Solubility
Remarks
Not determined.
It is not possible to measure the water solubility. The notified chemical contains
aliphatic hydrocarbon chains coupled to a polar end group. This constitution
indicates that the material will have surfactant properties and will form micelles in
solution.
Hydrolysis as a Function of pH
Remarks
The notified chemical contains an amide group, which may undergo hydrolysis at
extreme temperatures and pH conditions.
Partition Coefficient (n-octanol/water)
Remarks
Not Determined
Based on the anticipated surface activity the substance would be expected to
strongly adsorb to sediments. Quaternary ammonium compounds are known to
react with dissolved organic carbon in water to form part of the sediments, and
become completely inactivated on contact with soils (Nabholz JV, Miller P,
Zeeman M, 1993). They have also been shown to adsorb on a wide variety of
materials (Boethling RS, Lynch DG, 1992).
Dissociation Constant
Remarks
Not determined.
Contains quaternary ammonium groups that will be fully dissociated in an aqueous
environment. The pH of Crodazosoft DBQ ranges from 6-8.
Particle Size
Remarks
Not determined.
The notified chemical is in a form of waxy solid flakes with diameter of 6-10mm.
Flash Point
Remarks
Not determined.
Flash point is not applicable as the notified chemical is in solid form. No solid
flammability testing was conducted.
Flammability Limits
Remarks
Not applicable
The notified chemical is in solid form.
Autoignition Temperature
Remarks
Not Determined
The notified polymer has surface active properties. Thus, a reliable partition
coefficient cannot be obtained. The notified chemical would be expected to
partition to surfaces.
Adsorption/Desorption
Remarks
Not determined
Not determined.
Not expected to self-ignite.
Explosive Properties
Remarks
Not expected to be explosive
Reactivity
Remarks
Under normal conditions the notified chemical is stable. The notified chemical is
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NICNAS
incompatible with strong oxidising agents. Hazardous polymerization of the
notified chemical will not occur. Hazardous decomposition products of the
notified chemical are: oxides of carbon, nitrogen and sulphur.
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26 April 2006
7.
NICNAS
TOXICOLOGICAL INVESTIGATIONS
Toxicological data provided for Crodazosoft DBQ containing approximately 50% of the notified chemical are
summarised in the table below.
Endpoint and Result
Assessment Conclusion
Skin Irritation – in vitro (The MatTEK Corporation
EpiDerm™ Skin Model In Vitro Toxicity Testing
System)
Skin Sensitisation, Human Volunteers, Repeated
Insult Patch Test
Eye Irritation – in vitro (HET-CAM test)
Expected in vivo dermal irritancy potential in the
moderate to mild range.
When diluted with water to 5% was non-irritating and
non-sensitising under the conditions of the test.
Non-irritating as 5% solution.
7.1. Irritation – skin – in vitro
TEST SUBSTANCE
Crodazosoft DBQ
METHOD
The MatTek Corporation EpiDerm™ Skin Model In Vitro Toxicity
Testing System
Tissue Sample – Normal human epidermal keratinocytes cultured to form
a multilayered, highly differentiated model of the human epidermis.
Cell viability is determined by the activity of mitochondrial succinate
dehydrogenase, which reduces a yellow, water-soluble, tetrazolium salt
to a purple, insoluble formazan derivative. The amount of reduction is
determined by spectrophotometry.
Species/Strain
Remarks – Method
The cell layer is incubated with test substance and controls in
microplates, extracted and the absorbance read at 570 nm.
RESULTS
Test Article
Crodazosoft DBQ
(100%* - 1hr)
(100%* - 4.5 hr)
(100%* - 20 hr)
System
Percent
Inhibition
EpiDerm
Conclusion
~ 5 hr
Moderate to mild
~ 2.9
Moderate
2
47
86
Triton X 100
EpiDerm
(1% - 1 hr)
(1% - 4.5 hr)
(1% - 20 hr)
*Moistened with 100 microliters of distilled water.
Remarks – Results
ET-50
22
63
95
The ET-50 is a measure of 50% cell viability. The irritation guidelines
were according to the MatTek corporation.
CONCLUSION
Under the conditions of this test, the results indicate that Crodazosoft
DBQ has an expected in vivo dermal irritancy potential in the moderate
to mild range. The reference article, 1% Triton X 100, has an expected in
vivo dermal irritancy potential in the moderate range.
TEST FACILITY
Consumer Products Testing (2002)
7.2 Irritation – Eye Irritancy Potential Utilizing the HET-CAM test.
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NICNAS
TEST SUBSTANCE
Crodazosoft DBQ (5% in distilled water)
METHOD
Fresh, fertile, White Leghorn eggs that were 7 days old were incubated
for 10 days were used in this study. A cut in the large end of each egg
where the air sack is located was made in the eggs. The shell was then
removed down to the shell-membrane junction. The inner egg membrane
was then hydrated with a warm, physiological saline solution. The saline
was removed after 2 to 5 minute exposure.
Remarks – Method
The test or reference article at a dosage of 0.3ml of a liquid or 0.3g of a
solid was administered to each of 4 chorioallantoic membranes (CAM).
After 20 seconds the test or control material was rinsed from each CAM
with saline. Observation periods were 0.5 seconds, 2 and 5 minutes.
Previous studies have shown that the CAM of the hen’s egg is more
sensitive to liquid irritants than is the rabbit eye. Therefore, the CAM
results of the test article at a specific concentration equate to Draize
results for the test article at 2 tomes that concentration.
RESULTS
Results show that Crodazosoft DBQ (5% solution) is non-irritating under
the conditions of the test..
CONCLUSION
Under the conditions of the test, the results indicate that Crodazosoft (5%
distilled water) at 1%, 2% and 10% would have practically no irritation
potential in vivo. (The CAM results for the test article at 0.5%, 1% and
5% are equivalent to Draize results for the test article at 1%, 2% and at
10%).
TEST FACILITY
Consumer Product Testing (2003)
7.3 Skin sensitisation – human volunteers – Repeated Insult Patch Test
TEST SUBSTANCE
Crodazosoft DBQ, (5% aqueous)
METHOD
Study Design
The Repeated Insult (semi-occlusive) Patch Test (RIPT)
Study Group
Vehicle
Induction Procedure
Rest Period
Challenge Procedure
RESULTS
Remarks – Results
Fifty-four females and 7 males, ranging in age from 20 to 69 years
completed the study.
Water
The upper back between the scapulae was administered with 0.2 ml of
the test substance under a semi-occlusive patch 3 times per week for a
total of 9 applications. Induction patches were removed after 24 hours.
Two weeks
A challenge patch was applied to a virgin site close to the induction site.
Challenge sites were scored 24 and 72 hours post-application.
All observations were within normal limits throughout the study.
CONCLUSION
A Repeated Insult Patch Test was conducted using Crodazosoft DBQ
diluted with water to 5% under semi-occlusive dressing. The notified
chemical was non-irritating and non-sensitising under the conditions of
the test.
TEST FACILITY
RCTS (2002)
In addition, published data (IUCLID 2000, CIR 1990, CIR 1991, CETOX 2001) on the following chemicals
were used to provide information for other endpoints: Betaines, Imidazoline derivatives and
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NICNAS
Distearyldimethylammonium chloride (DSDMAC). Results for the studies for the above mentioned analogues
are provided in the table below.
Endpoint
Rat, acute oral
Test Substance
Result and Assessment Conclusion
Betaines
Low toxicity, LD50 > 2000 mg/kg bw
Imidazoline derivatives
Low toxicity, LD50 > 2000 mg/kg bw
Distearyldimethylammoniumchloride
(DSDMAC)
DSDMAC 97+/- 1% pure, max. 3%
water:
Betaines: concentrations >10%:
Low toxicity, LD50 > 2000 mg/kg bw
Imidazoline derivatives:
concentrations >10%:
Slightly irritating
DSDMAC 97+/- 1% pure, max. 3%
water:
Betaines: concentrations > 10%
Non-irritating
Imidazoline derivatives:
concentrations > 10%
Moderately to severely irritating
Distearyldimethylammoniumchloride
(DSDMAC) 97+/- 1% pure, max. 3%
water:
Betaines
Irritating
No evidence
Skin sensitisation - Repeat
Insult patch test (nonOcclusive):
Imidazoline derivatives:
Not sensitising
Guinea
pig,
skin
sensitisation - MagnussonKligman
maximization
test:
(90% DSDMAC, ~5% isopropanol,
~5% water):
Not sensitising
Rat, gavage repeat dose
toxicity - 28 days.
(90% DSDMAC, ~5% isopropanol,
~5% water):
NOAEL: 100mg/kg/bw
LOAEL: 500 mg/kg bw
Rabbit, Dermal repeat
dose toxicity – 28 days
(~ 75% DSDMAC, ~ 25% Isopropanol
and water)
LOAEL: 4mg/kg bw
Genotoxicity - bacterial
reverse mutation
Betaines:
Non mutagenic
Imidazoline derivatives:
Non mutagenic
DSDMAC
(90% DSDMAC, ~5% isopropanol,
~5% water):
Non mutagenic
Non clastogenic
Rat, acute dermal
Rabbit, skin irritation
Rabbit, eye irritation
Guinea
pig,
skin
sensitisation - MagnussonKligman
maximization
test:
Genotoxicity – in vitro
Cytogenetic assay
DSDMAC
FULL PUBLIC REPORT: STD/1106
Low toxicity, LD50 > 2000 mg/kg bw
Moderately irritating
Irritating
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NICNAS
8.
ENVIRONMENT
8.1.
Environmental fate
8.1.1.
Ready biodegradability
TEST SUBSTANCE
Notified chemical
METHOD
Inoculum
Exposure Period
Auxiliary Solvent
Analytical Monitoring
Remarks - Method
OECD TG 301 D Ready Biodegradability: Closed Bottle Test.
Domestic waste water treatment plant secondary effluent
28 d
Not specified
Reference substance – sodium benzoate
Treatments - nutrient medium and inoculum
- test substance (10 mg)
- reference substance (2 mg)
- toxicity control (test substance 10 mg and reference
substance 2 mg).
All treatments were done in duplicate.
RESULTS
Day
4
7
11
14
18
21
25
28
Test substance
% Degradation
5.9
10.1
13.0
14.2
15.4
14.1
19.2
19.7
Remarks - Results
Sodium Benzoate
Day
% Degradation
4
7
70.2
11
80.2
14
67.2
18
21
25
28
87.9
Toxicity Control
Day
% Degradation
4
7
141.0
11
163.8
14
164.5
18
21
25
28
220.7
The degradation of the toxicity control is based on the theoretical oxygen
demand of the reference substance alone. Hence, the greater than 100%
degradation figures as a result of degradation of the test substance in the
toxicity control. As this is present in 5 times the amount of the reference
substance the oxygen consumed in degrading a small percentage of this
inflates the percentage degradation of the reference substance.
CONCLUSION
The test substance is not considered to be readily biodegradable.
TEST FACILITY
Vizon SciTec (2005)
8.1.2.
8.2.
8.2.1.
Bioaccumulation
The relatively high molecular weight and charged nature of the notified substance indicate that
unlikely to bioaccumulate (Connell 1989).
Ecotoxicological investigations
Acute toxicity to fish
Not Provided
8.2.2.
Acute toxicity to aquatic invertebrates
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NICNAS
TEST SUBSTANCE
Notified chemical
METHOD
OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction
Test - static.
EC Directive 92/69/EEC C.2 Acute Toxicity for Daphnia - static.
Daphnia magna
48 hours
None
Dilution water specified as moderately hard (80-110 mg CaCO3/L)
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks - Method
The test was conducted using water soluble fractions (WSFs) at five
nominal loading levels with each loading level done in quadruplicate.
WSFs were prepared by stirring fixed weights of the test substance in
dilution water for ~24 h at 22-23°C, settling for ~1 h and siphoning the
from the centre of the solution. The siphoned solution was then filtered
through a 0.45 µm acetate filter before adding to test vessels. A WSF
control was prepared in an analogous manner without the addition of the
test substance. Water quality measurements (conductivity, temperature,
pH and dissolved oxygen) were conducted throughout the study and were
within acceptable ranges. No analysis of the test material was performed.
RESULTS
Concentration mg/L
Nominal
Actual
Lab Control
WSF Control
0.34
0.57
1.49
2.94
5.83
EL50
LOEL
Remarks - Results
Number of D. magna
20
20
20
20
20
20
20
Number Immobilised
24 h
48 h
0
0
0
0
0
10
20
10
20
20
20
20
20
20
0.57-1.49 mg/L at 24 hours
0.42 (95% CI 0.28-0.54) mg/L at 48 hours
0.34 mg/L at 48 hours
Zinc sulphate heptahydrate was used as a reference toxicant with an
LC50 of 0.56 (95% CI 0.21-0.78) mg/L Zn2+. The results are quoted in
terms of the nominal loading level. The 48 h EL50 and 95% confidence
intervals were calculated using the probit method and ToxCalcTM
(Version 5.0.18; Tidepool Scientific Software).
CONCLUSION
The test substance is highly toxic to daphnia (Mensink et al. 1995). As
this is an effect loading based on a WSF, with no analysis of the test
solution, the actual result could be much lower.
TEST FACILITY
Vizon SciTec (2005)
8.2.3.
Algal growth inhibition test
TEST SUBSTANCE
Notified chemical
METHOD
OECD TG 201 Alga, Growth Inhibition Test.
EC Directive 92/69/EEC C.3 Algal Inhibition Test.
Selenastrum capricornutum
72 hours
Nominal:
0.17, 0.60, 1.17, 3.00, 6.63 mg/L
None
Not specified
Species
Exposure Period
Concentration Range
Auxiliary Solvent
Water Hardness
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Analytical Monitoring
Remarks - Method
NICNAS
WSFs were prepared in an analogous manner to the daphnia study
described above with the exception that test media was passed through a
0.2 µm Naglene filter unit prior to exposing test organisms. Water quality
measurements (conductivity, temperature, pH and dissolved oxygen)
were conducted throughout the study and were within acceptable ranges.
No analysis of the test material was performed.
RESULTS
EL50
mg/L
0.32 (0.17-0.60)
Remarks - Results
NOEL
mg/L
0.17
LOEL
mg/L
0.60
For the test material, an obvious all-or-none response was observed,
where there was no growth inhibition at the lowest nominal loading rate
and 100% growth inhibition at the higher loading rates (≥0.60 mg/L).
Zinc sulphate heptahydrate was used as a reference toxicant with an
EC50 of 0.038 mg/L Zn2+.
CONCLUSION
The test material is highly toxic to algae (Mensink et al. 1995) . As this is
an effect loading based on a WSF, with no analysis of the test solution,
the actual result could be much lower.
TEST FACILITY
Vizon SciTec (2005)
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NICNAS
9.
RISK ASSESSMENT
9.1.
Environment
9.1.1.
Environment – exposure assessment
During formulation of the hair care products the notifier estimates that up to 10 kg per annum of
notified polymer will be released into the environment as a result of residues in import
containers, spills and equipment cleaning. Subsequent water washes will pass to interceptor pits
where the settled material will be collected and disposed of in landfill. Treated wastewater will
be released to sewer.
In a worst case based on maximum annual imports of 1 tonne per annum, 10% (90% or products
exported) of which is released to sewer and assuming that none is removed during sewage
treatment processes, assuming a national population of 20,100,000 and that each person
contributes an average 200 L/day to overall sewage flows, the predicted concentration for release
to ocean and river on a nationwide basis are 0.007 and 0.07 g/L, respectively.
Amount of entering sewer annually
Population of Australia
100 kg
20.1
million
Amount of water used per person per day
Number of days in a year
Estimated PECOcean
0.007 g/L
Estimated PECRiver
0.07 g/L
200 L
365
The plastic import drums containing residual notified polymer (up to 10 kg per annum) will be
disposed of to landfill. The bottles in which the hair product will be sold to consumers and the
residues they contain (up to 5 kg per annum) will be disposed of either in domestic landfill or
recycled.
The majority of the notified chemical will be incorporated into hair products and as such will
almost completely be released to the environment.
9.1.2.
Environment – effects assessment
The notified chemical is highly toxic to both daphnia (EL50 0.42 mg/L) and algae (EL50
0.32 mg/L). As only two toxicity endpoints are available a PNEC of 0.32 µg/L has been
determined from the endpoint for the most sensitive organism and applying an assessment
factor of 1000. Concerns above (see section 8.2) that toxicity may be even higher should be
noted.
9.1.3.
Environment – risk characterisation
The intended use pattern of the notified chemical is expected to result in the majority of the
chemical used in Australia being eventually released to the environment. However, this will be
in dilute manner as the notified chemical contained within the hair care products will be released
from domestic use at low concentrations.
The risk of the release of 10% imported notified chemical during use in hair care products can
be estimated by determining the aquatic risk quotient (RQ = PEC/PNEC).
Removal by STP
PNEC
Risk Quotient (RQ)
Ocean
0%
0.07 µg/L
0.02
0.32 g/L
River
0%
0.007 µg/L
0.2
0.32 g/L
The values of the worst case risk quotients for the aquatic environment are less than 1, for both
marine and fresh water organisms, indicating an acceptable risk to the aquatic compartment.
While in a sewage system some adsorption could occur, this could be offset by the doubt that
the toxicity results may be underestimated.
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PEC
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NICNAS
In landfill the notified polymer has the potential to be mobile in both terrestrial and aquatic
comportments. However, over time it is expected to adsorb to soil and sediments and degrade
slowly through biotic and abiotic processes to give water and oxides of carbon and nitrogen.
The charged nature of the notified polymer indicates its potential to bioaccumulate will be low
(Connell 1990).
Therefore, the environmental exposure and overall environmental risk from the notified
chemical is expected to be acceptable, noting that release to fresh water constitutes only about
25% of total Australian release. However, if local consumption rises above 1 tonne the chemical
would need to be reassessed with the provision of all tests for physical and chemical properties
and ecotoxicity including repeated daphnia and algae test with measured concentrations and a
chronic daphnia study as per schedule requirements.
9.2.
9.2.1.
Human health
Occupational health and safety – exposure assessment
Transport & Storage
Occupational exposure to the notified chemical during its transport and storage, or of finished
products containing < 1% notified chemical, is only likely in the event of accidental container
spillage involving breach of packaging. Exposure in these circumstances is expected to be
infrequent and limited by use of appropriate personal protective equipment (PPE) during cleanup operations.
Reformulation and packaging
Worker exposure to the notified chemical at 50% or less during reformulation into hair care
products may occur when weighing the notified chemical and adding it to the mixing vessel, and
also during sampling for QA testing. Any exposure is expected to be primarily dermal. Ocular
exposure is less likely because the chemical is supplied as solid pellets, however this may also
occur as a result of spills or as secondary to skin contamination. Inhalation exposure is not
expected to occur in these processes.
Exposure to products containing < 1% of the notified chemical during mixing and filling
operations is expected to be low, as the concentration is low, and exposure is limited by
engineering and PPE controls.
End-use in salons
Repeated dermal and possibly ocular exposure to hairdressers can occur when products
containing < 1% of the notified chemical are dispensed and applied to customers’ hair. Exposure
could be limited by use of gloves and safe work practices. However it is not expected that gloves
will be worn during shampooing. Inhalation exposure should not occur, as use spray products
have not been proposed.
9.2.2.
Public health – exposure assessment
Public exposure to wash-off hair care products containing < 1% of the notified chemical is
expected, through use of conditioners in hairdressing salons. The main potential route of
exposure would be dermal, through application to the scalp. Some accidental ocular exposure is
also possible. The frequency of salon treatment for individual clients may be up to once weekly.
An estimate of exposure is as follows:
Product
Application
Application
Retention % Notified
Exposure to
Quantity
Frequency per Factor
Chemical Notified Chemical
(g/application)*
Day
(%)*
in Product (mg/kg bw/day)**
conditioner
14.0
0.14
1
1
0.003
*data from EU SCCNFP (Scientific Committee on Cosmetic Products and Non-food products
intended for Consumers) (SNCNFP, 2003)
** assuming 60kg body weight
9.2.3.
Human health – effects assessment
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NICNAS
Toxicological data are not available on the notified chemical itself. In vitro skin irritation and
eye irritation studies and a human repeat insult patch test were carried out on Crodazosoft DBQ
containing approximately 50% of the notified chemical. Information on other endpoints has
been obtained for other surfactant classes that have general structural resemblances to the
notified chemical.
Toxicokinetics, metabolism and distribution.
No specific information was provided on the toxicokinetics, metabolism or distribution of the
notified chemical.
Acute toxicity.
On the basis of data provided, the notified chemical is expected to have low acute oral and
dermal toxicity.
Irritation and Sensitisation.
From in vitro testing of Crodazosoft DBQ, it is expected to be moderately irritating to the skin,
and this is consistent with the effects of other amphoteric and cationic surfactants. Crodazosoft
DBQ was not irritating at 5% in a human repeat insult patch test (RIPT).
Crodazosoft DBQ at 5% was not irritating in a HET-CAM test, designed to test the potential for
eye irritation. Similar surfactant categories demonstrate moderate to severe eye irritation
characteristics.
Skin sensitisation was not observed in a human repeat insult patch test using 5% Crodazosoft
DBQ. However, a structurally related chemical previously assessed by NICNAS was classified
as a skin sensitiser based on the results of skin sensitisation studies in guinea pigs. In addition,
although betaines did not cause skin sensitisation in a guinea pig maximisation test, various
instances of contact allergy in this surfactant groups have been reported. Observed reactions
were linked to the presence of impurities. (CETOX, 2001).
Repeated Dose Toxicity.
A cationic surfactant had a NOAEL of 100 mg/kg/bw day and LOAEL of 500 mg/kg bw/day in
a rat 28-day oral study and the LOAEL in a rat 28-day dermal study (based on local effects) was
4 mg/kg bw/day. It is not possible to determine a NOAEL/LOAEL for the notified chemical
based on this information.
Other toxicological data
Data on the analogue groups suggests that the notified chemical would not be mutagenic. No
information was available from the notified chemical or analogues regarding potential
carcinogenicity or toxicity to reproduction.
The notifier advised that no adverse health effects of the chemical had been observed from its
use in a hair product overseas.
Hazard classification for health effects.
Based on limited data relevant to skin irritation, the notified chemical is classified as R38:
Irritating to skin.
An R41 classification (Risk of serious eye damage) for the notified chemical is considered
appropriate, based on the characteristics of similar surfactant categories. The HET-CAM study
carried out tested only a dilute form of the chemical. (The HET-CAM test method is not yet
validated. The EU national regulatory authorities accept positive outcomes from this test method
for classifying and labelling severe irritants (R41). Where a negative result is obtained, an in vivo
test is subsequently required, as the HET-CAM test method has not been shown to adequately
discriminate between eye irritants and non-irritants. For the detection of ocular corrosives and
severe irritants it is recommended that all test substances should be evaluated undiluted unless
dilution is justified. (ICCVAM, 2004).)
On the basis of the skin sensitising potential of a structurally related chemical and contact allergy
observed in some cationic surfactants, the notified chemical is classified as R43 (May cause
sensitisation by skin contact) as a precautionary measure. Although the RIPT on dilute (5%)
Crodazosoft DBQ was did not show sensitisation, as the conditions of this test have not been
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26 April 2006
NICNAS
maximised, the skin sensitisation potential of the notified chemical cannot be discounted. In
addition, the notified chemical is a reaction mixture and not fully characterised. Sensitisation
can occur in some cationic surfactants and can be caused by impurities.
Based on the available data, the notified chemical is classified as a hazardous substance in
accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC
2004).
9.2.4.
Occupational health and safety – risk characterisation
The notified chemical has the potential to cause irritation to the skin, skin sensitisation and
serious damage to the eyes.
Workers that have the potential for exposure to the notified chemical at a concentration of 50%
include transport and storage workers, QA chemists and production personnel. Exposure and
hence the risk of irritation/sensitisation is most likely for production personnel during the
transfer of the notified chemical to the mixing vessels. Due to the possible risk of skin
irritation/sensitisation the following personal protective equipment should be worn: chemical
resistant industrial clothing (coveralls) and impermeable gloves. Although the notified chemical
is introduced as solid pellets, therefore limiting the potential for ocular exposure due to the
potential for severe eye irritation, protective eyewear should also been worn as a precaution.
The risk to transport and storage workers and QA chemists is expected to be low due to the
limited predicted exposure. However, in order minimise the risk of adverse
irritancy/sensitisation effects, similar PPE to that described above should be worn.
Following formulation of the hair conditioner, there is the potential for exposure to up to 1%
notified chemical. At this concentration, the notified chemical is below the cut off for
classification as a skin and eye irritant and skin sensitiser according to NOHSC Approved
Criteria for Classifying Hazardous Substances. Therefore, the risk of an adverse
irritant/sensitisation response from exposure to the notified chemical at this concentration is
considered to be low. This is supported by the results from the human repeat insult patch test.
Overall, the risk to workers following formulation including salon workers is expected to be low
due to the low exposure predicted, although the risk of sensitisation in sensitive individuals
cannot be ruled out.
9.2.5.
Public health – risk characterisation
Although dermal exposure (through the scalp) and accidental ocular exposure to the notified
chemical could occur during use of hair conditioner, due to the low concentration of the notified
chemical in the hair conditioner and the fact that the product is rinsed from the scalp shortly
after application, the risk of an adverse irritant/sensitisation response is considered to be low,
however, the risk of sensitisation in sensitive individuals cannot be ruled out.
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS
10.1. Hazard classification
Based on the limited toxicological data for the notified chemical, it is not possible to classify the
notified chemical as a hazardous substance in accordance with the NOHSC Approved Criteria
for Classifying Hazardous Substances (NOHSC, 2004). However, based on the in vitro skin
irritation study, the data provided for other surfactant classes and classification of similar
chemicals, the following classification and labelling details should apply:
R38 Irritating to skin
R41 Risk of serious damage to eyes
R43 May cause sensitisation by skin contact
and
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NICNAS
As a comparison only, the classification for skin irritation/environmental hazards of the notified
chemical using the Globally Harmonised System for the Classification and Labelling of
Chemicals (GHS) (United Nations, 2003) is presented below. This system is not mandated in
Australia and carries no legal status but is presented for information purposes.
Skin corrosion/irritation
Acute hazards to the aquatic
environment
Hazard
category
2
1
Hazard statement
Causes skin irritation
Very toxic to aquatic life
10.2. Environmental risk assessment
On the basis of the PEC/PNEC ratio, the chemical is not considered to pose a risk to the
environment based on its reported use pattern at the proposed low level of domestic release.
10.3. Human health risk assessment
10.3.1. Occupational health and safety
Production Personnel
There is Moderate Concern to occupational health and safety under the conditions of the
occupational settings described due to the potential for skin sensitisation.
All other workers
There is Low Concern to occupational health and safety under the conditions of the
occupational settings described.
10.3.2. Public health
There is No Significant Concern to public health when used in the proposed manner
11.
MATERIAL SAFETY DATA SHEET
11.1. Material Safety Data Sheet
The MSDS for Crodazosoft DBQ provided by the notifier was in accordance with the NOHSC
National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC 2003). It
is published here as a matter of public record. The accuracy of the information on the MSDS
remains the responsibility of the applicant.
11.2. Label
The label for Crodazosoft DBQ provided by the notifier was in accordance with the NOHSC
National Code of Practice for the Labelling of Workplace Substances (NOHSC 1994). The
accuracy of the information on the label remains the responsibility of the applicant.
12.
RECOMMENDATIONS
REGULATORY CONTROLS
Hazard Classification and Labelling

Use the following risk phrases for products/mixtures containing the notified chemical:
 conc>20%:
R38; R41; R43
 10%<conc<20%: R41; R43
 5%<conc<10%: R36; R43
 1%<conc<5%:
R43
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NICNAS

Use the following safety phrases for products/mixtures containing the notified
chemical:
 S24 Avoid skin contact (conc >1%)
 S25 Avoid contact with eyes (conc >10%)
 S26 In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice (conc >10%)
 S37 Wear suitable gloves (conc >1%)
 S39 Wear eye/face protection (conc >10%)
Health Surveillance

As the notified polymer is a potential skin sensitiser, employers should carry out health
surveillance for any worker who has been identified in the workplace risk assessment as
having a significant risk of sensitisation.
CONTROL MEASURES
Occupational Health and Safety

Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical as introduced:
 Avoid contact with skin and eyes

Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced:
 Protective eyewear, chemical resistant industrial clothing (coveralls) and
impermeable gloves;

Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.

A copy of the MSDS should be easily accessible to employees.

If products and mixtures containing the notified chemical are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Public Health

As the notified chemical is a potential skin sensitiser, NICNAS must be advised of any
customer reported adverse health effects from use of products containing the notified
chemical as they occur.
Environment

The following control measures should be implemented by end users to minimise
environmental exposure during use of the notified chemical:
 Do not allow material or contaminated packaging resulting from spills to enter
drains, sewers or water courses.
Disposal

The notified chemical should be disposed of to landfill.
Emergency procedures

Gross spills/release of the notified chemical should be contained by sand or inert
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NICNAS
powder and earth. Collect and seal in properly labelled drums for disposal in landfill.
12.1. Secondary notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1)
Under Section 64(1) of the Act; if
 the release of the notified chemical to the Australian aquatic environment exceeds
1000 kg per annum; or
 Crodazosoft DBQ (containing 50% notified chemical) is used either in wash-off
products at > 2% or in leave in products.
or
(2)
Under Section 64(2) of the Act:
 if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required. For the two conditions
described under subsection 64 (1) the following information will need to be submitted if a
secondary notification is required:
 all physicochemical and ecotoxicity tests required under the schedule including
repeated daphnia and algae tests with measured concentrations and a chronic
daphnia study as per schedule requirements (increase in release volume).
 evidence that the notified chemical is unlikely to cause skin sensitisation at that
concentration or exposure duration (increase in concentration/use in leave in
products).
13.
BIBLIOGRAPHY
Boethling RS and Lynch DG (1992) Quaternary Ammonium Surfactants, pp 146-176. In, Hutzinger, O. & de
Oude, N.T. (eds), Handbook of Environmental Chemistry, Vol 3: Part F, Anthropogenic Compounds:
Detergents, Springer-Verlag, Berlin.\
CIR (1990) Final report on the Safety Assessment of Cocoamphoacetate, Cocoamphodiacetate, and
Cocoamphodipropionate. The Cosmetic Ingredient Review. Journal of the American College of Toxicology,
Vol:9 (2), 1990, 121-142.
CIR (1991) Final report on the Safety Assessment of Cocamidopropyl Betaine. The Cosmetic Ingredient
Review. Journal of the American College of Toxicology, Vol:10 (1), 1991, 33-51.
Connell DW (1989) General characteristics of organic compounds which exhibit bioaccumulation. In: Connell
DW ed, Bioaccumulation of Xenobiotic Compounds. CRC Press, Boca Raton, USA.
Consumer Product Testing (2002) Test: The MatTek Corporation EpiDerm™ Skin Model In Vitro Toxicity
Testing System. Test Article: Crodazosoft DBQ. Experiment reference no.: V99-0015-3 for Croda Inc.,
Edison, New Jersey. The Consumer Product Testing Co., Fairfield, New Jersey, USA (unpublished report
provided by notifier).
Consumer Product Testing (2003) Test: The Hen’s Egg Test – Utilizing the Chorioallantoic Membrane (HETCAM). Test Article: Crodazosoft DBQ (5% dd water), Lot Number p-2814, Date: 5-06-03. Experiment
reference no.: V03-0113-3, for Croda Inc, Edison, New Jersey. The Consumer Product Testing Co.,
Fairfield, New Jersey, USA (unpublished report provided by notifier).
CETOX (2001) Environmental and Health Assessment of Substances in Household Detergents and Cosmetic
Detergent Products. Environment Project No. 615 2001. MiljØ-og Energi-ministeriet, Danmark. Centre for
Integrated Environment and Toxicology (CETOX) Accessed at
http://www.mst.dk/udgiv/publications/2001/87-7944-596-9/pdf/87-7944-597-7.pdf
IUCLID (2000) IUCLID Data Set Existing Chemical ID: 107-64-2 Dimethyldioctadecylammonium chloride
European Chemicals Bureau (2000).
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NICNAS
ICCVAM (2004) The Interagency Coordinating Committee on the Validation of Alternative Methods: Test
Method Evaluations. Draft Background Review Document Current status of in vitro test methods for
identifying ocular corrosives and severe irritants: the hen’s egg test – chorioallantoic membrane (HET-CAM)
test method (November 2004). National Toxicology Program (NTP) Interagency Center for the Evaluation of
Alternative Toxicological Methods (NICEATM).
<http://iccvam.niehs.nih.gov/methods/ocudocs/ocu_brd.htm>, Accessed February 2005
Mensink BJWG, Montforts M, Wijkhuizen-Maslankiewicz L, Tibosch H and Linders JBHJ (1995) Manual for
summarising and evaluating the environmental aspects of pesticides. National Institute of Public Health and
Environmental Protection, Bilthoven, The Netherlands. Report No. 679101022.
Nabholz JV, Miller P and Zeeman M (1993) Environmental Risk Assessment of New Chemicals Under the
Toxic Substances Control Act (TSCA) Section Five. In: Landis WG, Hughes JS & Lewis MA ed
Environmental Toxicology and Risk Assessment, ASTM STP 1179, American Society for Testing and
Materials, Philadelphia, PA.
NOHSC (1994) National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)].
National Occupational Health and Safety Commission, Canberra, Australian Government Publishing Service.
NOHSC (2004) Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)]. National
Occupational Health and Safety Commission, Canberra, AusInfo.
NOHSC (2003) National Code of Practice for the Preparation of Material Safety Data Sheets, 2nd edn
[NOHSC:2011(2003)]. National Occupational Health and Safety Commission, Canberra, Australian
Government Publishing Service.
RCTS (2002) Test: Repeated Insult Patch Test. Test Article: P-2453 (Crodazoquat DBQ, 5% aqueous)
Amended report 4/4/02 for Croda, Edison, NJ. RCTS Code No: 1122.1249, Reliance Clinical Testing
Services, Inc., Irving, Texas, USA (unpublished report provided by notifier).
United Nations (2003) Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
United Nations Economic Commission for Europe (UN/ECE), New York and Geneva.
Vizon Scitec (2005) Final Report: Ecotoxicity and environmental fate of [Notified Chemical] (lot # DBQ-1016;
sample date 7/8/2004), Viz0n SciTec Inc. Vancouver Canada. Unpublished report supplied by the notifier.
FULL PUBLIC REPORT: STD/1106
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