File No: STD/1033
22 June 2006
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Poly(oxy-1,2-ethanediyl), α-[2-[bis(2-aminoethyl)methylammonio]ethyl]-ω-hydroxy-, N,N'-bis(C16-18
and C18-unsatd. acyl) derivs., Me sulfates (salts)
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 ascc.library@dewr.gov.au
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....................................................................................................................................... 5
4.
INTRODUCTION AND USE INFORMATION ..................................................................................... 5
5.
PROCESS AND RELEASE INFORMATION ........................................................................................ 6
5.1.
Distribution, transport and storage .................................................................................................. 6
5.2.
Operation description ...................................................................................................................... 6
5.3.
Occupational exposure .................................................................................................................... 6
5.4.
Release ............................................................................................................................................ 7
5.5.
Disposal .......................................................................................................................................... 7
5.6.
Public exposure ............................................................................................................................... 7
6.
PHYSICAL AND CHEMICAL PROPERTIES ....................................................................................... 8
7.
TOXICOLOGICAL INVESTIGATIONS ............................................................................................. 10
7.1.
Acute toxicity – oral ..................................................................................................................... 11
7.2.
Acute toxicity – dermal................................................................................................................. 11
7.3.
Acute toxicity – inhalation ............................................................................................................ 12
7.4.1
Irritation – skin ............................................................................................................................. 12
7.4.2
Irritation – skin ............................................................................................................................. 12
7.4.3
Irritation – skin - human volunteers .............................................................................................. 13
7.5.1
Irritation – eye............................................................................................................................... 13
7.5.2
Irritation – eye............................................................................................................................... 14
7.6.1
Skin sensitisation .......................................................................................................................... 15
7.6.2
Skin sensitisation .......................................................................................................................... 15
7.7.
Repeat dose toxicity ...................................................................................................................... 16
7.8
Genotoxicity – bacteria ................................................................................................................. 17
7.9
Genotoxicity – in vivo .................................................................................................................. 18
8.
ENVIRONMENT ................................................................................................................................... 18
8.1.
Environmental fate ........................................................................................................................ 18
8.1.1. Ready biodegradability ............................................................................................................ 18
8.2.
Ecotoxicological investigations .................................................................................................... 19
8.2.1. Acute toxicity to fish ................................................................................................................ 19
8.2.2. Acute toxicity to aquatic invertebrates ..................................................................................... 20
8.2.3. Algal growth inhibition test ..................................................................................................... 21
9.
RISK ASSESSMENT ............................................................................................................................ 21
9.1.
Environment ................................................................................................................................. 21
9.1.1. Environment – exposure assessment ........................................................................................ 21
9.1.2. Environment – effects assessment ........................................................................................... 22
9.1.3. Environment – risk characterisation ......................................................................................... 22
9.2.
Human health ................................................................................................................................ 23
9.2.1. Occupational health and safety – exposure assessment ........................................................... 23
9.2.2. Public health – exposure assessment ........................................................................................ 23
9.2.3. Human health – effects assessment .......................................................................................... 24
9.2.4. Occupational health and safety – risk characterisation ............................................................ 24
9.2.5. Public health – risk characterisation......................................................................................... 25
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS ........................................................................................................................................................ 25
10.1.
Hazard classification ..................................................................................................................... 25
10.2.
Environmental risk assessment ..................................................................................................... 26
10.3.
Human health risk assessment ...................................................................................................... 26
10.3.1.
Occupational health and safety ............................................................................................ 26
10.3.2.
Public health ........................................................................................................................ 26
11.
MATERIAL SAFETY DATA SHEET ............................................................................................. 26
11.1.
Material Safety Data Sheet ........................................................................................................... 26
11.2.
Label ............................................................................................................................................. 26
12.
RECOMMENDATIONS................................................................................................................... 26
12.1.
Secondary notification .................................................................................................................. 27
13.
BIBLIOGRAPHY ............................................................................................................................. 28
Created on 6/18/2015 2:45:00 AM
Last Saved 7/23/2015 3:30:00 AM
2006
NICNAS
FULL PUBLIC REPORT
Poly(oxy-1,2-ethanediyl), α-[2-[bis(2-aminoethyl)methylammonio]ethyl]-ω-hydroxy-, N,N'-bis(C16-18
and C18-unsatd. acyl) derivs., Me sulfates (salts)
1.
APPLICANT AND NOTIFICATION DETAILS
APPLICANT
Concept Chemical Corporation Pty Ltd (ABN 38 001 907 464)
14/33 Ryde Road, Pymble NSW 2073
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:
Percent weight of hazardous and non-hazardous impurities
Identity of sites
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
Variation to the schedule of data requirements is claimed as follows:
Melting Point/Boiling Point
Density
Vapour pressure
Water Solubility
Hydrolysis as a function of pH
Partition coefficient
Adsorption/Desorption
Dissociation constant
Flash point
Flammability
Autoignition
Explosivity
Reactivity
Acute oral toxicity
Acute dermal toxicity
Skin irritation
Eye irritation
Skin sensitisation
Mutagenicity
In vitro clastogenicity
Biodegradation
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT
None
NOTIFICATION IN OTHER COUNTRIES
None
2.
IDENTITY OF CHEMICAL
CHEMICAL NAME
Poly(oxy-1,2-ethanediyl), α-[2-[bis(2-aminoethyl)methylammonio]ethyl]-ω-hydroxy-, N,N'-bis(C1618 and C18-unsatd. acyl) derivs., Me sulfates (salts)
FULL PUBLIC REPORT
STD/1033
June 2006
4/29
2006
NICNAS
MARKETING NAME
Accosoft 780 (Ingredient of this product)
CAS NUMBER
468743-76-2
MOLECULAR FORMULA
Unspecified
STRUCTURAL FORMULA
MeSO4-
O
CH3
NH
R1
N
O
H
NH
R1
O
n
Where R1C(O)- = C16-18 and C18-unsatd. acyl and n = 1-4 (average2.4-2.7)
MOLECULAR WEIGHT
The notified chemical is a UVCB substance (based on ranging chain lengths). The average molecular
weight of the notified chemical is 866.08.
SPECTRAL DATA
METHOD
Remarks
TEST FACILITY
Infra Red spectroscopy
IR peaks: 3327, 3007, 2926, 2856, 1741, 1652, 1544, 1463, 1378, 1247, 1216, 1127, 1058,
1007, 953, 818 and 763 cm-1
Stepan Company (1999)
METHODS OF DETECTION AND DETERMINATION
METHOD
Remarks
TEST FACILITY
3.
Potentiometric titration
According to the ASTM D5070 “Standard Test Method for Synthetic Quaternary
Ammonium Salts in Fabric Softeners by Potentiometric Titrations”.
Not reported
COMPOSITION
DEGREE OF PURITY
73% of the product Accosoft 780
The notified chemical is a UVCB substance that has not been isolated; it is only manufactured in
liquid products such as Accosoft 780.
4.
INTRODUCTION AND USE INFORMATION
FULL PUBLIC REPORT
STD/1033
June 2006
5/29
2006
NICNAS
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Imported as an ingredient (73%) of the imported product Accosoft 780.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year
Tonnes
1
50
2
70
3
80
4
100
5
100
USE
Anti-static agent to be used in consumer fabric softener products.
5.
PROCESS AND RELEASE INFORMATION
5.1.
Distribution, transport and storage
PORT OF ENTRY
Melbourne
IDENTITY OF MANUFACTURER/RECIPIENTS
Accosoft 780 containing 73% of the notified chemical will be imported by the notifier and distributed
to customers who will reformulate it into fabric softener products.
TRANSPORTATION AND PACKAGING
Accosoft 780 will be imported in steel 200 L drums, and transported by road in commercial carrier
trucks either to the notifier’s warehouse before distribution to reformulation customers, or directly to
the customer’s reformulation facilities.
5.2.
Operation description
Reformulation
Accosoft 780 containing 73% of the notified chemical will be transferred from product drums to a
mixing vessel through a single unloading pump. The mixing vessel will typically be 20,000 L
maintained under agitation/circulation.
In the mixing vessel, Accosoft 780 will be blended with water and other ingredients (including colour,
thickener, fragrance, preservative, non-ionic surfactants). The blending process can be completed
without heating. If heat is used during the blending process, it should not exceed 50°C. The mixing
process takes approximately 30-60 minutes.
The product containing 5% Accosoft 780 (3.7% of the notified chemical) will be transferred by
stainless steel dedicated pipeline directly to a filling machine for automated filling into 1.25 L high
density polyethylene (HDPE) bottles. The bottles will be packed into cardboard boxes and palletised
for transport.
End Use
The packaged fabric softeners will be distributed to retail outlets for sale to the public.
5.3.
Occupational exposure
Number and Category of Workers
Category of Worker
Compounder
Mixing tank operator
Quality control chemist
Filling line operator
Number
1-2
1-2
1
1-2
Exposure Duration
2 hours
2 hours
0.5 hours
3 hours
Exposure Frequency
48 times/year
48 times /year
48 times /year
48 times /year
Exposure Details
Transport & Storage
Waterside workers, transport workers and warehouse workers are only likely to be exposed to the
notified chemical in the event of accidental spill involving breach of sealed import drums of Accosoft
FULL PUBLIC REPORT
STD/1033
June 2006
6/29
2006
NICNAS
780.
Formulation
There is a possibility or dermal and/or ocular exposure to 73% of the notified chemical for workers
involved in transfer of Accosoft 780 into the mixing vessel, and to 3.7% of the notified chemical for
workers involved in transfer of formulated products into end use containers. Exposure during these
operations is expected to be minimal, as the blending/dispensing process will employ a closed, sealeddelivery system. Exposure will be further limited by the use of recommended PPE including goggles,
face shield, gloves and protective clothing.
End Use
Workers in retail outlets may be exposed to the formulated fabric softener products containing 3.7% of
the notified chemical in the case of accidental spillage only.
5.4.
Release
RELEASE OF CHEMICAL AT SITE
Environmental release could arise from accidental spills associated with transport accidents and or
mishandling of containers. In this scenario, it is expected that any spilt notified chemical would be
physically contained and collected and would be subsequently destroyed by either thermal
decomposition in high temperature incinerators or disposed of to secure landfill.
During the reformulation process, environmental release could arise from equipment malfunction.
However, this is expected to be contained by standard physical engineering structures. The main
source of environmental release arising during the reformulation process is as a result of equipment
maintenance and cleaning operations. It is expected that up to 400 L of rinse water containing less
than 0.1% notified chemical would be released to sewer per cleaning/maintenance operation.
Prior to the import containers being sent to drum recycling facilities, the drums are typically rinsed
with hot water, and as such, are expected to contain much less than 1% residual notified chemical.
The rinse water is recycled back into the mixing tank.
RELEASE OF CHEMICAL FROM USE
During use, up to 80% of the notified chemical in the consumer products applied to fabrics remains
with the fabric, the remainder being released to sewer. However, nearly 95% of the adhered notified
chemical is subsequently released to sewer during the next fabric washing process. Therefore
approximately 96% of applied notified chemical is released to sewer after one washing after initial
application.
The consumer product containers are expected to contain less than 1% residual notified chemical and
will most likely be disposed of as domestic waste to landfill.
5.5.
Disposal
It is expected that only 1% of notified chemical will be disposed of to landfill as residual in consumer
product containers. Nearly all of the imported quantity of notified chemical is expected to be
eventually released to sewer, based on the suggested use patterns of products containing the notified
chemical.
5.6.
Public exposure
The public may be exposed to the notified chemical via two major routes: direct contact with fabric
softener products formulated with Accosoft 780 and contact with textile articles treated with products
containing the notified chemical.
Domestic End Use
There is likely to be wide, dispersive exposure to the notified chemical through end use of domestic
fabric softener products. The most likely route of consumer exposure is through inadvertent dermal or
ocular contact with fabric softeners, as they are usually used in machine washing. A higher level of
exposure could occur if the fabric softeners were used hand wash clothes, without wearing gloves.
Provided use is in accordance with instructions and warnings provided on product labels, biologically
significant exposure is expected to be negligible.
FULL PUBLIC REPORT
STD/1033
June 2006
7/29
2006
NICNAS
However as the fabric softener containing 3.7% of the notified chemical is used in a household
situation, it may be also possible for small children to accidentally ingest it.
Treated Textiles
There is likely to be wide, dispersive exposure to textiles treated with products containing the notified
chemical, via dermal contact. Exposure will be limited by the low concentration of notified chemical
in final textile articles, which is estimated to be 0.005% of fabric weight. The notifier advised that
approximately 5 to 8g of the notified chemical would be deposited on 2.7 kg of clothing through
application of fabric softener in an automatic wash cycle. Approximately 94% of this quantity would
be removed during the next wash cycle. Therefore, in general, consumer contact with the notified
chemical in dry clothes is expected to be very low.
A possible scenario leading to higher exposure is if infants or children may mouth or suck on treated
fabric such as clothes or bed linen.
6.
PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20oC and 101.3 kPa
The product Accosoft 780 (73% notified chemical) is a clear,
yellow liquid.
The notified chemical is believed to be a low melting point
solid, but is manufactured only in liquid form, in Accosoft 780.
Chemical Analogue Data
Data reported below are for the following chemical, that has been accepted as an analogue for the purpose of
assessing physical and chemical properties of the notified chemical: The commercial form of the analogue
chemical, of 75-85% purity, was used for the physical and chemical property testing below:
Chemical Name
CAS Number
Fatty acids C10-C20 and C16-C18 unsaturated, reaction products with triethanolamine,
dimethyl sulphate-quaternised
91995-81-2
Melting Point
Remarks
Boiling Point
Remarks
Density
> 85oC
This analogue chemical decomposed slowly at the melting point
> 100oC at 101.3 kPa
This analogue chemical decomposed slowly at the boiling point
Approximately 1000 kg/m3
Remarks
Based on the density of the commercial form of the analogue chemical
Vapour Pressure
Expected to be negligible
METHOD
Remarks
Water Solubility
METHOD
FULL PUBLIC REPORT
STD/1033
Estimation
Based on the fact that the notified chemical is an organic salt with a relatively high
molecular weight.
Between 10 and 500 mg/L
A preliminary test was carried out by step wise addition of water to 0.1 g of test
substance. This was not found to dissolve in 10 mL of water (1%) at room
temperature. No peak could be found in HPLC testing of the solution. The above
result is based on visual appearance of stock solutions for ecotoxicity tests for
Daphnia (10 mg/L – clear solution) and fish (500 mg/L – cloudy solution).
June 2006
8/29
2006
NICNAS
Remarks
This result is for the notified chemical
Hydrolysis as a Function of pH
Remarks
Not determined
The notified chemical has amide groups which may hydrolyse under extreme pH,
but are unlikely to hydrolyse within the standard environmental pH range (4 – 9).
Partition Coefficient (n-octanol/water)
Remarks
The notified chemical is amphiphilic (having a polar water soluble group attached
to a water insoluble hydrocarbon chain) in nature and belongs to the class of
cationic surfactants and therefore, attempts to measure its n-octanol/water partition
coefficient would be invalid.
100% adsorbed to both soil types tested within 24 h.
Adsorption/Desorption
METHOD
Remarks
Not determined
OECD TG 106 Adsorption – Tier 1
Suspensions of Accosoft 780 in 0.01M CaCl2 were prepared by sonification at a
concentration of 401 ppm (the lowest concentration that could be measured), and
were subsequently added to soil samples of known dry weight using 3 soil solution
ratios (1:10, 1:25, 1:100). The mixtures were agitated for an appropriate time. The
soil suspensions were then separated by centrifugation and the aqueous phase was
analysed using the preparation procedure in AOAC Official Method 954.06,
followed by absorbance reading at 532 nm. The AOAC method is specific for the
determination of quaternary ammonium compounds in aqueous solutions using
eosin yellow.
The amount of test substance remaining on the soil was calculated as the
difference between the initial concentration of suspension used and the amount
remaining in the aqueous phase at the end of the experiment. Preliminary
experiments to recover the test substance from soil by chloroform extraction
indicated that it could not easily be recovered from the soil. For this reason the
mass balance method was not expected to be successful.
Analysis was done using the parallel method where multiple sample tubes with the
same soil/solution ratio are prepared, and an entire tube used for each
measurement.
Two soil types were used in this experiment, as detailed in the following table.
Parameter
Soil Texture
Organics %
Clay %
Silt %
Sand %
pH (0.01M CaCl2)
OECD Soil Type 1
Clay
1.4
30
60
10
5.7
OECD Soil Type 5
Loamy sand
1.6
3
18
79
6.5
The results showed that the test substance adsorbed onto soil after 2 hours in
OECD soil #1 for all soil/solution ratios tested and in OECD soil #5 for 1:10 and
1:25 soil/solution ratios. For the 1:100 soil/solution ratio (OECD soil #5), the test
substance was completely adsorbed after 24 hours, with 6% remaining in
suspension after 2 and 6 hours. The test results have been summarised in the table
below.
Ratio
1:10
1:25
1:100
FULL PUBLIC REPORT
STD/1033
OECD Soil Type 1
100% in 2 h
100% in 2 h
100% in 2 h
OECD Soil Type 5
100% in 2 h
100% in 2 h
100% in 24 h
June 2006
9/29
2006
NICNAS
The mass balance was done on the 1:100 soil/solution ratio for each soil type. The
Test substance could not be recovered off the OECD soil #1. The mass balance for
OECD soil #5 was 42%. This is consistent with preliminary experiments and
indicates that either the test substance is intractably adsorbed to the soil or, less
likely, is degraded on the soil. With OECD soil #5, it is not possible to conclude
with confidence that 40% has not simply precipitated from the suspension.
TEST FACILITY
It should be noted that the rate of adsorption appears to be much more strongly
correlated to the clay content, rather than the organic content, and this should be
taken into consideration when using the results of this test to determine
partitioning in sewage treatment plants.
Investigative Science Incorporated (2006)
Dissociation Constant
METHOD
Remarks
Not expected to possess any dissociation constants that lie
within the environmentally relevant range of pH 4 to 9.
pKa calculations using ACD/pKa v6.0 model
The quaternary ammonium group is expected to retain its cationic charge
throughout.
Particle Size
Remarks
Not determined
The notified chemical is believed to be a low melting point solid, but is
manufactured only in liquid form (such as the product Accosoft 780), for which
particle size is not applicable
Flash Point
Remarks
Not determined
The flash point of the product Accosoft 780 is 31.5°, due to the presence of
flammable solvent.
Flammability Limits
Remarks
Not determined
The flammable limits of the product Accosoft 780 are 2-13% in air, on the basis of
its flammable solvent content.
Autoignition Temperature
Remarks
The autoignition temperature of the product Accosoft 780 is 399°C, based on its
flammable solvent content.
Explosive Properties
METHOD
Remarks
Not expected to show any explosive tendencies.
Criteria for assessing explosivity in Bretherick (1990)
The notified chemical contains none of the functional groups expected to cause or
enhance explosivity.
Reactivity
Remarks
7.
Not determined
Not designed or expected to be reactive in use.
The main thermal decomposition products of the notified chemical are expected to
be carbon monoxide, carbon dioxide and water, together with smaller amounts of
oxides of nitrogen and sulfur.
TOXICOLOGICAL INVESTIGATIONS
Chemical Analogue Data
FULL PUBLIC REPORT
STD/1033
June 2006
10/29
2006
NICNAS
Data reported below are for the following chemical, that has been accepted as an analogue for the purpose of
assessing toxicological properties of the notified chemical. The commercial form of the analogue chemical of 7585% purity, was used for the toxicological testing below:
Chemical Name
CAS Number
Fatty acids C10-C20 and C16-C18 unsaturated, reaction products with triethanolamine,
dimethyl sulphate-quaternised
91995-81-2
Endpoint and Result
Rat, acute oral LD50 > 5000 mg/kg bw
Rat, acute dermal LD50 > 2000mg/kg bw
Rat, acute inhalation
Rabbit, skin irritation (100%)
Rabbit, skin irritation (20%)
Human volunteers, skin irritation
Rabbit, eye irritation (100%)
Rabbit, eye irritation (20%)
Guinea pig, skin sensitisation – adjuvant test.
Guinea pig, skin sensitisation –non-adjuvant test.
Rat, repeat dose – oral gavage - toxicity – 90 days.
Genotoxicity – bacterial reverse mutation
Genotoxicity – in vivo Mouse micronucleus
7.1.
Assessment Conclusion
low toxicity
low toxicity
not available
irritating
slightly irritating
non-irritating
irritating
slightly irritating
inadequate evidence of sensitisation
inadequate evidence of sensitisation
NOEL 300 mg/kg
non mutagenic
non genotoxic
Acute toxicity – oral
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Species/Strain
Remarks - Method
EC Directive 92/69/EEC B.1 Acute Toxicity (Oral).
Rat/Sprague-Dawley
No significant protocol deviations.
RESULTS
Group
1
2
LD50
Remarks - Results
Number and Sex
of Animals
5/sex
5/sex
Dose
mg/kg bw
2000
5000
Mortality
0
0
> 5000 mg/kg bw
No abnormality in behaviour was noted in the animals treated at the dose
level of 2000 mg/kg.
A slight decrease in the spontaneous activity of the animals treated at the
dose level of 5000 mg/kg was observed for a few hours after treatment
and was accompanied with a slight reduction in the body weight gain of
the males. From day 2 to day 15, the general behaviour of the females
was not influenced by the treatment.
No deaths occurred at the dose levels of 2000 and 5000 mg/kg.
The macroscopic examination revealed no abnormalities in all animals.
CONCLUSION
The analogue chemical (commercial form) is of low toxicity via the oral
route.
TEST FACILITY
Centre International de Toxicologie (1991)
7.2.
Acute toxicity – dermal
TEST SUBSTANCE
Analogue chemical (commercial form containing 85% partially
hydrogenated tallow EQ and 15% 2-propanol)
METHOD
OECD TG 402
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STD/1033
June 2006
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2006
NICNAS
Species/Strain
LD50
Rat
> 2000 mg/kg bw
Remarks
CONCLUSION
Only a brief summary of the study was provided
The analogue chemical (commercial form) is of low toxicity via the
dermal route.
TEST FACILITY
Centre International de Toxicologie (1991a).
7.3.
Acute toxicity – inhalation
There was no acute inhalation toxicity test submitted.
7.4.1 Irritation – skin
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Species/Strain
Number of Animals
Observation Period
Type of Dressing
Remarks - Method
EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).
Rabbit/New Zealand White
3 male
15 d
Semi-occlusive.
No significant protocol deviations. Residual test substance was removed
by a dry compress after 4 h.
RESULTS
Lesion
Mean Score*
Maximum
Maximum Duration
Animal No.
Value
of Any Effect
1
2
3
Erythema/Eschar
2.7
2.0
0.3
3
10 days
Oedema
2.0
2.0
0.3
4
2 days
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Remarks - Results
Maximum Value at End
of Observation Period
0
0
Cutaneous reactions which were slight in one animal and marked in 2
animals were observed after the application of the test substance.
The cutaneous lesions consisted of erythema (scores of 1 to 3) and
oedema (scores of 1 to 4) and were no longer observed on day 3 for one
animal or between day 8 and day 11 for the other 2 animals. A
desquamation of the skin at the treatment site remained between day 8
and day 15.
The pH of the test substance was 3 at 5% in water.
CONCLUSION
The analogue chemical (commercial form) is irritating to the skin.
TEST FACILITY
Centre International de Toxicologie (1991b)
7.4.2 Irritation – skin
TEST SUBSTANCE
Analogue chemical (commercial form) (20% in water)
METHOD
Species/Strain
Number of Animals
Vehicle
Observation Period
Type of Dressing
Remarks - Method
EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).
Rabbit/New Zealand White
3 male
Water
72 h
Semi-occlusive.
No significant protocol deviations. The test substance was not washed
from the skin after the 4 h treatment period.
RESULTS
FULL PUBLIC REPORT
STD/1033
June 2006
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2006
NICNAS
Lesion
Mean Score*
Maximum
Maximum Duration
Animal No.
Value
of Any Effect
1
2
3
Erythema/Eschar
0.7
0
0
1
48 h
Oedema
0
0
0
0
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Remarks - Results
Maximum Value at End
of Observation Period
0
0
One hour after the removal of the dressing, no cutaneous reactions were
observed in the animals.
After 24 and 48 hours, only a slight erythema was noted in one animal.
No cutaneous reactions persisted after 72 hours.
The pH of the test substance was approximately 3.
CONCLUSION
The analogue chemical (commercial form) (20% in water) is slightlyirritating to the skin.
TEST FACILITY
Centre International de Toxicologie (1990)
7.4.3 Irritation – skin - human volunteers
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Study Group
Observation Period
Remarks - Method
Open epicutaneous test (Burckhardt-Test)
20 human volunteers
40 minutes
The analogue chemical (commercial form) was applied in a concentration
of 5% AS, 10% AS, 20% AS and 50% AS.
The test solution was continuously applied (1 to 2 drops) with a glass
stick to an area of about 3 cm in diameter on the skin of inner surface of
the forearm for 30 minutes. The application is repeated each 30 seconds.
RESULTS
Remarks - Results
The method chosen was stated to be suitable for testing substances with a
high level of irritation to the skin.
20 volunteers applied analogue chemical (commercial form) (5% AS) to
the left arm. 1 of 20 volunteers showed a slight erythema after 16 minutes
of exposure and which disappeared 10 minutes after the end of
application.
The same volunteers applied analogue chemical (commercial form) (10%
AS, 20% AS and 50% AS) to the right arm. All volunteers showed no
reactions.
CONCLUSION
The analogue chemical (commercial form) is non-irritating to the skin.
TEST FACILITY
Henkel KGaA (1991)
7.5.1 Irritation – eye
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Species/Strain
Number of Animals
Observation Period
Remarks - Method
EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation).
Rabbit/New Zealand White
3 male
8d
No significant protocol deviations. Fluorescein was used during
examinations.
FULL PUBLIC REPORT
STD/1033
June 2006
13/29
2006
NICNAS
RESULTS
Lesion
Mean Score*
Maximum
Maximum Duration
Animal No.
Value
of Any Effect
1
2
3
Conjunctiva: redness
1.7 1.0 2.0
2.0
7d
Conjunctiva: chemosis
2.0 1.3 3.0
3.0
6d
Conjunctiva: discharge
3** 3** 3**
3**
2d
Corneal opacity
0.7 0.3 1.7
2.0
7d
Iridial inflammation
0.0 0.0 1.0
1.0
3d
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
**White purulent discharge
Remarks - Results
Maximum Value at End
of Observation Period
0
0
0
0
0
After the instillation of the test substance, marked conjunctival reactions
(chemosis: mean scores at 2.0 or 3.0 in 2 animals and redness: score of
2.0 in one animal, during 72 hours) or moderate (redness in 2 animals and
chemosis in one animal) were observed. White purulent discharge
occurred in 3 animals at 24 h and 1 animal at 48 h.
After 24, 48 and 72 hours, an irritation of the iris (score 1) was noted in
one animal.
Corneal opacity which was slight (score of 1) in 2 animals or moderate
(score maximal of 2) for 72 hours in one animal was observed on an area
less than a half or less than one quarter of the cornea.
All the ocular lesions had resolved between day 4 and day 8.
The pH of the test substance was 3.at 5% in water.
CONCLUSION
The analogue chemical (commercial form) is irritating to the eye.
TEST FACILITY
Centre International de Toxicologie (1991c)
7.5.2 Irritation – eye
TEST SUBSTANCE
Analogue chemical (commercial form) (20% in water)
METHOD
Species/Strain
Number of Animals
Observation Period
Remarks - Method
EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation).
Rabbit/New Zealand White
3 male
3d
No significant protocol deviations. Fluorescein was used at the 24 h
examination.
RESULTS
Lesion
Mean Score*
Maximum
Maximum Duration
Animal No.
Value
of Any Effect
1
2
3
Conjunctiva: redness
0
0.3
0
1
1d
Conjunctiva: chemosis
0
0
0
0
Conjunctiva: discharge
0
0
0
0
Corneal opacity
0
0
0
0
Iridial inflammation
0
0
0
0
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Remarks - Results
CONCLUSION
FULL PUBLIC REPORT
STD/1033
Maximum Value at End
of Observation Period
0
0
0
0
0
One hour after the instillation of the test substance, slight (chemosis,
enanthema) conjunctival reactions were observed in all the animals.
After 24 hours, only a slight redness of the conjunctiva persisted in one
animals.
No ocular reactions were noted after 48 and 72 hours.
The analogue chemical (commercial form) (20% in water) is slightly-
June 2006
14/29
2006
NICNAS
irritating to the eye.
TEST FACILITY
Centre International de Toxicologie (1990d)
7.6.1 Skin sensitisation
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Species/Strain
OECD TG 406 Skin Sensitisation - maximisation method.
Guinea pig/Pirbright white
Maximum Non-irritating Concentration: intradermal: All
concentrations used found to be irritating (0.5% - 3%)
topical:
5%
PRELIMINARY STUDY
MAIN STUDY
Number of Animals
INDUCTION PHASE
Signs of Irritation
Test Group: 20
Control Group: 10
Induction Concentration:
intradermal: 0.5% (v/v) with Paraffine perliquid
topical:
5% (v/v) with Paraffine perliquid
Intradermal injection: An examination of the injections was performed
one and 24 hours after treatment. On both dates weak dermal reactions
were observed at the test group animals and all but three control group
animals showed no effects.
Topical induction: In the test group animals, one hour after the exposure
ended, weak to moderate skin reactions were observed and after 24 hours
weak skin reactions were seen. The control group animals also showed
weak skin reaction on both times.
CHALLENGE PHASE
topical:
Remarks - Method
2% (v/v) with Paraffine perliquid
No significant protocol deviations. The study report was a translation.
RESULTS
Animal
Challenge Concentration
Number of Animals Showing Skin Reactions after
challenge
24 h
48 h
Test Group
2%
1/20
1/20
0
0/10
0/10
Control Group
Remarks - Results
24 and 48 hours after termination of the challenge moderate skin
reactions were observed in 19 test group animals and in the 10 control
group animals.
Neither test group animals nor control group animals died during the
study and no significant difference was observed in their body weights.
The observed effects occurring in both control and test animals may be
due to irritation. Such irritation effects would mask any sensitisation
effects if they were present.
CONCLUSION
No conclusion can be drawn from this study as to the sensitising potential
of the analogue chemical (commercial form).
TEST FACILITY
Henkel KGaA (1991a)
7.6.2 Skin sensitisation
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
OECD TG 406 Skin Sensitisation – Buehler Test.
FULL PUBLIC REPORT
STD/1033
June 2006
15/29
2006
NICNAS
Species/Strain
Guinea pig/Pirbright white/Charles River
Maximum Non-irritating Concentration:
topical:
15%,(w/w) in saline (minimally irritating)
PRELIMINARY STUDY
MAIN STUDY
Number of Animals
INDUCTION PHASE
Signs of Irritation
Test Group: 10
Control Group: 10
Induction Concentration:
Topical:
15%
One hour after terminating the third induction, 6 test group animals
showed slight and one moderate effects on the exposed skin area. 24 hours
later 9 test group animals showed up to strong effects. The control group
animals showed no dermal alterations on the treated skin areas at any time.
CHALLENGE PHASE
challenge
Remarks - Method
topical: 5%
No positive controls were included in the study. A rechallenge was not
performed.
RESULTS
Animal
Challenge Concentration
Test Group
5%
Control Group
5%
Remarks - Results
Number of Animals Showing
Skin Reactions after challenge.
Left Flank
Right flank
24 h
48 h
24 h
48 h
4
6
7
4
3
2
2
2
Slight erythema only was seen in both test and control animals after
challenge, and the higher incidence in test animals is noted in the table
above. Skin reactions that occurred only at 48 h or were sustained at the
same level between 24 h and 48 h occurred in both test and control
animals, however at a higher incidence in the test animals. No test group
animals or control group animals died during the study and no significant
difference was observed in their body weights.
CONCLUSION
Based on the data above it is considered the erythema is likely to be due
to irritation rather than sensitisation. However the possibility remains that
a sensitisation response may have occurred, based on the higher incidence
of slight erythema in the test animals.
TEST FACILITY
Henkel KGaA (1991b)
7.7.
Repeat dose toxicity
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Species/Strain
Route of Administration
OECD TG 408 Repeated Dose 90-Day Oral Toxicity Study in Rodents.
Sprague-Dawley CD (Charles River)
Oral – gavage.
Dose – 0, 100, 300, 1000 mg/kg bw/day
Total exposure days: 90 days;
Dose regimen: 5/7 days per week;
Post-exposure observation period: Not stated
Exposure Information
Vehicle
Remarks - Method
Based on summary only of study, there were no significant protocol
deviations. Recovery groups for the control and high dose groups were
included.
RESULTS
FULL PUBLIC REPORT
STD/1033
June 2006
16/29
2006
NICNAS
Mortality and Time to Death
In the course of the study there were no mortality and clinical symptoms of intoxication.
Clinical Observations and Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis
In comparison of the control group there was no differences in food intake, body weight gain, haematological
parameters, status of the eyes and organ weights which could be considered as attributable to the
administration of the test substance.
Effects in Organs
At gross necropsy, effects were observed in the high dose (1000 mg/kg bw/day) group in the following organs:
fore stomach (irritations and even ulcerations) and urinary bladder (epithelium desquamation). These
pathological lesions were considered to be treatment related.
Remarks – Results
Only summary report was provided
A further finding in the high dose group consisting of a distinct increase of alanin-aminotransferase in male
and female animals indicated possible liver injury.
At the other dose levels there was no treatment related lesions.
CONCLUSION
The No Observed Effect Level (NOEL) was established as 300 mg/kg bw/day in this study, based on the
lesions in the stomach and bladder at 1000 mg/kg bw/day.
TEST FACILITY
7.8
Henkel KGaA (1991c).
Genotoxicity – bacteria
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
OECD TG 471 Bacterial Reverse Mutation Test.
Off. J. Europ. Commun. No 42, March 2, 1983
Plate incorporation procedure
S. typhimurium: TA1538, TA1535, TA1537, TA98, TA100
S9 fraction from Aroclor 1254 induced rat liver
1st test with and without metabolic activation:
8, 40, 200, 1000,
5000 µg/plate
2nd test With and without metabolic activation:
6.25, 25, 100,
400, 1600 µg/plate
Tween 80/Aqua bidest
No significant protocol deviations.
Species/Strain
Metabolic Activation System
Concentration Range in
Main Test
Vehicle
Remarks - Method
RESULTS
Metabolic
Activation
Absent
Test 1
Test 2
Present
Test 1
Test 2
Remarks - Results
CONCLUSION
FULL PUBLIC REPORT
STD/1033
Test Substance Concentration (µg/plate) Resulting in:
Cytotoxicity in Main Test
Precipitation
Genotoxic Effect
> 200 µg/plate
> 100 µg/plate
Not noted
Not noted
negative
negative
> 1000 µg/plate
> 400 µg/plate
Not noted
Not noted
negative
negative
Toxic effects were noted starting at concentrations of 100 µg/plate or
higher.
No enhanced revertant rates compared to concurrent negative controls,
induced by the test substance, were observed in all tested strains, neither
in the presence nor in the absence of metabolic activation.
The analogue chemical (commercial form) was not mutagenic to bacteria
June 2006
17/29
2006
NICNAS
under the conditions of the test.
TEST FACILITY
Henkel KGaA (1989)
Genotoxicity – in vivo
7.9
TEST SUBSTANCE
Analogue chemical (commercial form)
METHOD
Species/Strain
Route of Administration
Vehicle
Remarks - Method
OECD TG 474 Mammalian Erythrocyte Micronucleus Test.
Mice/albino CFW 1 Winkelman
Oral – gavage/.
Water
No significant protocol deviations. A dose of 5000 mg/kg bw was chosen
for the main study. The positive control used was cyclophosphamide at
10 mg/kg. The volume of dose for all groups was 20 mL/kg.
Group
Negative Control
Positive Control
Test Group
Test Group
Test group
Number and Sex
of Animals
6M/6F
6M/6F
6M/6F
6M/6F
6M/6F
Dose
mg/kg bw
0
10 mg/kg (CP)
5000 mg/kg
5000 mg/kg
5000 mg/kg
Sacrifice Time
hours
24
24
24
48
72
CP = cyclophosphamide.
RESULTS
Doses Producing Toxicity
Genotoxic Effects
Remarks - Results
In the preliminary range-finding study using 3000, 4000 and 5000 mg/kg,
no animals up to the highest dose died within the first three days or
showed signs of severe morbidity. Slight piloerection was observed at all
animals up to 24 hours after administration.
Based on the preliminary results 5000 mg/kg body weight was selected as
appropriate dose for the micronucleus test and no significant toxicity at
this dosage was noted in the main study.
No increase in the frequency of micronucleated cells was observed, and
was reduced in all female test groups and in male test groups at 48 h and
72 h sacrifice. This reduction was not statistically significant.
The incidence of micronuclei in the negative control groups was in the
range of historical control data. The positive control substance,
cyclophosphamide, induced a statistically significant increase in the
number of micronuleated cells in both sexes.
. A slight reduction in the ratio of polychromatic to normochromatic
erythrocytes was determined in female mice 24 and 48 hours after
administration, demonstrating that the test substance had reached the
bone marrow and indicating possibly a weak toxic effect to the bone
marrow.
No mortality was registered during the main study. Signs at clinical
examination were slight piloerection.
CONCLUSION
The analogue chemical (commercial form) was not clastogenic under the
conditions of this in vivo Bone Marrow Cells of the Mouse test.
TEST FACILITY
Henkel KGaA (1990)
8.
ENVIRONMENT
8.1.
Environmental fate
8.1.1.
Ready biodegradability
FULL PUBLIC REPORT
STD/1033
June 2006
18/29
2006
NICNAS
TEST SUBSTANCE
Notified Chemical
METHOD
Inoculum
Exposure Period
Auxiliary Solvent
Analytical Monitoring
Remarks - Method
OECD TG 301 D Ready Biodegradability: Closed Bottle Test.
Supernatant from settled domestic activated sludge.
28 days
None
No details were provided.
The percent biodegradation of the test item was determined from the
chemical oxygen demand (COD), which was determined by closed reflux
(Stantec SOP #393). The test was validated by referencing to several
control tests. These include procedure controls using the reference
substance, phthalic acid, and an inoculum control.
RESULTS
Day
0
7
14
21
28
Test substance
% Degradation
0
1.3
7.5
8.8
11.3
Remarks - Results
Day
0
7
14
21
28
Phthalic Acid
% Degradation
0
72.4
81.2
88.7
84.9
Accuracy of the dissolved oxygen meter was ± 2%. At each time period,
the dissolved oxygen content was measured in two replicate BOD bottles
in the test series and two replicated BOD bottles in the inoculated control
series. Endpoints were calculated using the average of these replicate
readings. As the reference test biodegraded by > 60% in 14 days, the test
was validated.
CONCLUSION
The notified chemical was found to be not readily biodegradable (i.e.
<60% degradation in 28 days), under the test conditions.
TEST FACILITY
Stantec Consulting Ltd (2004a)
8.2.
8.2.1.
Ecotoxicological investigations
Acute toxicity to fish
TEST SUBSTANCE
Notified Chemical
METHOD
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
OECD TG 203 Fish, Acute Toxicity Test – 96 h static.
Rainbow Trout (Oncorhynchus mykiss).
96 hours
None
~280 mg CaCO3/L
pH, dissolved oxygen, conductivity, temperature, visual observations,
water hardness
The test solution was prepared by weighing 500.0 mg of the test item and
adding it to 1000 mL of laboratory dilution water to yield a nominal
concentration of 500 mg/L. Each test solution was prepared by adding the
appropriate amount of stock solution to 15 L of dilution water. The
dilution series was set up as a 0.56 logarithmic series to achieve five
exposure concentrations and a control. The stock solution remained
cloudy after stirring for 1 hour, however, all dilutions remained clear at
all times.
Remarks – Method
No chemical analysis was conducted to confirm the nominal
concentrations of the test item.
FULL PUBLIC REPORT
STD/1033
June 2006
19/29
2006
NICNAS
RESULTS
Concentration mg/L
Nominal
Actual
10
5.6
3.2
1.8
1.0
Control
LC50
NOEC
Remarks – Results
Number of Fish
10
10
10
10
10
10
3h
3
0
0
0
0
0
24 h
10
10
2
0
0
0
Mortality
48 h 72 h
10
10
10
10
8
8
0
0
0
0
0
0
96 h
10
10
8
0
0
0
>10.0 mg/L at 3 hours.
3.8 mg/L at 24 hours
2.7 mg/L at 48 hours
2.7 mg/L at 96 hours – 95% C.I. = 1.8 - 5.6
1.8 mg/L at 96 hours
As mortality and impairment did not exceed 10% in the control, constant
conditions were maintained throughout the test, and the dissolved oxygen
concentration was at least 60% of the air saturation value throughout the
test, the test was considered valid.
CONCLUSION
The notified chemical was found to be moderately toxic to the test
organism based on the LC50 of 2.7 mg/L at 96 hours under the test
conditions.
TEST FACILITY
Stantec Consulting Ltd (2004b)
8.2.2.
Acute toxicity to aquatic invertebrates
TEST SUBSTANCE
Notified Chemical
METHOD
OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction
Test – 48 hour static.
Daphnia magna
48 hours
None
273 mg CaCO3/L
None
The test solution was prepared by weighing 10.03 mg of the test item and
adding it to 1000 mL of laboratory dilution water to yield a nominal
concentration of 10 mg/L. Each test solution was prepared by adding the
appropriate amount of dilution water. Definitive testing was conducted by
setting up a dilution series to bracket the EC50 calculated in a rangefinding test. The dilution series was set up as a 0.5 geometric series to
achieve six exposure concentrations and a control. All solutions were
visually clear.
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks - Method
No chemical analysis was conducted to confirm the nominal
concentrations of the test item.
RESULTS
Concentration mg/L
Nominal
Actual
1.00
0.50
0.25
0.13
FULL PUBLIC REPORT
STD/1033
Number of D. magna
4 x 5 = 20
4 x 5 = 20
4 x 5 = 20
4 x 5 = 20
Number Immobilised
24 h
48 h
20
20
1
20
1
4
0
0
June 2006
20/29
2006
NICNAS
0.625
0.0313
Control
EC50
NOEC (or LOEC)
Remarks - Results
4 x 5 = 20
4 x 5 = 20
4 x 5 = 20
0
0
0
0
0
0
0.68 mg/L at 24 hours
0.31 mg/L at 48 hours – 95% C.I. = 0.25 – 0.50
0.13 mg/L at 48 hours
CONCLUSION
The notified chemical was found to be highly toxic to Daphnia based on
the EC50 of 0.31 mg/L at 48 hours under the test conditions.
TEST FACILITY
Stantec Consulting Ltd (2004c)
8.2.3.
Algal growth inhibition test
TEST SUBSTANCE
Notified Chemical
METHOD
Species
Exposure Period
Concentration Range
Auxiliary Solvent
Analytical Monitoring
Remarks - Method
OECD TG 201 Alga, Growth Inhibition Test.
Selenastrum capricornutum
96 hours
Nominal:
0.031, 0.063, 0.125, 0.250, 0.500 and 1.000 mg/L
None
None
The first stock solution was prepared by weighing 10.01 mg of the test
item and adding it to 1000 mL of filter-sterilised algal nutrient solution to
yield a nominal concentration of 10.0 mg/L. A second stock solution was
prepared by mixing 50 mL Stock 1 into 500 mL of filter-sterilised algal
nutrient solution to yield a nominal concentration of 1 mg/L. Stock 2 was
used as the highest test concentration and was diluted with filter-sterilised
algal nutrient solution to prepare the test concentrations.
No chemical analysis was conducted to confirm the nominal
concentrations of the test item.
RESULTS
Biomass
EbC50
mg/L at 72 h
0.191 (0.177 – 0.195)
Remarks – Results
NOEbC
mg/L
0.125
Growth
ErC50
mg/L at 72 h
0.318 (0.298 – 0.344)
NOErC
mg/L
0.125
The culture prior to testing was not observed to have unusual appearance.
There were no unusual conditions or deviations from the test protocol. As
there was a greater than 16-fold increase in cell numbers in the control
sample, the test was considered to be valid.
CONCLUSION
The notified chemical was found to be highly toxic to algae based on the
EbC50 value of 0.191 mg/L at 72 hours under the test conditions. The 72
hour end point is used rather than the slightly lower toxicity end point at
96 hours, as this is the standard time, and some reversal occurs after 72
hours.
TEST FACILITY
Stantec Consulting Ltd (2004d)
9.
RISK ASSESSMENT
9.1.
Environment
9.1.1.
Environment – exposure assessment
FULL PUBLIC REPORT
STD/1033
June 2006
21/29
2006
NICNAS
The notified chemical is intended for use as a fabric softener. The major environmental
exposure of the notified chemical is from wash water after fabric cleaning activities. It is
expected that the notified chemical will be used throughout Australia.
It is estimated that approximately 96% of the total volume of notified chemical that is applied to
fabric will be released to the sewer after the first fabric washing, with the remainder being
released from subsequent washings. Residual notified chemical in containers is expected to
account for less than 1% of the total import volume. The majority of this is expected to be
disposed of to secure landfill, where it should slowly degrade by biotic and abiotic processes.
Estimates of the predicted environmental concentrations (PECs) resulting from the treatment of
fabric in a worst case scenario of all imported notified chemical being released to sewer, are
provided in the following table.
Predicted Environmental Concentration (PEC) for the Aquatic Compartment
Annual quantity of chemical released to sewer
Days per year where release occurs
Daily chemical release:
Water use
Population of Australia (Millions)
Daily effluent production:
Dilution Factor - River
Dilution Factor - Ocean
PEC - River:
PEC - Ocean:
100,000
365
273.97
200.0
20.496
4,099
1.0
10.0
66.84
6.68
kg/year
days/year
kg/day
L/person/day
million
ML
μg/L
μg/L
The SIMPLETREAT model cannot be used as three required factors are either unknown (log
POW and vapour pressure) or unclear (water solubility). Therefore, a figure of 90% adsorption
has been used, based on a reference in Nabholz et al (1997, p203) based on typical levels of
solids removal in Sewage Treatment Plants.
The OECD TG 106 – Tier 1 Adsorption/Desorption Test reports that up to 100% may be
adsorbed to suspended soil and organic material, however its direct applicability to sewage
treatment plants is questionable given the following problems. Firstly, not all of the notified
chemical tested was in solution; the majority was simply suspended. Secondly, there appears to
be a stronger correlation to clay content rather than organic carbon. Thirdly, it is quite likely
that in the sandy loam (OECD soil #5), a large proportion (up to 40%) may simply have
precipitated from suspension.
STP effluent re-use for irrigation occurs throughout Australia. The agricultural irrigation
application rate is assumed to be 1000 L/m2/year (10 ML/ha/year). The notified chemical in this
volume is assumed to infiltrate and accumulate in the top 0.1 m of soil (density 1000 kg/m 3).
Using these assumptions, irrigation with a concentration of 6.68 µg /L may potentially result in
a soil concentration of approximately 6.68 X 10 -2 mg/kg. Assuming accumulation of the
notified chemical in soil for 5 and 10 years under repeated irrigation, the concentration of
notified chemical in the applied soil in 5 and 10 years may be approximately 3.34 X 10 -1 mg/kg
and 6.68 X 10-1 mg/kg, respectively.
9.1.2.
Environment – effects assessment
The results of the ecotoxicological data indicate that the notified chemical is highly toxic to
both aquatic invertebrates (72 h LC50 = 0.31 mg/L) and plants (72 h E bC50 = 0.191 mg/L), and
moderately toxic to fish (LC50 = 2.7 mg/L). Based on this data, a PNEC was calculated, using a
safety factor of 100, to be 1.91 µg/L.
9.1.3.
Environment – risk characterisation
The risk of the release of all the imported notified chemical can be estimated by determining the
aquatic risk quotient (RQ = PEC/PNEC).
FULL PUBLIC REPORT
STD/1033
June 2006
22/29
2006
NICNAS
Removal by STP
PEC
PNEC
Q
River
0%
90 %
97 %
66.84 µg/L
6.68 µg/L
2.01 µg/L
0%
90 %
97 %
6.68 µg/L
0.67 μg/L
0.20 µg/L
1.91 µg/L
1.91 µg/L
1.91 µg/L
34.99
3.50
1.05
1.91 µg/L
1.91 μg/L
1.91 µg/L
3.50
0.35
0.11
Ocean
A figure of 97% removal in STPs has been chosen as the mitigation factor based on the average
of the 6 hour (which is approximately the retention time in sewers) results of the OECD TG 106
- Tier 1 Adsorption/Desorption Test. However as noted above this needs to be treated with
caution. Calculations show that 97.2% removal in the sewer is needed for an acceptable Q <1.
Also, as only approximately 25% of Australia sewage is released to fresh water, the Q values
for freshwater may be divided by 4, and thus even using the Q for only 90% mitigation within
the sewage treatment plant, 3.5/4 = 0.87, which is acceptable. Further, Nabholz et al (1993,
p48), suggests that further mitigation (up to 90%) typically occurs in rivers
The above risk quotients, after considerable mitigation, indicates that the risk to aquatic
organisms is only just acceptable. However, it should be noted that the applicability of the
results of the OECD TG 106 – Tier 1 Adsorption/Desorption Test to STPs is questionable as the
results were more strongly correlated to clay content, rather than organic content and actual
complete adsorption to the loamy sand was not demonstrated.
9.2.
9.2.1.
Human health
Occupational health and safety – exposure assessment
Worker exposure to the notified chemical during consumer fabric softener formulation will be
greater than for workers handling the notified chemical in the final product. Formulation
workers will be exposed to the notified chemical as imported at concentration of 73%. Those
workers handling the finished product eg during filling into bottles, will be exposed to the
notified chemical at 3.7 % in the finished consumer fabric softener product.
Worker exposure during the formulation of the final product is expected to be minimal, as the
blending/dispensing process will employ a closed, sealed-delivery system. Dermal and ocular
exposure may occur during QC procedures prior to use, dispensing (decanting from the drum or
connecting and disconnecting hoses for pumping) the solution of the notified chemical, charging
the blending vessel, and QC sampling. Some exposure may occur during the maintenance of the
manufacture equipment.
Worker exposure will be minimised by use of the appropriate personal protection equipment.
When dispensing, charging of blending vessel, QC sampling and maintenance the workers will
wear eye protection, gloves and overalls. Local exhaust ventilation will be used in areas where
the raw materials are charged to blending vessels.
Worker exposure during the transport, storage, and distribution of the imported notified chemical
and finished product is unlikely to occur unless there is an accidental spillage or packaging
breach. Exposure for retail workers is not likely to occur, unless the packaging of the final
product is breached.
9.2.2.
Public health – exposure assessment
Public exposure will usually be restricted to those people using the final consumer fabric
softener products. The maximum concentration of notified chemical in the final consumer
fabric softener product will be 3.7%. Contact may also occur to water containing fabric
softener, in which the concentration would be substantially lower. Dermal and accidental ocular
may occur when products are decanted for use. Accidental oral exposure to children could also
occur. For a 10 kg child ingesting 20 g of fabric softener (containing 3.7% notified chemical)
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accidental exposure could occur to 740 mg, or 74 mg/kg.
After rinsing and drying, only low levels of residual chemical are expected to be on the treated
clothing and other fabics, and it will be temporarily bound onto the fabric. Thus exposure of
the public to the notified chemical is expected to be low. However there is also potential oral
exposure to babies or children through the mouthing of treated fabrics. Under a worst case
scenario which involves a child sucking 10 g of treated fabric every day, the possible daily
exposure would be 3.0 mg/kg bw/day for a 10 kg child. (Based on maximum of 8 g of notified
chemical deposited on 2.7 kg fabric, a maximum of 30mg of notified chemical is deposited on
10 g of treated fabric)
Direct public exposure during transport and storage is unlikely.
9.2.3.
Human health – effects assessment
Acute toxicity
The commercial form of the analogue chemical is of low acute toxicity via the oral and dermal
route.
Irritation
Based on the studies provided in rabbits the commercial form of the analogue chemical is
considered to be irritating to the skin while the analogue (20% of the commercial form) is
slightly irritating. The commercial form of the analogue chemical was not irritating in the human
volunteer skin test. Based on the studies provided for the rabbit eye test the commercial form of
the analogue chemical is considered to be irritating to the eyes while the analogue (20% of the
commercial form) is slightly irritating.
Sensitisation
Two guinea pig sensitisation studies were provided. No conclusion could be drawn from the
maximisation test, due to a high level of irritation evident in both control and test animals at
challenge. The Buehler test gave equivocal results that can probably be attributed to irritation,
however the possibility that they were indicative of a sensitisation response cannot be ruled out.
The results only of other adjuvant and non-adjuvant guinea pig sensitisation studies on the
commercial form of the analogue chemical were supplied via a HEDSET document (Henkel
Iberica 1995). These results indicated that the analogue chemical (commercial form) chemical is
non-sensitising.
Repeated Dose Toxicity
In a 90-day oral repeat dose study in rats, a No Observed Effect Level (NOEL) was established
for the commercial form of the analogue chemical as 300 mg/kg bw/day, based on the lesions in
the stomach and bladder at 1000 mg/kg bw/day.
Genotoxicity
The commercial form of the analogue chemical tested was not mutagenic to bacterial cells in a
reverse mutation study with and without metabolic activation, or genotoxic to bone marrow cells
of the mouse treated in vivo.
Based on the available data, the notified chemical is likely to be classified as a hazardous
substance in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances (NOHSC 2004), with risk phrases R36/R38 – Irritating to eyes and skin.
9.2.4.
Occupational health and safety – risk characterisation
The greatest potential for occupational exposure will occur at the formulation site. Inadvertent
dermal and ocular exposure to 73% of the notified chemical can occur during handling of the
imported solution. Similar exposure may also occur to 3.7% of the notified chemical in the final
formulation and finished consumer fabric softener. Once the final consumer fabric softener
product is packed, exposure should be low. Hence, exposure for warehousing and distribution
workers and retail workers is unlikely unless the packaging is breached.
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Based on animal testing of analogue chemical (commercial form), the notified chemical is a skin
and eye irritant. Irritation effects on workers would be greater when handling more concentrated
solutions, and would be reduced by the PPE and engineering controls in place at the formulation
plant.
Available test reports on the sensitisation potential of the analogue chemical (commercial form)
were not conclusive and did not distinguish well between irritation and sensitisation. However
there were no strong indications of sensitisation potential. Provision of a local lymph node assay
(LLNA) study on the notified chemical itself would clarify any uncertainty regarding this
endpoint.
9.2.5.
Public health – risk characterisation
The level of the notified chemical in the final consumer fabric softener product to which the
public may have dermal or ocular exposure during use is low (3.7%).
Young children may accidentally ingest fabric softener product. The acute dermal toxicity of
the chemical is low (LD50 > 5000 mg/kg) and the margin of safety would be 68 if a 10 kg child
accidentally ingested 20 g of fabric softener.
Low levels of exposure may also occur from dermal contact with treated fabric or, in the case of
young children, to oral contact with treated fabric. A worst case calculation of exposure to the
notified chemical by a 10 kg child sucking treated fabric indicates possible daily exposure of 3.0
mg/kg bw/day. Based on the NOEL in the 90-day repeat dose study in rats, the margin of safety
is 100.
Most consumer exposure would be dermal or ocular, where the irritation potential demonstrated
in testing of the analogue chemical (commercial form) would be relevant. Testing of the
commercial form of the analogue chemical at 20% indicated mild irritation. Irritation is likely to
be reduced but not eliminated by the relatively low concentration of 3.7% of the notified
chemical in the consumer product. Irritation potential would increase if higher levels were used
in fabric softener products.
The analogue chemical (commercial form) did not give strong indications of skin sensitisation
in animal testing however, the tests were not conclusive and further testing of the notified
chemical would be needed to remove uncertainty about the sensitisation potential.
After rinsing and drying, low levels of residual chemical expected to be on the clothing/linen.
Thus exposure and risk to the public through dermal contact with the treated fabric is expected
to be low
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS
10.1. Hazard classification
Based on the available data the notified chemical is likely to be classified as hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances. The classification and
labelling details are:
R36/38 Irritating to skin and eye
S24/25 Avoid contact with skin and eyes
S26 In case of contact will eyes, rinse immediately with plenty of water and seek medical advice
S36/37/39 Wear suitable protective clothing, gloves and eye/face protection
and
As a comparison only, the classification of notified chemical using the Globally Harmonised
System for the Classification and Labelling of Chemicals (GHS) (United Nations 2003) is
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presented below. This system is not mandated in Australia and carries no legal status but is
presented for information purposes.
Skin corrosion/irritation
Serious eye damage/eye
irritation
Chronic hazards to the
aquatic environment
Hazard category
3
2A
1
Hazard statement
Causes mild skin irritation
Causes serious eye irritation
Very toxic to aquatic life with longlasting effects.
10.2. Environmental risk assessment
On the basis of the Q (PECRiver/PNEC) ratio after very extensive mitigation, the notified
chemical is not expected to pose a significant risk to the environment based on the notified use
pattern. However, further testing work should be undertaken to confirm this finding, as this
depends on a number of assumptions. This testing should be directed at determining the actual
level of removal of notified chemical in STP’s and the mitigating effect that dissolved organic
carbon, as opposed to clay, has on the ecotoxicity of the notified chemical.
10.3. Human health risk assessment
10.3.1. Occupational health and safety
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 of the product containing the notified chemical 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 the product containing the notified chemical 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

The notifier should apply the following health hazard classification for the notified
chemical and products containing the notified chemical at  20%:
 R36/38 Irritating to skin and eye

The following safety phrases should be used:
 S24/25 Avoid contact with skin and eyes
 S26 In case of contact will eyes, rinse immediately with plenty of water and seek
medical advice
 S36/37/39 Wear suitable protective clothing, gloves and eye/face protection
CONTROL MEASURES
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Occupational Health and Safety

Employers should implement the following safe work practices to minimise
occupational exposure during handling of the notified chemical as introduced:
 Prevent spills and splashes

Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced
 Chemical resistant gloves, protective clothing, and safety goggles or safety glasses.

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
 Product containing > 5% of the notified chemical should be packaged and labelled
according to the requirement of the Standard for the Uniform Scheduling of Drugs and
Poisons (SUSDP), under the category “quaternary ammonium compounds”.

The following measures should be taken by the formulators of consumer products
containing the notified chemical to minimise public exposure to the notified chemical:
 Advice on the label of products containing the notified chemical should include
information on the possibility of dermal and eye irritation to sensitive individuals
and recommend washing of skin and eyes immediately following exposure to the
fabric softener product.
Environment

The following control measures should be implemented by end users to minimise
environmental exposure during use of the notified chemical:
o Do not allow concentrated material or contaminated packaging to enter drains,
sewers or water courses.
Disposal

The notified chemical should be disposed of by thermal decomposition in incinerators
or to landfill.
Emergency procedures

Spills/release of the notified chemical should be handled by physical containment and
subsequent collection for safe disposal.
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 import volume of the notified chemical exceeds 100 tonne per annum. If this
occurs, further testing may be required (for example, OECD TG 303A Simulation
Test) relating to adsorption/desorption to the organic fraction (rather than clay) in
the sewerage treatment plant and/or Local Lymph Node Assay (LLNA) for skin
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
sensitisation
The concentration of the notifier chemical in fabric softeners is > 15%
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.
13.
BIBLIOGRAPHY
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Control Act, Chapter 10. In: Ecological Assessment of Polymers: Strategies for Product Stewardship and
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A Multiple Comparison Procedure for Comparing Several Treatments with a Control. J Am Stat Assoc 50,
1096-1121.
Bretherick (1990) Bretherick’s Handbook of Reactive Chemical Hazards, Fourth Edition. Butterworths, London,
UK
Centre International de Toxicologie (1990) Analogue chemical (20% commercial form): Skin Irritation in
Rabbits, Final Report July 1990, Study 6535 TAL for Stepan Europe Voreppe, France. Centre International
de Toxicologie, Evreux, France (Unpublished report provided by notifier).
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de Toxicologie, Evreux, France (Unpublished report provided by notifier).
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Toxicologie, Evreux, France (Unpublished report provided by notifier).
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Test in rats. Study 7376 TAR 24/5/91. Summary only supplied as part of HEDSET on CAS91995-81-2
(Unpublished report provided by notifier).
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Final Report July 1991, Study 7641 TAL for Stepan Europe Voreppe, France. Centre International de
Toxicologie, Evreux, France (Unpublished report provided by notifier).
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Final Report July 1991, Study 7642 TAL for Stepan Europe Voreppe, France. Centre International de
Toxicologie, Evreux, France (Unpublished report provided by notifier).
Henkel KGaA (1989) Analogue chemical (commercial form): Salmonella/Mammalian-Microsome Mutagenicity
Test (Ames Test), Final Report October 1989, Study 890793 for Henkel KGaA, Dusseldorf, Germany.
Department of Toxicology, Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).
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of the Mouse, Final Report February 1990, Study 890452 for Henkel KGaA, Dusseldorf, Germany.
Department of Toxicology, Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).
Henkel KGaA (1991) Analogue chemical (commercial form): Skin Irritation in Human Volunteers, Final Report
March 1991, Study HTX 910050. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany
(Unpublished report provided by notifier).
Henkel KGaA (1991a) Analogue chemical (commercial form): Skin Sensitisation (Maximisation Method), Final
Report March 1991, Study HTX900018 for Henkel KGaA, Dusseldorf, Germany. Department of
Toxicology, Henkel KGaA, Dusseldorf, Germany (Unpublished report provided by notifier).
Henkel KGaA (1991b) Analogue chemical (commercial form): Skin Sensitisation (Buehler Test), Final Report
August 1991, Study HTX 910284 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology,
Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).
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Henkel KGaA (1991c) Analogue chemical (commercial form): 90 day subchronic oral toxicity in rat. Final
Report 1991, Study TBD 910041 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology,
Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).
Henkel Iberica SA-Division PULCRA; KAP Corporation S.A.; Stepan Europe; CECA SA. (1995) HEDSET
Data Sheet for CASRN 91995-81-2 / EINECS No. 295-343-8 / IUPAC Name: Fatty Acids, 110-20 and C1618-unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized (unpublished document
provided by notifier).
Investigative Science Incorporated (2006) Physical/Chemical test by OECD Method 106 – Tier 1 (Soil
Adsorption/Desorption), Report 05-22-4 F, Investigative Science Incorporated, 1050 Cooke Blvd., Unit 2,
Burlington, Ontario, Canada L7T4A8.
Nabholz, J.V., Miller, P. and Zeeman, M., “Environmental Risk Assessment of New Chemicals Under the Toxic
Substances Control Act TSCA Section Five”, in Environmental Toxicology and Risk Assessment, W. G.
Landis, J. S. Hughes and M. A. Lewis (Eds), 1993, pp 40-55
NOHSC (1994) National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)].
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[NOHSC:2011(2003)]. National Occupational Health and Safety Commission, Canberra, Australian
Government Publishing Service.
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Occupational Health and Safety Commission, Canberra, AusInfo.
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Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).
Stantec Consulting Ltd (2004b), Notified chemical: Acute Toxicity to Rainbow Trout. Stantec Consulting
Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).
Stantec Consulting Ltd (2004c), Notified chemical: Acute Toxicity to Daphnia magna. Stantec Consulting
Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).
Stantec Consulting Ltd (2004d), Notified chemical: Growth Inhibition Test with the Freshwater Green Alga,
Selenastrum capricornutum. Stantec Consulting Limited, Guelph, Ontario, Canada (Unpublished report
provided by notifier).
Stepan Company (1999) IR: Notified chemical, Stepan Company, Northfield, IL USA (Unpublished report
provided by notifier).
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