File No STD/1028
18 May 2004
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Notified Chemical in AG 6206
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
National Occupational Health and Safety Commission
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.
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:
334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
Postal Address:
GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL:
+ 61 2 8577 8800
FAX
+ 61 2 8577 8888.
Website:
www.nicnas.gov.au
Director
Chemicals Notification and Assessment
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
6. PHYSICAL AND CHEMICAL PROPERTIES ....................................................................................... 10
7. TOXICOLOGICAL INVESTIGATIONS ................................................................................................ 14
8. ENVIRONMENT ..................................................................................................................................... 20
9. RISK ASSESSMENT ............................................................................................................................... 25
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS ......................................................................................................................................................... 27
11.
MATERIAL SAFETY DATA SHEET ............................................................................................... 28
12.
RECOMMENDATIONS ..................................................................................................................... 28
13.
BIBLIOGRAPHY................................................................................................................................ 29
File No: STD/1028
22 March 2016
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Notified Chemical in AG 6206
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
National Occupational Health and Safety Commission
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.
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:
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
Director
Chemicals Notification and Assessment
22 March 2016
NICNAS
FULL PUBLIC REPORT
Notified Chemical in AG 6206
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Akzo Nobel Chemicals Pty Ltd (ACN 000 017 354) Level 2, 369 Royal Parade, Parkville, Victoria
3052
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: chemical name, CAS No., molecular and
structural formulae, spectral data, customer details, import volume and certain marketing names.
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
Variation to the schedule of data requirements is claimed as follows: Particle size, Flammability
Limits, Acute Inhalation Toxicity. In addition data for a close analogue was substituted for all
physico-chemical properties except partition coefficient and all mammalian toxicity data except those
for skin sensitisation and genotoxicity.
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None.
NOTIFICATION IN OTHER COUNTRIES
The notifier states “None”.
2. IDENTITY OF CHEMICAL
MARKETING NAME(S)
AG 6206, the formulation to be imported contains 75% notified chemical in an aqueous solution.
METHODS OF DETECTION AND DETERMINATION
ANALYTICAL
METHOD
Gas chromatography/ Mass spectroscopy.
3. COMPOSITION
DEGREE OF PURITY
99%
HAZARDOUS IMPURITIES/RESIDUAL MONOMERS
Chemical Name
CAS No.
Hazardous Properties
hexanol
111-27-3
Weight %
0.6 – 0.9
Harmful if swallowed and inhaled. Irritating to respiratory system and skin.
NON HAZARDOUS IMPURITIES/RESIDUAL MONOMERS (>1% by weight)
None.
ADDITIVES/ADJUVANTS
FULL PUBLIC REPORT: STD/1028
Water is present in AG 6206.
Page 4 of 31
22 March 2016
Chemical Name
CAS No.
NICNAS
Water
7732-18-5
Weight %
25
4. INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
The notified chemical will be imported in an aqueous solution at a concentration of 75% or less (AG
6206). It will also be imported as part of a proprietary blend of ethoxylated non ionic surfactants and
water at concentrations less than 75%.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year
Tonnes
1
30–100
2
100–300
3
100–300
4
100–300
5
100–300
USE
The notified chemical functions as a surfactant in a wide range of applications. It is particularly useful
in aqueous alkaline applications where low foaming and effective wetting properties are desirable.
Typical applications include a variety of cleaning products such as vehicle cleaning and machine
dishwashing, personal care, industrial and commercial cleaning products, and as an adjuvant in
agricultural chemicals.
The maximum concentration used in concentrates is 20%. These concentrates are further diluted 5 –
100 times depending on the particular application.
5. PROCESS AND RELEASE INFORMATION
5.1.
Distribution, Transport and Storage
PORT OF ENTRY
The notified chemical will initially be imported through Sydney, or Melbourne.
IDENTITY OF MANUFACTURER/RECIPIENTS
AG 6206, the product containing the notified chemical, will arrive at wharf and be delivered to the
customers site by road transport for storage and reformulation. It may be initially stored and
distributed in a third party warehouse in either Melbourne or Sydney.
TRANSPORTATION AND PACKAGING
AG 6206 will be imported in 200 L steel drums or 1000 L isotainers. These drums or isotainers will
be transported by road from the wharf to warehouse or delivered to the customers site for
reformulation.
The following table describes the transportation and packaging arrangements for formulated products:
Product Type
Consumer cleaning product (eg
dishwashing detergent)
Container Size/Description
0.5-5 litres
Institutional cleaning product
(eg heavy duty detergent for
cleaning of vehicles/kitchens)
5-50 litres
Industrial (brewery cleaning)
200 litres
FULL PUBLIC REPORT: STD/1028
Distribution Mode
Plastic bottles are filled at the
site of formulation and packed
in cardboard cartons.
The
boxes are transported to retail
stores by road transport.
Plastic/steel containers are
filled at site of formulation.
The containers are transported
by road to wholesale stores.
Plastic/steel drum filled at site
of formulation and transported
by road to customer site.
Page 5 of 31
22 March 2016
Agricultural formulation
5.2.
NICNAS
1-200 litres
Plastic/steel container filled at
site of formulation and
transported to a wholesale
store.
Operation Description
The notified chemical will be imported as an aqueous solution. Reformulation will be carried out in
Australia.
Formulation of Domestic/Institutional/Industrial Cleaning Products
The typical composition of a liquid cleaning agent includes 5–40 wt% surfactant(s) together with
other constituents such as a hydrotropic material, additives (eg hand lotion, colourant, perfume), and
water added to give the formulation its desired characteristics. Alkyl glucosides are useful when
process temperatures are not too high and the medium is not too acidic, and favourable
ecotoxicological properties are desired (Balzer 1997). The notified chemical is used at a maximum
of 20% in cleaning formulations and is particularly suitable for alkaline cleaning applications.
Customers for the notified chemical have not been identified as yet. Most potential customers
operate manufacturing facilities in metropolitan Sydney, Melbourne, Brisbane or Adelaide. Of the
maximum of 300 tonnes to be imported per year it is estimated that 80% will be used in cleaning
products. Cleaning products are typically formulated by stirring the ingredients for 1-4 hours in a
mixing tank, usually stainless steel and ranging in size from approximately 150-250,000 L. Mixing
usually takes place at room temperature. The notified chemical can be added directly to the mixing
vessel from a 205 L drum or it can be added to the mixer via a manifold and metering system from a
drum or storage vessel. Smaller quantities are often pre-weighed into smaller drums or buckets
before addition to the mixer. Product is packed off into containers ranging in size from < 1 L
(generally plastic containers) to 205 L (drums). The containers are filled either by gravity feed from
the mixing vessel or by pneumatic filling. The larger packs are distributed to repackagers and to the
larger cleaning companies.
At the end of the blending process, a sample of product is normally taken for quality control using a
pipette.
The blending vessel and filling lines will be cleaned after the formulation of each batch by flushing
the system with water. Cleaning residues are either reused again in the blending process or process
wastewater will be sent to a waste water pit on the manufacturing site. After emptying, the drums
containing AG 6206 will be sent to a drum recycler, and the isotainers sent back to the manufacturer
of the notified chemical.
Domestic/Institutional/Industrial Cleaning Products End Use
Cleaning products are generally applied by one of the following methods:
• washing with liquid cleaner, for example, with a cloth or sponge, and wiping the surface;
• spraying the surface and then wiping;
• applying liquid cleaner by mop or brush;
• applying the cleaner as a liquid stream, for example, using a wash or squeeze bottle; or high
pressure;
• applying the cleaning solution by machine, for example, in hot and cold water pressure cleaners,
including steam and foam cleaning; or
• soaking in liquid cleaner.
In most cases, the cleaning product as marketed needs to be diluted with water prior to application.
The dilution factor, which is often on the label, depends on the type of surface to be cleaned, the soil
loading, and the type and method of application. For example, in degreasing and oven cleaning a
dilution factor up to 1:5 is often used; as a spray for floor and wall cleaning dilution ranges from 1:10
to 1:30, and as a wash for delicate surfaces dilution ranges from 1:20 to 1:100.
FULL PUBLIC REPORT: STD/1028
Page 6 of 31
22 March 2016
NICNAS
Formulation of Brewery Cleaner
The notified chemical may be used as a dispersant in the formulation of brewery cleaner.
Formulation is normally high alkaline aqueous solution containing 25-48% caustic soda and
dispersant (up to 20%).
Ingredients are blended in a mixing vessel followed by batch adjustment and laboratory quality
control testing. After filling of 1000 L isotainers or road tanker and road transport to the brewery,
conductivity controlled dosing to vats or tanks occurs. Stainless steel vats or tanks are prerinsed with
water then washed with the formulation. Waste water containing the formulation is recirculated,
reclaimed and disposed of via trade waste sewer. Release to sewer occurs following pH control.
Containers/road tankers are rinsed at suppliers site and containers are reused or recycled.
Good work practices minimise the probability of spillage occurring. The chemical or the formulation
are non volatile therefore do not represent an emission hazard to atmosphere. Discharges to sewer are
controlled by Local or State government environmental legislation.
Formulation of Agricultural Chemical
The manufacture of agricultural chemical formulations (using approximately 20% of the imported
volume) is a simple mixing process and is the same as that described for the cleaning products. The
notified chemical will be blended with agrochemical active ingredients (eg simazine or glyphosate)
together with other surfactants, additives and solvents/water. No elevated temperatures or pressures
are involved. The agricultural product is filled into containers and then warehoused for distribution
to resellers.
5.3.
Occupational exposure
Category of
Worker
State
No.
Task
Duration
Task
Frequency
Exposure Controls
Personal
Protection
Transport and
storage
Aqueous
solution
(max 75%)
50
4 h/day
52 days/year
Spill kits are carried on
vehicles. Storage
warehouses are fully
bunded and have effluent
traps
If required to
clean up spill,
chemical
resistant gloves
and safety
goggles.
Warehouse
Aqueous
solution
(max 75%)
10
2 h/day
100
days/year
Storage warehouses are
fully bunded and have
effluent traps
If required to
clean up spill,
chemical
resistant gloves
and safety
goggles.
Process
operator
Aqueous
solution
(max 75%)
100
2.5 h/day
52 days/year
Dedicated filling lines.
Exhaust ventilation, eye
wash stations.
Long sleeve
overalls,
chemical
resistant gloves,
safety goggles
and safety
boots.
Consumer/
Institutional/
Industrial
Cleaning
FULL PUBLIC REPORT: STD/1028
Page 7 of 31
22 March 2016
NICNAS
Quality
control
Aqueous
solution
(max 20%)
5
1 h/day
52 days/year
Analysis occurs in fume
cupboards. Eyewash
stations.
Long sleeve
overalls,
chemical
resistant gloves,
safety goggles
and safety
boots.
Packaging
Formulated
liquid (max
20%)
20
3 h/day
52 days/year
Dedicated filling lines.
Exhaust ventilation, eye
wash stations.
End use
Formulated
liquid (max
20% in
concentrate)
5000
0.5 h
/day
365 days/year
Containers fit for purpose.
Appropriate labelling and
dilution instructions.
Household products,
relatively small volume
containers may contain
child-proof closures. May
be corrosive solutions and
scheduled
poisons/hazardous
substances
Long sleeve
overalls,
chemical
resistant gloves,
safety goggles
and safety
boots.
Dependent on
formulation.
Eye protection
must be
recommended if
the
concentration of
the notified
chemical is 5%
or greater due to
its irritant
nature.
Agricultural
chemical
production
workers
a) drum
handling
b) transfer of
chemical to
mixer-insert
& remove
drum pump
c) filling of
formulation
into
containers
Aqueous
solution
(max 75%)
50
(total)
4
20
Dedicated filling lines.
Exhaust ventilation, eye
wash stations.
Long sleeve
overalls,
chemical
resistant gloves,
safety goggles
and safety
boots.
Exposure during formulation of cleaning products or agricultural chemicals is likely to be limited to drips or
spills while adding the concentrated solution to the mixing vessel, sampling and testing small amounts for
quality control, drumming off and cleaning and maintenance of lines, mixing and dispensing machinery.
Potential dermal and ocular exposure is likely to be prevented by the use of personal protective equipment.
Local exhaust ventilation is employed to prevent inhalation exposure to fumes and aerosols.
There is a high likelihood of splashes and spills of the notified chemical when it is diluted for use and when it is
used for cleaning. The probability of ocular exposure is dependent on work practices employed to minimise
splashes and spills.
5.4.
Release
RELEASE OF CHEMICAL AT SITE
The notified chemical may be released during reformulation (both cleaning and agricultural
FULL PUBLIC REPORT: STD/1028
Page 8 of 31
22 March 2016
NICNAS
applications) via spills (0.1%), drum residues (0.1%) and equipment washings (0.1%). Spilt material
and washings will end up in the on-site wastewater pit or treatment plant, while the drums will either
be collected by licensed waste contractors or reused by the company. In either case it is likely that the
drums will be rinsed before leaving the site, with the rinsate going into the process or the on-site
wastewater pit or treatment plant. The effluent from the wastewater pit or treatment plant will be
released to sewer, generally after some form of treatment. Thus, a maximum of 0.3% (900 kg) of the
notified chemical will be released to sewer presuming none is removed during treatment.
Direct release to soil is expected to be negligible during formulation. Some spills of the notified
chemical may be absorbed with an absorbent and disposed of to landfill.
The process described above is a simple blending process conducted within a closed system.
Consequently, release to the atmosphere is expected to be negligible.
RELEASE OF CHEMICAL FROM USE
Given the use pattern of the notified chemical, initial release is entirely expected to occur to the
aquatic compartment. Assuming the maximum importation volume of up to 300 tonnes and all
cleaning operations using the notified chemical occurring year round, the average daily releases will
be as shown in the table below. This release is expected to be relatively diffuse, however, a large
proportion of the release will occur in major coastal metropolitan centres.
Product Type
Volume Used
(tonne/year)
Release Rate
Release to Sewer
(tonne/year)
Emission to sewer1
PEC effluent2
PEC water3
TOTAL PEC Water
mg/L
1.
2.
3.
Cleaners
240 (80%)
Agrochemicals
59.85 (19.95%)
All Spills
0.15 (0.05%)
100%
240
20%
14.37
100%
0.15
61.5
30.8
3.1
3.3 mg/L per year
(0.009 mg/L/d)
3.7
1.85
0.185
0.039
0.020
0.002
Emission to sewer is calculated as the emission rate (mg/year)/volume of wastewater. The
volume of wastewater used is 3900 ML which assumes 200 L per person per day released to
sewers Australia wide for a population of 19.5 million.
PEC effluent is the emission to sewer multiplied by the percentage removal from sewer. It is
assumed that 0.5 is removed in the STP due to degradation.
PEC water is the PEC effluent divided by a dilution factor for receiving waters. As the
majority of cleaning products are formulated and used in coastal areas (particularly major
metropolitan centres) a dilution rate of 10 (ocean outfall) is used.
There may be localised release to soil in the event cleaning solutions are discarded directly to this
compartment (eg, onto lawns or gardens), but this is not expected to be significant.
During application of agrochemicals direct release to soil of 80% of the import volume is expected (ie
up to 59.9 tonnes).
The nature of surfactants indicates they could associate with sludge due to hydrophobic moieties or
remain in solution due to hydrophilic moieties. Consequently, once in the sewage treatment plant, the
chemical may end up in receiving waters or associated with sludge where it could be incinerated, or in
some cases, applied to agricultural land. In the above assessment it has been conservatively assumed
that all the notified substance will end up in receiving waters.
5.5.
Disposal
During formulation, empty drums are sent to a drum recycler, while empty isotainers are returned to
the manufacturer of the notified chemical.
From end use of the cleaning products, the majority of the notified chemical will be released to sewer
and subsequently the aquatic environment. The notified chemical used in agrochemicals will
subsequently be released to the environment, generally the soil.
FULL PUBLIC REPORT: STD/1028
Page 9 of 31
22 March 2016
NICNAS
In both cases the empty containers are likely to be flushed with water, which will go to sewer, and then
disposed of in the general rubbish which will be disposed of to landfill.
5.6.
Public exposure
The notified chemical may be sold to the public in formulations of up to 20% as part of domestic
cleaning products.
Public exposure to the notified chemical (in products) as a result of transportation within Australia is
unlikely unless there is an accident. The material safety data sheets (MSDS) supplied for the notified
chemical have adequate instructions for clean-up and disposal of any accidental spills and therefore
public exposure as a result of a transport accident is likely to be negligible.
AG 6206 will be reformulated in Australia to produce formulated products. Direct public exposure as a
result of reformulation is considered to be negligible since adequate engineering controls and standard
operating procedures largely prevent any significant release of the notified chemical into the immediate
vicinity of the site of reformulation.
Since the notified chemical will be in products sold to the general public, widespread public exposure
is expected. Members of the public are likely to make accidental dermal and possibly ocular contact
with the notified chemical as a result of spills and splashes during dilution and use. During dilution of
cleaning products, members of the public are likely to be exposed to the notified chemical at
concentrations of less than 20%. During floor cleaning, members of the public are only likely to be
exposed to the notified chemical at a concentration of 0.1-2%. As a worst case, it is estimated that
floor cleaning will be conducted once per day every day of the year. Although public exposure is
expected to occur frequently, the amounts to which people will be exposed is likely to be very small
and the concentration of the notified chemical is low. At concentrations greater than 5%, products
containing the notified chemical are classified as eye irritants. It is expected that cleaning products
containing the notified chemical would carry appropriate directions to avoid contact with eyes as well
as first aid directions.
Since cleaning products are stored and used in a domestic environment, there is the possibility of
accidental ingestion by a child. The notified product is an acetal of a sugar structure, as such it is likely
to break down in acidic environments (pH < 4) to fatty acid and glucose therefore it has a low acute
oral toxicity. No adverse effects are expected as a result of ingestion of the notified chemical in the
product.
The notified chemical may be released into the environment as a result of disposal of waste from
reformulation, accidental spills during transport or disposal of diluted products and containers after
use. The environmental releases are expected to be relatively small and most of the notified chemical
released into the environment is expected to enter sewers where large dilutions are expected.
Therefore, environmental concentrations are expected to be very low and indirect public exposure as a
result of releases into the environment is expected to be negligible
6. PHYSICAL AND CHEMICAL PROPERTIES
The following test results describe the chemical and physical properties for a related alkyl glucoside. A partition
coefficient test for the notified chemical has been conducted and the results are similar to those obtained for a
related alkyl glucoside.
Appearance at 20oC and 101.3 kPa
Clear pale yellow liquid.
Melting Point/Freezing Point
-5oC
METHOD
Remarks
TEST FACILITY
Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.
Conducted on a related alkyl glucoside (84% solid, 16% water).
Huntingdon Research Centre (1993a)
Boiling Point
FULL PUBLIC REPORT: STD/1028
100oC at 101.3 kPa
Page 10 of 31
22 March 2016
Remarks
NICNAS
Reported on MSDS
Density
METHOD
Remarks
TEST FACILITY
1182.9 kg/m3 at 20oC (liquid)
Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.
Conducted on a related alkyl glucoside (84% solid, 16% water). A test report is
not available for AG 6206 however in internal testing reported on the MSDS the
density was 1170 kg/m3.
Huntingdon Research Centre (1993a)
Vapour Pressure
METHOD
Remarks
TEST FACILITY
510-8 kPa at 25oC.
Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.
The vapour pressure of the notified chemical was determined using the vapour
pressure isoteniscope method on a sample of a related alkyl glucoside (84% solid,
16% water). The vapour pressure of a known mass of the sample was determined
at various temperatures ranging from ambient to 250ºC. Extrapolation of the
resulting vapour pressure/temperature curve was used to determine the vapour
pressure of the substance at 25ºC. The value calculated suggests that the notified
chemical is very slightly volatile.
Huntingdon Research Centre (1993a)
Water Solubility
METHOD
Remarks
TEST FACILITY
79% (w/w) at 20oC
Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.
Mixtures of the test substance (a related alkyl glucoside, 84% solid, 16% water) in
distilled water were prepared at concentrations between 5 and 95% (w/w). The
resulting solutions were incubated at 30ºC for 30 min, mixed using a whirlimixer,
ultrasonicated for 15 min and then allowed to equilibrate at 20ºC for 24 h. After 24
h, solutions containing the test substance at concentrations of below 79.273%
(w/w) appeared clear and free flowing while those above this concentration were
cloudy and immobile. Therefore, the solubility of the notified chemical as
determined by visual assessment is equal to 79% (w/w).
Huntingdon Research Centre (1993a)
Hydrolysis as a Function of pH
Remarks
Saccharides such as the notified chemical are susceptible to hydrolysis under
extremes of pH. However in the environmental pH range of 4-9, significant
hydrolysis is unlikely to occur.
Partition Coefficient (n-octanol/water)
METHOD
Remarks
TEST FACILITY
log Kow at 20oC = 1.1
EC Directive 92/69/EEC A.8 Partition Coefficient. (Shake Flask Method)
The partition coefficient of the related alkyl glucoside was determined using the
shake flask method. A stock solution of the test substance (~0.3 g) in water
saturated octanol (200 mL) was prepared. To aliquots (10, 20 and 40 mL) of this
solution was added octanol saturated water (40 mL) and the resulting bi-phasic
solutions were shaken mechanically for 15 min. The phases were separated by
centrifugation at 3000 rpm for 15 min followed by analysis by HPLC to determine
the concentration of the test substance in each phase. The ratio of these equilibrium
concentrations was then used to calculate the partition coefficient. The value
obtained is indicative of partitioning into the aqueous phase.
Huntingdon Research Centre (1993a)
Partition Coefficient (n-octanol/water)
Notified Chemical
METHOD
Not determined
log Kow at 20oC = 1.72-1.77
EC Directive 92/69/EEC A.8 Partition Coefficient. (HPLC Method)
FULL PUBLIC REPORT: STD/1028
Page 11 of 31
22 March 2016
Remarks
TEST FACILITY
NICNAS
The partition coefficient of the notified chemical was determined using the HPLC
method. An aliquot of the test substance (~0.1 g) was diluted to 20 mL with 50%
aqueous methanol. In addition to this solution, standard solutions of 2-butanone,
aniline, benzyl alcohol, benzonitrile, benzene and toluene were also prepared in
methanol. A comparison of the retention time for the notified chemical against those
obtained for the standards was used to calculate the partition coefficient. The value
obtained is indicative of partitioning into the aqueous phase.
Safepharm (1998a)
Not determined.
Adsorption/Desorption
Remarks
The notified chemical is surface active and contains both hydrophobic and
hydrophilic moieties. In contact with soil such molecules strongly adsorb to the
soil particles and as such are not mobile in either terrestrial or aquatic
compartments. The notified chemical is expected to behave in a similar manner.
Not determined.
Dissociation Constant
Remarks
The notified chemical does not contain any acidic or basic groups.
Particle Size
Remarks
Not determined.
Test not conducted as the notified chemical is a liquid.
Flash Point
METHOD
Remarks
TEST FACILITY
> 110 oC
EC Directive 92/69/EEC A.9 Flash Point.
Conducted on a related alkyl glucoside (84% solid, 16% water).
Huntingdon Research Centre (1993a)
Flammability Limits
Remarks
TEST FACILITY
Not flammable
The flammability limits were not determined, as the test substance could not be
ignited with a flame under the conditions of the test. The notified chemical was not
flammable under the conditions of the test.
Conducted on a related alkyl glucoside (84% solid, 16% water).
Huntingdon Research Centre (1993a)
Autoignition Temperature
METHOD
Remarks
TEST FACILITY
92/69/EEC A.15 Auto-Ignition Temperature (Liquids and Gases).
No self ignition of the test substance was observed under the conditions of the test.
Conducted on a related alkyl glucoside (84% solid, 16% water).
Huntingdon Research Centre (1993a)
Explosive Properties
Remarks
Does not self-ignite up to a temperature of 450oC
Not determined.
Test not conducted.
Reactivity
Remarks
The notified chemical is expected to be stable under normal environmental
conditions. No test of oxidising properties was performed, as the test method is not
applicable to liquids. The notified chemical does not have any structural indications
of oxidising properties of other unusual activity.
Viscosity
Remarks
775 mPa.s
Reported on the MSDS for AG 6206
Surface Tension
FULL PUBLIC REPORT: STD/1028
30.2 mN/m for a 1% (w/v) aqueous solution at 23 oC
Page 12 of 31
22 March 2016
METHOD
Remarks
TEST FACILITY
NICNAS
OECD harmonised ring method.
The surface tension of the notified chemical was determined on a 1% (w/v)
aqueous solution of a related alkyl glucoside with a direct reading surface
tension/torsion balance using the OECD harmonised ring method. The value
indicates that the notified chemical is surface active.
Huntingdon Research Centre (1993a)
FULL PUBLIC REPORT: STD/1028
Page 13 of 31
22 March 2016
NICNAS
7. TOXICOLOGICAL INVESTIGATIONS
Most investigations were conducted with a close analogue (the same related alkyl glucoside used to test some
physico-chemical properties) as indicated in the summary table below. Certain other investigations were
conducted with AG6206 containing 75% of the notified chemical.
Endpoint and Result
Rat, acute oral LD50 > 2000 mg/kg bw
Rat, acute dermal LD50 > 2380 mg/kg bw
Rabbit, skin irritation
Rabbit, eye irritation
Guinea pig, skin sensitisation - non-adjuvant test
(Buehler).
Rat, repeat dose toxicity – 28 day oral repeat dose
Genotoxicity - bacterial reverse mutation
Genotoxicity – in vitro metaphase chromosome
analysis of human lymphocytes
7.1.
Assessment Conclusion
low toxicity (result for analogue)
low toxicity (result for analogue)
non-irritating (result for analogue)
severely irritating (results for analogue)
no evidence of sensitisation (result for AG6206)
NOAEL – 750 mg/kg/day
NOEL – 150 mg/kg/day.
(result for analogue)
non mutagenic (result for AG6206)
non genotoxic (result for AG6206)
Acute toxicity – oral
TEST SUBSTANCE
METHOD
Analogue.
EC Directive 92/69/EEC B.1 Acute Toxicity (Oral).
Species/Strain
Vehicle
Remarks – Method
Rat/CD
Distilled water
Oral gavage administration. Examinations included external appearance
and behaviour, bodyweight (day 1 prior to dosing, day 8 and day 15)
mortality and macroscopic examination on Day 15.
RESULTS
Group
Control
Exposed 1
Exposed 2
Number and Sex
of Animals
10 (5 male, 5 female)
10 (5 male, 5 female)
10 (5 male, 5 female)
LD50
Signs of Toxicity
Effects in Organs
Dose
mg/kg bw
0
2000
5000
Mortality
0
0
4 (2 male, female, all mortality
observed 5 hours after dosing).
> 2000 mg/kg bw
Pilo-erection, hunched posture, waddling, lethargy, decreased respiratory
rate, ptosis (only in 5 g/kg group), pallor of extremities, ataxia (5 g/kg
group only), prostate (only in 5 g/kg group). A bodyweight loss was
recorded for one female dosed at 2.0 g/kg on Day 8; slightly low
bodyweight gains were recorded on Day 8 for two males dosed at 2 g/kg
and one male treated at 5 g/kg; these rats achieved anticipated gains on
Day 15.
No abnormalities were recorded at the macroscopic examination on day
15. No histopathology evaluation was conducted.
CONCLUSION
The notified chemical is of low toxicity via the oral route.
TEST FACILITY
Huntingdon Research Centre (1992a).
7.2.
Acute toxicity – dermal
FULL PUBLIC REPORT: STD/1028
Page 14 of 31
22 March 2016
NICNAS
TEST SUBSTANCE
METHOD
Species/Strain
Vehicle
Type of dressing
Remarks – Method
Analogue.
EC Directive 84/449/EEC B.3 Acute Toxicity (Dermal) – Limit Test.
Rat/CD
None.
Occlusive.
One day prior to treatment hair was removed from the dorso-lumbar
region of each rat with electric clippers (approximately 10% of total body
surface), 24-hour exposure period. No control animals were included in
this study. Observations included irritation, bodyweights, clinical signs
and macroscopic examination.
RESULTS
Group
1
Number and Sex
of Animals
10 (5 males, 5 females)
LD50
Signs of Toxicity - Local
Signs of Toxicity - Systemic
Effects in Organs
Remarks – Results
Dose
mg/kg bw
2380
Mortality
0
> 2380 mg/kg bw
No signs of irritation, no clinical signs of toxicity, slight changes in
bodyweight gains (low) were recorded for 4 males and 5 females on Day
8 and for 3 of these females on Day 15.
None
None
None
CONCLUSION
A structurally similar chemical to the notified chemical is of low toxicity
via the dermal route and the notified chemical is likely to have a low
order of toxicity via the dermal route.
TEST FACILITY
Huntingdon Research Centre (1993b).
7.3.
Acute toxicity – inhalation
Data not provided.
7.4.
Irritation – skin
TEST SUBSTANCE
Analogue
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
None.
72 hours.
Semi-occlusive.
0.5 ml of test substance applied for four-hour period. Animals assessed
for clinical signs, and dermal responses.
RESULTS
Lesion
Mean Score*
Animal No.
Maximum Value
Maximum
Duration of Any
Effect
1
2
3
Erythema/Eschar
0
0
0
0
0
Oedema
0
0
0
0
0
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
FULL PUBLIC REPORT: STD/1028
Maximum Value at
End of
Observation
Period
0
0
Page 15 of 31
22 March 2016
NICNAS
Remarks – Results
No irritation observed, no clinical signs observed.
CONCLUSION
A structurally similar chemical is non-irritating to skin and thus the
notified chemical is likely to be non-irritating to skin.
TEST FACILITY
Huntingdon Research Centre (1992b).
7.5.
Irritation – eye
TEST SUBSTANCE
Analogue
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
1
RESULTS
Dulling of the cornea and neo-vascularisation was observed one hour
after instillation and was still present on day 21. Iridial inflammation
was observed one, two and three days after instillation. Conjunctival
irritation was still present on day 21 and some injection of blood vessels
to diffuse redness with or without slight to obvious swelling was
observed.
Lesion
0.1 ml was placed into the lower everted lid of one eye then eyelids held
together for one second before releasing. Clinical signs and ocular
responses were evaluated.
Mean Score*
Animal No.
Maximum
Value
Maximum
Duration of Any
Effect
Maximum Value at
End of Observation
Period
1
2
3
Conjunctiva: redness
2
2
21 days
Conjunctiva: chemosis
2
2
7 days
Conjunctiva: discharge
Corneal opacity
2
3
21 days
Iridial inflammation
1
1
3 days
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
1
0
3
0
CONCLUSION
A structurally similar chemical is severely irritating to the eye thus the
notified chemical is expected to be severely irritating to the the eye.
TEST FACILITY
Huntingdon Research Centre (1992c).
7.6.
Skin sensitisation
TEST SUBSTANCE
Notified chemical (AG6206).
METHOD
Species/Strain
OECD TG 406 Skin Sensitisation - Buehler Delayed Contact.
Guinea pig/Dunkin Hartley
Maximum Non-irritating Concentration: undiluted
Topical induction: undiluted
Topical challenge: undiluted
PRELIMINARY STUDY
MAIN STUDY
Number of Animals
Induction phase
Signs of Irritation
Test Group: 20
Induction Concentration: undiluted
None
Control Group: 10
CHALLENGE PHASE
1st challenge
2nd challenge
Remarks – Method
FULL PUBLIC REPORT: STD/1028
Topical application: undiluted
Topical application: not conducted
Topical induction, elicitation, no positive control.
Page 16 of 31
22 March 2016
NICNAS
RESULTS
No skin reactions were noted at challenge sites at any observation period
(day 1-30).
Animal
Challenge Concentration
Test Group
Control Group
Number of Animals Showing
Skin Reactions after:
1st challenge
2nd challenge
24 h
48 h
24 h
48 h
0
0
0
0
0
0
0
0
CONCLUSION
There was no evidence of reactions indicative of skin sensitisation to the
notified chemical under the conditions of the test.
TEST FACILITY
Safepharm (1998b).
7.7.
Repeat dose toxicity
TEST SUBSTANCE
Analogue.
METHOD
The method followed was that outlined in Annex V, Part B, Method B7
in the EEC Directive 84/449/EEC and OECD Guidelines for Testing of
Chemicals No. 407, “Repeated Dose Oral Toxicity – Rodent: 28-day or
14 – day study”.
Rat / Sprague-Dawley
Oral – gavage.
Species/Strain
Route of Administration
Exposure Information
Total exposure days: 28 days;
Dose regimen: 7 days per week;
Post-exposure observation period: - All animals were killed and
examined macroscopically on day 29.
Distilled water.
No significant protocol deviations.
Vehicle
Remarks – Method
RESULTS
Group
I (control)
II (low dose)
III (mid dose)
IV (high dose)
V (control recovery)
VI (high dose recovery)
Number and Sex
of Animals
5 male, 5 female
5 male, 5 female
5 male, 5 female
5 male, 5 female
Dose
mg/kg bw/day
0 (distilled water)
15 mg/kg/day
150 mg/kg/day
750 mg/kg/day
Mortality
0
0
0
0
Mortality and Time to Death
No mortality was observed during treatment period.
Clinical Observations
Three female rats receiving 750 mg/kg/day had a thin looking appearance throughout week 3. Overall
bodyweight gain was lower than control for females receiving 750 mg/kg/day. Slightly lower than control
food consumption was recorded for females receiving 750 mg/kg/day.
Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis
Differences from control seen in haematology, biochemistry, macroscopic and microscopic pathology were
not considered to be treatment related.
Effects in Organs
FULL PUBLIC REPORT: STD/1028
Page 17 of 31
22 March 2016
NICNAS
Higher than control liver weight (bodyweight adjusted) was recorded for males treated at 750 mg/kg/day, but
this finding was not associated with histopathological or biochemical change.
Remarks – Results
In this sub-acute rat toxicity study with the analogue, lower food consumption and hence bodyweight gains for
female rats from the high dosage group was thought to be treatment related. Some of these female rats were
reported as being clinically thin during week 3. However the final bodyweight of the rats was comparable to
that of controls and the rats were otherwise healthy.
Higher than control liver weights were recorded for the high dosage male group. Although this finding may
possibly be adaptive in nature it was not considered to be of toxicological importance in view of the absence of
histopathological or biochemical changes.
Considering the above findings 750 mg/kg/day was rejected as a no effect level (NOEL) for the notified
chemical in the rat, but was considered to represent the no adverse effect level (NOAEL).
No effects considered to be related to treatment were seen in rats treated at 150 or 15 mg/kg/day.
CONCLUSION
The No Observed (Adverse) Effect Level (NO(A)EL) was established as 750 mg/kg bw/day in this study, based
on there being no treatment related toxic effects observed in rats treated with the highest dose.
TEST FACILITY
7.8.
Huntingdon (1994).
Genotoxicity – bacteria
TEST SUBSTANCE
Notified chemical (AG6206).
METHOD
Species/Strain
OECD TG 471 Bacterial Reverse Mutation Test.
S. typhimurium:
TA1535, TA1537, TA98, TA100.
E. coli: WP2 uvrA,
S9
a) With metabolic activation:
0 - 5000 g/plate.
b) Without metabolic activation: 0 - 5000 g/plate.
None
Amber viscous liquid.
Positive and negative controls were utilised appropriately.
cytotoxicity was observed at 5000 g/plate in preliminary test.
Metabolic Activation System
Concentration Range in
Main Test
Vehicle
Physical Form
Remarks – Method
No
RESULTS
Metabolic
Activation
Present
Test 1
Test 2
Absent
Test 1
Test 2
Test Substance Concentration (µg/plate) Resulting in:
Cytotoxicity in
Cytotoxicity in
Precipitation
Genotoxic Effect
PreliminaryTest
Main Test
None
None
None
None
None
Negative
Negative
None
None
None
None
None
Negative
Negative
Remarks – Results
CONCLUSION
FULL PUBLIC REPORT: STD/1028
No toxicity was exhibited to any of the strains of bacteria used. No
significant increases in the frequency of revertant colonies were recorded
for any of the strains of bacteria, at any dose level either with or without
metabolic activation.
The notified chemical was not mutagenic to bacteria under the conditions
of the test.
Page 18 of 31
22 March 2016
NICNAS
TEST FACILITY
7.9.
Huntingdon Research Centre (1998c).
Genotoxicity – in vitro
TEST SUBSTANCE
Analogue
METHOD
Cell Type/Cell Line
Metabolic Activation
System
Vehicle
Physical Form
OECD TG 473 In vitro Mammalian Chromosomal Aberration Test.
Human lymphocytes.
S9
None
Liquid
Metabolic
Test Substance Concentration (μg/mL)
Activation
Present
Test 1
625, 2500, 5000
Test 2
312.5, 1250, 2500
Absent
Test 1
156.3, 625, 1250
Test 2
131.3, 525, 1050
*Cultures selected for metaphase analysis.
Exposure
Period
Harvest
Time
18 hours
32 hours
18 hours
32 hours
18 hours
32 hours
18 hours
32 hours
RESULTS
Metabolic
Activation
Test Substance Concentration (µg/mL) Resulting in:
Cytotoxicity in
Cytotoxicity in
Precipitation
Genotoxic Effect
PreliminaryTest
Main Test
Present
Test 1
Test 2
Absent
Test 1
Test 2
Remarks – Results
5000
-
-
Negative
Negative
1250
525
-
Negative
Negative
No evidence of clastogenic activity in human lymphocytes cultured in
vitro.
CONCLUSION
The notified chemical was not clastogenic to human lymphocytes treated
in vitro under the conditions of the test.
TEST FACILITY
Huntingdon Research Centre (1993b).
FULL PUBLIC REPORT: STD/1028
Page 19 of 31
22 March 2016
NICNAS
8. ENVIRONMENT
8.1.
Environmental fate
8.1.1.
Ready biodegradability
8.1.1.1. Test 1
TEST SUBSTANCE
AG 6206
METHOD
Inoculum
Exposure Period
Auxiliary Solvent
Analytical Monitoring
Remarks – Method
OECD TG 301 D Ready Biodegradability: Closed Bottle Test.
Secondary activated sludge
28 day
Deionising water
Electrochemistry, pH.
Sodium acetate was used as a reference substance.
RESULTS
Day
0
7
14
21
28
Test substance
% degradation
Remarks – Results
50
63
71
71
Day
0
7
14
21
28
Sodium acetate
% degradation
0
80
85
The reference substance met all requirements, thus indicating the study
was valid. The test substance was 71% biodegraded at day 28 in the
Closed Bottle test. However, according to Guideline 301D, the substance
cannot be considered to be readily biodegradable as from the graph it
appears to have failed to satisfy the 10 day window criterion whereby
60% degradation must be attained within 10 days of the degradation
exceeding 10%. However, a literature report (Garcia, 1997) confirms the
ready biodegradability of alkylglucosides in both the OECD closed bottle
and modified screening tests.
CONCLUSION
The notified chemical is not ready biodegradable but can be considered
to be inherently biodegradable.
TEST FACILITY
Akzo Nobel Central Research Arnhem (1997).
8.1.1.2. Test 2
TEST SUBSTANCE
AG 6206
METHOD
Inoculum
Exposure Period
Auxiliary Solvent
Analytical Monitoring
Remarks – Method
OECD TG 301 D Ready Biodegradability: Closed Bottle Test.
Secondary activated sludge
28 day
Deionising water
Electrochemistry, pH.
The test method was modified to allow for increased measurements to
better test for the 10-day window criterion. Sodium acetate was used as a
reference substance.
RESULTS
FULL PUBLIC REPORT: STD/1028
Page 20 of 31
22 March 2016
Day
0
3
7
10
14
17
21
24
28
NICNAS
Test substance
% degradation
0
4
42
42
67
71
67
71
71
Remarks – Results
Sodium acetate
% degradation
0
61
70
-
Day
0
3
7
10
14
17
21
24
28
The test conditions (pH and temperature) remained within appropriate
ranges. The reference substance met all requirements, thus indicating the
study was valid. The test substance was 71% biodegraded at day 28 in
the Closed Bottle test and satisfied the 10-day window criterion whereby
60% degradation must be attained within 10 days of the degradation
exceeding 10% (64% was achieved).
CONCLUSION
The notified chemical is ready biodegradable.
TEST FACILITY
Akzo Nobel Central Research Arnhem (2004).
8.1.1.3 Test 3
TEST SUBSTANCE
AG 6206
METHOD
Inoculum
Exposure Period
Auxiliary Solvent
Analytical Monitoring
Remarks – Method
Biodegradability in Seawater test OECD 306
Nutirient fortified seawater
28 day
Sea water
O2 Electrode
A predetermined amount of the test compound is dissolved in test
medium (nutrient-fortified sea water) to give a test concentration of 2-10
mg/L. Solutions are incubated in filled closed bottles in the dark at 20 C.
Biodegradation is followed by oxygen analyses over a 28 day period.
Sodium benzoate was used as a reference substance.
RESULTS
Day
0
5
15
28
Test substance
% degradation
0
63.5
70
66.9
Remarks – Results
Day
0
5
15
28
Sodium Benzoate
% degradation
0
62.9
74
69.8
With in 3-7 days the biodegradation of the reference substance (sodium
benzoate) had exceeded 50%, so the study was valid.
Biodegradation of the test substance reached 70% on day 15 and by day
28 it was 66.9%.
CONCLUSION
The notified chemical is readily biodegradable in seawater after 28 days.
TEST FACILITY
TERRA Environment Norway (1998).
FULL PUBLIC REPORT: STD/1028
Page 21 of 31
22 March 2016
8.1.2.
8.2.
NICNAS
Bioaccumulation
No study available. It is unlikely to bioaccumulate as it is unlikely to partition to fat given the
log Pow of 1.7 and is inherently biodegradable.
Ecotoxicological investigations
The following ecotoxity data were provided by the notifier.
8.2.1.
Acute toxicity to fish
TEST SUBSTANCE
AG 6206 (75% notified chemical)
METHOD
OECD TG 203 Fish, Acute Toxicity Test – Rainbow trout, semistatic
conditions.
Rainbow trout Oncorhynchus mykiss
96 hour
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks – Method
100 mg CaCO3/L
None
Actual concentrations not measured, daily renewal of test water, fish were
not fed during exposure. Observations on abnormal behaviour and
mortality were conducted at 3 and 6 hours and then at 24 hours intervals
until the end of the study. Water temperature was 14 oC, the DOC was 9.4
mg/L or greater and a 16 hours light and 8 hours dark luminescence cycle
was maintained.
RESULTS
Concentration mg/L
Nominal(ai)
Actual
180
320
560
1000
1800
LC50
NOEC
Remarks – Results
Number of Fish
10
10
10
10
10
3h
0
0
0
0
0
Mortality
48 h 72 h
0
0
0
0
10
10
10
10
10
10
96 h
0
0
10
10
10
420 mg/L at 96 hours (95% C.I. 320-560 mg/L) (notified chemical).
180 mg/L at 96 hours.
The LC50 was determined by the Thompson’s (1947) moving averages
method.
CONCLUSION
The notified chemical is slightly toxic to fish
TEST FACILITY
Safepharm (1998d)
8.2.2.
24 h
0
0
0
0
10
Acute toxicity to aquatic invertebrates
TEST SUBSTANCE
AG 6206 (75% notified chemical)
METHOD
OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction
test, static test conditions.
Daphnia magna
48 hours
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks – Method
FULL PUBLIC REPORT: STD/1028
250 mg CaCO3/L
Nominal
2 replicates of 10 daphnids were exposed to an aqueous dispersion of the
Page 22 of 31
22 March 2016
NICNAS
test material at nominal concentrations of 18, 32, 56, 100, 180, 320, 560,
1000 and 1800 mg/l for 48 hours under static test conditions. The test
was conducted under static conditions with a photoperiod of 16 hours
light and 8 hours dark and at a temperature of 21 oC. The daphnia were
not fed during the study. The concentration of the test substance in each
test solutions was not determined.
RESULTS
Concentration mg/L
Nominal(ai)
Actual
18
32
56
100
180
320
560
1000
1800
LC50
NOEC
Remarks – Results
Number of D. magna
% Immobilised
24 h
48 h
10
0
0
10
0
0
10
0
0
10
0
0
10
0
0
10
0
15
10
0
65
10
0
95
10
0
100
490 mg/L at 48 hours (95% C.I. 420-580 mg/L) (notified chemical).
180 mg/L at 48 hours
The results are based on nominal concentrations. The LC50 was
determined by the Thompson’s (1947) moving averages method.
CONCLUSION
The notified chemical is very slightly toxic to Daphnia magna.
TEST FACILITY
Safepharm (1998e).
8.2.3.
Algal growth inhibition test
TEST SUBSTANCE
AG 6206 (75% notified chemical).
METHOD
OECD TG 201 Alga, Growth Inhibition Test
Species
Exposure Period
Concentration Range
Nominal
Remarks – Method
Scenedesmus subspicatus
72 hours
62.5, 125, 250, 500 and 1000 mg ai/L (three replicate flasks per
concentration)
The nominal cell density in the test vessels was 104 cells/mL. The vessels
were covered, incubated at 24 oC, continuously illuminated and shaken at
100 rpm for 72 hours.
Biomass
Growth
NOEC
EbC50
mg/L at 72 h
180
ErC50
mg/L at 72 h
780
mg/L at 72 h
Not determined
CONCLUSION
The notified chemical is very slightly toxic to algae.
TEST FACILITY
Safepharm (1998f).
FULL PUBLIC REPORT: STD/1028
Page 23 of 31
22 March 2016
8.2.4
NICNAS
Assessment of Inhibition of Nitrification of Activated Sewage Sludge
TEST SUBSTANCE
AG 6206 (75% notified chemical)
METHOD
ISO Guidelines No 9509 Method for Assessing the Inhibition of
Nitrification of Activated Sewage Sludge
Allylthioureas was used as a reference substance.
Remarks – Method
An aliquot of either the test or reference substance was laced in a 500 mL
conical flask. 1225 mL of deionised water was then added to the flask
followed by 125 mL of washed activated sewage sludge. The mixtures
were aerated at 0.5-1 L/min, and the flasks were maintained at a
temperature of 21oC under normal laboratory lighting. After 4 hours
contact the contents of each flask was filtered after which ammonium,
nitrite and nitrate analysis was done.
RESULTS
4 hour EC50 > 1000 mg ai/L
NOEC  1000 mg/L
CONCLUSION
The notified chemical has not significant effect on the nitrifying activity
of activated sewage sludge.
TEST FACILITY
Safepharm (1998g).
FULL PUBLIC REPORT: STD/1028
Page 24 of 31
22 March 2016
NICNAS
9. RISK ASSESSMENT
9.1.
9.1.1.
Environment
Environment – exposure assessment
Release
The notified chemical will eventually be released into the environment with approximately 80%
being discharged into sewerage systems and approximately 20% being released through washing
agricultural use. A small amount may go to landfill in disposed end-user containers.
Fate
Cleaning applications:
Assuming that 80% of the importation volume is used and that all cleaning operations occur
throughout the year and are conducted nationwide, the worst case predicted environmental
concentration is:
Amount released to sewer
Water used per person
Australian population
Number of days used
Concentration in the STPs effluent
240 tonnes
200 L
19.5 million
365 days
2.4 × 1011/(200)(19.5 × 106)(365) = 0.17 mg/L
For that proportion of the chemical which reaches sewage treatment plants (ie is not volatilised
or otherwise destroyed during passage to the plant), the proportions of the chemical which
partition into the different environmental compartments may be estimated using the Simple
Treat Model (EEC Technical Guidance Document, 1996). These estimates, based on the
chemical having a calculated Henry’s constant of 2.2785 × 10-8 Pa/m3/mole based on measured
vapour pressure and water solubility, a Log Pow of 1.7 and exceeding 60% biodegradation level
within 28 days, indicate that the chemical would be expected to partition into the air, water and
sewer sludge compartments and the amount degraded as follows:
Air
Water
Sewage Sludge
Degraded
0%
33%
0%
67%
Accordingly, at equilibrium most of the notified chemical will degrade and the remainder will
reside in the aqueous compartment where the modified PEC is 0.056 mg/L.
This release is expected to be relatively diffuse and widespread. There may also be localised
release to soil in the event cleaning solutions are discarded directly to this compartment (eg,
onto lawns or gardens) from wall cleaning or the disposal to landfill of rags used to clean ovens.
While this is not expected to be significant, release of the notified chemical via these uses will
serve to further reduce the value of the PEC calculated above.
The nature of surfactants indicates they could associate with sludge due to hydrophobic
moieties or remain in solution due to hydrophilic moieties. Consequently, once in the sewage
treatment plant, the chemical may end up in receiving waters or associated with sludge where it
could be incinerated, or in some cases, applied to agricultural land. In the above assessment it
has been conservatively assumed that all the notified substance will end up in receiving waters.
Any residual notified chemical disposed of into landfill in empty end-user containers may be
mobile, due to its water solubility, but is expected to be slowly adsorbed to soil/sediment
particles and be degrade due to biotic and abiotic processes.
Agricultural applications:
During application of agrochemicals direct release to soil of 20% (up to 60 tonnes) of the
import volume is expected. Assuming a maximum level of 20% in a concentrate formulation,
which is applied at a usage rate of 5 L per hectare, the application rate for the notified chemical
is 1 L per hectare or 1170 gram per hectare of notified substance (specific gravity 1.17). In soil,
assuming that the applied preparation is distributed in the top 10 cm over one hectare, the EEC
would be 1170 g in 1,300,000 kg of soil would be 0.9 mg/kg of soil. In soil the notified
chemical will degrade due to biotic and abiotic processes.
FULL PUBLIC REPORT: STD/1028
Page 25 of 31
22 March 2016
NICNAS
Due to its low partition coefficient (1.1) the notified chemical is not expected to bioaccumulate.
9.1.2.
Environment – effects assessment
The results of the ecotoxicological data indicate the notified chemical is slightly toxic to fish and
only very slightly toxic to Daphnia and algae, and not toxic to activated sewage sludge
microorganisms. The most sensitive species is algae where the EbC50 is 180 mg/L.
A predicted no effect concentration (PNEC) can be determined when at least one acute EC50 for
each of the three trophic levels is available (ie. fish, Daphnia, algae). The PNEC is calculated by
dividing the LC50 or EC50 value of the most sensitive species in this case by an assessment safety
factor of either 100 (OECD) or 1000 (EU). Using a worst case scenario safety factor of 100,
since results for fish, daphnia and algae are available, the PNEC for the notifier polymer is 1.8
mg/L.
Under the OECD GHS characterisation scheme, the notified chemical should be not considered
as ‘Harmful to Aquatic Life’.
9.1.3.
Environment – risk characterisation
Due to the proposed use pattern the notified chemical will be released into the environment,
either the aquatic or the terrestrial. With its high water solubility, the notified chemical will be
mobile in both aquatic and terrestrial compartment. However as a consequence of its surfactant
characteristic, it is expected to eventually associate with soil and sediment. It is readily
biodegradable, so will degrade through biological and abiotic processes to water and oxides of
carbon.
The worst case PEC/PNEC ratio for the aquatic environment, assuming nationwide use, is 0.1.
This value is significantly less than 1, indicating no immediate concern to the aquatic
compartment.
Based on the indicated use patterns and its dispersed release, the likely risk to the environment
is expected to be low.
9.2.
9.2.1.
Human health
Occupational health and safety – exposure assessment
Transport and storage workers are unlikely to be exposed unless containers are ruptured in an
accident.
Process workers involved in producing cleaning products will use largely closed systems for
introducing the imported concentrated solution into mixing vessels and filling the final products
into containers. Some drips and spills can be expected and the notifier indicates that protective
clothing, gloves and safety goggles will be worn. Exhaust ventilation is used to control exposure
to aerosols and vapours. Quality control technicians perform tests on small amounts of product
in fume cupboards and wear the same PPE as the process workers.
End users will typically be exposed to the notified chemical at a maximum concentration of 20%
but the concentrate may be diluted further for use. If used neat there is potential for direct eye
contact or transmission from the hands.
End users of agricultural chemicals containing the notified chemical at a maximum of 8% will
dilute it further prior to spraying. The notifier indicates that protective clothing, gloves and
safety goggles will be employed to control exposure.
9.2.2.
Public health – exposure assessment
The public will be using cleaning products containing up to 20% notified chemical. Duration of
exposure to the concentrate should be approximately 10 minutes/day at most while it is diluted
for use. Exposure of skin and secondary transmission from hand to eye is possible at this time.
Once the notified chemical is diluted for use, it is at 0.1 – 2% and more extensive skin contact is
likely. The likelihood of transmission from hand to eye is also increased.
Since the cleaning products are stored in a domestic environment, accidental ingestion
(particularly by children) is possible.
FULL PUBLIC REPORT: STD/1028
Page 26 of 31
22 March 2016
NICNAS
The notified chemical may be released to the environment from disposal of waste, accidental
transport spills or disposal of emptied containers and diluted product after use. However,
indirect exposure to the public is expected to be very low either because of limited access to
landfill or to accident sites or to large dilution in the environment.
9.2.3.
Human health - effects assessment
Given the results of toxicity studies on a close analogue as well as the chemical itself, the
notified chemical is likely to be of low toxicity via the oral and dermal routes, is not a skin
irritant or a skin sensitiser, is not likely to exhibit systemic effects on repeated or prolonged
exposure and is not likely to be genotoxic. However, the notified chemical is a severe eye
irritant.
The notified chemical would be classified as a hazardous substance according to the NOHSC
Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999) and is assigned the
risk phrase R41: risk of serious eye damage.
9.2.4.
Occupational health and safety – risk characterisation
The primary hazard of the notified chemical is severe eye irritation. The imported formulation
and the 20% concentrate produced for industrial and agricultural use are also severe eye
irritants. Therefore, there is a risk of serious eye damage from splashes or from secondary
transfer to eyes from hands or gloves and eye protection is required to minimise this risk
particularly when the concentrate is used undiluted.
9.2.5.
Public health – risk characterisation
There is a risk of serious eye damage during dilution of cleaning products for use although this
is expected to occur infrequently (10 minutes/day). Nevertheless, given the consequences of eye
contact, eye protection should be employed.
The risk of adverse health effects is expected to be low from use of the diluted chemical in
domestic situations or from accidental ingestion as the notified chemical is not expected to be an
eye irritant in the diluted form and is not harmful if ingested. However, scenarios of accidental
ingestion by children may involve spillage of product with the potential for ocular contact.
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS
10.1. Hazard classification
Based on the available data the notified chemical is classified as hazardous under the NOHSC
Approved Criteria for Classifying Hazardous Substances. The classification and labelling details
are:
R41: Risk of serious eye damage.
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 patterns.
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 provided eye protection is employed when working with
concentrates.
10.3.2. Public health
There is Low Concern to public health when used as described provided eye protection is worn
FULL PUBLIC REPORT: STD/1028
Page 27 of 31
22 March 2016
NICNAS
while the concentrated solution is diluted or if it is used neat.
11.
MATERIAL SAFETY DATA SHEET
11.1. Material Safety Data Sheet
The MSDS of a 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, 1994a). 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 a 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, 1994b). The accuracy of the information on the label remains the
responsibility of the applicant.
12.
RECOMMENDATIONS
REGULATORY CONTROLS
Hazard Classification and Labelling

The NOHSC Chemicals Standards Sub-committee should consider the following health
hazard classification for the notified chemical:
 R41: Risk of serious eye damage

Use the following risk phrases for products/mixtures containing the notified chemical:
 > 10% : R41: Risk of serious eye damage
 5 – 10%: R36 Irritating to eyes

Products containing more than 10% notified chemical and available to the public must
carry the following safety directions on the label:
 Risk phrases:
R41, Risk of serious eye damage
 Safety phrases: S26, In case of contact with eyes, rinse immediately with plenty
of water and seek medical advice
S39, Wear eye/face protection

The National Drugs and Poisons Standing Committee (NDPSC) should consider the
notified chemical for listing on the SUSDP.
–
Warning Statements:
5: Irritant
79: Will irritate eyes
–
Safety Directions:
1: Avoid contact with eyes
3: Wear eye protection when mixing or using
6: Wash hands after use
–
First Aid: If in eyes, hold eyes open, flood with water for at least 15 minutes and
see a doctor.
CONTROL MEASURES
Occupational Health and Safety

Employers should ensure that the following personal protective equipment is used by
workers to minimise occupational exposure to the notified chemical as introduced, as
diluted for use or in products:
–
Protective clothing and footwear, impervious gloves and safety glasses or face
FULL PUBLIC REPORT: STD/1028
Page 28 of 31
22 March 2016
NICNAS
shield.

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.
Environment

The following control measures should be implemented by the manufacture to minimise
environmental exposure during use of the notified chemical:
 Clear labelling indicating dilutions and potential hazards if not diluted.
Disposal

The pure notified chemical should be disposed of by landfill or by incineration.
Preparations (products) containing the notified chemical, which are not going to be sold
or used, should be disposed of to landfill or by incineration. At no time should they be
applied directly to water or land.
Emergency procedures

Spills/release of the notified chemical should be handled by containment and the
application of an absorbant (eg sand or straw).
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:
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(2) of the Act:
 if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
13.
BIBLIOGRAPHY
Akzo Nobel Central Research (1997) Biodegradability of AG6206 in the Closed Bottle Test. Project No. RGL
F97098 T97006 C. Akzo Nobel Central Research, Arnhem, The Netherlands (unpublished report submitted by
the notifier).
Akzo Nobel Central Research (2004) Biodegradability of AG6206 in the Closed Bottle Test. Project No. CER
F04007 T03023 C. Akzo Nobel Central Research, Arnhem, The Netherlands (unpublished report submitted by
the notifier).
Balzer D (1997) “Alkyl polyglucosides” In Specialist Surfactants Chapter 7. Ed. Robb I D. Blackie Academic
and Professional, Chapman and Hall, UK.
FULL PUBLIC REPORT: STD/1028
Page 29 of 31
22 March 2016
NICNAS
European Commission (1996) Technical Guidance Document in Support of Commission Directive 93/67/EEC
on Risk Assessment for New Notified Substances and Commission Regulation (EC) No 1488/94 on Risk
Assessment for Existing Substances – Part III.
Garcia MT, Ribosa I, Campos E, Sanchez Leal J (1997) Ecological Properties of Alkylglucosides,
Chemosphere, 35, 545.
Huntingdon Research Centre (1992a) Acute Oral Toxicity to the Rat. Project No. 911021D/KND 54/AC.
Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).
Huntingdon Research Centre (1992b) Skin Irritation to the Rabbit. Project No. 920058D/KND 55/SE.
Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).
Huntingdon Research Centre (1992c) Eye Irritation to the Rabbit. Project No. 920059D/KND 56/SE.
Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).
Huntingdon Research Centre (1993a) Physico-chemical properties. Project No. KND76/931443. Huntingdon
Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).
Huntingdon Research Centre (1993b) Acute Dermal Toxicity to the Rat. Project No. KND 73/930839/AC.
Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).
Huntingdon Research Centre (1993c) Metaphase Chromosome Analysis of Human Lymphocytes Cultured in
vitro. Project No. KND 72/931182. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished
report submitted by the notifier).
Huntingdon Research Centre (1994) Twenty Eight Day Oral Toxicity Study in the Rat. Project No. KND
69/931043. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the
notifier).
National Occupational Health and Safety Commission (1994a) National Code of Practice for the Preparation of
Material Safety Data Sheets [NOHSC:2011(1994)]. Australian Government Publishing Service, Canberra.
National Occupational Health and Safety Commission (1994b) National Code of Practice for the Labelling of
Workplace Substances [NOHSC:2012(1994)]. Australian Government Publishing Service, Canberra.
NOHSC (1999) National Occupational Health and Safety Commission (1999): Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(1999)]. Australian Government Publishing Service,
Canberra.
Safepharm (1998a) AG 6206: Determination of Partition Coefficient. SPL Project Number 142/345. Safepharm
Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).
Safepharm (1998b) AG 6206: Buehler Delayed Contact Hypersensitivity Study in the Guinea Pig. SPL Project
Number 142/337. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).
Safepharm (1998c) AG 6206: Reverse Mutation Assay “Ames Test” Using Salmonella typhimurium and
Escherichia coli. SPL Project Number 142/338. Safepharm Laboratories Limited, Derby, UK (unpublished
report submitted by the notifier).
Safepharm (1998d) AG 6206: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss). SPL Project Number
142/325. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).
Safepharm (1998e) AG 6206: Acute Toxicity to Daphnia magna. SPL Project Number 142/326. Safepharm
Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).
Safepharm (1998f) AG 6206: Algal Inhibition Test. SPL Project Number 142/327. Safepharm Laboratories
Limited, Derby, UK (unpublished report submitted by the notifier).
FULL PUBLIC REPORT: STD/1028
Page 30 of 31
22 March 2016
NICNAS
Safepharm (1998g) AG 6206: Assessment of Inhibition of Nitrification of Activated Sewage Sludge. SPL
Project Number 142/328. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the
notifier).
Terra Environment (1998) Assessment of Aerobic Biodegradability in Seawater of AG6206. Test Ref No.
60431.Akn/1216/biodeg. Terra Environment, Bergen, Norway (unpublished report submitted by the notifier).
FULL PUBLIC REPORT: STD/1028
Page 31 of 31