Full Public Report format
File No: SN/17
May 2007
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Arachidyl Glucoside
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 Water Resources.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by
appointment only at 334-336 Illawarra Road, Marrickville NSW 2204.
This Full Public Report is also 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
NICNAS
TABLE OF CONTENTS
FULL PUBLIC REPORT....................................................................................................................................... 4
1. APPLICANT AND NOTIFICATION DETAILS ................................................................................... 4
2. IDENTITY OF CHEMICAL ................................................................................................................... 5
3. COMPOSITION ...................................................................................................................................... 6
4. INTRODUCTION AND USE INFORMATION..................................................................................... 7
5. PROCESS AND RELEASE INFORMATION ....................................................................................... 7
5.1. Distribution, transport and storage ................................................................................................. 7
5.2. Operation description...................................................................................................................... 8
5.3. Occupational exposure.................................................................................................................... 8
5.4. Release............................................................................................................................................ 9
5.5. Disposal .......................................................................................................................................... 9
5.6. Public exposure............................................................................................................................. 10
6. PHYSICAL AND CHEMICAL PROPERTIES .................................................................................... 10
7. TOXICOLOGICAL INVESTIGATIONS ............................................................................................. 12
7.1. Acute toxicity ?oral ..................................................................................................................... 12
7.2.1. Acute toxicity ?dermal................................................................................................................. 13
7.2.2. Acute toxicity ?dermal................................................................................................................. 13
7.3. Acute toxicity ?inhalation............................................................................................................ 13
7.4.1 Irritation ?skin ............................................................................................................................. 13
7.4.2. Irritation ?skin ............................................................................................................................. 14
7.4.3. Skin irritation ?human patch test ..................................................................................................... 15
7.5.1 Irritation ?eye .............................................................................................................................. 15
7.5.2 Eye irritation - Hen's egg test ....................................................................................................... 16
7.5.3 Eye irritation - Red blood cell test ................................................................................................ 17
7.6.1 Skin sensitisation - Guinea pig ?Magnusson and Kligman test................................................... 18
7.6.2. Skin sensitisation - Guinea pig ?Magnusson and Kligman test................................................... 18
7.6.3. Skin sensitisation - Human repeat patch test ................................................................................ 19
7.7. Repeat dose toxicity...................................................................................................................... 20
7.8. Genotoxicity ?bacteria................................................................................................................. 21
7.9.1. Genotoxicity ?in vitro.................................................................................................................. 21
7.10. Genotoxicity ?in vitro.................................................................................................................. 22
7.11. Comedogenicity ?human repeated use study............................................................................... 22
8. ENVIRONMENT .................................................................................................................................. 23
8.1. Environmental fate........................................................................................................................ 23
8.1.1. Ready biodegradability ............................................................................................................ 23
8.1.2. Bioaccumulation ...................................................................................................................... 23
8.2. Ecotoxicological investigations .................................................................................................... 24
9. RISK ASSESSMENT ............................................................................................................................ 25
9.1. Environment ................................................................................................................................. 25
9.1.1. Environment ?exposure assessment........................................................................................ 25
9.1.2. Environment ?effects assessment ........................................................................................... 26
9.1.3. Environment ?risk characterisation ........................................................................................ 26
9.2. Human health................................................................................................................................ 26
9.2.1. Occupational health and safety ?exposure assessment ........................................................... 26
9.2.2. Public health ?exposure assessment ....................................................................................... 27
9.2.3. Human health ?effects assessment.......................................................................................... 27
9.2.4. Occupational health and safety ?risk characterisation ............................................................ 28
9.2.5. Public health ?risk characterisation ........................................................................................ 28
10. CONCLUSIONS ?ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS ........................................................................................................................................................ 29
10.1. Hazard classification..................................................................................................................... 29
10.2. Environmental risk assessment..................................................................................................... 29
10.3. Human health risk assessment ...................................................................................................... 29
10.3.1. Occupational health and safety ........................................................................................... 29
10.3.2. Public health........................................................................................................................ 29
11. MATERIAL SAFETY DATA SHEET............................................................................................. 29
11.1. Material Safety Data Sheet ........................................................................................................... 29
Created on 8/05/2007 2:49 PM Last Saved 8/05/2007 2:49 PM
11.2. Label ............................................................................................................................................. 29
12. RECOMMENDATIONS .................................................................................................................. 29
12.1. Secondary notification .................................................................................................................. 30
13. BIBLIOGRAPHY ............................................................................................................................. 30
May 2007 NICNAS
FULL PUBLIC REPORT
Arachidyl Glucoside
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Johnson & Johnson Pacific Pty Ltd (ABN 73 001 121 446)
Level 3
1 Bay Street
Broadway NSW 2007
Assessment of the notified chemical was carried out under the Industrial Chemicals (Notification and
Assessment) Act 1989 (the IC(NA) Act), as LTD/1183, with the Summary Report of the assessment
published in the Chemical Gazette of 1 March 2005.
In August 2006, the Director of NICNAS was informed of changes to the import volume by Johnson
and Johnson only. Under the IC(NA) Act, the Director declared that a secondary notification was
required for the chemical known as Arachidyl Glucoside.
In accordance with Section 65 of the IC(NA) Act, a notice requiring the secondary notification of
Arachidyl Glucoside. was published in the Chemical Gazette. The notice of 6 March 2007 stipulated
the following data were required to undertake further assessment of Arachidyl Glucoside.
Part C Toxicity
Human Health
(a) the chemical's toxic effects after a single oral administration;
(b) the chemical's toxic effects after a single dermal exposure;
(d) the extent of dermal irritation caused by the chemical
(e) the extent of eye irritation caused by the chemical;
(g) the toxic effects of the chemical on administration for a period of 10 to 14 days;
(k) any production by the chemical of chromosome damage in mammalian cells grown in vitro
Any additional data available on toxicological and/or ecotoxicological effects of the chemical.
This report, SN/17, represents the revised assessment for Arachidyl Glucoside. This report also
contains information from the original assessment for the other joint notifier (Originally Orica now
Bronson and Jacobs) who is not an applicant for this secondary notification. New information
submitted by the applicant (Johnson and Johnson Pacific Pty Ltd) and considered in this secondary
notification assessment are located in this report at Sections:
4. Import volume
7.1 Acute toxicity - oral
7.2.1. Acute toxicity - dermal
7.2.2 Acute toxicity - dermal
7.4.1. Irritation - skin
7.4.2. Irritation - skin
7.5.1. Irritation - eye
7.7 Repeat dose toxicity
7.9.1 Genotoxicity ?In vitro
7.9.2 Genotoxicity ?In vitro
As a result of the new information the following changes have been made to Sections:
FULL PUBLIC REPORT: SN/17 Page 4 of 31
May 2007 NICNAS
5.4 Release
5.5 Disposal
9.1.1. Environment ?exposure assessment
9.1.2. Environment ?effects assessment
9.1.3. Environment ?risk characterisation
9.2.1. Occupational health and safety ?exposure assessment
9.2.2 9.2.2. Public health ?exposure assessment
9.2.3. Human health ?effects assessment
9.2.4. Occupational health and safety ?risk characterisation
This information completes the notification requirements for the standard category.
NOTIFICATION CATEGORY
Secondary Notification.
The information provided fulfils the data requirements for a standard notification. Certain data
requirements may have been waived (see below).
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
Data items and details claimed exempt from publication:
Detailed Composition
Detailed Non-Hazardous Impurities
Exact percentage of notified chemical in Montanov 202 and in finished products
Names of finished products
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
Variation to the schedule of data requirements is claimed as follows:
Vapour pressure
Water solubility
Hydrolysis as a function of pH
Dissociation constant
Particle size
Flammability
Autoignition
Acute dermal toxicity
Acute inhalation
Repeat dose toxicity
In vitro genotoxicity
Ready biodegradability
Acute toxicity to fish
Acute/chronic toxicity to aquatic invertebrates
Algal growth inhibition test
Inhibition of microbial activity
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
Assessment of the notified chemical was carried out under the Industrial Chemicals (Notification and
Assessment) Act 1989 (the IC(NA) Act), as LTD/1183, with the Summary Report of the assessment
published in the Chemical Gazette of 1 March 2005.
NOTIFICATION IN OTHER COUNTRIES
Montanov 202, the commercial mixture to be imported, containing <20% notified chemical, is
authorised as a quasi drug for use in Japan by Ministry of Health and Welfare n8
20900CZY00013000.
EINECS number for the notified chemical: 309-369-5.
2. IDENTITY OF CHEMICAL
CHEMICAL NAME
FULL PUBLIC REPORT: SN/17 Page 5 of 31
May 2007 NICNAS
D-glucoside, eicosyl
OTHER NAME(S)
Arachidyl glucoside
D-Glucopyranoside, C20 straight chain monoalkyl-
MARKETING NAME(S)
Arachidyl glucoside
Montanov 202 (commercial mixture containing <20% notified chemical and >80% eicosanol and
docosanol)
CAS NUMBER
100231-68-3
MOLECULAR FORMULA
C26H52O6
STRUCTURAL FORMULA
CH2OH CH2OH
H H H O
O O
H H
(CH2)xCH3 (CH2)xCH3
OH H OH H
O
HO HO H
OH OH
H H
Where x= 19
Where x= 19
1-Eicosyl alpha-D- 1-Eicosyl beta-D-
Glucopyranoside Glucopyranoside
MOLECULAR WEIGHT
460
SPECTRAL DATA
Infra-red (IR) spectroscopy
METHOD
Remarks The IR Spectrum provided was for Montanov 202 with major peaks at 661, 720, 759,
1059,1378, 1466, 2849, 2916 and 2966cm-1. A film of the test substance was placed
between NaCl plates for the determination.
TEST FACILITY SEPPIC S.A.
METHODS OF DETECTION AND DETERMINATION
IR spectroscopy
METHOD
TEST FACILITY SEPPIC S.A.
3. COMPOSITION
DEGREE OF PURITY
The notified chemical is produced as part of the commercial mixture Montanov 202, which contains
<20% notified chemical and >80% eicosanol and docosanol. The notified chemical is not
FULL PUBLIC REPORT: SN/17 Page 6 of 31
May 2007 NICNAS
manufactured in isolation or subsequently separated.
HAZARDOUS IMPURITIES/RESIDUAL MONOMERS
None.
NON HAZARDOUS IMPURITIES/RESIDUAL MONOMERS (>1% by weight)
Chemical Name 1-Eicosanol
CAS No. 629-96-9 Weight % 50-60% of Montanov 202
Chemical Name 1-Docosanol
CAS No. 661-19-8 Weight % 25-35% of Montanov 202
Chemical Name 1-Octadecanol
CAS No. 112-92-5 Weight % 1-2% of Montanov 202
ADDITIVES/ADJUVANTS
None.
4. INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
The notified chemical will be imported at up to 1.5% in finished cosmetic products, and at up to 20%
in the commercial mixture Montanov 202.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year 1 2 3 4 5
Tonnes Tonnes Tonnes Tonnes Tonnes Tonnes
0.975 0.975 0.975 0.975 0.975
Original
assessment
3.5 4.0 4.0 4.0 4.0
Secondary
Notification
4.475 4.975 4.975 4.975 4.975
Maximum total
amount imported
USE
Used at levels of less than 1.5% as an emulsifier and to contribute to qualities of smoothness, thickness
and creamy consistency in cosmetic cream and lotion products.
5. PROCESS AND RELEASE INFORMATION
5.1. Distribution, transport and storage
PORT OF ENTRY
Sydney and Melbourne.
IDENTITY OF MANUFACTURER/RECIPIENTS
The recipient for Montanov 202 will be:
Bronson & Jacobs Pty Ltd
70 Marple Ave
Villawood NSW 2163
In some cases the material may be despatched directly to customer sites.
The identity of local manufacturers for reformulation of Montanov 202 into finished cosmetic
products is not yet known.
FULL PUBLIC REPORT: SN/17 Page 7 of 31
May 2007 NICNAS
Johnson & Johnson Pacific Pty Ltd will import the notified chemical in finished cosmetic products to
their warehouse at:
Exel Logistics
Cnr Walter's Road and Great Western Highway
ARNDELLE PARK, NSW 2148
TRANSPORTATION AND PACKAGING
Montanov 202 will be imported in 20 kg drums on pallets inside containers, and will travel from the
wharf by road to the Bronson and Jacobs or customer site. It will be transported from there to local
reformulation sites (as yet unspecified) by road.
Finished products containing the notified chemical will be imported in small jars and bottles up to 400
mL, suitable for retail sale. These containers will be packed in cardboard cartons, with cartons
packed 12 per cardboard shipper. The shippers will be transported in a container from the wharf to
the Johnson & Johnson warehouse. Cartons will then be transported from the warehouse to retail
customers' central distribution centres by road.
5.2. Operation description
The majority of the notified chemical is expected to be imported in finished products. In this case, the
products will be in small containers suitable for retail sale. The products will be transported to
warehouse facilities, and thence to retail outlets for sale to the public.
However, there may be significant use in locally formulated products at a later date. In this case,
imported Montanov 202 will be transported from the notifier's warehouse to local manufacturers for
reformulation. Reformulation operations will likely involve weighing an appropriate amount of
Montanov 202 into a separate container, then adding it directly to a mixing tank. In the mixing vessel
heat will be required to melt Montanov 202. QA chemists will sample from the mixing vessel using a
dip tube (large pipette). Filling and packing of retail containers will most likely be automated, with
packers monitoring the line filler and the capper. Store persons will remove pallets of finished product
from the end of the packing line to the finished store.
5.3. Occupational exposure
Number and Category of Workers
Category of Worker Number Exposure Duration Exposure Frequency
(hours per day) (days per year)
Transport & Storage 12 4 12
Professional Compounder 1 8 12
Chemist 1 3 12
Packers (Dispensing and Capping) 2 8 12
Store persons 3 4 12
Exposure Details
Transport & Storage of Imported Finished Products
Approximately ten dockside and warehouse workers per shipment will be involved in transporting
imported finished products from the wharf to the notifiers' sites and placing pallets of product into
their warehouses. Dockside and warehouse workers may handle monthly shipments for 4 hours per
day. A further two warehouse workers will be involved in transferring pallets of imported finished
products from the notifier's warehouse to retailers' central distribution depots.
Dockside and warehouse workers routinely wear uniforms and safety shoes. They are not expected to
have any contact with the notified chemical except in the case of spills.
Reformulation
If local manufacture of finished products using reformulated Montanov 202 becomes viable, the
following exposure will apply. Reformulation processes are expected to occur monthly at most.
Store persons will receive Montanov 202 when delivered from the wharfs and store it in the raw
material store.
FULL PUBLIC REPORT: SN/17 Page 8 of 31
May 2007 NICNAS
Quantities of Montanov 202 would be released to the compounder for production. The compounder
will weigh an appropriate amount into a separate container, then add it directly to the mixing tank.
Mixing and dispensing will be carried out in a closed system, or in a system designed to prevent the
creation of aerosols or dust hazards. In the mixing vessel heat will be used to melt Montanov 202.
During this process, there is potential for accidental drips and spills, or accidental release of vapours,
resulting in dermal, ocular or inhalation exposure. The compounder is to wear safety goggles, gloves
and protective clothing. Personal respiratory protection is generally not used, as inhalation exposure
is limited by local exhaust ventilation. Respirators will be required if local ventilation is inadequate.
A chemist will sample Montanov 202 using a dip tube (large pipette), for QA testing. This process
carries a risk of dermal or ocular exposure due to accidental spills or splashes. The chemist will wear
PPE appropriate for the protection of eyes and skin.
Packers will monitor the line filler and capper where the finished product (containing up to 1.5%
notified chemical) is filled into retail containers. Packers will wear safety glasses, gloves and
protective clothing to limit accidental exposure.
Store persons will remove pallets of finished product from the end of the packing line to storage.
In general, occupational exposure will be limited by provision of appropriate PPE including safety
glasses with side shields or goggles, aprons or coveralls, gloves, full face shields if exposure to
aerosols or splashes is likely, heat resistant gloves for handling of heated product, and respirators if
ventilation is inadequate.
Spills should be contained with absorbent material and placed in an appropriate sealed container for
disposal.
5.4. Release
RELEASE OF CHEMICAL AT SITE
The notified chemical will not be manufactured in Australia. It will be reformulated into personal skin
care products or imported in ready to use products. Release during a transport accident is not likely to
constitute a major hazard, as the material is likely to be containerised, or in packaging designed to
withstand impact. Accidental spills during transportation should be relatively easily recovered and
disposed of.
Release of the notified chemical will be generated during reformulation via:
- Spills less than 1% less than 50 kg,
- Import container residues less than 1% less than 50 kg,
- Process Equipment cleaning up to 3% less than 150 kg.
These losses would be expected if local manufacture of cosmetics from directly imported Montanov
202 takes place.
RELEASE OF CHEMICAL FROM USE
Less than 1% notified chemical will remain in end-use containers when disposed of to landfill,
generally in domestic rubbish. This equates to less than 50 kg annually. Since it is a component in
skin care products the majority (up to 97%) of the notified chemical will ultimately be washed into
the sewer.
5.5. Disposal
Reformulation solid wastes, including spills and import containers and any residues present, will be
disposed of to landfill. This represents less than 100 kg per year of the notified chemical. A further
50 kg will be disposed of to landfill in end-use containers.
The process equipment cleaning effluent, containing up to 3% (150 kg/year) of notified chemical, will
be disposed of to the on-site wastewater collection system and then to a biological treatment plant.
Approximately 97% (up to 4850 kg) of the notified chemical will end up in the sewer from end use of
FULL PUBLIC REPORT: SN/17 Page 9 of 31
May 2007 NICNAS
cosmetic products.
5.6. Public exposure
The commercial product Montanov 202 will not be sold to the general public. The public will only be
exposed to Montanov 202 in the event of accidental spill and breach of import containers. The
material safety data sheets (MSDS) supplied for Montanov 202 have instructions for clean-up and
disposal of any accidental spills and public exposure as a result of a transport accident is likely to be
negligible.
If the notified chemical is blended in Australia to produce finished cosmetic creams or lotions,
engineering controls and standard operating procedures largely prevent any significant release of the
notified chemical from the site of blending. Thus direct public exposure to the notified chemical as a
result of blending is considered to be negligible.
The notified chemical will be sold in finished products to the general public for cosmetic use.
Therefore widespread public exposure is expected. Members of the public are likely to make dermal
and possibly ocular contact with the notified chemical as a result of use of the product at a
concentration of up to 1.5%
The notified chemical may be released into the environment as a result of disposal of waste from
blending, 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 public exposure through
the environment is considered negligible.
6. PHYSICAL AND CHEMICAL PROPERTIES
Most physico-chemical information below relates to Montanov 202, the product to be imported (see section 3
for composition).
Appearance at 20oC and 101.3 kPa White flakes
74-78oC
Melting Point/Freezing Point
SEPPIC Method S52009B
METHOD
Remarks This result is for Montanov 202.
No test report provided.
859 kg/m3 at 20oC
Density
METHOD OECD TG 109 Density of Liquids and Solids.
Remarks Pycnometer method. This result is for Montanov 202.
TEST FACILITY SEPPIC S.A. (2004)
Not determined
Vapour Pressure
METHOD
Remarks The notified chemical is imported as a solid in a solid mixture. Vapour pressure is
expected to be low, for the notified chemical and for Montanov 202. The lowest
molecular weight component in Montanov 202 is 1-octadecanol, which has a
vapour pressue of <10-5 kPa.
>100 g/L at 20oC
Water Solubility
Remarks Estimation of the water solubility is difficult due to the surface activity of the
notified chemical. This result is for Montanov 202, which forms an emulsion in
water up to at least 10%. Water solubility would be lower based on log Kow and
FULL PUBLIC REPORT: SN/17 Page 10 of 31
May 2007 NICNAS
log Koc estimates.
Not determined.
Hydrolysis as a Function of pH
Remarks This test has not been carried out as Montanov 202 is supplied and recommended
(and has been sold overseas for at least 2 years) for use in the pH range of 3-9.
The notified chemical is expected to be stable over a wide pH range due to its ether
linkage and its non ionic nature. Under extreme pH and temperature, the notified
chemical hydrolyses to C20 fatty alcohol and glucose. Hydrolysis products are
claimed to be easily biodegraded.
log Kow = 7.18 (calculated estimate)
Partition Coefficient (n-octanol/water)
KowWin log Kow calculation (QSAR).
METHOD
Remarks The notified chemical is an emulsifier and therefore it was not possible accurately
to measure the n-octanol-water partition coefficient. An estimated value has been
determined from the contributions to log Kow from the individual components
using a fragmentation procedure.
TEST FACILITY SEPPIC (2004)
log Koc = 5.285 (calculated estimate)
Adsorption/Desorption
log Koc calculation (QSAR).
METHOD
Remarks The notified chemical is an emulsifier and therefore it was not possible accurately
to measure adsorption/desorption. An estimated value has been determined from
the log Koc Lyman equation of log Koc=0.544*logKow + 1.377.
TEST FACILITY SEPPIC (2004)
Not determined.
Dissociation Constant
Remarks Not conducted because the notified chemical contains no groups likely to
dissociate. pH of a 5% emulsion is 5.5 to 7.5 at 20 oC.
Not determined.
Particle Size
>100oC at 101.3 kPa
Flash Point
AFNOR Method No NFT60103 (AFNOR, 1968)
METHOD
Remarks No test report provided.
Not determined.
Flammability Limits
Not determined.
Autoignition Temperature
Not determined.
Explosive Properties
Reactivity
Remarks The notified chemical as contained in Montanov 202 is stable under normal
environmental conditions. Montanov 202 is compatible with other cosmetic
substances under normal usage conditions and is stable between pH 3 and pH 9. In
extreme conditions (extreme pH and temperature), the notified chemical in
Montanov 202 hydrolyses to a C20 fatty alcohol and glucose.
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May 2007 NICNAS
7. TOXICOLOGICAL INVESTIGATIONS
Toxicological studies below were conducted using either Montanov 202 or Montanov 68, which contains 10-
40% of a mixture of cetyl glucoside, stearyl glucoside, cetyl alcohol and stearyl alcohol. Montanov 68
components are shorter alkyl chain analogues of Montanov 202 components. Acute dermal toxicity, repeat
dose oral toxicity and in vitro genotoxicity studies performed on higher molecular weight analogues, alkyl
polyglycosides, have also been reported.
Endpoint and Result Test Material Assessment Conclusion
Rat, acute oral Montanov 202 (10-20% notified LD50>2000 mg/kg bw, low
chemical) toxicity
Rat, acute dermal Alkyl (C8-C10) Polyglycosides LD50>2000 mg/kg bw, low
toxicity
Rat, acute dermal Alkyl (C12-C14) Polyglycosides LD50>2000 mg/kg bw, low
toxicity
Rabbit, skin irritation 5% Montanov 202 Slightly irritating
Rabbit, skin irritation 5% Montanov 202 Slightly irritating
Rabbit, eye irritation 5% Montanov 202 Slightly irritating
Eye irritation ?Hen's egg test on 1% Montanov 202 Non irritant
chorio-allantoic membrane
Eye irritation ?Red blood cell test 1% Montanov 202 Non irritant
Human patch test ?irritation 5% Montanov 202 Non irritating
Guinea pig, skin sensitisation ? Montanov 202 Slight evidence of sensitisation
adjuvant test/non-adjuvant test.
Guinea pig, skin sensitisation ? Montanov 68 No evidence of sensitisation
adjuvant test/non-adjuvant test.
Human repeat insult patch test ? 5% Montanov 202 Non irritating
sensitisation Slight evidence of sensitisation
Rat, repeat dose toxicity ? Alkyl (C12-C14) Polyglycosides NOAEL 250 mg/kg bw/day
90 days.
Genotoxicity ?bacterial reverse Montanov 202 Non mutagenic
mutation
Genotoxicity ? in vitro Alkyl (C12-C14) Polyglycosides Non genotoxic
mammalian cytogenetictest
Genotoxicity ? in vitro Alkyl (chain length not specified) Non genotoxic
cytogenetic test Polyglycoside
Comedogenicity 5% Montanov 202 Non comedogenic
7.1. Acute toxicity ?oral
TEST SUBSTANCE Montanov 202 (10-20% notified chemical)
Similar to OECD TG 401 Acute Oral Toxicity ?Limit Test.
METHOD
Species/Strain Rat/WISTAR
Vehicle Liquid paraffin (1:4, Montanov 202:vehicle)
Remarks - Method Statement of GLP.
Significant protocol deviations include:
1. No pathology performed.
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw
I 5 males 2000 0/5
II 5 females 2000 0/5
LD50 > 2000 mg/kg bw (10-20% notified chemical)
FULL PUBLIC REPORT: SN/17 Page 12 of 31
May 2007 NICNAS
Signs of Toxicity None.
Effects in Organs Not applicable
Remarks - Results There were no deaths or notified chemical related clinical signs or
remarkable body weight changes during the study period.
The notified chemical at a concentration of 10-20% is of low toxicity via
CONCLUSION
the oral route.
TEST FACILITY COSMEPAR (1996a)
7.2.1. Acute toxicity ?dermal
TEST SUBSTANCE Alkyl (C12-C14) Polyglycosides
Unspecified in summary report.
METHOD
Species/Strain Rabbit
RESULTS
Remarks - Results LD50>2000 mg/kg
The test substance is of low toxicity via the dermal route.
CONCLUSION
TEST FACILITY USEPA (2005)
7.2.2. Acute toxicity ?dermal
TEST SUBSTANCE Alkyl (C8-C10) Polyglycosides
Unspecified in summary report.
METHOD
Species/Strain Rabbit
RESULTS
Remarks - Results LD50>2000 mg/kg
The test substance is of low toxicity via the dermal route.
CONCLUSION
TEST FACILITY USEPA (2005)
7.3. Acute toxicity ?inhalation
Not determined
REMARKS
7.4.1 Irritation ?skin
TEST SUBSTANCE 5% Montanov 202 (0.5-1% notified chemical)
Similar to OECD TG 404 Acute Dermal Irritation/Corrosion.
METHOD
Species/Strain Rabbit/New Zealand White
Number of Animals 3 males
Vehicle None, liquid applied neat.
Observation Period 48 hours
Type of Dressing Occlusive
Remarks - Method Significant protocol deviations:
1. No clinical observations made at 24 and 72 hours
2. Occlusive dressing used
FULL PUBLIC REPORT: SN/17 Page 13 of 31
May 2007 NICNAS
3. Exposure period 24 h
4. Tested with and without scarification of the skin
5. Test material not removed from skin after exposure period
The experimental conditioned used in this study were such that they were
more likely to produce an adverse effect than the standard OECD
protocol.
RESULTS
Lesion Mean Score* Maximum Maximum Maximum Value at End
Animal No. Value Duration of Any of Observation Period
Effect
1 2 3
Erythema/Eschar 0 0 0 1 < 48 hours 0
Oedema 0 0 0 0 - 0
*Calculated on the basis of the scores at 48, for EACH animal.
Remarks - Results Slight erythema was noted in only one animal on scarified skin after one
hour after patch removal by 48 hours this reaction was not observed.
The test substance is slightly irritating to the skin.
CONCLUSION
TEST FACILITY EViC-CEBA (1998)
7.4.2. Irritation ?skin
TEST SUBSTANCE 5% aqueous dispersion of Montanov 202 (0.5-1% notified chemical)
Similar to OECD TG 404 Acute Dermal Irritation/Corrosion.
METHOD
Species/Strain Rabbit/New Zealand White
Number of Animals 3 males
Vehicle None, administered as supplied.
Observation Period 48 hours
Type of Dressing Occlusive
Remarks - Method Statement of GLP.
Significant protocol deviations:
1. No clinical observations made at 24 and 72 hours
2. Occlusive dressing used
3. Exposure period 24 h
4. Tested with and without scarification of the skin
The experimental conditioned used in this study were such that they were
more likely to produce an adverse effect than the standard OECD
protocol.
RESULTS
Lesion Mean Score* Maximum Maximum Maximum Value at End
Animal No. Value Duration of Any of Observation Period
Effect
1 2 3
Erythema/Eschar 0 0 0 1 < 48 hours 0
Oedema 0 0 0 0 - 0
*Calculated on the basis of the scores at 48, for EACH animal.
Remarks - Results Slight erythema was noted in only one animal after one hour after patch
removal. By 48 hours this reaction was not observed in either animal.
The test substance is slightly irritating to the skin.
CONCLUSION
FULL PUBLIC REPORT: SN/17 Page 14 of 31
May 2007 NICNAS
TEST FACILITY COSMEPAR (1996b)
7.4.3. Skin irritation ?human patch test
TEST SUBSTANCE 5% Montanov 202 (0.5-1% notified chemical)
Single Patch Test
METHOD
Study Design Induction Procedure: Single application to the skin of the back under
occlusive patch for 48 hours.
Study Group 10 adult Caucasian volunteers (7 women and 3 men)
Vehicle Paraffin oil
Remarks - Method Macroscopic examinations of the skin were performed 30 minutes after
patch removal. Test sites were compared with patch-only controls, and
only differences between test and control sites were scored. The
following reactions (with scales) were recorded: erythema (0-4), oedema
(0-3), presence of papulae/vesicles/bullae/pustules (0-4),
dryness/desquamation (0-4), detergent effect (0-4) and reflectivity (0-4).
The index of Primary Cutaneous Irritation (maximum 23) was calculated
by summing the scores for each reaction for the entire cohort, then
dividing by the number of subjects. Irritant classification was based on
the following:
PCI index Classification
0 Very well tolerated
0
>=0.5 Slight intolerance to
Very badly tolerated
Individual scores were also taken into account when interpreting results.
RESULTS
Remarks - Results No signs of irritation were observed in any of the test subjects.
Montanov 202 (5%) was non-irritating under the conditions of the test.
CONCLUSION
TEST FACILITY IEC (1996)
7.5.1 Irritation ?eye
TEST SUBSTANCE 5% Montanov 202 in solution (0. 5-1% notified chemical)
Similar to OECD TG 405 Acute Eye Irritation/Corrosion.
METHOD
Species/Strain Rabbit/New Zealand White
Number of Animals 3
Observation Period 7 days
Remarks - Method
RESULTS
Lesion Mean Score* Maximum Maximum Maximum Value at End
Animal No. Value Duration of Any of Observation Period
Effect
1 2 3
Conjunctiva: redness 0.7 0 0 1 >48 h <72 h 0
Conjunctiva: chemosis 0 0 0 0 0 0
FULL PUBLIC REPORT: SN/17 Page 15 of 31
May 2007 NICNAS
Conjunctiva: discharge 0 0 0 2 < 24 h 0
Corneal opacity 0 0 0 0 0 0
Iridial inflammation 0 0 0 0 0 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Remarks - Results After one hour discharge of the conjunctiva was noted in all three
animals but was not present after 24 hours. Slight redness of the
conjunctiva was observed in all three animals after one hour and in one
animal up to 48 hours.
The test substance is slightly irritating to the eye.
CONCLUSION
TEST FACILITY EViC-CEBA (1998)
7.5.2 Eye irritation - Hen's egg test
TEST SUBSTANCE Montanov 202 was dissolved as a 1% solution in demineralised water.
Hen's egg test ?chorio-allantoic membrane of a hen's egg
METHOD
Remarks - Method The test compound is applied to the chorio-allantoic membrane of
embryonated hen's eggs. In this test the highly vascularised chorio-
allantoic membrane mimics the cornea. Irritant compounds induce
hyperaemia, haemorrhage and protein coagulation on the membrane
surface.
Fresh, intact White Leghorn hen fertilised eggs of about 60 g are
incubated at 37.5癈 for 10 days, with the large end up. Eggs were
automatically rotated every hour and 0.3 mL of the prepared sample was
spread over the chorio-allantoic membrane using a 1 mL pipette. Rinsing
with 5mL of demineralised water was carried out 20 seconds later.
Hyperaemia, haemorrhage and coagulation were scored against a scale of
irritant effects 0.5, 2 and 5 minutes after treatment to maxima of 5, 7 and
9 respectively. The numerical scores were summed to give a single
numerical value for 4 or 6 eggs treated with each compound or
concentration. The mean score value allows the irritant potential to be
assigned to one of 5 classes (non irritant, slightly irritant, moderately
irritant, irritant and severely irritant).
The classification was determined using the following chart:
CLASS SCORE
Non Irritant Score < 1
Slightly Irritant 1 < = Score < 5
Moderately Irritant 5 < = Score < 9
Irritant 9 < = Score < 12
Severely Irritant Score > = 12
RESULTS
Hyperaemia No signs of hyperaemia observed.
Haemorrhage No signs of haemorrhage observed.
Coagulation No signs of coagulation observed.
Remarks - Results No positive or negative controls were included in the test.
1% Montanov 202 was non-irritating under the conditions of the test.
CONCLUSION
FULL PUBLIC REPORT: SN/17 Page 16 of 31
May 2007 NICNAS
TEST FACILITY SEPPIC (2000a)
7.5.3 Eye irritation - Red blood cell test
TEST SUBSTANCE Montanov 202 was dissolved in phosphate buffered isotonic saline (PBS)
to produce a 1% solution. This was then diluted 100 times for the
Haemolysis solution and 10 times for the Denaturation solution.
The RBCA (red blood cell) test uses red blood cells to quantify adverse
METHOD
effects of surfactants on cytoplasmic membranes (haemolysis) and
cellular proteins (denaturation). Various concentrations of test sample
were incubated with a red blood cell suspension for 10 minutes. At the
end of the incubation period, the resulting supernatant was monitored to
evaluate haemolysis and protein denaturation. The Lysis/ Denaturation
ratio was then calculated. The L/D ratio may be compared with acute eye
irritation data.
Haemolysis Eight aliquots (from 10 to 80 礚) of 1% Montanov 202 were made up to
975 礚 with PBS, after which 25 礚 samples of red blood cells were
added and incubated at room temperature for 10 minutes, then
centrifuged for 1 minute. The supernatant absorbance was measured at
530 nm. At each concentration the relative percentage of haemoglobin
released was calculated. The concentration of test substance causing 50%
RBC lysis, L, was calculated.
Denaturation A 1% solution of Montanov 202 was prepared in PBS. To 100 礚 of this
preparation was added 25 礚 of red blood cells that had undergone lysis
(releasing oxyhaemoglobin) in 875 礚 of PBS. This was incubated at
room temperature for 10 minutes and then centrifuged for 1 minute. The
supernatant was decanted and the absorbance measured at 540 nm
(E540) and 575 nm (E575). The ratio of E575/E540, D, is a measure of
the denaturation of oxyhaemoglobin.
Calculation The relationship between haemolysis (L) and denaturation (D), defined
as the lysis/denaturation ratio L/D, was calculated for each sample.
Remarks ?Method Irritant classification was based on the following:
IN VIVO EYE IRRITATION IN VITRO L/D
Non Irritant >100
Slightly Irritant >10
Moderately Irritant >1
Irritant >0.1
Very Irritant <0.1
RESULTS The Lysis value was >1000 礚. L>=1000 is classified as non
haemolysing.
The Denaturation value was 1.4%. D<=10% is classified as non
denaturing.
The eye irritation index for 1% Montanov 202, calculated as the Lysis/
Denaturation ratio, was determined to be >100.
No positive or negative controls were included in the test.
1% Montanov 202 was non irritating under the conditions of the test.
CONCLUSION
FULL PUBLIC REPORT: SN/17 Page 17 of 31
May 2007 NICNAS
TEST FACILITY SEPPIC (2000b)
7.6.1 Skin sensitisation - Guinea pig ?Magnusson and Kligman test
TEST SUBSTANCE Montanov 202 (10-20% notified chemical)
OECD TG 406 Skin Sensitisation ?Magnusson and Kligman method.
METHOD
Species/Strain Guinea pig/Hartley (Charles River, France)
Maximum Non-irritating Concentration:
PRELIMINARY STUDY
topical: 50%
MAIN STUDY
Number of Animals Test Group: 10 female Control Group: 5 female
Induction Concentration:
INDUCTION PHASE
intradermal: 5% (maximum administrable)
topical: 50%
Signs of Irritation None reported.
CHALLENGE PHASE
1st challenge topical: 50% and 20%
2nd challenge Not conducted.
Remarks - Method None.
RESULTS
Animal Challenge Concentration Number of Animals Showing Skin Reactions after:
1st challenge 2nd challenge
24 h 48 h 24 h 48 h
Test Group 50% 1/10 0/10
20% 0/10 0/10
Control Group 50% 0/5 0/5
20% 0/5 0/5
Remarks - Results No positive control was included in the test.
There was slight evidence of reactions indicative of skin sensitisation to
CONCLUSION
Montanov 202 under the conditions of the test.
TEST FACILITY Evic-Ceba (1997)
7.6.2. Skin sensitisation - Guinea pig ?Magnusson and Kligman test
TEST SUBSTANCE Montanov 68
OECD TG 406 Skin Sensitisation ?Magnusson and Kligman method
METHOD
EC Directive 96/54/EC B.6 Skin Sensitisation - Magnusson and Kligman
method
Species/Strain Guinea pig/Dunkin-Hartley (Centre de Production Animale, France)
Maximum Non-irritating Concentration:
PRELIMINARY STUDY
intradermal: 10% (maximum concentration tested)
topical: 10% (maximum concentration tested)
MAIN STUDY
Number of Animals Test Group: 6 female + 5 male Control Group: 2 female + 3 male
Induction Concentration:
INDUCTION PHASE
intradermal: 10%
topical: 10%
Signs of Irritation None reported.
CHALLENGE PHASE
1st challenge topical: 10% and 5%
2nd challenge Not conducted.
FULL PUBLIC REPORT: SN/17 Page 18 of 31
May 2007 NICNAS
Remarks - Method None.
RESULTS
Animal Challenge Concentration Number of Animals Showing Skin Reactions after:
1st challenge 2nd challenge
24 h 48 h 24 h 48 h
Test Group 10% 2/11 0/11
5% 2/11 0/11
Control Group 10% 2/5 0/5
5% 1/5 0/5
Remarks - Results None.
There was no evidence of reactions indicative of skin sensitisation to
CONCLUSION
Montanov 68 under the conditions of the test.
TEST FACILITY Phycer (2004)
7.6.3. Skin sensitisation - Human repeat patch test
TEST SUBSTANCE 5% Montanov 202
Marzulli & Maibach's method
METHOD
Repeated epicutaneous 48-hour applications under occlusive patch.
Preliminary Study Four successive occlusive epicutaneous applications to the arm of 10
volunteers (9 women and 1 man), for 48 or 72 hours. 3 concentrations
were tested on each subject: 1%, 2.5% and 5% (w/w).
Main Study Design Induction Procedure: 9 consecutive applications of 5% (w/w) Montanov
202, to the arm, for 24-72 hours.
Rest Period: 15 days
Challenge Procedure: Single application of 5% (w/w) Montanov 202, to
the back, for 48 hours.
Main Study Group 50 adult Caucasian volunteers (45 women and 5 men) started the study
49 were evaluated for irritation (44 women and 5 men) and
48 were evaluated for sensitisation (43 women and 5 men)
Vehicle Distilled water
Remarks - Method Macroscopic examinations of test sites for signs of irritation and/or
sensitisation were performed 24 and 48 hours after the 8th induction
application, and after the challenge application, by comparison with a
negative vehicle-only control patch. Both irritation and sensitisation
were scored on a scale of 0 (no reaction) to 4 (severe erythema and/or
oedema). A mean irritation index was calculated for the entire cohort.
Classification of irritancy potential was according to the following:
Mean Irritation Index Classification
<0.25 Non-irritant
0.25<=MII<1 Slightly irritant
1<=MII<2 Irritant
2<=MII<3 Very irritant
3-4 Severely irritant
An individual sensitisation score of 3 or more was considered positive
evidence for sensitising potential of the test substance.
RESULTS
Preliminary Study No irritation was observed at any of the concentrations tested.
FULL PUBLIC REPORT: SN/17 Page 19 of 31
May 2007 NICNAS
Main Study-Induction A single instance of slight irritation (irritation score of 1) was observed in
10/49 of subjects.
Several instances of slight irritation were observed in 4/49 of subjects.
The mean irritation index for all subjects during the induction phase was
0.06.
Main Study-Challenge A single instance of slight reaction (sensitisation score of 1) was
observed in 2/48 subjects.
Slight to mild reaction (sensitisation scores of 1-2) was observed at both
24 and 48 hour time points in 1 subject.
No subject showed a response that was considered positive for
sensitisation.
Montanov 202 was non-irritating and showed limited evidence of
CONCLUSION
sensitisation under the conditions of the test.
TEST FACILITY IEC (1997a)
7.7. Repeat dose toxicity
TEST SUBSTANCE Alkyl (C12-C14) Polyglycosides
Not specified
METHOD
Species/Strain Rat (strain unspecified)
Route of Administration Oral ?gavage
Exposure Information Total exposure days: 90 days
Dose regimen: 5/7 days per week
Post-exposure observation period: 27
Vehicle Unknown
Remarks - Method Full study report not cited.
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw/day
I (control) males and females (no. 0 0
unknown)
II (low dose) males and females (no. 250 0
unknown)
III (mid dose) males and females (no. 500 0
unknown)
IV (high dose) males and females (no. 1000 0
unknown)
VI (high dose recovery) males and females (no. 1000 0
unknown)
Mortality and Time to Death
No deaths were reported.
Clinical Observations
No adverse treatment-related effects reported.
Laboratory Findings ?Clinical Chemistry, Haematology, Urinalysis
No adverse treatment-related effects reported.
Effects in Organs
Adverse treatment-related effects were limited to the forestomach in both males and females in the mid and
high dose group although these effects were reversible after 27 days. No other adverse treatment-related
effects were reported.
FULL PUBLIC REPORT: SN/17 Page 20 of 31
May 2007 NICNAS
Remarks ?Results
A LOAEL of 500 mg/kg bw/day was established based on acanthosis, subepithelial inflammatory oedema,
and hyperkeratosis (females only) of the forestomach at this dose level.
CONCLUSION
The No Observed (Adverse) Effect Level (NO(A)EL) was established as 250 mg/kg bw/day in this study,
based on treatment-related effects at higher dose levels.
TEST FACILITY USEPA (2005)
7.8. Genotoxicity ?bacteria
TEST SUBSTANCE Montanov 202 (10-20% notified chemical)
OECD TG 471 Bacterial Reverse Mutation Test.
METHOD
Plate incorporation procedure
Method also conforms to guidelines published by the major Japanese
Regulatory Authorities.
Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100
E. coli: WP2uvrA-
Metabolic Activation System Aroclor 1254-induced rat liver S9 fraction.
Concentration Range in a) With metabolic activation: 0-5000 礸/plate
Main Test b) Without metabolic activation: 0-5000 礸/plate
Vehicle Dimethylformamide
Remarks - Method None.
RESULTS
Metabolic Test Substance Concentration (礸/plate) Resulting in:
Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect
Preliminary Test Main Test
Absent
Test 1 None observed None observed 1500 None observed
Test 2 None observed None observed 1500 None observed
Present
Test 1 None observed None observed 1500 None observed
Test 2 None observed None observed 1500 None observed
Remarks - Results Negative controls were within the historical range and positive controls
demonstrated the sensitivity of the test.
Montanov 202 was not mutagenic to bacteria under the conditions of the
CONCLUSION
test.
TEST FACILITY SafePharm (1998)
7.9.1. Genotoxicity ?in vitro
TEST SUBSTANCE Alkyl (C12-C14) Polyglycosides
In vitro Mammalian Cytogenetics Assay.
METHOD
Remarks No study details were provided in the summary.
The test substance was negative with and without activation, in vitro,
CONCLUSION
under the conditions of the test.
FULL PUBLIC REPORT: SN/17 Page 21 of 31
May 2007 NICNAS
TEST FACILITY USEPA (2005)
7.10. Genotoxicity ?in vitro
TEST SUBSTANCE Alkyl polyglycoside (chain length not specified)
METHOD In vitro cytogenetic test in Chinese hamster V79 lung fibroblasts
Remarks - Method No study details were provided in the summary.
CONCLUSION The test substance was considered to be non-mutagenic under the conditions of
the test.
TEST FACILITY USEPA (2005)
7.11. Comedogenicity ?human repeated use study
TEST SUBSTANCE 5% Montanov 202
METHOD "Normal conditions of use"
Study Design Test article applied twice a day, to the skin of the face and neck, for 4 weeks.
Applications were performed by volunteers at home, under normal conditions
of use as a skin and face care lotion.
Study Group Of 21 adult Caucasian female volunteers whose facial skin showed acneic
tendency, 9 had oily skin and 12 had "mixed with oily tendency" skin. 8
subjects had "sensitive" facial skin. Age range: 20 to 44 years.
Vehicle Not specified: "white thick emulsion".
Remarks - Method Local tolerance was evaluated at the end of the 4-week application period, from
cutaneous clinical examinations. Comedogenicity was evaluated by a statistical
comparison of the number of "retentional and inflammatory elements" at the
start and at the end of the study.
RESULTS
Remarks - Results 20/21 subjects reported "rather good to very good" acceptability of the test
material (the remaining subject reported moderate acceptability). 19/21
reported no adverse cutaneous symptoms. The remaining 2 subjects, both of
whom had "sensitive" facial skin (including 1 subject with prior experience of
adverse reactions to cosmetics), reported weak to moderate skin dryness for 5-
15 minutes after each application. No evidence of intolerance was observed at
the end of the study.
None of the subjects reported ocular symptoms.
No significant comedogenic effect was observed when comparing skin scores
from the beginning and the end of the study.
CONCLUSION Montanov 202 (5%) was well tolerated and non comedogenic under the
conditions of the test.
TEST FACILITY IEC (1997b)
FULL PUBLIC REPORT: SN/17 Page 22 of 31
May 2007 NICNAS
8. ENVIRONMENT
Ecotoxicological studies below were conducted using either Montanov 202 or Montanov 68, which contains
10-40% of a mixture of cetyl glucoside, stearyl glucoside, cetyl alcohol and stearyl glucoside. Montanov 68
components are shorter alkyl chain analogues of Montanov 202 components.
8.1. Environmental fate
8.1.1. Ready biodegradability
TEST SUBSTANCE Montanov 68.
EC Directive 84/449 - Annex V Method C5 (1984) Adapted Modified
METHOD
Sturm Test
Inoculum Activated sludge from a municipal sewage treatment plant receiving little
or no industrial effluent (from Pierre-Benite- 69310 Lyon)
Exposure Period 28 days
Auxiliary Solvent None.
Determination of CO2 production by back titration with barium
Analytical Monitoring
hydroxide
Remarks - Method Concentration of test substance (Montanov 68) and reference substance
(sodium acetate) was 20 mg/L.
RESULTS
Test substance Sodium acetate
Day % Degradation Day % Degradation
2 5 2 3
10 78 10 14
15 97 15 20
20 97 20 68
25 97 25 85
28 97 28 84
Remarks - Results The test substance showed biodegradability of 97% in 28 days under the
conditions of a Modified Sturm test, which was reached by day 15. The
10-day window criterion was also clearly met (78% degraded by day 10).
The test was validated, as the reference substance (sodium acetate)
showed a biodegradability of >84% for the 28 day study period.
This is in line with literature results (Madsen et al, 2000) for similar alkyl
glycosides, with alkyl polyglycosides of C8-16 having biodegradabilities
of 100% (Modified OECD screening test, 28 d) and 80% (Closed bottle
test, 30 d), and alkyl polyglycosides of C12-16 having biodegradabilities
of 100% (Modified OECD screening test, 28 d) and 78% (Closed bottle
test, 30 d).
The test substance can be classified as readily biodegradable.
CONCLUSION
TEST FACILITY Societe d'Elevage Piscicole Controle (1991)
8.1.2. Bioaccumulation
Not determined. However, due to its ready biodegradability the notified
REMARKS
chemical is unlikely to bioaccumulate.
FULL PUBLIC REPORT: SN/17 Page 23 of 31
May 2007 NICNAS
8.2. Ecotoxicological investigations
No new ecotoxicological data has been provided.
No ecotoxicological data are available for the notified chemical, however literature data (Madsen et al, 2000)
is available for toxicity of other alkyl glycosides to fish, Daphnia and algae:
For Zebra fish, the reported 96 h LC50 of alkyl glycosides with alkyl polyglycosides of C8-16 is 7.8 mg/L,
while that for alkyl polyglycosides of C12-14 is 2.5-5.0 mg/L.
For Daphnia magna, the reported 48 h EC50 of alkyl glycosides with alkyl polyglycosides of C8-16 is 85
mg/L, while that for alkyl polyglycosides of C12-14 is 7-12 mg/L.
For algae, the reported 96 h EC50 of alkyl glycosides with alkyl polyglycosides of C8-16 are 14.8 mg/L and
NOEC = 5.0 mg/L. Again the C12-14 analogue is more toxic with a 72 h EC50 of 6-11 mg/L.
As the notified chemical is a mix of C20 and C22 alcohol chains, the C12-14 alkyl polyglycoside data are
considered more relevant, since toxicity appears to rise with longer chains (the C8-16 analogues may be
expected to have contained a significant proportion of C8-10 chains).
FULL PUBLIC REPORT: SN/17 Page 24 of 31
May 2007 NICNAS
9. RISK ASSESSMENT
9.1. Environment
9.1.1. Environment ?exposure assessment
The notified chemical will be imported into Australia either in a ready to use product or as part
of the commercial mixture Montanov 202 for subsequent formulation into products. The
majority (97%) of the imported polymer will eventually be discharged into sewerage systems
through washing. Approximately 3% will be disposed of to landfill in empty containers from
reformulation or end-users, and from clean up of spills. Up to 150 kg per annum will be
released due to equipment cleaning during the reformulation process, which will go to on-site
treatment.
The notified chemical forms an emulsion up to at least 10% and therefore may be relatively
mobile in both the aquatic and terrestrial compartments. However, the estimated Koc and Kow
are high, indicating that it may be expected to be immobile in soil and sediments. All these
results need to be treated with caution due to the surface activity of the notified chemical, which
can be classed as readily biodegradable based on analogue data, and as such is likely to be
biodegraded in the sewer. Residual chemical disposed of to landfill with empty containers can
also be expected to be adsorbed to soil particles and will be degraded through biological and
abiotic processes. The ready biodegradability of the notified polymer will limit
bioaccumulation.
Given the use pattern of the notified chemical, the predicted environmental concentration (PEC)
in the aquatic environment can be estimated using the following worst-case scenario, assuming a
maximum importation volume of 5000 kg, year-round use of the notified chemical, and no
removal due to biodegradation or physical/chemical means:
Amount released to sewer 5000 kg
Number of days used 365
Australian population 20.5 million
Water use per person 200 L
5000 000 000 000
PECsewer/freshwater
365X20 500 000X200
= 3.34 礸/L
0.334 礸/L
PECocean (dilution factor of 10)
The actual PECs are likely to be much lower, since the notified chemical is readily
biodegradable. Therefore, the DEW STP model (Environment Australia, 2003) has been used to
estimate how the notified chemical will behave in a sewage treatment plant. The modelled
results, assuming a yearly release to sewer of 5000 kg, are as follows:
Daily chemical release: 13.70 kg
Daily effluent production (100% population) 4,099 ML
Amount remaining in effluent 7%
Amount removed due to degradation 21%
Chemical load partitioning to sludge/biosolids: 72%
As can be seen from the results it is likely that approximately 7% of the notified chemical
loading will remain in the effluent leaving the STP and be released to either a freshwater/marine
water body. In which case the PECfreshwater and the PECocean become 0.23 and 0.02, respectively.
Partitioning to biosolids in STPs Australia-wide may result in an average biosolids
concentration of 24.06 mg/kg (dry wt). Biosolids will either be disposed of to landfill or they
maybe applied to agricultural soils at an assumed average rate of 10 t/ha/year. Assuming a soil
bulk density of 1000 kg/m3 and a soil mixing zone of 0.1 m, the concentration of the notified
chemical may approximate 0.241 mg/kg in applied soil. STP effluent re-use for agricultural
irrigation occurs throughout Australia The following calculation is undertaken assuming an
application rate of 1000 L/m2/year (10 ML/ha/year) and that any notified chemical in the water
FULL PUBLIC REPORT: SN/17 Page 25 of 31
May 2007 NICNAS
is assumed to infiltrate and accumulate in the top 0.1 m of soil (density 1000 kg/m3).
PECsoil (mg/kg) (assumes no degradation)
Recycled water Application of biosolids
Soil concentration 1 year 0.002 0.241
5 years 0.01 1.205
10 years 0.02 2.41
However, the PECsoils is expected to be lower due to the degradation of the notified chemical
which will continue in the soil.
Bioaccumulation is not expected due to the diffuse use pattern, and the notified chemical's
ready biodegradability, which would limit its bioaccumulation potential.
9.1.2. Environment ?effects assessment
While no data were provided on environmental effects, the use of this chemical indicates high
exposure to the aquatic environment. As such the absolute predicted no effect concentration
(PNEC) cannot be derived, but based on literature data (Madsen et al, 2000) an estimate for the
aquatic PNEC may be obtained.
Using the lowest relevant LC50 for zebra fish, 96 h LC50 = 2.5 mg/L, and assuming a safety
factor of 1000 as only surrogate data are available, the aquatic PNEC is 2.5 礸/L.
However, as no ecotoxicity data is available for soil organisms, a soil PNEC cannot be
estimated.
9.1.3. Environment ?risk characterisation
The risk associated with the use of the notified chemical in personal care products can be
estimated by determining the aquatic risk quotient (RQ = PEC/PNEC).
The risk associated with the worst case scenario, where all of the imported notified chemical is
released and there is no removal in the STP, is estimated below and indicates a marginal risk in
freshwater.
Location PEC PNEC Risk Quotient (RQ)
3.34 礸/L
Freshwater 2.5 礸/L 1.34
0.33 礸/L
Ocean outfall 2.5 礸/L 0.13
However, this risk will be mitigated by the behaviour of the notified chemical in the STP (as
discussed in the previous section) and is recalculated below taking into account the likely
removal in the STP.
Location PEC PNEC Risk Quotient (RQ)
0.23 礸/L
Freshwater 2.5 礸/L 0.092
Ocean outfall 2.5 礸/L 0.009
0.02礸/L
Since the RQ values are less than 1, the proposed use of the notified chemical is unlikely to
pose an unacceptable risk to aquatic life.
9.2. Human health
9.2.1. Occupational health and safety ?exposure assessment
FULL PUBLIC REPORT: SN/17 Page 26 of 31
May 2007 NICNAS
Transport & Storage
Occupational exposure to the notified chemical during transport and storage of Montanov 202
(the imported mixture containing <20% notified chemical), or of finished products containing up
to 1.5% notified chemical, is only likely in the event of accidental container spillage involving
breach of import packaging. Exposure in these circumstances is expected to be infrequent and
acute, and can be limited by use of gloves, goggles, masks and protective clothing during clean-
up operations.
Reformulation
During local reformulation of Montanov 202 into cosmetic creams and lotions, dermal exposure
is the most likely route. Ocular exposure may also occur as a result of accidental drips or spills.
Exposure may occur when workers weigh out Montanov 202 and add it to the mixing vessel,
and also during sampling for QA testing.
Exposure during mixing operations is expected to be minimal, as closed systems will be used.
Exposure during dispensing of finished product into retail containers is expected to be minimal,
as automated systems will be used. Exposure is only likely in the event of accidental container
spill or breakage; in this case exposure will be limited by the concentration of notified chemical
in retail products (up to 1.5%).
9.2.2. Public health ?exposure assessment
Public exposure to Montanov 202 is expected to be negligible. Montanov 202 will not be sold
to the general public. Exposure to Montanov 202 during transport or industrial use will only
occur in the event of serious accidental spill; exposure would be limited by clean-up and
disposal operations in accordance with the MSDS.
Widespread public exposure is expected to the notified chemical at up to 1.5% in finished
cosmetic creams and lotions. Frequent, prolonged dermal exposure is expected, with a
concomitant chance of accidental ocular exposure.
9.2.3. Human health ?effects assessment
Toxicokinetics
No information was submitted on the notified chemical. USEPA (2005) reports that similar
chemicals are hydrolysed to form sugar and long chain alcohols, which are then processed as
carbohydrates and lipids, with most metabolites excreted via urine.
Acute toxicity
Montanov 202, containing 10-20% of the notified chemical was of low oral toxicity to rats
(LD50>2000 mg/kg). Alkyl polyglycoside analogues were also of low acute oral toxicity
(USEPA, 2005). The analogue alkyl polyglycosides were also of low toxicity via the dermal
route, however it should be notified that the notified chemical may have a higher potential for
dermal absorption because of its lower molecular weight.
Irritation
Montanov 202 has been tested in a number of studies for irritancy. In two tests for surrogate
markers of eye irritation (Hen's Egg Test on Chorio-Allantoic Membrane and Red Blood Cell
test), 1% Montanov 202 was found to be non-irritant. However, 1% Montanov is <0.2%
notified chemical, which is lower than the proposed concentrations of notified chemical in
cosmetic products (up to 1.5%). A 5% solution of Montanov 202 (0.5-1% notified chemical)
was slightly irritating to rabbit eyes and skin. Because of the low concentration used in the
studies the irritation potential of the notified chemical cannot be fully characterised.
Skin sensitisation
In an adjuvant test in guinea pigs, higher concentrations of Montanov 202 showed slight
evidence of sensitisation, although this was well below the level required for classification as a
potential sensitiser. In a similar test in guinea pigs, Montanov 68, a commercial mixture
containing shorter chain analogues of the components of Montanov 202, showed no evidence of
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May 2007 NICNAS
sensitisation.
Repeated dose toxicity
A higher molecular weight analogue polyglycoside was found to have a NOAEL of 250 mg/kg
bw/day in a 90 oral study in rats. Adverse treatment related effects were limited to the site of
contact (forestomach) in animals treated at higher doses.
It is expected that the analogue and notified chemical would have similar routes of metabolism.
Whilst the chain length of the formed alcohol differ, alcohols with a chain length C18-C22 are
of low acute toxicity and did not cause adverse effects when dosed at 1000 mg/kg bw/day in a
28 day study (ECB (2000a), ECB (2000b), ECB (2000c))
Genotoxicity
Montanov 202 was non genotoxic in a bacterial reverse mutation test and the analogue
polyglycoside was not genotoxic in two in vitro mammalian cytogenic studies.
Human studies
In human studies, 5% Montanov 202 was found to be non irritating and non sensitising in single
and repeat insult patch tests. 5% Montanov 202 was also found to be well tolerated and non
comedogenic after 4 weeks of twice daily application to the face and neck of female volunteers
prone to acne. 5% Montanov 202 corresponds most closely to the proposed levels of notified
chemical in finished cosmetic products.
It should be noted that all available toxicological data relates either to low concentrations of the
notified chemical or to analogue data.
Based on the available data, the notified chemical is not classified as a hazardous substance in
accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC
2002).
9.2.4. Occupational health and safety ?risk characterisation
The most likely route of occupational exposure is through dermal contact with Montanov 202 or
with finished products containing up to 1.5% notified chemical with the highest level of
exposure expected during manual weighing and transfer of Montanov 202.
Available toxicological data show that the notified chemical is not sensitising or significantly
irritating at the low concentrations proposed for finished cosmetic products. However, the risk
of irritation or sensitisation following dermal exposure to Montanov 202 is not known.
Therefore gloves, goggles and protective clothing should be worn during operations involving
potential exposure to Montanov 202.
Although systemic toxicity of the notified chemical or Montanov 202 has not been tested, there
are no indications of likely hazards to human health in the structure of the notified chemical or
the known properties of Montanov 202. In addition, a higher molecular weight analogue
polyglycoside showed adverse effects only at the site of contact (forestomach) which were
possibly related to irritation and therefore only applicable to the oral route of exposure.
Exposure and hence the risk of adverse systemic effects would be limited by the use of gloves,
goggles and protective clothing during operations involving potential exposure to Montanov
202. Local exhaust ventilation, and the expected low vapour pressure of the notified chemical,
will limit the risk of inhalation exposure.
9.2.5. Public health ?risk characterisation
It is expected that public exposure to Montanov 202 will be minimal except in the rare event of
an accidental spill involving breach of import packaging. There will be widespread public
exposure to the notified chemical from frequent, prolonged dermal exposure to cosmetic creams
and lotions containing up to 1.5% notified chemical. Based on the low concentrations of
notified chemical in finished products, and the available toxicological data, the public risk from
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May 2007 NICNAS
exposure to the notified chemical through all phases of its life cycle is considered 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 not classified as a hazardous substance
under the NOHSC Approved Criteria for Classifying Hazardous Substances.
10.2. Environmental risk assessment
On the basis of the estimated PEC/PNEC ratio, the notified chemical is not considered to pose a
risk to the environment based on its reported use pattern.
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 at up to 1.5% in cosmetic creams
and lotions.
11. MATERIAL SAFETY DATA SHEET
11.1. Material Safety Data Sheet
The MSDS of products containing the notified chemical provided by the notifiers were in
accordance with the NOHSC National Code of Practice for the Preparation of Material Safety
Data Sheets (NOHSC 2003). They are 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 products containing the notified chemical provided by the notifier were 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
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 in the product
Montanov 202:
- Gloves
- Safety eyewear
- Protective clothing
? 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.
FULL PUBLIC REPORT: SN/17 Page 29 of 31
May 2007 NICNAS
Environment
? The following control measures should be implemented by the reformulator to
minimise environmental exposure during the formulation of personal care products of
the notified chemical:
- All process and storage areas are bunded with any drains going to an onsite
effluent treatment plant.
Disposal
? The notified chemical should be disposed of to landfill.
Emergency procedures
? Spills/release of the notified chemical should be handled by containment, collection by
either manual means or adsorption, and then placed in a labelled sealable container.
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:
(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.
No additional secondary notification conditions are stipulated.
13. BIBLIOGRAPHY
AFNOR (1968) Agence Francaise de Normalisation Method NF T60 103 Closed Cup Flash Point of
Lubricating Oils and Greases, December 1968, Paris, France
AFNOR (2004) Agence Francaise de Normalisation Method NF EN 1262 Determination of pH Value of
Solutions and Dispersions, January 2004, Paris, France
COSMEPAR (1996a) Innocuousness test by single administration in the rat: Montanov 202. Study 962715 for
Seppic, Castres. Cosmepar Conseil & Experimentation, Issy-Les-Moulineaux (Unpublished report provided
by notifier)
COSMEPAR (1996b) Primary skin irritation in the rabbit: Screening 3 Animals: Montanov 202 Dispersion
Aqueuse 5%. COS 96027. Report number 962675 29/8/96 for Seppic, Castres. Cosmepar Conseil &
Experimentation, Issy-Les-Moulineaux (Unpublished report provided by notifier)
Environment Australia (2003) Model and Guidance for Estimating Predicted Environmental Concentrations to
Surface Water and Soil from Chemicals Released to the Environment Through a Sewage Treatment Plant.
Chemical Assessment Section, Environment Australia, Canberra Australia.
European Chemicals Bureau (ECB) (2000a) International Uniform Chemical Information Database (IUCLID)
Data Set. Icosan-1-ol
European Chemicals Bureau (2000b) International Uniform Chemical Information Database (IUCLID) Data
Set. Docosan-1-ol
European Chemicals Bureau (2000c) International Uniform Chemical Information Database (IUCLID) Data
Set. Octadecan-1-ol
Evic-Ceba (1997) Determination du Potentiel Sensibilisant Cutane de la Preparation: Montanov 202, Evic-Ceba
Laboratoire de Recherche et d'Experimentation 17 April 1997, Blanquefort, France (Unpublished report
provided by the notifer)
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Evic-Ceba (1998) Assessment of the local tolerance of the product COS98064. Study report Te540 / 98-3122 of
4/9/98, for SEPPIC. Evic-CEBA Laboratoire de Recherche et d'Experimentation, Blanquefort, France
(unpublished report provided by notifier).
IEC (1996) Verification of the Good Epicutaneous Local Tolerance of a Cosmetic Test Article: "Single Patch
Test": Montanov 202 (Report No. R61073D), 25 October 1996, Institut D'Expertise Clinque, Lyon France.
(unpublished report provided by the notifier)
IEC (1997a) Evaluation of the Irritating and Sensitising Potentials of an Ingredient Used in Cosmetics (Marzulli
and Maibach's Method): Montanov 202 (Report No. 70168RD3), 16 July 1997, Institut d'Expertise
Clinique, Lyon, France (Unpublished report provided by the notifier)
IEC (1997b) Clinical Study for the Appreciation of the Cutaneous Local Tolerance, with Evaluation of
Comedogenicity: Montanov 202 (Report No. COS97046), 25 November 1997, Institut d'Expertise Clinique,
Lyon, France (Unpublished report provided by the notifier)
Madsen T, Boyd HB, Nylen D, Pedersen, AR, Petersen GI and Simonsen F (2000) Environmental and health
assessment of substances in household detergents and cosmetic detergent products. Environmental Project
No. 615 2001, Centre for Integrated Environment and Toxicology, Horsholm, Denmark.
NOHSC (1994) National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)].
National Occupational Health and Safety Commission, Canberra, Australian Government Publishing
Service.
NOHSC (2002) Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2002)]. National
Occupational Health and Safety Commission, Canberra, AusInfo.
NOHSC (2003) National Code of Practice for the Preparation of Material Safety Data Sheets, 2nd edn
[NOHSC:2011(2003)]. National Occupational Health and Safety Commission, Canberra, Australian
Government Publishing Service.
Phycher (2004) Assessment of Sensitising Properties on Albino Guinea Pig: Maximisation Test According to
Magnusson and Kligman, 16 January 2004, Phycher Bio Development, Castres, France (Unpublished report
provided by the notifier)
SafePharm (1998) Montanov 202: Reverse Mutation Assay "Ames Test" Using Salmonella Typhimurium and
Escherichia Coli (Project Number 1190/005), 11 June 1998, SafePharm LaboratoriesLimited, Derby, UK
(Unpublished report provided by the notifier)
SEPPIC (2000a) Tolerance According to the HET-CAM Test on the Chorio-Allantoic Membrane of a Hen's
Egg, 4 October 2000, Societe d'Exploitation des Produits Pour l'Industrie Chimique S.A., Paris, France
(Unpublished report provided by the notifier)
SEPPIC (2000b) Tolerance According to RBCA Test on Red Blood Cells, 20 November 2000, Societe
d'Exploitation des Produits Pour l'Industrie Chimique S.A., Paris France (Unpublished report provided by
the notifier)
SEPPIC (2002) Melting Point Method 52-009 B, 18 November 2002, Societe d'Exploitation des Produits Pour
l'Industrie Chimique S.A., Paris, France (Unpublished report provided by the notifier)
SEPPIC (2004) Arachidyl Glucoside C20 Monoglucosides: n-octanol/water partition coefficients,
Adsorption/Desorption coefficients, 1 June 2004, Societe d'Exploitation des Produits Pour l'Industrie
Chimique S.A., Paris, France (Unpublished report provided by the notifier)
Soci閠?d'Elevage Piscicole Controle (1991) Test to Evaluate Biotic Degradation - Modified Sturm Test, 1
August 1991, Pontcharra-sur-turdine France (Unpublished report provided by the notifier)
USEPA (2005) Alkyl (C10 ?C16) Polyglycosides; Exemptions from the Requirement of a Tolerance. US
Environmental Protection Agency. Federal Register Environmental Documents. Federal Register: September
14, 2005 (Volume 70, Number 177). Page 54281-54286. Accessed via the Federal Register Online via GPO
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