Disodium Wheatgermamphodiacetate
File No: NA/601
May 1998
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
Disodium Wheatgermamphodiacetate
T h i s Assessment has been compiled in accordance with the provisions of the
Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), and
R e g u l a t i o n s . This legislation is an Act of the Commonwealth of Australia. The
National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is
administered by the National Occupational Health and Safety Commission which
also conducts the occupational health & safety assessment. The assessment of
environmental hazard is conducted by the Department of the Environment and the
assessment of public health is conducted by the Department of Health and Family
Services.
For the purposes of subsection 78(1) of the Act, copies of this full public report may
be inspected by the public at the Library, National Occupational Health and Safety
C o m m i s s i o n , 92-94 Parramatta Road, Camperdown NSW 2050, between the
following hours:
Monday - Wednesday 8.30 am - 5.00 pm
Thursday 8.30 am - 8.00 pm
Friday 8.30 am - 5.00 pm
Copies of this full public report may also be requested, free of charge, by
contacting the Administration Coordinator on the fax number below.
For enquiries please contact the Administration Coordinator at:
Street Address: 92 Parramatta Rd Camperdown, NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, Sydney 2001, AUSTRALIA
Telephone: (61) (02) 9577-9466 FAX (61) (02) 9577-9465
Director
Chemicals Notification and Assessment
NA/601
Disodium Wheatgermamphodiacetate
1. APPLICANT
Bristol-Myers Squibb Australia Pty Ltd of 320 Victoria Road RYDALMERE NSW
2116 has applied for the following information relating to `disodium
wheatgermamphodiacetate'. No application for exempt information was submitted
by the notifier and the report is published here in its entirety.
2. IDENTITY OF THE CHEMICAL
Chemical Name: imidazolium compounds, 1-(2-
(carboxymethoxy)ethyl)-1-(carboxymethyl)-4,5-
dihydro-2-norwheatgerm oil alkyl, hydroxides,
inner salts, disodium salts
Chemical Abstracts Service
(CAS) Registry No.: not assigned
Other Names: disodium wheatgermamphodiacetate
Trade Name: MACKAM 2W
Molecular Formula: A representative molecular formula based on the
predominant fatty acid (linoleic acid) would be:
C26H44N2O6.2Na
Structural Formula:
O
C
? +
O
H O Na
R N
C N
O O
C
+
?br>
O Na
R
C
Where represents the fatty acids derived from wheatgerm oil
O
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Molecular Weight: the molecular weight corresponding to the
representative molecular formula is 527 g.mol-1;
the molecular weight range for the constituents is
525-531 g.mol-1.
Weight Percentage of
Ingredients: 100%
Chemical Name CAS No. Weight %
saturated fatty acids (eg stearic acid) - 15
112-80-1
oleic acid 30
linoleic acid 60-33-3 44
linolenic acid 463-40-1 11
Method of Detection infra-red spectral data has been provided for the
and Determination: chemical
Spectral Data: 1 600 and 1 650 cm-1 (secondary amide)
700 and 3 020 cm-1 (cis C-C bonds)
1 450 and 1 600 cm-1 (carboxylic acid)
1 200 cm-1(tertiary amine)
1 150 cm-1 (ether)
2 900 cm-1 (carbon-hydrogen bonds)
3. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20癈 clear amber viscous liquid with a mild organic
and 101.3 kPa: odour
Boiling Point: ~105癈
Specific Gravity: 1.02
Vapour Pressure: not determined (see comments below)
Water Solubility: ~ 40% (see comments below)
Partition Co-efficient
(n-octanol/water): log P ow ~ 0.5
Hydrolysis as a Function stated to be stable over a pH range of 3-11;
of pH: outside this range it hydrolyses to the fatty acids
of wheat germ oil and a chelating agent
Adsorption/Desorption: not determined (see comments below)
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Dissociation Constant: not determined (see comments below)
Flash Point: not determined - notified chemical is an aqueous
solution
Flammability Limits: not determined - notified chemical is an aqueous
solution
Autoignition Temperature: > 350癈
Explosive Properties: not explosive
Reactivity/Stability: non-reactive
Comments on Physico-Chemical Properties
As the notified chemical is a disodium salt of a high molecular compound its
vapour pressure is expected to be low.
No reports to support the water solubility and partition co-efficient were provided.
Hence, the method by which these values were derived is unknown. As the
chemical contains both polar and non polar moieties, it is likely that the chemical
will display some surface activity. It is noted that any surface activity would affect
the measurement of the partition co-efficient.
No data were provided for the adsorption/desorption behaviour of the notified
chemical. Based on the high water solubility and low partition coefficient the
chemical should not bind strongly to organic matter in the soil and may potentially
be mobile. However, any surface activity would increase the binding of the
chemical to soils and sediments.
The notified chemical contains a tertiary amine functionality and carboxylate
funtionalities that are expected to have typical basicity. The conjugate carboxylic
acid form of the notified chemical would be expected to display typical acidity.
4. PURITY OF THE CHEMICAL
Degree of Purity: > 99.9%
Toxic or Hazardous
Impurities:
Chemical name: chloroacetic acid
CAS No.: 79-11-8
Weight percentage: < 100 ppm
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toxic by inhalation; toxic in contact with the skin;
Toxic properties:
toxic if swallowed;causes severe burns [1]
Non-hazardous Impurities
(> 1% by weight): none
Additives/Adjuvants: 3.04%
Chemical name: hexylene glycol
CAS No.: 107-41-5
Weight percentage: 3%
Toxic Properties: irritating to eyes and skin [1]
25 ppm (TWA); peak limitation 121 mg.m-3
Exposure Standard:
(STEL) [2]
Chemical name: glycolic acid (formed by the breakdown of
hexylene glycol)
Weight percentage: <4%
CAS No.: 79-14-1
Chemical name: butylated hydroxytoluene
Synonyms 2,6-di-tert-butyl-p-cresol
CAS No.: 128-37-0
Weight percentage: 0.02%
10 mg.m-3 (TWA) [2]
Exposure Standard
Chemical name: hypophosphorous acid
CAS No.: 14332-09-3
Weight percentage: 0.02%
5. USE, VOLUME AND FORMULATION
The notified chemical will not be manufactured in Australia. It will be imported as a
25% component of the product, Mackam 2W, in 200 L closed head plastic High
Density Polyethylene drums. Import volumes for the notified chemical are expected
to be around 200 kg per annum over the first five years.
The product, Mackam 2W, containing the notified chemical will be reformulated into
a hair care product at a concentration below 1%. The hair care product will be
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NA/601
packaged in 14 mL sachets and will form part of a hair colourant kit. It is likely that
the kits will be used at 4 to 6 weekly intervals by an individual.
6. OCCUPATIONAL EXPOSURE
The notified chemical will be stored in sealed unbreakable containers. Worker
exposure should not occur during transportation and storage unless packaging is
breached. This phase of operation occurs 25 days per year for approximately 2
hours per day.
Workers involved in quality assurance will manually remove appropriate quantities
of the notified chemical for analysis. There is potential for exposure of these
workers primarily via dermal contact.
Dispensing of the notified chemical involves insertion of a tap into elevated 200 L
containers, and manual decanting of required amounts of the notified chemical
into 50 L containers. The dispensing area is subject to cross flow ventilation. The
closed 50 L containers are taken by trolley to the formulation area where the
notified chemical is transferred to the blending vessels under local exhaust
ventilation. Operators engaged in dispensing of the 25% aqueous solution of
notified chemical for formulation are at most risk of exposure, primarily via dermal
contact. All workers may be subjected to ocular exposure, however given the
viscous properties of the notifed chemical, it is not so likely that splashes would
reach the eye. Exposure by inhalation should be negligible on account of the
predicted low vapour pressure of the notified chemical.
7. PUBLIC EXPOSURE
The notified chemical is reformulated into hair care preparations at a level of less
than 1%. One application would contain less than 0.14 g of the notified chemical,
and would be used once every 4 to 6 weeks. In addition, products containing the
notified chemical would only be used by a proportion of members of the public who
use hair colourant kits and the associated rinse-off hair conditioning products.
Although there will be public exposure to the notified chemical, this will be low and
restricted given that the concentration of the notified chemical in the products is
low, the amount of product used is small and the use is relatively infrequent.
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8. ENVIRONMENTAL EXPOSURE
Release
Releases to the environment should be limited to those that occur during
formulation and use. The formulation and packaging of the hair care products are
to be performed in a closed system. During formulation and packaging of the hair
care products the equipment used is expected to be washed and cleaned
occasionally. The company has indicated that these washings will be disposed of
through the plant's liquid waste treatment facility and will subsequently be
discharged to the sewer. The notifier estimates that such waste would account for
less than 1 kg of the notified chemical per annum.
The notifier has estimated that a maximum of 500 g of the product, Mackam 2W,
will remain in the import drums after use. At the proposed maximum import of the
product this would correspond to a maximum of 1.5 kg of the product (375 g of the
notified chemical) per annum. The drums will either be recycled in-house or sold
to a drum recycling company.
The hair care products containing the notified chemical are expected to be used in
bathrooms and other wet areas throughout Australia. All of the product is expected
to enter the sewers from these wet areas and to be treated with the sewage before
being released to the environment.
Fate
Mackam 2W is intended for use in hair care products and is expected to be
released to the environment via consumer use through rinsing the chemical from
the hair and into the sewerage system. In the sewer, it is anticipated that some
would adsorb to sewage sludge due to the expected surface active nature of the
chemical. The sludge will either be sent to landfill or be incinerated. Incineration
products will include water and oxides of carbon and nitrogen.
The biodegradability of the notified polymer was not determined. This is
acceptable for polymers with import volumes less than 1 tonne per year according
to the Act.
No bioaccumulation of the chemical is expected because its very high water
solubility and low octanol/water partition co-efficient.
9. ASSESSMENT OF TOXICOLOGICAL EFFECTS
No toxicological information was submitted with the notification statement as this
is not a requirement for chemicals imported at less than one tonne per annum
according to the Act.
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10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
No ecotoxicological information was submitted with the notification statement as
this is not a requirement for chemicals imported at less than one tonne per annum
according to the Act. Calculation of acute toxicity data for the linoleic acid
component in acid form yielded LC50 values for fish and daphnia between 1 and 5
mg.L-1.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The vast majority of notified polymer will be discharged to sewer through product
use. As the product will be available nationwide, and sent to sewage treatment
plants in both city and country locations, a predicted environmental concentration
(PEC) based on continental use has been calculated:
Import Volume per annum 200 kg
Amount discharged to sewer 100%
Volume discharged per day 0.55 kg
Sewer output per day* 2 700 ML
0.20 礸.L-1 (ppb)
Concentration in Sewage Treatment Plant
*Sewer output based on an Australian population of 18 million, each using 150 L water per day.
The notifier has estimated that 40% of the product containing the notified chemical
will be sold in Sydney. A predicted environmental concentration (PEC) based on
Sydney's water use for the year ending 1996 has been calculated:
Volume Sold in Sydney per annum 80 kg
Amount discharged to sewer 100%
Volume discharged per day 0.22 kg
Sewer output per day 1 050 ML
0.21 礸.L-1 (ppb)
Concentration in Sewage Treatment Plant
The widespread use, and the resultant low concentration of the chemical in
surface waters (well below the estimated toxicities for fish and daphnia) indicates
that the overall environmental hazard of the notified chemical can be rated as low.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
No toxicological information was submitted for the notified chemical. However, as
it is a typical surface active material with a pH ranging from 8 to 10 it has the
potential to cause eye and skin irritation. Airborne mist or spray has the potential
to irritate the respiratory tract. On this basis the notified chemical would be
classified as hazardous according to the criteria of the National Occupational
Health and Safety Commission.
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Workers handling the pre-formulated notified chemical (as a viscous 25% liquid)
are at most risk of exposure and any consequent adverse health effects. Workers
may become contaminated by spills or drips. Given the viscous nature of the
chemical, splashing resulting in either skin or eye contact is unlikely to be a major
means of exposure. Chances of exposure should also be reduced if workers are
equipped with suitable industrial clothing, gloves and goggles. Formulation will be
carried out in a closed system and will be carried out under conditions designed
not to create aerosols (sampling,dispensing and transfer). Accordingly, the risk of
adverse effects on the respiratory system of workers conducting these tasks is
likely to be negligible. Both hexylene glycol and butylated hydroxytoluene
(ingredients in the mixture containing the notified chemical) have a National
Occupational Health and Safety Commission exposure standard [2]. Employers
are responsible for ensuring that these exposure standards are not exceeded.
Public contact with the notified chemical will occur, albeit it at relatively low
concentrations (less than 1%), of short duration and of intermittent frequency.
Provided that the products containing the notified chemical are rinsed-off, the risk
of adverse health effects in users appears to be negligible
13. RECOMMENDATIONS
To minimise occupational exposure to disodium wheatgermamphodiacetate the
following guidelines and precautions should be observed:
Safety goggles should be selected and fitted in accordance with Australian
?br>
Standard (AS) 1336 [3] to comply with Australian/New Zealand Standard
(AS/NZS) 1337 [4];
Industrial clothing should conform to the specifications detailed in AS 2919
?br>
[5];
Impermeable gloves or mittens should conform to AS 2161 [6];
?br>
All occupational footwear should conform to AS/NZS 2210 [7];
?br>
Workers handling the formulation should also be informed that it contains
?br>
hexylene glycol and hydroxybutylated toluene, both of which have exposure
standards set by the National Occupational Health and Safety Commission
[2];
Spillage of the notified chemical should be avoided. Spillages should be
?br>
cleaned up promptly with absorbents which should then be put into
containers for disposal;
Good personal hygiene should be practised to minimise the potential for
?br>
ingestion;
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A copy of the MSDS should be easily accessible to employees.
?br>
14. MATERIAL SAFETY DATA SHEET
The MSDS for the notified chemical was provided in accordance with the National
Code of Practice for the Preparation of Material Safety Data Sheets [8].
This MSDS was provided by the applicant as part of the notification statement. It is
reproduced here as a matter of public record. The accuracy of this information
remains the responsibility of the applicant.
15. REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, secondary notification of the notified chemical shall be required if
any of the circumstances stipulated under subsection 64(2) of the Act arise. In
particular, Environment Australia would require the notifier to supply test reports for
physico-chemical results, full aquatic toxicity data and biodegradation studies if
annual import quantities exceed 1 tonne. No other specific conditions are
prescribed.
16. REFERENCES
1. National Occupational Health and Safety Commission, List of Designated
Hazardous Substances [NOHSC:10005(1994)]. 1994, Canberra: Australian
Government Publishing Service.
2. National Occupational Health and Safety Commission, Adopted National
Exposure Standards for Atmospheric Contaminants in the Occupational
Environment, [NOHSC:1003(1995)], in Exposure Standards for Atmospheric
Contaminants in the Occupational Environment: Guidance Note and
National Exposure Standards. 1995, Australian Government Publishing
Service: Canberra.
3. Standards Australia, Australian Standard 1336-1994, Eye protection in the
Industrial Environment. 1994, Sydney: Standards Association of Australia.
4. Standards Australia/Standards New Zealand, Australian/New Zealand
Standard 1337-1992, Eye Protectors for Industrial Applications. 1992,
Sydney/Wellington: Standards Association of Australia/Standards
Association of New Zealand.
5. Standards Australia, Australian Standard 2919-1987, Industrial Clothing.
1987, Sydney: Standards Association of Australia.
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6. Standards Australia, Australian Standard 2161-1978, Industrial Safety
Gloves and Mittens (excluding electrical and medical gloves). 1978, Sydney:
Standards Association of Australia.
7. Standards Australia/Standards New Zealand, Australian/New Zealand
Standard 2210-1994, Occupational Protective Footwear. 1994,
Sydney/Wellington: Standards Association of Australia/Standards
Association of New Zealand.
8. National Occupational Health and Safety Commission, National Code of
Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(1994)]. 1994, Canberra: Australian Government Publishing
Service.
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