File No STD/1071
June 2004
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Component of Caltex RPM Grease SRI 2
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification
and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of
Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered
by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational
health and safety. The assessment of environmental risk is conducted by the Department of the Environment and
Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
National Occupational Health and Safety Commission
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.
This Full Public Report is available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:
Street Address:
334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
Postal Address:
GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL:
+ 61 2 8577 8800
FAX
+ 61 2 8577 8888.
Website:
www.nicnas.gov.au
Director
Chemicals Notification and Assessment
TABLE OF CONTENTS
FULL PUBLIC REPORT ....................................................................................................................................... 4
1. APPLICANT AND NOTIFICATION DETAILS ...................................................................................... 4
2. IDENTITY OF CHEMICAL ...................................................................................................................... 4
3. COMPOSITION ......................................................................................................................................... 5
4. INTRODUCTION AND USE INFORMATION ....................................................................................... 5
5. PROCESS AND RELEASE INFORMATION .......................................................................................... 5
6. PHYSICAL AND CHEMICAL PROPERTIES ......................................................................................... 7
7. TOXICOLOGICAL INVESTIGATIONS .................................................................................................. 8
8. ENVIRONMENT ..................................................................................................................................... 11
9. RISK ASSESSMENT ............................................................................................................................... 13
10.
CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS ......................................................................................................................................................... 14
11.
MATERIAL SAFETY DATA SHEET ................................................................................................ 14
12.
RECOMMENDATIONS ...................................................................................................................... 14
13.
BIBLIOGRAPHY................................................................................................................................. 15
File No: STD/1071
June 2004
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Component of Caltex RPM Grease SRI 2
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification
and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of
Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered
by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational
health and safety. The assessment of environmental risk is conducted by the Department of the Environment and
Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
National Occupational Health and Safety Commission
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.
This Full Public Report is available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:
Street Address:
Postal Address:
TEL:
FAX
Website:
334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
+ 61 2 8577 8800
+ 61 2 8577 8888
www.nicnas.gov.au
Director
Chemicals Notification and Assessment
June 2004
NICNAS
FULL PUBLIC REPORT
Component of Caltex RPM Grease SRI 2
1.
APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Caltex Australia Petroleum Pty Ltd (ABN 17 000 032 128)
Level 12, MLC Centre
19 – 29 Martin Pl
SYDNEY NSW 2000
Australasian Lubricants Manufacturing Company (ACN 088 894 857)
Tanker St
LYTTON QLD 4178
NOTIFICATION CATEGORY
Standard: Chemical other than polymer (more than 1 tonne per year).
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
Data items and details claimed exempt from publication: chemical name, CAS No., molecular and
structural formulae, molecular weight, spectral data, purity, additives, manufacture and import
volumes and identity of manufacturing sites.
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
No variation to the schedule of data requirements is claimed.
Variation to the schedule of data requirements is claimed as follows: vapour pressure, water solubility,
hydrolysis as a function of pH, partition coefficient, adsorption/desorption, dissociation constant,
particle size, flash point, flammability limits, autoignition temperature, acute oral toxicity, acute
dermal toxicity, acute inhalation toxicity, skin irritation, eye irritation, skin sensitisation, repeated
dose toxicity, induction of point mutations, induction of germ cell damage, chromosomal damage, fish
acute toxicity, Daphnia acute toxicity, alga growth inhibition test, ready biodegradation.
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None.
NOTIFICATION IN OTHER COUNTRIES
None.
2.
IDENTITY OF CHEMICAL
MARKETING NAME(S)
The notified chemical is a component of Caltex RPM Grease SRI 2.
MOLECULAR WEIGHT
< 1000
METHODS OF DETECTION AND DETERMINATION
ANALYTICAL
METHOD
Remarks
Atomic and IR spectroscopy
An infrared (IR) spectrum was provided.
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June 2004
3.
NICNAS
COMPOSITION
DEGREE OF PURITY
High.
HAZARDOUS IMPURITIES/RESIDUAL MONOMERS
None.
NON HAZARDOUS IMPURITIES/RESIDUAL MONOMERS (>1% by weight)
None.
ADDITIVES/ADJUVANTS
The grease product of which the notified chemical is a component contains:
Distillates, petroleum, hydrotreated heavy paraffinic (CAS No. 64742-54-7)
Polyurea thickener
Additives
4.
> 80%
< 10%
< 10%
INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
The notified chemical will be imported as a component (at 1% (w/w)) of a grease product in 181 kg
metal, open head drums lined with a polyethylene liner.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year
Tonnes
1
< 10
2
< 10
3
< 10
4
< 10
5
< 10
USE
Grease component used for lubricating anti-friction ball, needle and roller bearings operating at high
speeds and high temperatures or where salt water may penetrate the bearings.
5.
PROCESS AND RELEASE INFORMATION
5.1.
Distribution, Transport and Storage
PORT OF ENTRY
Unknown.
IDENTITY OF MANUFACTURER/RECIPIENTS
Notifier.
TRANSPORTATION AND PACKAGING
The notified chemical will be transported as a component of grease in 181 kg metal drums to 3
repackaging sites in Perth, W.A., Newport, Victoria and Lytton, Queensland. It will be repackaged
into 181 kg drums, 20 kg pails, 2.5 kg tins and 450 gram plastic cartridges for transport to retailers.
5.2.
Operation Description
For repackaging the drum is opened and a drum pump inserted into the grease. The pump consists of a
rubber lid that holds the grease down while it is being pumped through a hose. The grease is drawn out
of the drum into a packaging machine. The packaging machine is fully automated and will fill the
various sized containers.
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June 2004
5.3.
NICNAS
Occupational exposure
Number and Category of Workers
Category of Worker
Transport and storage
Repackaging
Equipment cleaning
Laboratory staff
End users
Number
10 – 20
1 – 5 per site
1 – 5 per site
1 – 2 per site
> 1000
Exposure Duration
1 – 2 hours
0.5 – 1 hour
0.5 – 1 hour
0.25 hour
1 – 8 hours
Exposure Frequency
50 days/year
200 days/year
50 days/year
200 days/year
200 days/year
Exposure Details
The hoses are dedicated to each product. The metal fittings attached to the hoses are cleaned with
solvent before use, and the solvent goes to incineration. The drum pump and follower plate are wiped
clean with rags after each use. The rags are taken by a recycling company that cleans the rags with
solvent and the solvent is incinerated. The repackaging equipment is cleaned using cleaning rods, then
the next product is pushed through the equipment. Waste from this process is collected and used for
the lubrication of non-critical equipment. Dermal or ocular exposure to grease residues or greasecontaining solvent may occur but is controlled by the use of coveralls, safety boots and gloves.
Laboratory staff will take samples of the grease at the time of delivery and may be dermally exposed.
Such exposure will be limited to a few minutes per batch.
End users (auto mechanics, electric motor refurbishers and agricultural mechanics) will load grease
guns and apply grease to bearings. Exposure may occur during loading and use of the grease guns.
Workers will wear overalls, cotton hat and safety boots when handling the grease. Handling parts
which may have been in contact with grease is likely to be the route of maximum exposure. In all
cases exposure will be to formulated grease containing 1% (w/w) notified chemical.
5.4.
Release
RELEASE OF CHEMICAL AT SITE
Environmental release is unlikely during importation, storage and transportation, with spillage during
a transport accident the most likely reason for environmental release. Individual container capacity
(181 kg), container specifications (lined steel drums) and emergency procedures would limit the
extent of release. Significant release of the notified chemical during repackaging is unlikely due to the
minimal amount of handling required, environmental controls, wastewater and solid waste
management practices and spill response procedures. Spilled grease will be collected and reused. A
fraction of the grease containing the notified chemical may come into contact with worker clothing.
After washing of clothing, the notified chemical may subsequently be collected in wastewaters for
either on-site treatment at a wastewater treatment plant (WWTP) or sent to sewer for disposal.
RELEASE OF CHEMICAL FROM USE
The proposed use of the grease containing the notified chemical is unlikely to result in releases to the
environment, with the most likely release occurring due to accidental spillage of individual containers.
Equipment regreasing activities using a pneumatic grease gun may result in a proportion of the aged
grease being collected and discarded to landfill. A fraction of the grease containing the notified
chemical may come into contact with worker clothing. After washing of clothing, the notified
chemical may subsequently be collected in wastewaters and sent to sewer for disposal.
5.5.
Disposal
Drum liners will be removed and any grease residues attached to liners will be disposed of by
incineration (< 10 kg of notified chemical/year). The presence of liners should prevent drums being
contaminated with the grease. Emptied drums will be sent to commercial drum recyclers for steam
cleaning prior to reuse. Rags used to wipe down drum pumps, etc, will be recycled, cleaned in solvent,
with the solvent waste incinerated (< 10 kg/year). Solvents used to clean equipment at the repackaging
facility will be collected and incinerated (< 10 kg/year). Unwanted grease products, spilled material
and residues in emptied consumer products are likely to be sent to landfill for disposal (< 100 kg/year).
Greased machinery may eventually be recycled as metal scrap or sent to landfill for disposal. Wash
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June 2004
NICNAS
water from soiled clothing that potentially contain a small quantity of the notified chemical (eg. < 10
kg/year) may be sent to on-site WWTP and/or sewer for disposal.
5.6.
Public exposure
Consumer exposure to the grease containing the notified chemical can be high when car or truck
owners add grease to their wheel bearings or do their own repair work. Exposure to the notified
chemical is limited by its low concentration in the grease.
6.
PHYSICAL AND CHEMICAL PROPERTIES
No actual test results were provided and the following were estimated using the EPIWIN (EPI) computer
program: vapour pressure, water solubility, partition coefficient and adsorption/desorption.
Appearance at 20oC and 101.3 kPa
Grease containing the notified chemical has typical green
appearance.
Melting Point/Freezing Point
62oC
Density
1030 kg/m3 at 25oC
Vapour Pressure
METHOD
2.84 x 10-19 kPa at 25C
Estimated using the modified Grain Method.
Water Solubility
METHOD
8.35 x 10-12 to 6.2124 x 10-10 g/L at 25oC
Estimated using the WATERNT (v1.01) and WSKOW (v1.41) computer programs.
Hydrolysis as a Function of pH
REMARKS
Not likely to hydrolyse in the environmentally relevant pH range pH 4-9 since
there are no hydrolysable groups.
log Pow = 11.88 at 20oC
Partition Coefficient (n-octanol/water)
METHOD
Estimated using the KOWWIN v1.67 computer program. Will strongly partition to
octanol phase.
log Koc = 3.509 x 107
Adsorption/Desorption
METHOD
Estimated using the PCKOCWIN (v1.66) computer program. Expected to strongly
sorb to soils and sediments.
Test not conducted.
Dissociation Constant
REMARKS
Contains a carboxylic acid functionality that will dissociate at low pH.
Flash Point
Not determined.
Flammability Limits
Not flammable.
Autoignition Temperature
460oC (analogue chemical)
METHOD
DIN 51794
Explosive Properties
Reactivity
REMARKS
Not explosive.
Expected to be stable under normal environmental conditions. May react with
strong oxidising agents.
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June 2004
7.
NICNAS
TOXICOLOGICAL INVESTIGATIONS
Toxicity data are not available for the notified chemical. However, there are adequate data available for the
close analogues designated here as analogues A, B and C. Data for acute dermal toxicity and chromosomal
damage are not available for the analogues, however, if the notified chemical is to be imported at
concentrations above 1%, data covering these endpoints may need to be supplied (see section 12.1 Secondary
notification).
Endpoint and Result
Rat, acute oral LD50 > 25 mL/kg bw (analogue A); LD50 > 10 g/kg bw
(analogue C)
Rabbit, skin irritation (analogue A)
Rabbit, eye irritation (analogue A)
Contact allergy in humans(analogue B)
Rat, feeding study, 13 weeks (analogue B)
Rat, feeding study, 3 months (analogue C)
Genotoxicity - bacterial reverse mutation (analogues B and C)
Genotoxicity – in vitro chromosomal aberrations (analogue B)
Genotoxicity – in vivo mouse micronucleus test (analogue B)
Developmental and reproductive effects (analogues B and C)
Carcinogenicity (analogue C)
7.1.
Assessment Conclusion
low toxicity
slightly irritating
slightly irritating
evidence of sensitisation
NOAEL = 2.5% in the diet
NOEL = 2500 mg/kg/day bw
non mutagenic
non genotoxic
non genotoxic
negative
negative
Acute toxicity – oral
Analogue A in doses of 12.5, 20.0 and 25.0 mL/kg was administered to groups of 10 mice. In the 20.0 mL/kg
group one mouse died within 24 hours; in the 25.0 mL/kg group two mice died between days 4 and 7 preceded
by a loss of body weight (in common with other test animals). It was concluded that the LD50 value for
Analogue A was greater than 25.0 mL/kg. Therefore the test substance can be considered to be of low acute
toxicity via the oral route (CIR, 1988).
Analogue C was administered to albino rats at doses of 0.05 to 10.0 g/kg at 25% in corn oil. The LD50 was
greater than 10.0 g/kg (CIR, 1982).
7.2.
Irritation – skin
A 0.5 mL sample of analogue A was applied to the skin of 4 New Zealand White rabbits under occlusive patch
for 24 hours. Two of the rabbits had very slight erythema at 24 hours and 1 rabbit had well-defined erythema.
The remaining rabbit had no reactions. The test substance was judged to be mildly irritating to the skin (CIR,
1988).
Undiluted analogue A (5.0 g) was applied to 6 New Zealand White rabbits under composite dressings for 24
hours. No reactions were noted up to 72 hours after patch removal and the test substance was judged to be nonirritant (CIR, 1988).
Products containing 5.6% analogue A were evaluated as single insult under occlusive patch in 2 studies of 20
and 19 panellists and found not to be irritating (CIR, 1988).
Analogue C (0.5 g) applied under occlusive patch for 4 hours or 24 hours to 6 albino rabbits was not irritating
(CIR, 1982).
7.3.
Irritation - eye
Mild irritation of the conjunctiva lasting no longer than 24 hours was observed up to 7 days after 0.1 mL of
analogue A instilled into one eye of 3 New Zealand White rabbits (CIR, 1988).
A further study of 6 New Zealand White rabbits involved checking corneal opacity at 24, 48 and 72 hours
visualised by fluorescein dye after instillation of 0.10 g of analogue A into the conjunctival sac of one eye. No
irritation was detected (CIR, 1988).
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June 2004
NICNAS
Analogue C applied to eyes of 6 albino rabbits was not irritating up to day 3 after instillation (CIR, 1982).
7.6.
Skin sensitisation
Two cases of contact allergy to analogue B in cosmetics have been reported (Brandle et al., 1983; Sai, 1983).
7.7.
Repeat dose toxicity
F344/N rats or B6C3F1 mice (10/sex) were fed analogue B continuously in the diet for 13 weeks at 0, 0.62,
1.25, 2.5, 5.0 or 10% (NTP, 1992).
For the rats there was no effect on body weight or survival. Haematological effects in male rats not thought to
be biologically significant included a slight decrease in MCHC at day 21 at the high dose, a statistically
significant decrease in MCV at the high dose, a decrease in MCH in the 5% and 10% groups and an increase in
platelets in the 1.25%, 5% and 10% groups. In females there was a statistically significant decrease in
reticulocyte counts at day 5 in groups receiving 0.62% or 10%. For clinical chemistry parameters at treatment
and dose-related increase in serum alkaline phosphatase was observed in male and females at days 5, 21 and
termination. Total bile acids were increased in males receiving the higher dietary levels at days 5 and 21 but not
at termination. Other minor changes were recorded but were isolated. Absolute liver weights and liver to body
weight ratio were increased in high dose male rats. Heart to body weight ratios were increased in males
receiving 0.62%, 5% and 10% but absolute weights were not. The organ changes had no histopathological
correlates.
Screening for reproductive toxicity involved checking sperm motility and morphology and vaginal cytology. A
slight decrease in epididymal weight that occurred in the middle and high dose groups but was not dose-related.
There were no other reproductive effects.
There was no effect of treatment on survival of the mice and high dose male exhibited lower body weight from
week 3 to the end of the study. Liver weights were higher in animals receiving 5% or 10% test substance and
kidney weights were elevated in females at these doses. There were no histopathological correlates. Analogue B
had no effect on any male (testes weight, epididymal sperm motility, density or testicular spermatid head count)
or female (estrual cycle length or time spent in each phase of the cycle) reproductive parameter.
Analogue C was fed to groups of male and female outbred Wistar/Af/Han/Mol (Han 67) rats (20/sex) at levels
of 0, 5, 10 and 20% in a semisynthetic diet for 3 months (Søndergaard et al., 1980). Decreased weight gain
occurred in high dose males and stone formation (due to high magnesium diet) was observed in the low urinary
tract of 8 males and 7 females of the high dose group. Reduced liver weights were seen in males of the 10% and
20% groups and an increase in iron was found in the livers of the 20% group. The no effect level was estimated
as 2500 mg/kg/day bw based on the liver effects.
7.8.
Genotoxicity - bacteria
Analogue C was not mutagenic in Salmonella typhimurium TA 1535, TA 1537 or TA 1538 or in
Saccharomyces cerevisiae D4 with or without metabolic activation by liver and lung preparations from rats,
mice and monkeys (Litton Bionetics, 1976).
Analogue B was negative in a Salmonella mutagenicity test conducted by the US National Toxicology Program
(NTP, 1992). Strains TA 100, TA 1535, TA 97 or TA 98 were tested with a preincubation protocol in the
presence or absence of metabolic activation (S9) at 100 – 10000 g/plate.
7.9.
Genotoxicity – in vitro
Analogue B was negative in vitro in tests for chromosomal aberrations and sister chromatid exchange in
Chinese Hamster ovary cells conducted by the US National Toxicology Program (NTP, 1992) at concentrations
up to 5000 g/mL.
7.10. Genotoxicity – in vivo
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NICNAS
Analogue B was negative in vivo in a mouse micronucleus test conducted by the US National Toxicology
Program (NTP, 1992). Peripheral blood erythrocytes were sampled from B6C3F1 mice+ at the termination of
the 13-week repeated dose study described above.
7.11.
Developmental toxicity
A vehicle used in coated pharmaceutical tablets, containing 5.5% analogue C was assayed for teratogenicity in
rabbits. Fourteen females received the test substance orally at 2.5 mg/kg 70 hours post coitus and 13 females
were given the same dose 192 hours post coitus. The absence of teratogenesis was indicated by 11% anomalies
in the offspring of 16 untreated mothers as against 11% and 12% anomalies in the treated groups (dosed at 70
and 192 hours hours post coitus, respectively) (CIR, 1982).
7.12.
Chronic toxicity/carcinogenicity
Pellets of analogue C implanted in the bladders of 41 mice for 30 weeks produced a 5% incidence of bladder
tumours, similar to the 4% incidence in 67 mice implanted with smooth glass beads (CIR, 1982).
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June 2004
8.
ENVIRONMENT
8.1.
Environmental fate
NICNAS
8.1.1.
Biodegradable.
Ready biodegradability
Test not conducted. Estimated using the BIOWIN (v4.01) computer program. Estimates of
biodegradability using EPI suite model indicate that biodegradation will be rapid.
8.1.2.
Bioaccumulation
Tests not conducted. Based on the high log P ow of 11.88 and very low water solubility, the
notified chemical is unlikely to bioaccumulate.
8.2.
Ecotoxicological investigations
8.2.1.
Acute toxicity to fish
TEST SUBSTANCE
FM Grease EP NLGI (contains 5% notified chemical).
METHOD
USEPA (1993) Methods for measuring the acute toxicity of effluents and
receiving waters to freshwater and marine organisms (EPA/600/490/027F)
Rainbow trout (Onchorhynchus mykiss)
96 hours
None
38 - 49 mg CaCO3/L
Dissolved oxygen (DO), pH, and conductivity measured before, during
and after tests, as well as alkalinity and hardness. Test temp. 12.4 - 13C,
pH 7.4 - 8.0, DO 6.7 - 8.7 mg/L – acceptable.
WAF loading rate was 1000 mg/L. WAF was obtained by smearing
grease (3.5 g) onto the inside of a WAF jar containing 3.5 L of spring
water, and stirred at 21C for 24 hours in a sealed container. 1 hour after
stirring, 3 L of the 100% WAF solution was pipetted from inside the jar
(first 20-30 mL rejected) to a 4 L jar for use in the tests. Photoperiod: 16
hours light:8 hours dark. 23 day old trout.
Species
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks – Method
RESULTS
Concentration mg/L
Nominal
0
1000 mg/L WAF
LC50
NOEC (or LOEC)
Remarks – Results
CONCLUSION
TEST FACILITY
Number of Fish
10
10
% Survival
96 h
100
80
> 1000 mg/L WAF at 96 hours
1000 mg/L WAF at 96 hours.
The treatment result was not significantly less than that for the control
(P > 0.05).
The test material is not toxic to rainbow trout up to the limit of its water
solubility.
Pacific EcoRisk, California, USA (2000b).
8.2.2. Acute toxicity to aquatic invertebrates
TEST SUBSTANCE
FM Grease EP NLGI (contains 5% notified chemical).
METHOD
USEPA (1993) Methods for measuring the acute toxicity of effluents and
receiving waters to freshwater and marine organisms (EPA/600/490/027F)
Daphnia magna
Species
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June 2004
Exposure Period
Auxiliary Solvent
Water Hardness
Analytical Monitoring
Remarks - Method
NICNAS
48 hours
None
42-94 mg CaCO3/L (100 mg/L WAF test). 35-49 mg CaCO3/L (1000
mg/L WAF test).
Dissolved oxygen (DO), pH, and conductivity measured before, during
and after tests, as well as alkalinity and hardness. Test temp. ~ 19-21.5C,
pH 7.1 - 8.1, DO 6.5 - 8.7 mg/L – acceptable.
WAF loading rates were 100 and 1000 mg/L. WAF was obtained by
smearing grease (0.35 and 3.5 g) onto the insides of WAF jars containing
3.5 L of spring water, and stirred at 21C for 24 hours in a sealed
container. 1 hour after stirring, 3 L of the 100% WAF solution was
pipetted from inside the jar (first 20 - 30 mL rejected) to a 4 L jar for use
in the tests. It is not stated whether the test solutions were clear or cloudy
(caused by globules of grease). Photoperiod: 16 hours light: 8 hours dark.
Neonates < 24 h old.
RESULTS
Concentration mg/L
Nominal
0
100 mg/L WAF
1000 mg/L WAF
Number of D. magna
10
10
10
% Survival
48 h
100
80
30*
* Significantly different from control (P<0.05%; ToxCalc v5.0).
LC50
NOEC
CONCLUSION
TEST FACILITY
>100 - <1000 mg/L WAF at 48 hours
100 mg/L WAF at 48 hours
The test material shows some toxicity to Daphnia magna below the limit
of water solubility; however, a physical effect may also be possible.
Pacific EcoRisk, California, USA (2000a, b).
8.2.3.
Algal growth inhibition test
Test not conducted. No significant toxicity to algae or plants is expected (expected EC50 >
1000 mg/L). Components of the notified chemical are essential for plant growth, and the notified
chemical has a plant origin with no phytotoxicity.
8.2.4.
Inhibition of microbial activity
Test not conducted.
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NICNAS
9.
RISK ASSESSMENT
9.1.
Environment
9.1.1.
Environment – exposure assessment
The grease containing the notified chemical will be imported into Australia for repackaging at
one facility prior to widespread and diffuse use throughout Australia. Environmental release of
the grease is expected to be limited during repackaging and use in mechanical applications.
Most waste grease containing the notified chemical is likely to be sent to landfill for disposal
where the notified chemical is not expected to migrate and will degrade over time to simpler
compounds of the constituent elements. Landfilled wastes are not likely to pose an unacceptable
risk to the environment. Wastes generated during repackaging are collected and incinerated. A
very small quantity of the notified chemical (eg. < 10 kg grease/year) may enter the sewerage
system from clothing wash waters. An average solution concentration of approximately 10 -9
mg/L is anticipated, assuming a national wastewater volume of 3900 ML/day and no sewerage
system attenuation. Releases to sewer are likely to attenuate within the sewerage system, with
most partitioning to solids and retained as biosolids.
9.1.2.
Environment – effects assessment
Aquatic toxicity data indicate that the WAF from grease containing 5% of the test material
shows some toxicity to Daphnia magna below its limit of water solubility; however, a physical
effect may also be possible. The notified chemical has a very low water solubility, low affinity
for octanol (log Kow estimated as 11.88) and is unlikely to bioaccumulate.
9.1.3.
Environment – risk characterisation
On the basis of the reported use pattern and expected waste management practices, the notified
chemical is not considered to pose an unacceptable risk to the environment.
9.2.
9.2.1.
Human health
Occupational health and safety – exposure assessment
Workers involved in testing and repackaging imported grease can be expected to be dermally
and, to a lesser extent, ocularly exposed on an intermittent basis. The grease can remain on the
skin for an extended period of time given its viscous nature. However, exposure to the notified
chemical in these circumstances is low as it comprises 1% (w/w) of the imported grease.
End users can be exposed to grease readily while handling machine parts but again, the exposure
level is low.
9.2.2.
Public health – exposure assessment
The public can be exposed to the grease when performing repairs or maintenance on vehicles
but the exposure to the notified chemical is limited by its low concentration in the grease.
9.2.3.
Human health - effects assessment
Data on analogues suggests the notified chemical is of low toxicity via the oral route, is a slight
skin and eye irritant, exhibits limited evidence of skin sensitisation and is neither genotoxic,
reprotoxic nor carcinogenic. Repeated dose studies with analogue B and analogue C did not
indicate significant organ toxicity.
9.2.4.
Occupational health and safety – risk characterisation
The low concentration of notified chemical in the imported grease coupled with a predicted
benign toxicity profile suggests there is minimal risk of adverse health effects to workers
handling the grease.
9.2.5.
Public health – risk characterisation
The risk to the public of adverse health effects from using the imported grease for vehicle repairs
and maintenance is expected to be low given the low and intermittent exposure and low
concentration of the notified chemical in the grease.
FULL PUBLIC REPORT: STD/1071
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June 2004
10.
NICNAS
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 hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances or using the Globally
Harmonised System for the Classification and Labelling of Chemicals (GHS) (United Nations,
2003).
10.2. Environmental risk assessment
The 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 Negligible Concern to public health when used as indicated.
11.
MATERIAL SAFETY DATA SHEET
11.1. Material Safety Data Sheet
The MSDS for the imported product containing the chemical provided by the notifier was in
accordance with the NOHSC National Code of Practice for the Preparation of Material Safety
Data Sheets (NOHSC, 2003). It is published here as a matter of public record. The accuracy of
the information on the MSDS remains the responsibility of the applicant.
11.2. Label
The label for the imported product containing the chemical provided by the notifier w 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

A copy of the MSDS should be easily accessible to employees.

If products and mixtures containing the notified chemical are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
Disposal

The notified chemical should be disposed of by incineration or to landfill in accordance
with State/territory waste management regulations.
Emergency procedures
FULL PUBLIC REPORT: STD/1071
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June 2004
NICNAS

Spills/release of the notified chemical should be handled by isolating the spill area,
scooping or wiping spilled material into a labelled container. Scrub spill area with
detergent and water. Minimise entry of spilled material into sewers and drainage
systems. Prevent entry by unauthorised persons to spill area. Prevent run-off to
groundwater or stormwater.
12.1. Secondary notification
The Director of Chemicals Notification and Assessment must be notified in writing within 28
days by the notifier, other importer or manufacturer:
(1) Under Section 64(1) of the Act; if
 uses are proposed which will result in a much higher release to the aquatic
compartment, a full suite of aquatic toxicity data for sensitive aquatic organisms
representative of receiving environments (eg. waterfleas, algae) using appropriately
sensitive test endpoints may be required as part of a secondary notification.
 the concentration of the notified chemical in the imported product is likely to
exceed 1% (v/v)
or
(2) Under Section 64(2) of the Act:
 if any of the circumstances listed in the subsection arise.
The Director will then decide whether secondary notification is required.
No additional secondary notification conditions are stipulated.
13.
BIBLIOGRAPHY
Brandle I, Boujnah-Khouadja A and Foussereau J (1983) Allergy to Castor Oil. Contact Dermatitis, 9: 424 – 5.
CIR (1982) Final Report of the Safety Assessment of Lithium Stearate, Aluminium Distearate, Aluminium
Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate
and Zinc Stearate. J. Am. Coll. Toxicol., 1: 143 – 177.
CIR (1988) Final Report of the Safety Assessment of Glyceryl Ricinoleate. J. Am. Coll. Toxicol., 7: 721 – 739.
Litton Bionetics (1976) Mutagenic Evaluation of Compound FDA 75-33 0057-04-0 Magnesium Stearate. LBI
Project No. 2468. Litton Bionetics, Maryland, USA (unpublished report submitted by notifier).
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 (2003) National Code of Practice for the Preparation of Material Safety Data Sheets, 2 nd edn
[NOHSC:2011(2003)]. National Occupational Health and Safety Commission, Canberra, Australian Government
Publishing Service.
NTP (1992) NTP Technical Report on the Toxicity Studies of Castor Oil in F344/N Rats and B6C3F1 Mice
(Dosed Feed Studies). Report No. NIH/PUB-92-3131. NTP-TOX-12. National Toxicology Program, NC, USA.
Pacific EcoRisk (2000a) Aquatic Toxicity of the “Water Accommodated Fraction” Produced from a Grease
Product (FM Grease EP NLGI 2) to Daphnia magna: Loading Rate = 100 mg/L. Pacific EcoRisk, Martinez,
California, USA (unpublished report submitted by notifier).
Pacific EcoRisk (2000b) Revised Report: Aquatic Toxicity Screening of the “Water Accommodated Fraction”
Produced from a Grease Product (FM Grease EP NLGI 2). Pacific EcoRisk, Martinez, California, USA
(unpublished report submitted by notifier).
Sai, S (1983) Lipstick Dermatitis Caused by Castor Oil. Contact Dermatitis, 9: 75.
FULL PUBLIC REPORT: STD/1071
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June 2004
NICNAS
Søndergaard D, Meyer O and Würtzen G (1980) Magnesium Stearate Given Perorally to Rats. A Short Term
Study. Toxicology, 17: 51 – 55.
United Nations (2003) Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
United Nations Economic Commission for Europe (UN/ECE), New York and Geneva.
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