March 2004
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
C9417This 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 3
1. APPLICANT AND NOTIFICATION DETAILS 3
2. IDENTITY OF CHEMICAL 3
3. COMPOSITION 3
4. INTRODUCTION AND USE INFORMATION 4
5. PROCESS AND RELEASE INFORMATION 4
6. PHYSICAL AND CHEMICAL PROPERTIES 6
7. TOXICOLOGICAL INVESTIGATIONS 7
8. ENVIRONMENT 14
9. RISK ASSESSMENT 15
10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 17
11. MATERIAL SAFETY DATA SHEET 17
12. RECOMMENDATIONS 17
13. BIBLIOGRAPHY 19
March 2004 NICNAS
FULL PUBLIC REPORT
C94171. APPLICANT AND NOTIFICATION DETAILS
1.1 / Applicant(s)Infineum Australia Pty Ltd (ABN 24084881863)
2/6 Riverside Quay
SOUTHBANK VIC 3006
1.2 / Notification Category
[Delete as appropriate]
Standard: Chemical other than polymer (more than 1 tonne per year).
1.3 / Exempt Information (Section 75 of the Act)
[Delete as appropriate]
Data items and details claimed exempt from publication: chemical name, CAS No., molecular and structural formulae, molecular weight, spectral data, purity, precise concentration in the additive package and final product and import volume.
1.4 / Variation of Data Requirements (Section 24 of the Act)
[Delete as appropriate]
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, flammability, autoignition temperature, skin irritation, skin sensitisation, induction of point mutations and chromosome damage.
1.5 / Previous Notification in Australia by Applicant(s)
None.
1.6 / Notification in Other Countries
None.
2. IDENTITY OF CHEMICAL
2.2 / Other Name(s) / (delete if confidential)C9417.
2.3 / Marketing Name(s)
The notified chemical will be imported as a component of lubricant additive packages P5314, P5414A, D3413 and D3426.
[Free Space for Structural Formula] (delete if confidential)
2.9 / Methods of Detection and DeterminationAnalyticalMethod / Infrared (IR) spectroscopy.
Remarks / An IR spectrum was provided.
3. COMPOSITION
3.1a / Degree of PurityHigh.
3.2 / Hazardous Impurities/Residual Monomers
None.
3.3 / Non Hazardous Impurities/Residual Monomers (> 1% by weight)
None.
3.4 / Additives/Adjuvants
The notified chemical as manufactured contains highly refined mineral oil.
The imported lubricant additive packages will contain < 20% (w/w) of the notified chemical.
4. INTRODUCTION AND USE INFORMATION
4.1 / Mode of Introduction of Notified Chemical (100%) Over Next 5 YearsAs a component of lubricant additive packages in bulk containers or 205 L drums.
4.2 / Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / < 1000 / < 1000 / < 1000 / < 1000 / < 1000
4.3b / Use
Lubricant additive.
5. PROCESS AND RELEASE INFORMATION
5.1. Distribution, Transport and Storage
5.1.1 / Port of EntryUnknown.
5.1.2b / Identity of Manufacturer/Recipients
Notifier.
5.1.3 / Transportation and Packaging
Bulk vessels or 205 L drums.
5.2. Operation Description
/ [Discuss in turn: manufacturing, processing, (re)formulation, and/or end use, as applicable]The lubricant additive packages containing the notified chemical will be transported to customer blending facilities and transferred to bulk storage tanks or retained in steel drums. The additive package is pumped to a blending tank together with other addenda and mineral oil or transmission fluid. After blending the finished product which contains < 2% notified chemical is automatically packed into containers of 2 – 200 L capacity.
[Free space for process flow diagram (where available)]
5.3. Occupational exposure
Number and Category of WorkersCategory of Worker / Number / Exposure Duration / Exposure Frequency
Transport / 3 - 4 / Up to 8 hours per day / 60 days per year
Lubricant blending / 1 – 4 per site (10 sites) / 1 hour per week / 48 hours per year
Mechanics / Hundreds / Up to 8 hours per day / Up to 230 days per year
Exposure Details
Inhalation exposure is unlikely as the notified chemical has a low vapour pressure. Exposure to oil mists will be controlled by local exhaust ventilation. Minor leakage is expected while connecting and disconnecting transfer hoses and cleaning out additive by flushing through with mineral oil. The losses are collected and recycled or sent for disposal. The filling lines will be automatic and exposure of packing operators should be minimal.
Mechanics may experience skin and eye contact while changing oil and handling car parts partially coated with oil. The oil can remain in contact with the skin or eye for an extended period.
5.4. Release
5.4.1 / Release of Chemical at SiteThe most likely release of the notified chemical at blending sites or during transport would be from accidental spillage. Losses during transfer and blending are expected to be low as a closed system will be used and any spillage will be contained and absorbed with earth or sand before disposal at an approved industrial facility.
The notifier estimates that about 1% of residues remain inside “empty” containers. If 1000 tonnes of the new chemical are imported per year, then about 10 tonnes will be disposed of by incineration as drum washings during the reconditioning of the containers.
5.4.2 / Release of Chemical from Use
The only end use of the additive package containing the new chemical is expected to be engine oil and transmission fluids where the new chemical will be < 2% of the finished lubricant. There may be some accidental losses when oil is added to vehicle engines or are “topped up”. In the closed system of an automotive transmission, fluids are not frequently changed and the lubricants are effective for the life of the machine. This is not so for engine oils which may be changed about every 5,000 - 10,000 kilometres. As the notified chemical will thermally decompose during use with a concurrent decline in its concentration in the lubricant, there is no expected release of the chemical to the environment under normal conditions of use, except for oil leaks.
5.5. Disposal
A survey by the Australian Institute of Petroleum (AIP, 1995) indicates that of the annual sales of automotive engine oils in Australia, some 60% are potentially recoverable (ie. not burnt in the engines during use). This report also indicates that around 86% of oil changes take place in specialised automotive service centres, where old oil drained from crankcases could be expected to be disposed of responsibly either to oil recycling or incineration. Assuming this is the case, negligible release of the notified chemical should result from these professional activities. The remaining 14% are removed by “do it yourself” (DIY) enthusiasts, and in these cases some of the used oil would be either incinerated, left at transfer stations where it is again likely to be recycled, or deposited into landfill. Meinhardt(2002) estimated that DIY activities account for 7 - 10% of the unaccounted used oil.According to a survey tracing the fate of used lubricating oil in Australia (Snow, 1997), only around 20% of used oil removed by enthusiasts is collected for recycling, approximately 25% is buried or disposed of in landfill, 5% is disposed of into stormwater drains and the remaining 50% is used in treating fence posts, killing grass and weeds or disposed of in other ways. In a worst case scenario of 14% of the used oil removed by DIY enthusiasts, the notified chemical could be collected for recycling (£ 28 tonnes), buried or disposed of in landfill (up to 35 tonnes), disposed of in stormwater drains (£ 7 tonnes) and used in treating fence posts, to kill weeds or disposed of in other ways (£70 tonnes).
Therefore, about 0.7% of the total import volume of the notified substance could be expected to enter the aquatic environment via disposal into the stormwater system. Since the use of the lubricating oils will occur throughout Australia, all releases resulting from use or disposal of used oil will be very diffuse, and release of the notified material in high concentrations is very unlikely except as a result of transport accidents.
Residues in empty containers from garages and DIY consumers would be disposed of in municipal landfills.
5.6. Public exposure
Dermal and ocular exposure to the public may occur during addition and changing of engine oil and collection and disposal of used oil, and while handling car parts coated with oil.6. PHYSICAL AND CHEMICAL PROPERTIES
The notified chemical is produced in solution in mineral oil. The following physico-chemical properties are for a typical chemical of the same class as the notified chemical and predominantly reflect the properties of the base oil.
[Assessor - where test not conducted this is stated in the “Remarks” row. The “Method” and “TEST FACILITY” row may be deleted in this case]
6.1 / Appearance at 20oC and 101.3 kPa / Amber coloured viscous liquid.and/or
6.2b / Boiling Point / 98oC at 101.3 kPa6.3 / Density / 1121 kg/m3
6.4 / Vapour Pressure / Negligible.
6.5 / Water Solubility / Not determined but expected to be low.
Remarks / The class of chemicals are formulated for use in oils and have low water solubilities; one member of the class has a solubility of 1.6 mg/L (American Chemistry Council, 2002).
6.6 / Hydrolysis as a Function of pH / Not determined.
Remarks / Hydrolysis is unlikely to occur at environmentally relevant conditions based on studies on the class chemicals at 85°C (American Chemistry Council, 2002).
6.7 / Partition Coefficient (n-octanol/water) / log P > 2.49
Remarks / The log P for an analogue chemical is 2.49. The notified chemical is expected to have a similar log P.
6.8a / Adsorption/Desorption / Not determined.
Remarks / Expected to be relatively high due to its expected low water solubility.
6.9 / Dissociation Constant / Not determined.
Remarks / The chemical does not contain any groups that are expected to dissociate.
6.10 / Particle Size / Not applicable.
6.11 / Flash Point / > 95oC
6.12 / Flammability Limits / Upper: 5%
Lower: 1% (finished lubricant).
6.13 / Autoignition Temperature / > 345oC (finished lubricant).
6.14 / Explosive Properties / Not considered explosive.
6.15 / Reactivity / Stable.
7. TOXICOLOGICAL INVESTIGATIONS
Toxicological data for the notified chemical were limited to acute oral toxicity in rats, acute dermal toxicity in rabbits and eye irritation in rabbits. A 28-day repeated dose dermal toxicity study was available for a close analogue of the notified chemical and the remaining end points have been obtained with a range of analogues.Endpoint and Result / Assessment Conclusion
Rat, acute oral LD50 = 2600 mg/kg / [Delete as appropriate]
low toxicity
Rabbit, acute dermal LD50 > 3160 mg/kg bw / low toxicity
Rabbit, skin irritation (analogues) / corrosive/severely irritating/moderately irritating
Rabbit, eye irritation / severely irritating
Guinea pig, skin sensitisation - adjuvant test/non-adjuvant test (analogues). [Delete as appropriate] / limited evidence of sensitisation.
Rat, oral repeat dose toxicity - 28 days (analogue MRD-80-53).
Rat, dermal repeat dose toxicity – 22 days (analogues)
Rabbit, dermal repeat dose toxicity – 21 - 28 days (analogues) / NOAEL = 10 mg/kg/day bw
No NOAEL established (< 500 mg/kg/day bw)
No NOAEL established
No NOAEL established
Genotoxicity - bacterial reverse mutation (analogues) / non mutagenic
Genotoxicity – in vitro mutagenicity in mouse embryo cells and mouse lymphoma cells (analogues) / genotoxic
Genotoxicity – in vivo mouse micronucleus test (analogues) / non genotoxic
Developmental and reproductive effects (analogue) / NOAEL = 30 mg/kg/day bw for parental animals and pups; no effects on reproductive parameters up to 200mg/kg/day bw
7.1. Acute toxicity – oral
7.1.1 Notified chemicalTest Substance / Notified chemical.
Method / [Delete as appropriate]
Not stated.
Species/Strain / Rat/Sprague-Dawley.
Vehicle / None.
Remarks - Method / Method similar to OECD TG 401.
Results
Group / Number and Sex
of Animals / Dose
mg/kg bw / Mortality
1 / 5 males / 681 / 0/5
2 / “ / 1000 / 0/5
3 / “ / 1470 / 0/5
4 / “ / 2150 / 0/5
5 / “ / 3160 / 5/5 (days 2 (2), 3(2) and 7)
6 / “ / 4640 / 5/5 (days 2(4) and 3)
7 / “ / 6810 / 5/5 (days 2(3) and 3(2))
LD50 / 2600 mg/kg bw
Signs of Toxicity / Animals dying prior to termination exhibited body weight loss. Excessive salivation, soft stool and faecal staining of the ano-genital area were observed on the day of dosing in most groups. Some animals also exhibited rales and/or motor activity decrease. Additional signs noted subsequently (primarily in animals which died spontaneously) included respiratory decrease, red nasal discharge, general poor condition, urinary staining, ataxia, hypothermia, decreased food consumption, prostration and in single animals tremors and cyanosis.
Effects in Organs / Animals which died typically exhibited distended stomach, pronounced brain vascularisation, undescended testes, dark red adrenals and diminished spleen.
Conclusion / The notified chemical is of low toxicity via the oral route. [Delete as appropriate]
Test Facility / Biodynamics (1980a).
7.1.2 Analogues of the notified chemical (The American Chemistry Council, 2002)