OLOA 11004
File No STD/1087
21 May 2004
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
OLOA 11004
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and
Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia.
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department
of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The
assessment of environmental risk is conducted by the Department of the Environment and Heritage.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:
Library
National Occupational Health and Safety Commission
25 Constitution Avenue
CANBERRA ACT 2600
AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.
This Full Public Report is available for viewing and downloading from the NICNAS website or available on request,
free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration
Coordinator at:
Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL: + 61 2 8577 8800
FAX + 61 2 8577 8888.
Website: www.nicnas.gov.au
Director
Chemicals Notification and Assessment
TABLE OF CONTENTS
FULL PUBLIC REPORT....................................................................................................................................... 4
1. APPLICANT AND NOTIFICATION DETAILS ................................................................................... 4
2. IDENTITY OF CHEMICAL ................................................................................................................... 4
3. COMPOSITION ...................................................................................................................................... 4
4. INTRODUCTION AND USE INFORMATION..................................................................................... 5
5. PROCESS AND RELEASE INFORMATION ....................................................................................... 5
5.1. Distribution, Transport and Storage ............................................................................................... 5
5.2. Operation description...................................................................................................................... 5
5.3. Occupational Exposure................................................................................................................... 5
5.4. Release............................................................................................................................................ 6
5.5. Disposal .......................................................................................................................................... 7
5.6. Public exposure............................................................................................................................... 8
6. PHYSICAL AND CHEMICAL PROPERTIES ...................................................................................... 8
7. TOXICOLOGICAL INVESTIGATIONS ............................................................................................. 10
7.1. Acute toxicity ?oral ..................................................................................................................... 10
7.2. Acute toxicity - dermal ................................................................................................................. 10
7.3. Irritation ?skin ............................................................................................................................. 11
7.4 Irritation - eye ............................................................................................................................... 12
7.5. Skin sensitisation (1)..................................................................................................................... 12
7.6. Skin sensitisation (2)..................................................................................................................... 13
7.7. Genotoxicity - bacteria ................................................................................................................. 14
7.8. Genotoxicity ?in vitro.................................................................................................................. 15
7.9. Acute toxicity ?oral ..................................................................................................................... 16
7.10. Acute toxicity - dermal ................................................................................................................. 16
7.11. Irritation ?skin ............................................................................................................................. 17
7.12. Irritation - eye ............................................................................................................................... 17
7.13. Skin sensitisation .......................................................................................................................... 18
7.14. Subchronic Toxicity, Neurotoxicity and Reproduction Study...................................................... 19
7.15. Genotoxicity - bacteria ................................................................................................................. 21
7.16. Genotoxicity ?in vivo .................................................................................................................. 22
7.17. A Ninety-Day Study of Terephthalic Acid Induced Urolithiasis and Reproductive Performance
in Wistar and CD Rats (Research Triangle Institute, 1982)........................................................................ 23
7.18. Chronic Dietary Administration of Terephthalic Acid (IIT Research Institute, 1983)................ 23
8. ENVIRONMENT .................................................................................................................................. 24
8.1. Environmental fate........................................................................................................................ 24
8.1.1. Ready biodegradability ............................................................................................................ 24
8.1.2. Bioaccumulation ...................................................................................................................... 24
8.2. Ecotoxicological investigations .................................................................................................... 25
8.2.1. Acute toxicity to fish................................................................................................................ 25
8.2.2. Acute toxicity to aquatic invertebrates..................................................................................... 25
8.2.3. Algal growth inhibition test ..................................................................................................... 26
8.2.4. Inhibition of microbial activity ................................................................................................ 27
9. RISK ASSESSMENT ............................................................................................................................ 28
9.1. Environment ................................................................................................................................. 28
9.1.1. Environment ?exposure assessment........................................................................................ 28
9.1.2. Environment ?effects assessment ........................................................................................... 28
9.1.3. Environment ?risk characterisation ........................................................................................ 28
9.2. Human health................................................................................................................................ 28
9.2.1. Occupational health and safety ?exposure assessment ........................................................... 28
9.2.2. Public health ?exposure assessment ....................................................................................... 28
9.2.3. Human health - effects assessment .......................................................................................... 28
9.2.4. Occupational health and safety ?risk characterisation ............................................................ 30
9.2.5. Public health ?risk characterisation ........................................................................................ 30
10. CONCLUSIONS ?ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND
HUMANS ........................................................................................................................................................ 31
10.1. Hazard classification..................................................................................................................... 31
10.2. Environmental risk assessment..................................................................................................... 31
10.3. Human health risk assessment ...................................................................................................... 31
10.3.1. Occupational health and safety ........................................................................................... 31
10.3.2. Public health........................................................................................................................ 31
11. MATERIAL SAFETY DATA SHEET............................................................................................. 31
11.1. Material Safety Data Sheet ........................................................................................................... 31
11.2. Label ............................................................................................................................................. 31
12. RECOMMENDATIONS .................................................................................................................. 31
12.1. Secondary notification .................................................................................................................. 31
13. BIBLIOGRAPHY ............................................................................................................................. 31
FULL PUBLIC REPORT
OLOA 11004
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Chevron Oronite Australia of Level 8, 520 Collins Street MELBOURNE VIC 3000
NOTIFICATION CATEGORY
Standard: Chemical other than polymer (more than 1 tonne per year).
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
Chevron Oronite applied to claim exempt information for the following data requirements: chemical
name, CAS number, structure, molecular formula, structural formula, molecular weight, spectral data,
purity, identity and percent hazardous and non-hazardous impurities, import volumes, manufacture
process, and manufacturing sites.
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
Chevron Oronite applied for variations of the schedule requirements for the following data elements:
melting point; boiling point; vapour pressure; water solubility; hydrolysis as a function of pH;
partition coefficient; adsorption/desorption; dissociation constant; autoignition temperature; toxicity
and ecotoxicity data.
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None.
NOTIFICATION IN OTHER COUNTRIES
US: Premanufacture Notice (PMN) in July 2000.
Canada: New Substance Notification in October 2001.
Korea: Notification in July 2003.
2. IDENTITY OF CHEMICAL
MARKETING NAME(S)
OLOA 11004,
OLOA 11009,
CEA 610.
MOLECULAR WEIGHT
>1000
METHODS OF DETECTION AND DETERMINATION
Analytical methods used to detect these products include FTIR. Detection down to one
ANALYTICAL
ppm is possible.
METHOD
Infrared can be used for routine detection in the workplace. Total Acid Number titration
may also be useful in certain circumstances.
3. COMPOSITION
DEGREE OF PURITY
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>60%
4. INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Imported.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year 1 2 3 4 5
Tonnes 10-30 10-30 10-30 10-30 10-30
USE
Engine oil additive.
5. PROCESS AND RELEASE INFORMATION
5.1. Distribution, Transport and Storage
PORT OF ENTRY
Melbourne
IDENTITY OF MANUFACTURER/RECIPIENTS
Lubricant oil manufacturers.
TRANSPORTATION AND PACKAGING
The notified chemical will be imported into Australia by ship in marine isotanks and 200 L drums.
The finished oil products containing OLOA 11004 will be packaged in 1 or 4 litre plastic bottles, 200
L drums or in 8000 L isotanks..
5.2. Operation description
After importation, these lubricating oil packages containing approximately 30% notified chemical are
supplied to the lubricating oil manufacturers in Australia. These manufacturers will blend the
lubricating oil packages with other substances to produce finished lubricants. Typically, the finished
lubricant contains <10% of the notified chemical.
The finished products are used as a lubricant for diesel, petroleum and natural gas engines.
5.3. Occupational Exposure
Number and Category of Workers
Category of Worker Number Exposure Duration Exposure Frequency
Transport and Storage 10-20 1-2 hours 50 days/year
Reformulation/Blending 2-3/site 0.5 ?1 hour 200 days/year
Laboratory Staff 1-2/site 0.25 hours 200 days/year
End Users >1000 1-8 hours 200 days/year
Exposure Details
Transport and Storage
Transport and storage workers are not expected to be exposed to the notified chemical during transport
except in the case of an accidental spill.
When imported in bulk, the additive package is transferred from the ship to a holding tank, then to
road tankers. During this process, exposure of the waterfront and transport workers to spills of the
additive package containing the notified chemical is possible while connecting and disconnecting the
transfer hoses. The main route of exposure for transport and storage workers will be dermal. These
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workers will wear overalls, safety boots and gloves when handling containers.
Reformulation / Blending
When the notified chemical arrives in either isotanks or by road tankers, it will be unloaded and
transferred to storage tanks via a 10 cm hosing. The connection of the hose line takes about 10 minutes
for a worker. A special air back flush system is used to prevent spillage during transfer. By adhering to
ISO 9001 procedures, spills and leaks will be minimised.
When the notified chemical arrives in drums, the transfer process takes 10 minutes for a worker to
place a drum pump and transfer drum contents. During the connection and disconnection of lines,
incidental skin contact from splashes, drips and spills is possible.
Transfer from storage tanks to the blend tank (10000 L capacity) will be automated, using computer-
controlled valves. The blending process occurs in a closed system at 60癈 and is also computer
controlled, thereby excluding the potential for occupational exposure. The blended lubricant
containing <10% notified chemical is transferred automatically to a storage tank.
The finished lubricants are packaged in 1 L bottles, 4 L bottles, 200 L drums, tank trucks or rail cars.
Workers may be exposed to the finished lubricant containing notified chemical during the filling
operations. The filling of the 1 L and 4 L bottles is highly automated, with little occupational exposure.
The drumming facility uses automated weight scales to fill the drums, and worker exposure may occur
as the operator watches from about 1-2 meters away to ensure the drum filling mechanism properly
enters the drum before the drum is filled. The operators then put on the bungs and labels. The filling of
bulk-tank truck or rail-car filling is performed via a transfer hose. Dermal exposure to drips and spills
of blended lubricant is possible during the connection and disconnection of transfer hoses while filling
the bulk containers.
The blending tank and the transfer lines are cleaned by rinsing with clean lubricating oil. Maintenance
workers handling the equipment used for blending and filling may also come into dermal contact with
residues containing the notified chemical. Empty drums are sent to drum recyclers where they are
steam cleaned.
The blending facilities are well ventilated, with control systems for accidental spills and wastewater
treatment. Workers involved in the blending activities receive training in the handling of additive
packages, and wear personal protective equipment such as gloves, eye protection, protective clothing
and hard hats.
Laboratory Staff
Laboratory staff at the blending facility will take samples of the additive package containing the
notified chemical and the blended products for testing. During sampling and analysis, there may be
skin contact. However, only minimal exposure would occur during the laboratory testing since the
sample size is small and testing will only take a few minutes per batch.
End Users
Occupational exposure to the products containing the notified chemical will occur at railway
manufacturing and repair facilities and automotive workshops throughout Australia. End users may be
exposed to the blended oil products containing <10% of the notified chemical. Exposure may occur
during the transfer the blended oil products from the storage containers into the vehicle being serviced
and during cleaning of equipment. There is potential for exposure when oils are added to and drained
from systems.
A large number of railway mechanics (>1000) may be exposed to the products under a wide range of
conditions. However, these workers are professionals and would be expected to have been trained in
the proper handling of lubricants and oil products. Workers will wear overalls, cotton hat and safety
boots when using products containing the notified chemical.
5.4. Release
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RELEASE OF CHEMICAL AT SITE
The notified chemical will not be manufactured in Australia. Local operation will include transport
and storage, blending, filling and packaging.
The additive package will be imported into Australia in isotanks and drums. Using ISO 9001
procedures, spills and leaks are expected to be <50 g (12.5-17.5 g notified substance) per unloading, or
45 g/y, before waste water treatment. The hose end is kept in an oily drain when not in use. Any spills
or leaks are sent to the on-site chemical/storm waste water system that includes an American
Petroleum Industry (API) water and oil separator which removes approximately 90% of the notified
substance from the waste water. The waste oil containing the notified substance is sent to a used oil
recycler who re-refines the waste oil into fresh lubricant base stock using hydrocracking technology.
The bottoms product containing the notified substance from the re-refining process becomes asphalt.
The waste water is sent to a pond where it is further treated by induced air flotation and biological
treatment with waste sludge incinerated off site. After biological treatment, the waste water is filtered
through a biodisk and sand before being released. This additional process removes a further 8% of the
spilled notified substance. Altogether about 0.9 g/y (about 2% of the imported amount) will be
released to the environment from spills during unloading.
The isotanks and drums are generally cleaned after use with oil, which is sent for used oil recycling.
About 0.1% of the notified substance would remain in the drum or isotank after emptying. Therefore,
a maximum of 20 kg/y of the notified substance would be sent to recycling, resulting in 400 g/y to be
released due to cleaning (based on 98% removal efficiency).
The blending operations will take place at specially constructed sites owned and operated by the major
lubricant manufacturers. It is anticipated that there will be minimal release of the notified chemical
during transfer from the storage containers to the blending tanks, as a special air back flush system
prevents any spillage. Blending occurs in fully enclosed automated systems. Blending tanks will be
cleaned with lube oil, which will typically be recycled during subsequent blending, or incinerated.
Any spills incurred in the blending operations will be contained within concrete bunds and either
reclaimed or sent to on-site waste-water treatment facilities where residual hydrocarbon based products
will be separated from the aqueous stream by the API process.
The notified substance will be blended into finished lubricant at <10% by weight. The filling
processes are computer automated, so minimal spills due to loading are expected. Therefore, losses
from spills and leaks are expected to be <50 g of the finished lubricant, or 1-2 g of the notified
chemical per year.
Activity Estimated release to environment (g/y)
Unloading isotanks and drums 0.9
Isotank and drum cleaning 400
Filling finished lubricant containers 2
RELEASE OF CHEMICAL FROM USE
The finished lubricants for use in engine oils will be sold in 1 and 4 L plastic containers, 200 L drums
and 8,000 L isotanks to industrial and commercial customers. The notified chemical is not
substantially altered during use in natural gas and railroad engines. There may be some accidental
losses when lubricant is added to or changed in vehicle engines which may be about every 5,000-
10,000 kilometres for light duty trucks and passenger car diesel and petrol engines. In the closed
system of an engine, there is no expected release of the chemical to the environment under normal
conditions of use, except for oil leaks.
Since the use of the lubricating oils will occur throughout Australia, any releases from use of old oil
would be diffuse.
5.5. Disposal
Isotanks and drums used to receive the additive packages
The isotanks and drums are generally cleaned with oil and reused. This oil is used in subsequent
blending operations.
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Drums used to distribute finished products
The drums are sent to recyclers where they are steam cleaned with water sent to wastewater treatment.
Assuming 0.1% remains in the drum after use, 20 kg/y will be disposed of to wastewater based on a
total import volume of 20,000 kg/y of the notified chemical. With a wastewater treatment efficiency
of 98%, about 400 g/y of the notified substance would be released to the environment.
Small containers
An estimated 10-20% of the finished lubricants are sold to consumers in small containers which are
likely to be sent to landfill for disposal. Assuming 0.1% remains in the containers after use and 20%
of the total import volume is sold in small containers, about 4,000 g/y would be sent to landfills.
Used oils
The greatest potential for environmental exposure is through disposal of oil product wastes containing
the notified chemical. 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%
(2,800 kg of the estimated maximum 20 tonnes imported) 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. However, changing of heavy duty engine
oils is likely to be carried out by specialists with less irresponsible disposal practices.
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 (560 kg), buried or disposed of in landfill (up to 700 kg), disposed of in stormwater drains
(140 kg) and used in treating fence posts, to kill weeds or disposed of in other ways (1,400 kg).
Therefore, about 0.7% (140 kg) 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
The public who will use the products containing the notified chemical will include automotive do-it-
yourself persons, farmers, or anyone who changes oil of their engines. It is estimated that 10-20% of
the finished lubricants will be sold into the consumer market.
The maximum concentration of the notified chemical in the combustion engine lubricant is <10%.
Changing lubricant is not a routine practice for the public users; however, they are not expected to
wear personal protective equipment when handling the products containing the notified chemical.
6. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20oC and 101.3 kPa Dark brown liquid
Not applicable
Melting Point/Freezing Point
Pour point is approximately -10oC (Concawe, 1997).
Remarks
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300-600oC
Boiling Point
Initial boiling point of highly refined lubricant base oil. Decomposes at > 400oC
Remarks
(Concawe, 1997).
912 kg/m3 at 15 oC
Density
ASTM D4053/OPM448
METHOD
< 1.7 x 10-7 kPa at 25oC
Vapour Pressure
Remarks Based on partial pressure of the highly refined lubricant base oil (Concawe, 1997).
0.125 mg/L at 20oC
Water Solubility
Removal of diluent oil by Soxhlet extraction followed by a generator column
METHOD
method.
Remarks The test was presumably performed on the polyolefin polyamine succinimide
parent (OLOA 371) used to make the notified chemical, but the identity of the
chemical could not be confirmed by DEH from the report provided. Although the
parent compound is neutral and the notified chemical is cationic and potentially
more soluble, the large hydrophobic chain is expected to dominate and render the
chemical relatively insoluble in water. The water solubility of OLOA 371 is 0.54
礸/L based on the QSAR estimated log KOW of 6.07.
TEST FACILITY Rausina et al. 1996
Not expected to hydrolyse in strong acid or base due to low
Hydrolysis as a Function of pH
water solubility and lack of hydrolysable functional groups.
log KOW at 20oC estimated to be >4
Partition Coefficient (n-octanol/water)
Remarks Estimated based on the low water solubility and QSAR modelling on the parent
OLOA 371 using EPIWIN parent models A, B and C indicating a range of 6.07-
8.20.
Koc estimated to be ~3000
Adsorption/Desorption
Remarks Based on the low water solubility of the parent OLOA 371 and QSAR modelling
(as above log KOW of 6.07-8.20), the notified chemical is expected to adsorb
strongly to soil and sediment.
Not provided.
Dissociation Constant
Remarks The notified chemical is a salt which is expected to become neutralised at high pH.
Not determined for liquid.
Particle Size
203-204oC
Flash Point
ASTM D92/OPM530-1
METHOD
Not flammable
Flammability Limits
Not tested due to the high flash point.
Autoignition Temperature
Not explosive
Explosive Properties
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Remarks This chemical will not detonate as a result of heat, shock or friction
May react with strong oxidizing agents, such as chlorates,
Reactivity
nitrates, and peroxides. Hazardous polymerisation will not
occur.
Viscosity 900 cSt at 40癈 and 65 cSt at 100癈
ASTM D445/OPM 521
METHOD
7. TOXICOLOGICAL INVESTIGATIONS
The notified chemical, OLOA 11004, is the reaction product of OLOA 371 and terephthalic acid (TPA). The
notifier provided toxicological studies on OLOA 232E, a chemical with a very close chemical structure, and
the two starting materials, OLA 371 and TPA.
Toxicological studies on OLOA 232E
Endpoint and Result Assessment Conclusion
Rat, acute oral LD50>5000 mg/kg bw, low toxicity
Rat, acute dermal LD50>5000 mg/kg bw, low toxicity
Rabbit, skin irritation slightly to moderately irritating
Rabbit, eye irritation slightly irritating
Guinea pig, skin sensitisation-non-adjuvant test (1). inadequate evidence of sensitisation.
Guinea pig, skin sensitisation-non-adjuvant test (2). limited evidence
Rat, repeat dose. Not study provided
Genotoxicity - bacterial reverse mutation non mutagenic
Genotoxicity ?in vitro mouse lymphoma cells non mutagenic
Genotoxicity ?in vivo Not study provided
7.1. Acute toxicity ?oral
TEST SUBSTANCE OLOA 232E
Similar to OECD TG 401 Acute Oral Toxicity ?Limit Test.
METHOD
Species/Strain Rat/Sprague Dawleys
Vehicle None
Remarks - Method None
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw
1 10 males 5000 0
LD50 >5000 mg/kg bw
Signs of Toxicity None.
Effects in Organs None.
Remarks - Results None
OLOA 232E is of low toxicity via the oral route.
CONCLUSION
TEST FACILITY Chevron Chemical Company (1972).
7.2. Acute toxicity - dermal
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TEST SUBSTANCE OLOA 232E
Similar to OECD TG 402 Acute Dermal Toxicity ?Limit Test.
METHOD
Species/Strain Rabbit/New Zealand White
Vehicle None
Type of dressing Occlusive.
Remarks - Method None
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw
1 6 males 5000 0
LD50 >5000 mg/kg bw
Signs of Toxicity - Local Moderate skin irritation was observed.
Signs of Toxicity - Systemic None.
Effects in Organs None except staining of the applied areas on 2 rabbits.
Remarks - Results None
OLOA 232E is of low toxicity via the dermal route.
CONCLUSION
TEST FACILITY Chevron Chemical Company (1972).
7.3. Irritation ?skin
TEST SUBSTANCE OLOA 232E
Similar to OECD TG 404 Acute Dermal Irritation/Corrosion.
METHOD
Species/Strain Rabbit/New Zealand White
Number of Animals 6
Vehicle None
Observation Period 72 hours
Type of Dressing Occlusive.
Remarks - Method 24-hour exposure study.
RESULTS
Intact skin
Lesion Mean Score* Maximum Value Maximum Maximum Value at End
Duration of Any of Observation Period
Effect
Erythema/Escha 1.8 2 72 hours 2
r
Oedema 1.1 3 72 hours 2
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
Abraded skin
Lesion Mean Score* Maximum Value Maximum Maximum Value at End
Duration of Any of Observation Period
Effect
Erythema/Escha 1.8 2 72 hours 2
r
Oedema 1.0 3 72 hours 2
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
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Remarks - Results Draize scores were recorded at 24 and 72 hours after treatment.
The primary irritation index (PII) for both intact skin and abraded skin
was 1.42.
OLOA 232E is slightly to moderate irritating to skin.
CONCLUSION
TEST FACILITY Chevron Chemical Company (1972).
7.4 Irritation - eye
TEST SUBSTANCE OLOA 232E
Similar to OECD TG 405 Acute Eye Irritation/Corrosion.
METHOD
Species/Strain Rabbit/New Zealand White
Number of Animals 6
Observation Period 7 days
Remarks - Method None
RESULTS
Lesion Mean Score* Maximum Maximum Maximum Value at
Value Duration of Any End of Observation
Effect Period
Conjunctiva: redness 0.9 2 7 days 1
Conjunctiva: chemosis 0.1 1 1 day 0
Conjunctiva: discharge 0.3 2 1 day 0
Corneal opacity 0 - - 0
Iridial inflammation 0 - - 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
Remarks - Results The mean Draize scores for redness, chemosis and discharge at 1 hour
were 1.8, 1 and 1.5, respectively.
OLOA 232E is slightly irritating to the eye.
CONCLUSION
TEST FACILITY Chevron Chemical Company (1972).
7.5. Skin sensitisation (1)
TEST SUBSTANCE OLOA 232E
OECD TG 406 Skin Sensitisation ?Buehler method
METHOD
Species/Strain Guinea pig/Hartley
Not reported.
PRELIMINARY STUDY
MAIN STUDY
Number of Animals Test Group: Control Group:
15 (low-dose) 10 (first challenge control)
15 (high-dose) 10 (second challenge control)
10 (irritation control)
Induction Concentration:
INDUCTION PHASE
topical: 5% in mineral oil (low dose group)
25% in mineral oil (high dose group)
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Number of animals showing skin reactions (Draize score 1) after
Signs of Irritation
inductions were listed below:
Animal Number of Animals Showing Skin Reactions
after 1st induction after 5th induction after 10th induction
24 h 48 h 24 h 24 h
Test Group
Low-dose 0/15 1/15 9/15 1/15
High-dose 0/15 2/15 7/15 3/15
Control Group
1st challenge control 0/10 2/10 4/10 1/10
2nd challenge control 0/10 2/10 4/10 1/10
irritation 0/10 0/10 7/10 1/10
CHALLENGE PHASE
1st challenge topical: 25% in mineral oil
2nd challenge topical: 25% in mineral oil
Remarks - Method GLP & QA
The induction course included 10 occluded dermal applications, which
were administered on alternate days. The animals were challenged 14
days and 21 days after the last induction.
RESULTS
Animal Challenge Concentration Number of Animals Showing Skin Reactions
1st challenge 2nd challenge 1st challenge 2nd challenge
24 h 48 h 72 h 24 h 48 h 72 h
Test Group
Low-dose 25% 25% 5/15 13/15 12/15 3/15 3/15 1/15
High-dose 25% 25% 8/15 13/15 12/15 7/15 4/15 7/15
Control Group
1st challenge 25% vehicle 3/10 8/10 8/10 4/10 4/10 4/10
2nd challenge vehicle 25% 3/10 6/10 6/10 8/10 5/10 3/10
Irritation vehicle - 1/10 5/10 7/10 - - -
Remarks - Results After challenges, the challenge control groups, which inducted with
mineral oil showed skin irritation greater than or equal to that in both test
groups.
OLOA 232E may have skin sensitising ability but the test conditions
CONCLUSION
employed are inadequate or not sufficiently documented. Therefore, on
the basis of inadequate evidence, no conclusion is made.
TEST FACILITY Chevron Environmental Health Center Inc (1986).
7.6. Skin sensitisation (2)
TEST SUBSTANCE OLOA 232E
OECD TG 406 Skin Sensitisation ?Buehler method
METHOD
Species/Strain Guinea pig/Hartley
Maximum Non-irritating Concentration:
PRELIMINARY STUDY
topical: <0.5%
MAIN STUDY
Number of Animals Test Group: Control Group:
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10/sex 5/sex (first challenge control)
5/sex (second challenge control)
Induction Concentration:
INDUCTION PHASE
topical: 100%
Signs of Irritation Not reported
CHALLENGE PHASE
1st challenge topical: 100%
2nd challenge topical: 100%
Remarks - Method GLP & QA
RESULTS
Animal Challenge Number of Animals Showing
Concentration Skin Reactions after:
1st challenge 2nd challenge
24 h 48 h 24 h 48 h
Test Group 100% 9/19 3/19 4/19 2/19
Control Group (1st challenge control) 100% 6/10 0/10 - -
Control Group (2nd challenge control) 100% - - 1/10 0/10
Remarks - Results Limited evidence of skin sensitisation was observed in the test group.
Limited evidence of reactions indicative of skin sensitisation to OLOA
CONCLUSION
232E under the conditions of the test.
TEST FACILITY Hill Top Biolabs Inc (1991).
7.7. Genotoxicity - bacteria
TEST SUBSTANCE OLOA 232E
OECD TG 471 Bacterial Reverse Mutation Test.
METHOD
Plate incorporation procedure
Species/Strain S. typhimurium: TA98, TA100 and TA102
E. coli: WP2 uvrA
Metabolic Activation System S9 mix
Concentration Range in a) With metabolic activation: 0-10000 礸/plate.
Main Test b) Without metabolic activation: 0-10000 礸/plate.
Vehicle 25% Pluronic F127 in ethanol
Remarks - Method GLP & QA.
RESULTS
Metabolic Test Substance Concentration (礸/plate) Resulting in:
Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect
PreliminaryTest Main Test
Absent
Test 1 >10000 Not reported Not observed
Present
Test 1 >10000 Not reported Not observed
OLOA 232E showed a weak mutagenic potency, 2x10-2 revertants per
Remarks - Results
礸 OLOA 232E, to TA100 with metabolic activation and to TA102 with
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and without metabolic activation.
OLOA 232E was not mutagenic to bacteria under the conditions of the
CONCLUSION
test.
TEST FACILITY Chevron Environmental Health Center (1985).
7.8. Genotoxicity ?in vitro
TEST SUBSTANCE OLOA 232E
OECD TG 473 In vitro Mammalian Chromosomal Aberration Test.
METHOD
Cell Type/Cell Line L5178Y TK+/- Mouse Lymphoma cells
Metabolic Activation System S9 mix
Vehicle Ethylene glycol diethyl ether
Remarks - Method GLP & QA.
Metabolic Test Substance Concentration (礸/mL) Exposure Harvest
Activation Period Time
Absent
Test 1 0, 7.5, 10, 13, 18, 24, 32, 42, 56, 75, and 100 4 hours 52 hours
Present
Test 1 0, 7.5, 10, 13, 18, 24, 32, 42, 56, 75, and 100 4 hours 52 hours
RESULTS
Remarks - Results The concentrations of OLOA 232E produced a range in suspension
growth of 19% to 51% for the culture without activation, and from 23% to
74% for the S9 activated cultures.
After cloning, 3 cultures without activation (100, 56 and 32 礚/mL)
exhibited higher mutant frequencies, which were 4.9, 4.9 and 2.3 times,
respectively, of the solvent controls. The total growth of these cultures
was 2%, 4% and 14%, respectively. The remaining cultures without
activation did not exhibit mutant frequencies, which were significantly
greater than the solvent controls. The total growth of these cultures ranged
from 12-35%. A dose dependent response was not evident in the treated
cultures.
After cloning, one culture with S9 activation (75 礚/mL) exhibited a
mutant frequency that was 4.8 times than the solvent control. The total
growth of this culture was 2%. The remaining cultures with S9 activation
did not exhibit mutant frequencies significantly greater than the solvent
controls. The total growth of these cultures ranged from 2-62%. A dose
dependent response was not evident in the treated cultures.
The results indicate that, under the conditions of this test, OLOA 232E
produced a negative response in the presence and absence of exogenous
metabolic activation.
OLOA 232E was not mutagenic to L5178Y TK+/- mouse lymphoma
CONCLUSION
cells treated in vitro under the conditions of the test.
TEST FACILITY Microbiological Associates Inc (1986).
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Toxicological studies on OLOA 371
Rat, acute oral LD50>5000 mg/kg bw, low toxicity
Rat, acute dermal LD50>2000 mg/kg bw, low toxicity
Rabbit, skin irritation slightly irritating
Rabbit, eye irritation slightly irritating
Guinea pig, skin sensitisation - non-adjuvant test. limited evidence
Rat, repeat dose oral toxicity - 29 days. NOAEL=1000 mg/kg/day
Neurotoxicity, oral ?29 days NOAEL=1000 mg/kg/day
Reproductive toxicity NOAEL=1000 mg/kg/day
Genotoxicity - bacterial reverse mutation non mutagenic
Genotoxicity ?in vivo mammalian bone marrow non genotoxic
chromosomal aberration
7.9. Acute toxicity ?oral
TEST SUBSTANCE OLOA 371
OECD TG 401 Acute Oral Toxicity ?Limit Test.
METHOD
Species/Strain Rat/Crl:CD (SD)BR
Vehicle None
Remarks - Method GLP & QA.
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw
1 5/sex 5000 0
LD50 >5000 mg/kg bw
Signs of Toxicity All animals appeared normal except 3 males exhibited a dark-stained anal
area on day 1-5.
Effects in Organs No lesions related to the treatment were observed.
Remarks - Results None
OLOA 371 is of low toxicity via the oral route.
CONCLUSION
TEST FACILITY Corning Hazleton Inc (1997a).
7.10. Acute toxicity - dermal
TEST SUBSTANCE OLOA 371
OECD TG 402 Acute Dermal Toxicity ?Limit Test.
METHOD
Species/Strain Rat/Crl:CD (SD)BR
Vehicle None
Type of dressing Semi-occlusive.
Remarks - Method GLP & QA.
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw
1 5/sex 2000 0
LD50 >2000 mg/kg bw
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Signs of Toxicity - Local The Draize scores were all zero during the observation period (up to 14
days).
Signs of Toxicity - Systemic None.
Effects in Organs No lesions related to the treatment were observed.
Remarks - Results None.
OLOA 371 is of low toxicity via the dermal route.
CONCLUSION
TEST FACILITY Corning Hazleton Inc (1997b).
7.11. Irritation ?skin
TEST SUBSTANCE OLOA 371
OECD TG 404 Acute Dermal Irritation/Corrosion.
METHOD
EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).
Species/Strain Rabbit/New Zealand White
Number of Animals 6
Vehicle None
Observation Period 72 hours
Type of Dressing Semi-occlusive.
Remarks - Method GLP & QA.
RESULTS
Lesion Mean Score* Maximum Value Maximum Maximum Value at End
Duration of Any of Observation Period
Effect
Erythema/Eschar 0.1 1 24 hours 0
Oedema 0 1 4 hours 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
Remarks - Results The primary irritation index (PII) was calculated as 0.3.
OLOA 371 is slightly irritating to skin.
CONCLUSION
TEST FACILITY Corning Hazleton Inc (1997c).
7.12. Irritation - eye
TEST SUBSTANCE OLOA 371
OECD TG 405 Acute Eye Irritation/Corrosion.
METHOD
Species/Strain Rabbit/New Zealand White
Number of Animals Unrinsed eye group: 6
Rinsed eye group: 3
Observation Period 72 hours
Remarks - Method GLP & QA.
RESULTS
Rinsed eye group
Lesion Mean Score* Maximum Maximum Maximum Value at
Animal No. Value Duration of Any End of Observation
Effect Period
1 2 3
Conjunctiva: redness 0.7 0.3 0.3 2 48 hours 0
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Conjunctiva: chemosis 0 0 0 - - 0
Conjunctiva: discharge 0 0 0 - - 0
Corneal opacity 0 0 0 - - 0
Iridial inflammation 0 0 0 - - 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Unrinsed eye group
Lesion Mean Score* Maximum Maximum Maximum Value at
Value Duration of Any End of Observation
Effect Period
Conjunctiva: redness 0.6 2 48 hours 0
Conjunctiva: chemosis 0 - - 0
Conjunctiva: discharge 0 - - 0
Corneal opacity 0 - - 0
Iridial inflammation 0 - - 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
Remarks - Results The mean Draize scores for redness, chemosis and discharge at 1 hour for
the rinsed group were 2, 1 and 0.3 respectively, and for the unrinsed
groups were 2, o.3 and 0.8 respectively.
OLOA 371 is slightly irritating to the eye.
CONCLUSION
TEST FACILITY Corning Hazleton Inc (1997d).
7.13. Skin sensitisation
TEST SUBSTANCE OLOA 371
OECD TG 406 Skin Sensitisation ?Buehler method
METHOD
Species/Strain Guinea pig/Hartley
Maximum Non-irritating Concentration:
PRELIMINARY STUDY
topical: <0.5%
MAIN STUDY
Number of Animals Test Group: 10/sex Control Group: 5/sex
Induction Concentration:
INDUCTION PHASE
topical: 100%
Signs of Irritation Not reported.
CHALLENGE PHASE
1st challenge topical: 2.5% in mineral oil
Remarks - Method GLP & QA
There were 3 topical inductions in test animals with 7-day interval.
RESULTS
Animal Challenge Concentration Number of Animals Showing Skin Reactions
after 1st challenge
24 h 48 h
Test Group 2.5% 1/20 0/20
Control Group 2.5% 0/10 0/10
Remarks - Results None
There was limited evidence of reactions indicative of skin sensitisation to
CONCLUSION
OLOA 371 under the conditions of the test.
TEST FACILITY Hill Top Research Inc (1997).
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7.14. Subchronic Toxicity, Neurotoxicity and Reproduction Study
TEST SUBSTANCE OLOA 371
Species/Strain Rat/Sprague-Dawley
Route of Administration Oral ?gavage.
Vehicle Corn oil
Remarks - Method GLP & QA
Subchronic Toxicity Phase
OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents.
METHOD
Exposure Information Total exposure days: 29-30 days;
Dose regimen: 7 days per week;
Post-exposure observation period: 14 days
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw/day
I (control) 6/sex 0 0
II (low dose) 6/sex 100 0
III (mid dose) 6/sex 500 0
IV (high dose) 6/sex 1000 0
V (control recovery) 6/sex 0 0
VI (high dose recovery) 6/sex 1000 0
Mortality and Time to Death
None.
Clinical Observations
No treatment-related effects were seen in the clinical observation.
Bodyweight and bodyweight gains, and food consumption in the test groups were comparable to the controls.
Laboratory Findings ?Clinical Chemistry, Haematology, Urinalysis
No treatment-related effects from the test groups were observed in haematological studies and urinalysis.
In clinical chemistry studies, higher AST levels in high-dose males recovery group, and a statistically
significant difference in creatine levels between high-dose female recovery group and the controls were
observed. However, these changes are not considered to be toxicologically significant.
Pathology
No treatment-related effects were observed. Organ weights, macro- and microscopic evaluations in the test
groups were comparable to that of the controls.
Remarks ?Results
As no treatment-related effects were observed in the study, the No Observed Averse Effect Level (NOAEL)
would be the high dose administered in the study.
CONCLUSION FOR THE SUBCHRONIC STUDY
The NOAEL for systemic effects was established as 1000 mg/kg bw/day (the highest dose) in this study.
Neurotoxicity Phase
OECD TG 424 Neurotoxicity Study in Rodents
METHOD
Exposure Information Total exposure days: 29 days;
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Dose regimen: 7 days per week;
Post-exposure observation period: 14 days
Remarks - Method At the end of study, the animals were perfused in situ for collection and
preservation of selected central nervous system (CNS) and peripheral
nerve tissues for microscopical examinations.
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw/day
I (control) 6 males 0 0
II (high dose) 6 males 1000 0
III (control recovery) 6 males 0 0
IV (high dose recovery) 6 males 1000 0
Mortality and Time to Death
None.
Clinical Observations
No treatment-related effects were observed.
Bodyweight and bodyweight gains, and food consumption in the test groups were comparable to the controls.
Functional Observational Battery Data
No treatment-related effects were observed except the landing foot splay distance for the high-dose group was
shorter than the controls during the study and at completion of the recovery period. However, the levels of
landing foot splay distance for the high-dose group were similar to their pre-test data. Thus, it is not
considered to be toxicologically significant or treatment-related.
Effects in Organs
Brain weight, length and width data in the test groups were comparable to the controls.
No treatment-related effects were observed in the neuropathologic examinations.
Remarks ?Results
As no treatment-related effects were observed in the study, the No Observed Effect Level (NOEL) would be
the high dose administered in the study.
CONCLUSION FOR NEUROTOXICITY STUDY
The NOAEL for neurotoxicity was established as 1000 mg/kg bw/day (the highest dose) in this study.
Reproduction Study Phase
OECD TG 415 One-Generation Reproduction Toxicity Study
METHOD
Exposure Information Total exposure days: from 29 days prior to mating to lactation day 4 for
females, and 70 days for males.
Dose regimen: 7 days per week.
RESULTS
Group Number and Sex Dose Mortality
of Animals mg/kg bw/day
I (control) 12/sex 0 0
II (low dose) 12/sex 100 0
III (mid dose) 12/sex 500 0
IV (high dose) 12/sex 1000 0
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Mortality and Time to Death
None.
Clinical Observations
No treatment-related effects were seen in the clinical observations.
During the pre-mating period, the bodyweight gain for the mid-dose females was significantly lower than the
controls from week 1 to week 2.
During the mating and post-mating period, the mid- and high-dose males had lower bodyweight gains between
weeks 9 to 10.
During gestation and lactation period, the mid- and high-dose females had higher bodyweight gains over days
7-14. The gestation length and parturition data in the test groups were comparable to the control data.
Mating, Pregnancy and Male Fertility Indices
Group
I (control) II (low dose) III (mid dose) IV (high dose)
Male mating index 100% 100% 100% 83.3%
Male fertility index 91.7% 91.7% 91.7% 100%
Female mating index 100% 100% 100% 91.7%
Pregnancy rate 91.7% 91.7% 91.7% 100%
Effects on Dams
The numbers of live pups at birth and at day 4 of lactation, pup body weight, pup viability indices, and pup sex
distribution in the test groups were comparable to the controls.
No malformations were seen in stillborn pups from the control or OLOA 371 treated groups.
Effects in Organs
No treatment-related effects in organs were observed in the reproduction study.
Remarks ?Results
As no treatment-related effects were observed in the study, the No Observed Adverse Effect Level (NOAEL)
would be the high dose administered in the study.
CONCLUSION FOR REPRODUCTION STUDY
The NOAEL for reproductive effects was established as 1000 mg/kg bw/day (the highest dose) in this study.
TEST FACILITY Huntingdon Life Science (1998).
7.15. Genotoxicity - bacteria
TEST SUBSTANCE OLOA 371
OECD TG 471 Bacterial Reverse Mutation Test.
METHOD
EC Directive 2000/32/EC B.13/14 Mutagenicity ?Reverse Mutation Test
using Bacteria.
Plate incorporation procedure
Species/Strain S. typhimurium: TA1535, TA1537, TA98, and TA100
E. coli: WP2 uvrA
Metabolic Activation System S9 mix
Concentration Range in a) With metabolic activation: 0-10000 礸/plate.
Main Test b) Without metabolic activation: 0-10000 礸/plate.
Vehicle 25% Pluronic F127 in ethanol
Remarks - Method GLP & QA.
RESULTS
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Test Substance Concentration (礸/plate) Resulting in:
Metabolic
Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect
PreliminaryTest Main Test
Absent >10000 3300
500
Test 1 >10000 Not observed
500
Test 2 >10000 Not observed
500
Test 3 >10000 Not observed
Present >1000 3300
500
Test 1 >10000 Not observed
500
Test 2 >10000 Not observed
500
Test 3 >10000 Not observed
Remarks - Results Test 3 was carried out with TA98, TA1535 and TA1537 only.
OLOA 371 was not mutagenic to bacteria under the conditions of the test.
CONCLUSION
TEST FACILITY Corning Hazleton Inc (1997e).
7.16. Genotoxicity ?in vivo
TEST SUBSTANCE OLOA 371
OECD TG 475 Mammalian Bone Marrow Chromosomal Aberration Test.
METHOD
Species/Strain Mouse/Cr1:CD-1(ICR)BR
Route of Administration Intraperitoneal injection
Vehicle Peanut oil
Remarks - Method GLP & QA.
Group Number and Sex Dose Sacrifice Time
of Animals mg/kg bw hours
1 5/sex/group 1250 24, 48, 72
2 5/sex/group 2500 24, 48, 72
3 5/sex/group 5000 24, 48, 72
4 (vehicle control) 5/sex/group Peanut oil, 10 mL/kg 24, 48, 72
5 (positive control) 5/sex CP, 60 mg/kg 24
CP=cyclophosphamide.
RESULTS
Remarks - Results Animals showed slight hypoactive, rough haircoats after i.p. treatment.
Some evidence of bone marrow toxicity was observed, as OLOA 371
induced statistically significant decreases in the PCE:NCE ratio in the
2500 mg/kg males at the 72 hour harvest time, in the 5000 mg/kg males at
the 48 and 72 hour harvest times, and in the 5000 mg/kg females at the 72
hour harvest time.
A statistically significant increase in micronucleated PCEs was observed
in the 5000 mg/kg males at the 24 hour harvest time. This increase was
considered not to be the result of OLOA 371 treatment, but was due to the
low number of micronucleated PCEs in the concurrent control group. In
addition, there was no observable dose response, and the value was within
the historical control range for the test laboratory.
No other statistically significant increases in micronucleated poly-
chromatic erythrocytes over the levels observed in the vehicle controls
occurred at any of the other harvest times.
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The positive control induced statistically significant increases in micro-
nucleated PCEs in both sexes as compared to the vehicle controls.
In this study, OLOA 371 induced a statistically significant increase in
micronuclei in bone marrow polychromatic erythrocytes in one sex at one
harvest time. However, the response was not dose responsive and was
within the historical control range for the lab. Thus, under the conditions
of this assay, OLOA 371 is considered negative in this mouse
micronucleus assay.
OLOA 371 was not clastogenic in this in vivo mammalian bone marrow
CONCLUSION
chromosomal aberration test under the conditions of the test.
TEST FACILITY Corning Hazleton Inc (1997f).
Toxicological studies on Terephthalic acid (TPA)
The notifier provided two study reports on TPA. However, only parts of the reports were submitted. The two
reports are summarised below.
7.17. A Ninety-Day Study of Terephthalic Acid Induced Urolithiasis and Reproductive Performance in
Wistar and CD Rats (Research Triangle Institute, 1982)
Dose-related decreases in food consumption, bodyweight and bodyweight weight gain were observed in male
and female rats during 90-days of feeding of 0, 0.03, 0.125, 0.5, 2.0 or 5% TPA in the diet. Diarrhea was
observed in some of the rats ingesting high concentration of dietary TPA. Five unscheduled deaths occurred
between 4 and 13 weeks in animals at 5% TPA.
TPA, at the dietary levels investigated, did not adversely affect reproductive performance in adult male and
female rats. However, TPA ingestion by the dams caused adverse effects in the foetuses and neonates. Of pups
found dead at birth, 76% of the Wistar and 96% of the CD animals were clustered in the groups of parents at 2
and 5% TPA diets. In addition, there were 50% reductions in viable Wistar male newborn at day 1 and in
survivability to day 21 of male and female CD pup in the 5% TPA groups.
Weanling Fl rats were maintained on the same TPA diets as their parents until sacrifice. Unscheduled deaths
during the post-weaning period were confined to the 5% TPA diets for both Wistar and CD offspring and were
associated with a high incidence of renal and bladder calculi. Similarly renal and bladder stones were frequently
observed at necropsy in those groups of offspring at 5% TPA diet. Other findings at necropsy included enlarged
caecums, enlarged or distended ureters, enlarged kidneys, and bladder wall thickening.
7.18. Chronic Dietary Administration of Terephthalic Acid (IIT Research Institute, 1983)
TPA was evaluated for toxicological and carcinogenic effects in male and female Fischer 344 rat following
dietary administration at levels of 0, 20, 142 and 1000 mg/kg/day for two years.
The number of survival animals in females may be affected by the treatment of TPA. However, the difference
was not evidenced in the final period of the study (18-24 months), and there was no evidence of a dose-response
relationship.
Clinical observations did not reveal any signs that could be directly attributable to treatment. Based on the
bodyweight data, animal growth was retarded in a dose-related manner for female rats. This effect at the low-
dose was of shorter duration with recovery evident after 6 months. The high-dose of TPA also retarded growth
in male rats.
Neither the neurological nor the ophthalmologic evaluations provided evidence of toxicological effects of TPA.
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At both 6 and 12 months, the high-dose females had higher relative liver weight. At study termination, heart and
kidney weights were reduced in the mid- and high-dose females and there was an increase in relative brain
weight at this period as well as at 18 months. For high-dose males, the weight of the lung, heart, liver and
kidney were reduced at study termination. These reductions were consistent with an overall reduction in
bodyweights of these animals.
Urolithiasis was induced in high-dose females, but not in male rats or in low-dose females. The high-dose of
TPA also induced transitional cell tumours and squamous metaplasia in the bladder of females and may have
increased the incidence of bladder hyperplasia.
8. ENVIRONMENT
8.1. Environmental fate
8.1.1. Ready biodegradability
TEST SUBSTANCE OLOA 371
European Communities CO2 Evolution Test (Method C. 4-C) 1992
METHOD
Inoculum Activated sludge from the Downingtown Regional Water Pollution
Control Center
Exposure Period 29 d
Auxiliary Solvent Tap water
Analytical Monitoring Total and soluble organic carbon (TOC/SOC), pH and standard plate
counts (SPC) for microorganisms.
Remarks - Method OLOA 371 was added by direct weight at 10 mg C/L to duplicate
inoculated flasks with positive and negative controls. Flasks were shaken
at 110 rpm for 29 d at 21.6-23.4癈 with CO2 measured regularly in
Ba(OH)2 traps.
RESULTS
Test substance Sodium benzoate reference substance
Day % degradation Day % degradation
14 5.9-14.9 14 85.1
29 8.6-23.3 29 88.1
Remarks - Results No explanation was provided for the large variability in results between
the two replicates of the treatment. The reference substance achieved a
satisfactory level of biodegradation thus validating the test.
The test substance did not achieve 60% biodegradation within 28 d and is
CONCLUSION
therefore not considered readily biodegradable.
TEST FACILITY Roy F Weston (1997), Weston Fate and Effect Laboratory, Lionville,
Pennsylvania, USA
8.1.2. Bioaccumulation
While the low water solubility and high log KOW indicated a potential for
bioaccumulation, this is discounted by the high MW. The company
performed QSAR modelling for the bioconcentration factor (BCF) for
three likely protonated lower MW homologs as their ionic hydrochloride
salts. The BCFs were ~70 indicating they were not expected to
bioconcentrate in organisms.
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8.2. Ecotoxicological investigations
8.2.1. Acute toxicity to fish
TEST SUBSTANCE OLOA 371
OECD TG 203 Fish, Acute Toxicity Test ?static renewal, US EPA
METHOD
(1993).
Species Juvenile rainbow trout (Oncorhynchus mykiss), mean wet weight 1.3 g,
mean total length 46.4 mm.
Exposure Period 96 h
Auxiliary Solvent None
40-44 mg CaCO3/L
Water Hardness
Analytical Monitoring Total organic carbon (TOC) analyses, 5.8-9.9 mg/L dissolved oxygen,
temperature 11.6-13.1癈 and pH 7.0-7.7 were satisfactory.
Remarks ?Method Water accommodated fractions (WAF) of the relatively insoluble
chemical were prepared every 24 h for renewal of the exposure medium
by stirring a mixture for about 20 h and allowing it to settle for 4 h. The
water phase was siphoned off for use without any centrifuging or filtering
to remove possible micelles or fine emulsions. However, when the TOC
analysis is corrected for the organic carbon added to the water by the fish
themselves, the mean measured concentration in water was 0.87-2.4
mg/L for the nominal concentration of 1,000 mg/L. It is reasonable to
assume the actual concentration was limited by the water solubility of the
chemical.
RESULTS
Concentration mg/L Number of Fish Mortality
Nominal Actual (TOC) 2h 24 h 48 h 72 h 96 h
0 0 30 0 0 0 0 0
1000 0.87-2.4 30 0 0 0 1 1
EC50 >2.4 mg/L at 24-96 h
Remarks ?Results Only one of 30 fish (3%) died in the nominal treatment 1,000 mg/L water
accommodated fraction (2.4 mg/L measured concentration by TOC)
indicating the EC50 was >2.4 mg/L. No sublethal effects were noted
during the test. A thin film of insoluble material was observed on the
surface of all treated vessels throughout the test.
At the limit of water solubility (2.4 mg/L in this test) of OLOA 371, no
CONCLUSION
adverse effects were noted in 96 h.
TEST FACILITY TR Wilbury Laboratories Inc (1997a)
8.2.2. Acute toxicity to aquatic invertebrates
TEST SUBSTANCE OLOA 371
OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction
METHOD
Test ?static, US EPA (1993).
Species Neonate Daphnia magna (<24 h old)
Exposure Period 48 hours
Auxiliary Solvent None
168 mg CaCO3/L
Water Hardness
Analytical Monitoring Total organic carbon (TOC) analyses, 7.8-8.8 mg/L dissolved oxygen,
temperature 19.4-21.0癈 and pH 7.4-8.8 were satisfactory.
Remarks - Method The method of producing WAFs was the same as for the rainbow trout
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test. After correcting the TOC analysis for the organic carbon added to
the water by the daphnids themselves, the mean measured concentration
in water was 0.22-0.3 mg/L for the two reported nominal concentrations
of 130 and 1,000 mg/L, which were the lowest and highest treatments
respectively. It is reasonable to assume the actual concentrations of all
treatments (regardless of their nominal concentration) was limited by the
water solubility of the chemical and was in this range. No insoluble
material was noted during the test.
RESULTS
Concentration mg/L Number of D. magna Number Immobilised
Nominal Actual (TOC) 24 h [acute] 48 h [acute]
0 0 20 0 0
130 0.22-0.30 20 0 1
220 Not reported 20 0 1
360 Not reported 20 1 3
600 Not reported 20 1 4
1000 0.22-0.30 20 3 11
EC50 >0.3 mg/L at 24 h based on measured concentrations
>0.3 mg/L at 48 h based on measured concentrations
Remarks - Results The higher mortality of daphnids at the highest nominal concentration is
anomalous given the TOC analysis of the measured concentrations for
this and the lowest treatments to be in the 0.22-0.30 mg/L range.
Assuming the actual concentration of all treatments was in this range, the
mean 48-h mortality in the five treatments is 20% indicating the 48-h
EC50 is >0.30 mg/L. However this result must be treated with caution
given the anomalies of this test. It appears that the higher deaths at
nominal concentration 1,000 mg/L may have been a physical effect as a
thin, clear oily surface film was observed throughout the test.
At the limit of water solubility (0.22-0.30 mg/L in this test) of OLOA
CONCLUSION
371, a mean of 20% mortality was observed giving a 48-h EC50 of >0.30
mg/L. However, given the anomalies in this test, this result must be
treated with caution.
TEST FACILITY TR Wilbury Laboratories Inc (1997b)
8.2.3. Algal growth inhibition test
TEST SUBSTANCE Two separate experiments were performed on OLOA 371
OECD TG 201 Alga, Growth Inhibition Test, US EPA (1993) ?static.
METHOD
Species Pseudokirchneriella subcapitata
Exposure Period 96 h
Concentration Range
Experiment 1 Experiment 2
Nominal 0, 13, 23, 36, 60 and 100 mg/L 0, 33, 65, 130, 250, 500, 1,000 mg/L
Actual 0-0.22 mg/L (WAF) 0 mg/L (WAF)
Auxiliary Solvent None
Water Hardness Not reported
Analytical Monitoring Total organic carbon (TOC) analyses, temperature 23.2-24.0癈 and pH
7.3-10.7.
Remarks - Method A similar method of producing water accommodated fractions (WAF)
was used as for the fish and daphnid studies. After correcting the TOC
for the carbon added to the water by the alga, the mean measured
concentrations were 0-0.22 mg/L for the nominal 13 and 100 mg/L
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treatments in Experiment 1 and <1 mg/L for the lowest and highest
nominal concentrations of 33 and 1,000 mg/L in Experiment 2. The
actual concentration of dissolved chemical of all treatments was likely
limited by the water solubility of the chemical of approximately 0.125
mg/L. No insoluble material was observed in any treatment vessel in
either experiment.
Although the method seemed adequate in Experiment 2, the definitive
test was conducted four times before a final test resulted in no anomalous
or unexpected effects such as poor or variable growth.
RESULTS
Experiment Biomass Growth
96-h EbC50 = 23 (21, 25) mg/L of the nominal 96-h ErC50 = 47 (29,86) mg/L of the nominal
1
WAF WAF
96-h EbC50 = 370 mg/L of the nominal WAF 96-h ErC50 = 510 (330, 820) mg/L of the
2
(no confidence limits reported) nominal WAF
Remarks - Results Experiment 1
Given the typical dose dependent response, the TOC analysis is not likely
an accurate measurement of the true exposure of the chemical in the
WAF to the alga. It is possible that chemical could be adsorbed to algal
cells and not measured by TOC analysis. Therefore the actual
concentration for all treatments was most likely similar to the water
solubility of 0.125 mg/L, making this the LOEC. When cells from the
highest treatment were cultured in clean media for 96 h, growth occurred
indicating the chemical was algistatic rather than algicidal.
Experiment 2
The inhibition of growth only at the two highest nominal concentrations
of 500 and 1,000 mg/L is anomalous given previous results and the TOC
analysis of the measured concentrations of <1 mg/L. As with Experiment
1, the TOC analysis is not likely an accurate measurement of the true
exposure which was probably the limit of water solubility of the
chemical. The chemical was again found to be algistatic.
The most sensitive 96-h EbC50 of the water accommodated fraction of
CONCLUSION
OLOA 371 was 23 (21, 25) mg/L nominal. However, the limit of water
solubility of 0.125 mg/L was likely the true exposure, making this the
LOEC. This is considered very toxic to aquatic life (United Nations
2003)
TEST FACILITY TR Wilbury Laboratories Inc (1997c and 1998a)
8.2.4. Inhibition of microbial activity
TEST SUBSTANCE OLOA 371
OECD TG 209 Activated Sludge, Respiration Inhibition Test.
METHOD
Inoculum Activated sludge from a municipal wastewater treatment plant receiving
predominantly domestic waste.
Exposure Period 3h
Concentration Range
Nominal 0, 650, 1,300, 2,500, 5,000, 10,000 mg/L
Remarks ?Method The static test was conducted at 18.0-18.7癈 and aerated during the
exposure at ambient light. Deionised water of hardness 8 mg/L as CaCO3
was used. Test material was added to treatment vessels and incubated for
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STD/1087
3 h. After this time, insoluble material was observed on the surface of all
treatment vessels.
RESULTS
3-h IC50 >10,000 mg/L nominal concentration
Remarks ?Results In the range of concentrations tested, no inhibition of respiration was
observed although raw data were not presented to allow confirmation.
The reference toxicant test with 3,5-dichlorophenol gave a 3-h EC50 of
19 mg/L which was within the acceptable range of 5-30 mg/L.
The 3-h IC50 for activated sludge exposed to OLOA 371 was >10,000
CONCLUSION
mg/L nominal concentration.
TEST FACILITY TR Wilbury Laboratories Inc (1998b)
9. RISK ASSESSMENT
9.1. Environment
9.1.1. Environment ?exposure assessment
The used oil and the sludge collected from the on-site wastewater treatment facilities may be
incinerated. This will generate water vapour and oxides of carbon. The main environmental
exposure is expected to result from inappropriate disposal of waste lubricant product, assuming
a worst case scenario of about 14% of oil changes in Australia are performed by DIY
enthusiast.
This improper disposal is, however, widespread across Australia. Most of the improperly
released notified chemical due to DIY activities is likely to become associated with soils or
sediments, as will the chemical released to landfill as container residues. The chemical released
into the aquatic environment would be expected to become associated with the sediments.
The amount released to stormwater drains (about 0.7% of the import volume) can enter the
aquatic compartment and could be expected to become associated with suspended organic
material (due to the estimated high Pow), settle out into the sediments and eventually be
biodegraded.
It is difficult to estimate the Predicted Environmental Concentration (PEC) of the notified
chemical released into the stormwater drains, which have the potential to directly enter the
aquatic environment. However, a worst case PEC may be calculated assuming that all of the
0.7% of the notified substance (i.e. 140 kg) were released into the stormwater drains in a single
metropolitan area with a geographical footprint of 500 square kilometres, and an average
annual rainfall of 50 cm. With a maximum annual release into this localised stormwater system
of 140 kg and the annual volume of water drained from this region estimated to be
approximately 250 X 106 m3, the resultant PEC is 0.56 礸/L. This is very much a worst case
scenario, and in reality releases of the chemical would be much more diffuse and at
significantly reduced levels.
9.1.2. Environment ?effects assessment
Based on the data provided and using the most sensitive endpoint of 0.125 mg/L for the 96-h
LOEC to algae, a predicted no effect concentration (PNEC) for aquatic ecosystems of 1.25
礸/L was derived by dividing the LOEC by an uncertainty (safety) factor of 100 because
toxicity data are available for three trophic levels.
9.1.3. Environment ?risk characterisation
The worst-case PEC is significantly below possible toxic levels and the resulting risk quotient
(Q = PEC ?PNEC = 0.56 礸 ?1.25 礸/L = 0.4) is below 1. Further, the limited release to the
aquatic environment (mainly via stormwater drainage) and more diffuse national use than
modelled is expected to reduce the PEC and the chemical is expected to associate with
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STD/1087
sediments. The moderate biodegradation will further reduce the exposure to aquatic life.
Overall, the chemical is not expected to pose a risk to the environment based on its reported use
pattern.
9.2. Human health
9.2.1. Occupational health and safety ?exposure assessment
Skin contact is possible during transfer operations (hose coupling/uncoupling) of the additive
package and the blended products containing the notified chemical at waterfront, formulation
sites, and customers' facilities.
At the formulation sites, inhalation exposure is unlikely as the process is unlikely to generate
aerosols and ventilation systems are in place. During the automatic blending, operators will have
low exposure by skin contact since they are only required to take samples for quality control
purposes. During packaging process, skin contact may occur for operators involved in
overseeing the filling process where manual intervention is required and during bunging and
labelling of the drums. However, in all instances potential exposure is for brief periods only.
Workers may have repeated skin or eye contamination with the finished products containing the
notified chemical during repairing and servicing of engine equipment. However, as the
concentration of the notified chemical in the formulated products is low, the potential exposure
for these end users is low.
9.2.2. Public health ?exposure assessment
Individuals who maintain their engine equipment will handle the products containing the
notified chemical. Infrequent dermal exposure (most likely to the hands and forearms), and
accidental ocular exposure could occur in these individuals. The notified chemical comprises
less than 10% in blended products, thus the public exposure is considered to be low.
The dermal exposure during formulation and end use can be estimated by the EASE (Estimation
and Assessment of Substance Exposure) program developed by the Health and Safety
Executive, UK (1997). In the calculation of dermal exposure, the surface area of occupational
exposure is selected to be 1000 cm2 (NICNAS, 1996).
EASE Prediction
Physical state Liquid
Temperature 25癈
Operation Formulation End use (occupational) End use (public)
Dermal exposure
Use pattern - Closed system - non-dispersive use - wide dispersive
Pattern of control - non-direct handling - direct handling - direct handling
Contact level - extensive - incidental
1-5 mg/cm2/day 0.1-1 mg/cm2/day
Predicted exposure (product) Very low
or 1000-5000 mg/day or 100-1000 mg/day
Predict exposure (chemical) Very low 100-500 mg/day 10-100 mg/day
9.2.3. Human health - effects assessment
Based on data for the analogue OLOA 232E, the notified chemical, OLOA 11004 is considered
to be of low acute oral and dermal toxicity in rats. It is a slight skin and eye irritants in rabbits.
There is limited evidence of skin sensitisation to OLOA 11004 in guinea pigs based on data
from two Buehler studies. Regarding genotoxicity, OLOA 11004 is not expected to be
mutagenic in the bacterial reverse mutation test or the in vitro mouse lymphoma cells test.
OLOA 11004 is the reaction product of OLOA 371 and TPA. According to the toxicity data
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STD/1087
provided by the notifier, OLOA 371 was of low acute oral and dermal toxicity in rats, and was
slightly irritating skin and eyes in rabbits. Limited evidence of skin sensitisation was noted in a
Buehler study guinea pigs. The NOAEL for OLOA 371 in a combined repeat-dose (280day
oral), neurotoxicity and reproductive toxicity study in rats was 1000 mg/kg/day, the highest
dose. OLOA 371 was non-mutagenic in an Ames test and non-genotoxic in an in vivo
mammalian bone marrow chromosomal aberration test.
Based on the data provided by the notifier and other available information (European
Commission, 2000), TPA was of low acute oral and dermal toxicity, and was a slight skin and
eye irritant. It was not a skin sensitiser. The NOEL from repeat-dose inhalation studies was
approximately 10 mg/m3/6 hours per day. It showed negative in Ames tests but was positive in
an in vivo micronucleus assay.
Based on all available data, the notified chemical is of low acute toxicity, it is a slight irritant
and may be a weak skin sensitiser. The notified chemical is unlikely to cause adverse effects
after repeated exposure and is most likely not genotoxic.
9.2.4. Occupational health and safety ?risk characterisation
The notified chemical is predicted to be a slight irritant. It is unlikely to exhibit irritant effects at
the low concentrations. The main concern of occupational health is the possible skin
sensitisation effect. Any workers who become sensitised with the notified chemical should avoid
further handling of the chemical. Risk from repeated exposure is considered to be low since at
1000 mg/kg/day (the NOAEL), the amount of product equivalent will be large and workers
would not be expected to be exposed repeatedly to large amounts.
Dermal contact will be the main route of exposure and the occupational exposure is considered
to be low. Pumps are used for transferring processes and automatic equipment is used for
formulation. In addition, the engineering controls such as automation and enclosure are in place
and workers will wear personal protective equipment. Therefore, the adverse health risk for
workers handling the notified chemical is assessed to be low.
9.2.5. Public health ?risk characterisation
The main concern of public health in handling products containing the notified chemical is the
possibility of skin sensitisation. Consumers who become sensitised to the notified chemical
should be advised to avoid any further handling of products containing the chemical.
Formulated products containing the notified chemical are on the market for sale to the general
public. Members of the public will make dermal contact and possibly accidental ocular contact
with products containing the notified chemical. However, the health risk for public will be low
because of the low concentrations of notified chemical present in the products, and the
intermittent use pattern.
The dermal exposure estimated by the EASE can also be used for risk characterisation. Based
on the assessment of health effects, the NOAEL of 1000 mg/kg/day is selected in the risk
characterisation. An absorption rate from dermal exposure of 10% and a bodyweight of 70 kg
are used for estimation. The margins of exposure (MOEs) are calculated for the various
scenarios (MOE = NOAEL/internal dose).
Risk characterisation based on EASE Prediction
Operation Formulation End use (occupational) End use (public)
Predict dermal exposure to chemical Very low 100-500 mg/day 10-100 mg/day
Internal dose (or absorbed dose) Very low 10-50 mg/day 1-10 mg/day
NOAEL = 1000 mg/kg/day
Margin of Exposure (MOE) Very high 1400-7000 7000-70000
(NOAEL*70 kg/internal dose)
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STD/1087
The EASE program did not include the scenario of exposure with personal protective equipment
(PPE). If PPE such as overalls, gloves and eye protection is worn to reduce the exposure, the
MOE is expected to be higher. Taking into account that exposure estimates were worst-case, the
risk of adverse health effects in workers or the general public exposed to the notified chemical is
considered to be low particularly when industrial control is in place and PPE is worn.
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 hazardous under the
NOHSC Approved Criteria for Classifying Hazardous Substances.
As a comparison only, the classification of notified chemical using the Globally Harmonised
System for the Classification and Labelling of Chemicals (GHS) (United Nations, 2003) is
presented below. This system is not mandated in Australia and carries no legal status but is
presented for information purposes.
Based on its toxicity to algae, the notified chemical is considered very toxic to aquatic life
(United Nations 2003).
10.2. Environmental risk assessment
On the basis of the PEC/PNEC ratio, the chemical is not considered to pose a risk to the
environment based on its reported use 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 Low Concern to public health based on its reported use pattern.
11. MATERIAL SAFETY DATA SHEET
11.1. Material Safety Data Sheet
The MSDS of the notified chemical provided by the notifier was in accordance with the NOHSC
National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC, 1994a).
It is published here as a matter of public record. The accuracy of the information on the MSDS
remains the responsibility of the applicant.
11.2. Label
The label for the notified chemical provided by the notifier was in accordance with the NOHSC
National Code of Practice for the Labelling of Workplace Substances (NOHSC, 1994b). The
accuracy of the information on the label remains the responsibility of the applicant.
12. RECOMMENDATIONS
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:
- gloves (nitrile, viton or silver shield) when handling additive packages
- eye protection
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STD/1087
- overalls, and
- occupational footwear
Guidance in selection of personal protective equipment can be obtained from
Australian, Australian/New Zealand or other approved standards.
? A copy of the MSDS should be easily accessible to employees.
? If products and mixtures containing the notified chemical are classified as hazardous to
health in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances, workplace practices and control procedures consistent with provisions of
State and Territory hazardous substances legislation must be in operation.
Environment
Disposal
? The notified chemical should be disposed of to landfill and not to water.
Emergency procedures
? Spills/release of the notified chemical should be handled by applying non-combustible
absorbent materials or pumping. Where feasible and appropriate, remove contaminated
soil. Place contaminated materials in disposable containers and dispose of in a manner
consistent with applicable regulations. If heated material is spilled, allow it to cool
before proceeding with disposal methods.
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 Subsection 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
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Chevron Environmental Health Center Inc (1986) Modified Buehler Test for the Skin Sensitization Potential of
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STD/1087
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Rausina, G.A., Biggs, W.R., Stonebraker, P.M., and Crecelius, E.A. (1996) Using Semipermeable Membrane
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