En3.unige.it

Existing Chemical Substance ID: 92045–14–2
CAS No. 92045–14–2
EINECS Name Fuel oil, heavy, high–sulfur
EINECS No. 295–396–7
Molecular Formula <no data>
Substance Group 6A
Dataset created by: EUROPEAN COMMISSION – European Chemicals Bureau
This dossier is a compilation based on data reported by the European
Chemicals Industry following ’Council Regulation (EEC) No. 793/93
on the Evaluation and Control of the Risks of Existing Substances’.
All (non–confidential) information from the single datasets, submitted
in the IUCLID/HEDSET format by individual companies, was integrated
to create this document.
The data have not undergone any evaluation by the European Commission.
Creation date: 19–FEB–2000
Number of Pages: 50
Chapters: all
Edition: Year 2000 CD–ROM edition
Flags: non–confidential
(C) 2000 EUROPEAN COMMISSION
European Chemicals Bureau
1. General Information Substance ID: 92045–14–2 ______________________________________________________________________________ 1.0.1 OECD and Company Information
Name: ELF ANTAR FRANCE
Street: 2 Place de la Coupole
Town: 92078 PARIS La Defense
Country: France
Phone: (33 1)47 44 45 46
Telefax: (33 1)47 44 32 33
Telex: 615 400 F
Cedex: 45
Name: Leuna Raffineriegesellschaft mbH
Street: Am Haupttor Bau 18
Town: 06236 Leuna
Country: Germany
Phone: +49 (0)3461 43 3298
Telefax: +49 (0)3461 43 3769
1.0.2 Location of Production Site
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1.0.3 Identity of Recipients
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1.1 General Substance Information
Substance type: petroleum product
Physical status: liquid
Substance type: petroleum product
Physical status: solid
1.1.1 Spectra
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1.2 Synonyms
Fioul lourd n°2 HTS (Haute Teneur en Soufre >=2%), FO2,FOL2 Source: ELF ANTAR FRANCE PARIS La Defense
Source: Leuna Raffineriegesellschaft mbH Leuna
Source: Leuna Raffineriegesellschaft mbH Leuna
1.3 Impurities
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1. General Information Substance ID: 92045–14–2 ______________________________________________________________________________ 1.4 Additives
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1.5 Quantity
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1.6.1 Labelling
Labelling: as in Directive 67/548/EEC
Symbols: T
Nota: other RM: H
Specific limits: no data
R–Phrases: (45) May cause cancer
S–Phrases: (53) Avoid exposure – obtain special instructions before use
(45) In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) 1.6.2 Classification
Classification: as in Directive 67/548/EEC
Class of danger: carcinogenic, category 2
R–Phrases: (45) May cause cancer
1.7 Use Pattern
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1.7.1 Technology Production/Use
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1.8 Occupational Exposure Limit Values
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1.9 Source of Exposure
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1.10.1 Recommendations/Precautionary Measures
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1.10.2 Emergency Measures
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1.11 Packaging
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1. General Information Substance ID: 92045–14–2 ______________________________________________________________________________ 1.12 Possib. of Rendering Subst. Harmless
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1.13 Statements Concerning Waste
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1.14.1 Water Pollution
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1.14.2 Major Accident Hazards
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1.14.3 Air Pollution
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1.15 Additional Remarks
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1.16 Last Literature Search
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1.17 Reviews
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1.18 Listings e.g. Chemical Inventories
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2. Physico–chemical Data Substance ID: 92045–14–2 ______________________________________________________________________________ 2.1 Melting Point
Value: –1 – 13 degree C
Decomposition: no
Sublimation: no
Method: other: ASTM D97
GLP: no data
Remark: Typical drop point range for catalytically cracked
clarified oil (CCCO), CAS No. 64741–62–4.
Source: ELF ANTAR FRANCE PARIS La Defense
2.2 Boiling Point
Value: 150 – 600 degree C at 1013 hPa
Decomposition: no
Method: other: ASTM D86
GLP: no data
Remark: Typical boiling range for catalytically cracked clarified
oil (CCCO), CAS No. 64741–62–4.
Source: ELF ANTAR FRANCE PARIS La Defense
2.3 Density
Type: density
Value: 1.01 – 1.07 g/cm3 at 15 degree C
Method: other: ASTM D1298
GLP: no data
Remark: Typical density range for catalytically cracked clarified
oil (CCCO), CAS No. 64741–62–4.
The density range of 1.01 to 1.07 g/cm3 corresponds to an Source: ELF ANTAR FRANCE PARIS La Defense
2.3.1 Granulometry
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2.4 Vapour Pressure
Value: > 5 hPa at 20 degree C
Method: other (calculated): ASTM D323
GLP: no data
Remark: Typical vapour pressure value for catalytically cracked
clarified oil (CCCO), CAS No. 64741–62–4.
Source: ELF ANTAR FRANCE PARIS La Defense
2. Physico–chemical Data Substance ID: 92045–14–2 ______________________________________________________________________________ 2.5 Partition Coefficient
log Pow: 2.7 – 6
Method: other (calculated)
Remark: The calculation was done by the CLOGP Version 3.5 program
(Calculation of LOG Partition coefficient octanol/water).
Calculated and/or measured Log Pow values for alkanes of carbon number C7 and above are greater than 4.3 and Log Pow values for aromatic hydrocarbons of C7 and above are greater Source: ELF ANTAR FRANCE PARIS La Defense
2.6.1 Water Solubility
Value: < .1 g/l at 20 degree C
Qualitative: of very low solubility
Method: other
GLP: no data
Remark: Limit value applies to catalytically cracked clarified oil
Source: ELF ANTAR FRANCE PARIS La Defense
2.6.2 Surface Tension
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2.7 Flash Point
Value: > 76 degree C
Type: open cup
Method: other: ASTM D92
GLP: no data
Remark: Typical open–cup flash point range for catalytically cracked
clarified oil (CCCO), CAS No. 64741–62–4.
Source: ELF ANTAR FRANCE PARIS La Defense
2.8 Auto Flammability
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2.9 Flammability
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2.10 Explosive Properties
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2. Physico–chemical Data Substance ID: 92045–14–2 ______________________________________________________________________________ 2.11 Oxidizing Properties
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2.12 Additional Remarks
Remark: The technical information contained in Chapters 2 to 5 of
this Data Set has been compiled by the Oil Companies’ European Organization for Environmental and Health Protection, CONCAWE, based at Madouplein–1, B–1030 Brussel, Belgium, and this organization holds copies of the reference Source: ELF ANTAR FRANCE PARIS La Defense
3. Environmental Fate and Pathways Substance ID: 92045–14–2 ______________________________________________________________________________ 3.1.1 Photodegradation
Type: air
Light source: Sun light
Conc. of subst.: at 25 degree C
INDIRECT PHOTOLYSIS
Sensitizer: OH
Conc. of sens.: 1000000 molecule/cm3
Year: GLP:
Test substance:
Remark: The vast majority of the hydrocarbon components of the
substances of this Group, and especially those with carbon number greater than C20, will have little or no tendency to partition to air (see Sub–chapter 3.3.2). The half lives for degradation of these hydrocarbons by reaction with hydroxyl radicals, in the troposphere, under the influence of sunlight, will all be less than one day, by extrapolation from the data quoted by Atkinson. Accordingly, any hydrocarbon material which does partition to air will be Source: ELF ANTAR FRANCE PARIS La Defense
3.1.2 Stability in Water
Year: GLP:
Test substance:
Remark: Hydrocarbons present in fuel oil components are not
susceptible to hydrolysis under environmental conditions.
Source: ELF ANTAR FRANCE PARIS La Defense
3. Environmental Fate and Pathways Substance ID: 92045–14–2 ______________________________________________________________________________ 3.1.3 Stability in Soil
Type: laboratory Radiolabel: no
Concentration: 50000 mg/kg
Soil temp.: 17 degree C
Content of clay: 24 %
silt: 40 %
sand: 36 %
Organ. carbon: 2.7 %
pH: 7.5 – 7.6
Cation exch.
Microbial
biomass:
Dissipation time
DT50: > 336 day
Method: other: procedure as detailed in paper by Song, Wang and Bartha
Year: 1990 GLP: no data
Test substance: other TS
Remark: The soil type used was loam. Other studies were done in
sand, clay and loam soils at temperatures of 27 and 37 degree C, and also in the presence of nitrogen and phosphorus compounds added to assist in bioremediation. In all cases, the test substance proved to be very persistent, with about 80% still being present after one year of Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Bunker C fuel oil, viz., residual fuel oil, CAS No.
3.2 Monitoring Data (Environment)
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3.3.1 Transport between Environmental Compartments
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3. Environmental Fate and Pathways Substance ID: 92045–14–2 ______________________________________________________________________________ 3.3.2 Distribution
Media: air – biota – sediment(s) – soil – water
Method: Calculation according Mackay, Level I
Remark: Distribution has been calculated according to Mackay Level I
using the parameters defined in a paper by van der Zandt Lower molecular weight alkanes and aromatic hydrocarbons will mainly partition to air; alkanes will have no tendency to enter the water phase, but up to 1.0% of aromatic hydrocarbons may distribute to this compartment. As the molecular weight increases, for all hydrocarbons, the distribution will be preferentially to soil and sediment.
Result: Results for typical hydrocarbons found in fuel oils are
n–tetradecane 76.6 0.0 22.8 0.5 0.0 0.0 Source: ELF ANTAR FRANCE PARIS La Defense
3.4 Mode of Degradation in Actual Use
Remark: In use, fuel oils are burnt to produce mainly carbon dioxide
and water vapour. However, in both manufacture and use, some loss of these substances to the environment occurs.
Evaporation, dissolution and degradation are the main routes by which fuel oils are removed from the environment.
The various hydrocarbon components of fuel oils show different rates of degradation following spills, as Source: ELF ANTAR FRANCE PARIS La Defense
3. Environmental Fate and Pathways Substance ID: 92045–14–2 ______________________________________________________________________________ 3.5 Biodegradation
Type: aerobic
Inoculum: other: industrial waste water adapted to oil contamination
Concentration: 1000 mg/l related to Test substance
Degradation: 11 % after 28 day
Result: other: biodegrades very slowly
Method: other: procedure as detailed in paper by Walker, Petrakis and
Year: GLP: no data
Test substance: other TS
Remark: A volume of 100 ml of a medium consisting of dissolved salts
supplemented with nitrogen and phosphate nutrients was innoculated with 1.0 ml of creek water and overlaid with 100 mg of fuel oil. The mixture was shaken for 28 days at 15 degree C. On completion, the remaining oil was extracted using chloroform and determined gravimetrically.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Fuel oil no. 6, CAS No. 68553–00–4.
3.6 BOD5, COD or BOD5/COD Ratio
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3.7 Bioaccumulation
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3.8 Additional Remarks
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Bunker C fuel oil.
4. Ecotoxicity Substance ID: 92045–14–2 ______________________________________________________________________________ AQUATIC ORGANISMS
4.1 Acute/Prolonged Toxicity to Fish
Type: semistatic
Species: Brachydanio rerio (Fish, fresh water)
Exposure period: 96 hour(s)
Unit: mg/l Analytical monitoring: no
NOEC: = 5.6
LC50: = 48
Method: OECD Guide–line 203 "Fish, Acute Toxicity Test"
Year: GLP: yes
Test substance: other TS
Remark: The test species was the Zebrafish.
Groups of fish were exposed to loading rate concentrations of the test substance in the range 3.2 to 100 mg/l. Their condition and mortality were compared with those of a control group of fish not exposed to the test substance.
Total mortality was observed at 100 mg/l. At 18 mg/l, all fish were alive after 96 hours but their condition was not as good as that of the control group. The 48–hour LC50 Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked residue, identified as carbon black oil, CAS
Type: static
Species: Menidia menidia (Fish, estuary, marine)
Exposure period: 96 hour(s)
Unit: mg/l Analytical monitoring: no data
LC50: = 130
Method: other: procedure as detailed in paper by Hollister, Ward and
Year: GLP: no data
Test substance: other TS
Remark: The test species was the Atlantic Silverside.
Tests were run on dispersions of the fuel oil in sea water, and LC50 results were expressed as loading rate Toxicity was largely attributed to the aromatic constituents, which have the highest bioavailability in the Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Fuel oil no. 6, CAS No. 68553–00–4.
4. Ecotoxicity Substance ID: 92045–14–2 ______________________________________________________________________________ 4.2 Acute Toxicity to Aquatic Invertebrates
Species: other: Acartia tonsa
Exposure period: 96 hour(s)
Unit: mg/l Analytical monitoring: no data
Method: other: procedure as detailed in paper by Hollister, Ward and
Year: GLP: no data
Test substance: other TS
Remark: The copepods were exposed to dispersions of the fuel oil in
sea water and the measured 96–hour EC50 was 5.1 mg/l, expressed as a loading rate concentration. However, this figure is suspect, since it would appear that some of the test species were immobilized due to physical fouling in the surface film of oil. Such smothering effects are not considered to be a true reflection of the ecotoxicity of the Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Fuel oil no. 6, CAS No. 68553–00–4.
4.3 Toxicity to Aquatic Plants e.g. Algae
Species: Skeletonema costatum (Algae)
Endpoint: biomass
Exposure period: 96 hour(s)
Unit: mg/l Analytical monitoring: no data
EC50: = 160
Method: other: procedure as detailed in paper by Hollister, Ward and
Year: GLP: no data
Test substance: other TS
Remark: Algae were exposed to dispersions of the test substance in
sea water, and the results were expressed in terms of Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Fuel oil no. 6, CAS No. 68553–00–4.
4.4 Toxicity to Microorganisms e.g. Bacteria
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4. Ecotoxicity Substance ID: 92045–14–2 ______________________________________________________________________________ 4.5 Chronic Toxicity to Aquatic Organisms
4.5.1 Chronic Toxicity to Fish
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4.5.2 Chronic Toxicity to Aquatic Invertebrates
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TERRESTRIAL ORGANISMS
4.6.1 Toxicity to Soil Dwelling Organisms
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4.6.2 Toxicity to Terrestrial Plants
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4.6.3 Toxicity to other Non–Mamm. Terrestrial Species
Species: Anas platyrhynchas (avian)
Endpoint: other: hatching success
Expos. period:
Method: other: procedure as detailed in paper by Szaro (see
Year: GLP: no data
Test substance: other TS
Remark: Physical entrapment and coating of the feathers of seabirds
following spills of heavy fuel oil has been widely Hatching success, expressed as a percentage of the control hatching success, after exposure to varying volumes of 98% of the untreated control eggs hatched.
Source: ELF ANTAR FRANCE PARIS La Defense
4. Ecotoxicity Substance ID: 92045–14–2 ______________________________________________________________________________ 4.7 Biological Effects Monitoring
Remark: Physical smothering of inter–tidal organisms may occur
following a spill; rapid recovery is seen in more mobile species. Stimulation of phytoplankton biomass and primary production has been observed. Rapid accumulation with slower depuration is observed in mussels (Mytilus edulis) and clams (Macoma balthica) following a spill. Marsh grasses show heavy effects within the first year after a spill, with recovery beginning in the second year and normal Source: ELF ANTAR FRANCE PARIS La Defense
4.8 Biotransformation and Kinetics
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4.9 Additional Remarks
Remark: The apparent effects of fuel oil spills vary considerably,
depending on the type of material spilled, the exposure conditions (volume, time of year, temperature, etc.) and the physical environment (low or high energy wave action).
Little long–term impact in supralittoral, littoral or pelagic zones, with possible resuspension and continued impact on benthic organisms, has been observed following a spill. In the laboratory, the composition and resulting toxicity varies depending on the amount and type of cutter stock (typically a no. 2 fuel oil) used.
Source: ELF ANTAR FRANCE PARIS La Defense
Remark: For the assessment of the ecotoxicity of poorly water
soluble mixtures of hydrocarbons, as found in petroleum products, it is now generally accepted that results should be expressed in terms of the "loading rate". The "loading rate" may be defined as the amount of the product which must be equilibrated with the aqueous test medium in order to produce a specified level of effect. Studies in which the results are expressed in terms of the measured concentrations of hydrocarbons in dilutions of "water soluble fractions (WSF)" do not allow the ecotoxicity of a product to be expressed in terms of the amount of that product required to produce a particular effect and, therefore, such results are not comparable to results obtained with other substances. This subject is further addressed in the following References.
Source: ELF ANTAR FRANCE PARIS La Defense
Remark: For the assessment of the ecotoxicity of poorly water
soluble mixtures of hydrocarbons, as found in petroleum products, it is now generally accepted that results should be expressed in terms of the "loading rate". The "loading rate" may be defined as the amount of the product which must be equilibrated with the aqueous test medium in order to 4. Ecotoxicity Substance ID: 92045–14–2 ______________________________________________________________________________ produce a specified level of effect. Studies in which the results are expressed in terms of the measured concentrations of hydrocarbons in dilutions of "water soluble fractions (WSF)" do not allow the ecotoxicity of a product to be expressed in terms of the amount of that product required to produce a particular effect and, therefore, such results are not comparable to results obtained with other substances. This subject is further addressed in the following References.
Source: ELF ANTAR FRANCE PARIS La Defense
______________________________________________________________________________ 5.1 Acute Toxicity
5.1.1 Acute Oral Toxicity
Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: > 24700 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Each animal in a group of five male and five female Sprague–Dawley rats was treated with a single dose of 25 ml/kg of test substance. Administration was by gavage.
Animals were observed for 14 days. No mortality or toxic signs were seen during the study. Gross necropsy revealed congested livers and kidneys in the test animals.
Similar studies with two other samples of No. 6 Heavy Fuel Oil, designated API 78–6 and API 78–7, each gave LD50 values Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–8 with API Gravity 23.1/0.2%S),
Fuel oil No. 6, CAS No. 68553–00–4.
Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: = 5500 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Groups of 5 male and 5 female Sprague–Dawley rats were tested at doses of 3.5, 6.5, 7.5, 10 and 25 ml/kg of the test substance. Administration was by gavage. Animals were observed for 14 days. Complete mortality was found at the two highest doses and 10% mortality at the lowest dose.
Animals that died were found to have congested livers and intestinal irritation. Surviving rats were found at necropsy to have slightly congested livers and kidneys.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–8), Fuel oil No. 6, CAS No.
______________________________________________________________________________ Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: = 4320 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Groups of 5 male and 5 female Sprague–Dawley rats were tested at doses of 3.2, 4.0, 5.0, 6.25 and 7.81 g/kg of test substance. Administration was by gavage. Animals were observed for 14 days. In addition to mortalities, the main clinical signs were hypoactivity, ataxia, prostration, diarrhoea, hair loss and eye opacity. The LD50 values for male and female animals were 5270 and 4320 mg/kg Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: > 2000 mg/kg bw
Method: OECD Guide–line 401 "Acute Oral Toxicity"
Year: GLP: yes
Test substance: other TS
Remark: Each animal in a group of five male and five female rats
was treated with a single dose of 2.0 g/kg of test substance. Administration was by gavage. No deaths resulted. Signs of intoxication were observed in males up to 4 hours after treatment and in females up to 24 hours after treatment. Bodyweight gains recommenced 3 days after treatment. At necropsy, no treatment–related effects were Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked residue, identified as carbon black oil, CAS
______________________________________________________________________________ Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: = 5898 mg/kg bw
Method: other: procedure as detailed in Exxon paper (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Groups of 5 male Sprague–Dawley rats were tested at doses of 3.5, 6.5, 7.5, 10 and 25 g/kg of the test substance.
Administration was by gavage in a single dose. Animals were observed for 14 days. All the animals survived at doses of 3.16 g/kg and below, whilst none survived at 10 g/kg. At gross necropsy, there were no notable findings.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked tar, identified as MRD–ECH–80–28, CAS No.
5.1.2 Acute Inhalation Toxicity
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5.1.3 Acute Dermal Toxicity
Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: > 2000 mg/kg bw
Method: OECD Guide–line 402 "Acute dermal Toxicity"
Year: GLP: yes
Test substance: other TS
Remark: The test substance was applied to the shaved skin of a group
of male and female rats at a single dose of 2.0 g/kg, and was kept in place by a patch for 24 hours. No deaths resulted. No clinical signs or skin reactions were exhibited by any of the animals. No treatment–related Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked residue, identified as carbon black oil, CAS
______________________________________________________________________________ Type: LD50
Species: rabbit
Number of
Animals:
Vehicle:
Value: > 4940 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–6 with API Gravity 11.7/2.7%S),
Fuel oil No. 6, CAS No. 68553–00–4.
Type: LD50
Species: rabbit
Number of
Animals:
Vehicle:
Value: > 5350 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Four male and four female New Zealand White rabbits were each exposed to a single dose of 5 ml/kg for 24 hours. The skins of 2 male and 2 female animals were abraded before exposure. The animals were observed for 14 days. In this period 3 of the 8 animals died. The primary finding from the gross necropsy was congested livers.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 79–2), Fuel oil No. 6, CAS No.
Type: LD50
Species: rabbit
Number of
Animals:
Vehicle:
Value: > 2000 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Four male and four female New Zealand White rabbits were each treated with 2.0 g/kg of test substance for 24 hours.
The skins of 2 male and 2 female animals were abraded before exposure. Animals were observed for 14 days. No deaths resulted and there were no significant clinical signs. Any ______________________________________________________________________________ erythema that may have been present after patch removal was obscured by the black tarry test substance.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: LD50
Species: rabbit
Number of
Animals:
Vehicle:
Value: > 3160 mg/kg bw
Method: other: procedure as detailed in Exxon paper (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was very similar to that given in OECD
Each animal in a group of 2 male and 2 female New Zealand White rabbits was treated dermally with 3.16 g/kg of the test substance for 24 hours. Animals were observed for 12 days after treatment. All the animals survived and minimal irritation was noted at the treatment sites. At gross necropsy, there were no notable findings.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked tar, identified as MRD–ECH–80–28, CAS No.
5.1.4 Acute Toxicity, other Routes
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5.2 Corrosiveness and Irritation
5.2.1 Skin Irritation
Species: rabbit
Concentration:
Exposure:
Exposure Time:
Number of
Animals:
Result: moderately irritating
EC classificat.: irritating
Method: OECD Guide–line 404 "Acute Dermal Irritation/Corrosion"
Year: 1959 GLP: yes
Test substance: other TS
Remark: DSM Limburg B.V., Acute dermal irritation/corrosion study
with Carbon Black – DSM Roetolie in albino rabbits. Study conducted by TNO. Report No. V89.197, DSM, Geleen, The ______________________________________________________________________________ Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked residue, identified as carbon black oil – DSM
Species: rabbit
Concentration:
Exposure:
Exposure Time:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity tests, API
78–6. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32814, API, Three male and three female New Zealand White rabbits were each treated for 24 hours, applying 0.5 ml of test substance to both abraded and non–abraded skin areas and covering with a closed patch. The animals were monitored over 72 hours post exposure and scored according to the Draize scale. A mean primary dermal irritation index of 0.35 out of a maximum score of 8.0 indicated that the test substance was minimally irritating. The mean erythema score for the intact skin was 0.25, and the mean oedema score was also Similar results were observed in studies on three further samples of No. 6 Heavy Fuel Oil, designated API 78–7, API 78–8 and API 79–2. The latter gave the highest primary irritation index score, scoring 1.54.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–6 with API Gravity 11.7/2.7%S),
Fuel oil No. 6, CAS No. 68553–00–4.
______________________________________________________________________________ Species: rabbit
Concentration:
Exposure:
Exposure Time:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity studies of
catalytic cracked clarified oil, API Sample 81–15. Study conducted by Hazleton Raltech Inc. Report No. 30–31854, Six New Zealand White rabbits were each treated for 24 hours, applying 0.5 ml of test substance to both abraded and non–abraded skin areas and covering with a closed patch.
Animals were observed for 14 days. Treated skin areas were scored at 24 and 72 hours according to the Draize scale, after first wiping off the black test substance, since this obscured the extent of erythema and oedema. A mean primary dermal irritation index of 0.2 out of a maximum score of 8.0 indicated that the test substance was minimally irritating.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Species: rabbit
Concentration:
Exposure:
Exposure Time:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity studies of
catalytic cracked clarified oil, API Sample 81–15. Study conducted by Hazleton Raltech Inc. Report No. 30–31854, Six New Zealand White rabbits were each treated for 24 hours, applying 0.5 ml of test substance to both abraded and non–abraded skin areas and covering with a closed patch.
Animals were observed for 14 days. Treated skin areas were scored at 24 and 72 hours according to the Draize scale, after first wiping off the black test substance, since this obscured the extent of erythema and oedema. A mean primary dermal irritation index of 0.2 out of a maximum score of 8.0 indicated that the test substance was minimally irritating.
Source: ELF ANTAR FRANCE PARIS La Defense
______________________________________________________________________________ Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
5.2.2 Eye Irritation
Species: rabbit
Concentration:
Exposure Time:
Comment:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity tests, API
78–8. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32816, API, Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–8 with API Gravity 23.1/0.2%S),
Fuel oil No. 6, CAS No. 68553–00–4.
Species: rabbit
Concentration:
Exposure Time:
Comment:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity studies of
catalytic cracked clarified oil, API Sample 81–15. Study conducted by Hazleton Raltech Inc. Report No. 30–31854, Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
______________________________________________________________________________ Species: rabbit
Concentration:
Exposure Time:
Comment:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: Each animal in a group of 3 male and 3 female New Zealand
White rabbits was treated in one eye with 0.1 ml of the test substance. Eyes were not washed after treatment. Effects on the eyes were monitored over 14 days. Conjunctival redness was noted in all animals, but there was no evidence of corneal or iridial damage. At the 24–hour point, conjunctival scores ranged from 2 to 9 out of a maximum of 110, with an average of 5.0. The scores declined thereafter and all irritation had subsided within 14 days.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked tar, identified as MRD–ECH–80–28, CAS No.
Species: rabbit
Concentration:
Exposure Time:
Comment:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity studies of
catalytic cracked clarified oil, API Sample 81–15. Study conducted by Hazleton Raltech Inc. Report No. 30–31854, Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
______________________________________________________________________________ Species: rabbit
Concentration:
Exposure Time:
Comment:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: Draize Test
Year: 1959 GLP: yes
Test substance: other TS
Remark: Each animal in a group of 3 male and 3 female New Zealand
White rabbits was treated in one eye with 0.1 ml of the test substance. Eyes were not washed after treatment. Effects on the eyes were monitored over 14 days. Conjunctival redness was noted in all animals, but there was no evidence of corneal or iridial damage. At the 24–hour point, conjunctival scores ranged from 2 to 9 out of a maximum of 110, with an average of 5.0. The scores declined thereafter and all irritation had subsided within 14 days.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked tar, identified as MRD–ECH–80–28, CAS No.
Species: rat
Concentration:
Exposure Time:
Comment:
Number of
Animals:
Result: slightly irritating
EC classificat.: not irritating
Method: OECD Guide–line 405 "Acute Eye Irritation/Corrosion"
Year: GLP: yes
Test substance: other TS
Remark: DSM Limburg B.V., Acute eye irritation/corrosion study with
Carbon Black – DSM Roetolie in albino rats. Study conducted by TNO. Report No. V89.200/290069, DSM, Geleen, The Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked residue, identified as carbon black oil – DSM
______________________________________________________________________________ 5.3 Sensitization
Type: Buehler Test
Species: guinea pig
Number of
Animals:
Vehicle:
Result: not sensitizing
Classification: not sensitizing
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Dermal sensitization study in
guinea pigs. Closed patch technique. Catalytic cracked clarified oil, API Sample 81–15. Study conducted by Hazleton Laboratories America Inc. Report No. 31–31417, Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: Patch–Test
Species: guinea pig
Number of
Animals:
Vehicle:
Result: not sensitizing
Classification: not sensitizing
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: American Petroleum Institute. Acute toxicity tests, API
78–8. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32816, API, Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–8 with API Gravity 23.1/0.2%S),
Fuel oil No. 6, CAS No. 68553–00–4.
______________________________________________________________________________ 5.4 Repeated Dose Toxicity
Species: rat Sex: male/female
Strain: New Zealand white
Route of admin.: dermal
Exposure period: 2 weeks (1 group) and 13 weeks (4 groups)
Frequency of
treatment: 5 times per week
Post. obs.
period: none
Doses: 4 Test groups (13–week exposure): 8, 30, 125 and 500
mg/kg/day. 1 test group (2–week exposure): 2000 mg/kg/day.
Negative control group: sham treatment. Each group contained Control Group: yes, concurrent no treatment
LOAEL: = 8 mg/kg bw
Method: other: procedure as detailed in paper by Cruzan et al. (see
Year: 1986 GLP: yes
Test substance: other TS
Remark: The test animals were fitted with collars, and the exposure
sites were left uncovered following treatment.
Result: DOSE–RELATED MORTALITY and DEPRESSION OF BODYWEIGHT GAIN
occurred in animals treated with CCCO at DOSES OF 30 mg/kg/day or greater. TOTAL MORTALITY occurred within two weeks for rats exposed to DOSES OF 2000 mg/kg/day, while ONLY 15% of those DOSED AT 500 mg/kg/day SURVIVED THE ENTIRE The PRIME TARGET ORGANS FOR CCCO TOXICITY were the LIVER, THYMUS and BONE MARROW, where serum chemistry and enzymological changes were observed as early as 4 weeks, and were more apparent after 13 weeks. The effects on the liver included increased weight, cholangiolitis, diffuse liver cell degeneration and hypertrophy, necrosis, fibrosis, decreased serum glucose, increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, bilirubin and triglycerides. The thymus was found to be small and, upon microscopic examination, to be atrophic or hypoplastic. Erythroid hyperplasia was found in the bone marrow of some of the rats dosed at 30 mg/kg/day, and increased in severity with increasing dose.
The erythroid hyperplasia was accompanied by a dose–related anaemia. Even in the rats dosed at 8 mg/kg/day, very slight abnormalities in the bile ducts were observed upon microscopic examination of the liver.
Other effects of CCCO administration included smaller ovaries and accessary sex organs in both sexes, congestion of the lymph nodes and reactive lymphoid hyperplasia, focal haemorrhages of the testes of several rats, and blood in the tubules and pelves of the kidneys. It is not known whether these additional organ effects were direct effects or were secondary to the effects of CCCO on the liver, thymus and bone marrow. Even though CCCO affected internal organs at very low doses, little effect was seen on the skin, even at high doses. The lethal and toxic effects observed following ______________________________________________________________________________ exposure to CCCO appear to be due to absorption of carbazoles, which are strong hepato–carcinogens and are readily bioavailable in animals by the dermal route.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), CAS No. 64741–62–4.
Species: rat Sex: male/female
Strain: Fischer 344
Route of admin.: dermal
Exposure period: 28 days
Frequency of
treatment: 5 times per week
Post. obs.
period: no data
Doses: 4 Test groups: 400, 1000, 2000 and 4000 mg/kg/day. Negative
control group: no treatment. Each group contained 5 male and Control Group: yes, concurrent no treatment
LOAEL: = 400 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: Studies on animals in the two highest dose groups were
terminated at day 11 due to toxicity, deaths and the Result: 12 TREATMENT–RELATED DEATHS occurred; 5/10 at 4000
mg/kg/day, 2/10 at 2000 mg/kg/day, 4/10 at 1000 mg/kg/day SIGNIFICANTLY LOWER MEAN BODYWEIGHTS were found for ALL SIGNIFICANTLY INCREASED LIVER WEIGHTS were found at 400 and SLIGHT to MODERATE DIFFUSE HEPATOMEGALY was found at 400 MINIMAL to SLIGHT SKIN IRRITATION was found at 400 Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
______________________________________________________________________________ Species: rat Sex: male/female
Strain: Fischer 344
Route of admin.: dermal
Exposure period: 84 days
Frequency of
treatment: 5 times per week
Post. obs.
period: no data
Doses: 3 Test groups: 40, 200 and 400 mg/kg/day. Negative control
group: no treatment. Each group contained 10 male and 10 Control Group: yes, concurrent no treatment
LOAEL: = 40 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The study was planned to last 90 days, but was terminated at
28 days for the highest dose group, and at 84 days for the other two test groups, due to excessive test animal deaths.
Result: 28 TREATMENT–RELATED DEATHS occurred; 20/20 at 400
mg/kg/day, 7/20 at 200 mg/kg/day and 1/20 at 40 mg/kg/day.
GENERAL SYSTEMIC TOXICITY was found, as evidenced by reduced bodyweight gains, reduced haematology indices, elevated enzyme levels and significantly increased liver weights.
Additionally, pathological changes in the liver were noted Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Species: rabbit Sex: male/female
Strain: New Zealand white
Route of admin.: dermal
Exposure period: 5 consecutive days, two–day rest period, then 5 additional
Frequency of
treatment: daily, covered for 24 hours
Post. obs.
Doses: Test group: 8.0 ml/kg/day. Negative control group: no
treatment. Each group contained 4 male and 4 female animals.
Control Group: yes, concurrent no treatment
LOAEL: = 8000 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Result: Animals showed decreased appetites and became emaciated.
EXPOSURE at the single dose rate of 8.0 ml/kg PRODUCED 25% MORTALITY. No mortality was observed in the control group.
The TEST MATERIAL PRODUCED, AT THE TREATMENT SITES, ACANTHOSIS, CHRONIC INFLAMMATION, CRUSTING, DERMAL CONGESTION, DERMAL OEDEMA, and HYPERKERATOSIS that varied in severity from very slight to moderate. Histopathologic examination of the tissues from the treated rabbits revealed EVIDENCE OF DERMAL AND HEPATIC TOXICITY and PROLIFERATIVE ______________________________________________________________________________ CHANGES in the TRANSITIONAL EPITHELIUM of the URINARY BLADDER. These changes were attributed to exposure to the test substance. The livers from 7 of the 8 treated rabbits contained evidence of multifocal necrosis that varied in degree of insult from very slight to severe. Three of the same 8 treated rabbits revealed centrilobular vacuolar degeneration in the liver that varied in severity from very slight to slight. Evidence of epithelial hyperplasia of the urinary bladder mucosa was diagnosed in 4 of the 8 treated animals that varied in severity from very slight to slight.
Studies at the same single dose rate with two further samples of No. 6 Heavy Fuel Oil, designated API 78–6 and API 78–7, also produced SEVERE DERMAL IRRITATION and INJURY AT THE TREATMENT SITES as well as a similar pattern of systemic toxicity, with the liver being the main target organ.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 78–8 with API Gravity 23.1/0.2%S),
Fuel oil No. 6, CAS No. 68553–00–4.
Species: rabbit Sex: male/female
Strain: Sprague–Dawley
Route of admin.: dermal
Exposure period: 5 consecutive days, two–day rest period, then 5 additional
Frequency of
treatment: daily, covered for 24 hours
Post. obs.
Doses: 3 Test groups: 1.0, 2.0 and 2.5 ml/kg/day. Negative control
group: no treatment. Each group contained 4 male and 4 Control Group: yes, concurrent no treatment
LOAEL: = 1070 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The major systemic effect was MULTIFOCAL NECROSIS of the
LIVER at ALL DOSE LEVELS. CENTRILOBULAR VACUOLAR SIGNIFICANT SKIN IRRITATION was found at the TREATMENT SITES. Effects ranged from slight to severe and included acanthosis, acute inflammation, chronic inflammation, crusting, deep pyoderma, dermal congestion, dermal oedema, hyperkeratosis and epidermal necrolysis.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: No. 6 Heavy Fuel Oil (API 79–2), Fuel oil No. 6, CAS No.
______________________________________________________________________________ Species: rabbit Sex: male/female
Strain: Fischer 344
Route of admin.: dermal
Exposure period: 28 days
Frequency of
treatment: 3 times per week
Post. obs.
period: no data
Doses: 3 Test groups: 200, 1000 and 2000 mg/kg/day. Negative
control group: no treatment. Each group contained 5 male and Control Group: yes, concurrent no treatment
NOAEL: = 200 mg/kg bw
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was similar to that given in OECD
Result: THREE TREATMENT–RELATED DEATHS occurred, two in the high
dose group and one in the middle dose group.
LIVER ENLARGEMENT was found in MALE ANIMALS at 2000 mg/kg and in FEMALE ANIMALS at 200 mg/kg and 1000 mg/kg, but not at 2000 mg/kg. PATHOLOGICAL CHANGES in the LIVER were found SIGNIFICANTLY REDUCED BODYWEIGHT GAINS were found in MALE and FEMALE ANIMALS at HIGH and MIDDLE DOSES.
SKIN IRRITATION ranged from MODERATE (low dose group) to SEVERE (middle and high dose group) with SKIN ULCERATION.
In the high dose group, histopathological examination revealed changes in the lymphoid organs and slight to severe hypocellularity in the bone marrow.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
5.5 Genetic Toxicity ’in Vitro’
Type: Bacterial gene mutation assay
System of
testing: Modified Ames Test
Concentration:
Metabolic
activation: with
Result: positive
Method: other: API procedure (see Reference).
Year: GLP: no data
Test substance: other TS
Remark: Mutagenesis assays with fuel oil components indicate that
these substances have mutagenic activity.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Fuel oil components.
______________________________________________________________________________ Type: Bacterial gene mutation assay
System of
testing: Modified Ames assay using Salmonella typhimurium strain TA98
Concentration: 33 to 3333 ul/ml
Metabolic
activation: with
Result: positive
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The test substance was dissolved in dimethyl sulphoxide
(DMSO). Assays were run at test substance levels of 1, 5, 10, 25 and 50 mg per plate in the presence of: (a) 80% of a mix of Aroclor 1254–induced rat liver (b) the normal 10% concentration of a mix of S9 and In both cases, significant and reproducible dose–dependent increases in the number of revertants were obtained.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), CAS No. 64741–62–4.
Type: HGPRT assay
System of
testing: Chinese hamster ovary (CHO)/Hypoxyanthine–Guanine
Phosphoribosyl Transferase (HGPRT) mammalian cell forward gene Concentration: 0.1 to 30 ug/ml without activation, 0.1 to 200 ug/ml with
Metabolic
activation: with and without
Result: negative
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The test substance was dissolved in dimethyl sulphoxide
(DMSO). Cells were exposed to the test substance at 5 concentrations both in the presence and absence of Aroclor 1254–induced rat liver S9. No dose–dependent increases in mutant frequencies were observed, either in the presence or absence of S9, in duplicate tests. The positive controls, ethlymethanesulphonate in the absence of S9 and dimethylnitrosamine in the presence of S9, gave the expected Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
______________________________________________________________________________ Type: Mouse lymphoma assay
System of
testing: Forward mutation assay using cell line L5178Y
Concentration: 1 to 125 nl/ml
Metabolic
activation: with and without
Result: positive
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was similar to that given in OECD
The test substance was dissolved in acetone. Cells were exposed to the test substance for 4 hours in the presence and absence of Aroclor 1254–induced rat liver S9.
Dose–dependent increases in mutant frequency were found in the presence of S9 over the concentration range 1.95 to 31.3 nl/ml. Toxicity was noted at all levels and survival was less than 10% at concentrations exceeding 3.9 nl/ml. In the absence of S9, evidence of weak mutagenicity was found at Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: Sister chromatid exchange assay
System of
testing: Assay using Chinese hamster ovary (CHO) cells
Concentration: 5 to 100 ug/ml without activation, 100 to 5000 ug/ml with
Metabolic
activation: with and without
Result: positive
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The test substance was dissolved in acetone. Cells were
exposed to the test substance at 5 concentrations both in the presence and absence of Aroclor 1254–induced rat liver S9. Significant increases in SCEs were found in the presence of S9 over the concentration range tested. In the absence of S9, SCEs levels were not significantly elevated.
Positive controls gave the expected results using Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
______________________________________________________________________________ Type: Unscheduled DNA synthesis
System of
testing: Assay using primary rat hepatocyte cultures obtained from male
Concentration: 0.0001 to 100 ug/ml
Metabolic
activation: without
Result: positive
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The test substance was dissolved in dimethyl sulphoxide.
The rat liver cells were exposed to 6 non–cytotoxic concentrations of the test substance. Significant increases above the solvent control values were observed, both for unscheduled DNA synthesis and in the percentage of cells in 2–acetylaminofluorene gave the expected results.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: other: Cell Transformation assay
System of
testing: Assay using BALB/3T3 mouse embryo cells
Concentration: 1 to 9 ug/ml without activation, 10 to 300 ug/ml with
Metabolic
activation: without
Result: ambiguous
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The test substance was dissolved in acetone. Without
activation, mouse embryo cells were exposed to the test substance at 4 concentrations for three days, with no significant increases in morphological transformation frequency. In the presence of Aroclor 1254–induced rat liver S9, there was a significant increase in transformation frequency at 100 ug/ml of test substance, following exposure for 4 hours. However, low survival rates were found at treatment levels of above 100 ug/ml in the presence of S9. Positive controls run with BaP in the presence of S9 and with N–methyl–N’–nitrosoguanidine in the absence of S9 gave the expected results.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
______________________________________________________________________________ 5.6 Genetic Toxicity ’in Vivo’
Type: Cytogenetic assay
Species: rat Sex: male/female
Strain: Sprague–Dawley
Route of admin.: i.p.
Exposure period: 5 days
Doses: 3 Test groups: 0.1, 0.3 and 1.0 g/kg daily (11 male and 11
female). Positive control group: 1.0 mg/kg triethylenemelamine single dose (10 male and 10 female).
Negative control group: 2.0 ml/kg corn oil daily (10 male and Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: The procedure used was similar to that given in OECD
Result: The test substance did not significantly increase the
frequency of chromosomal aberrations, nor did it increase the mitotic index in male and female bone marrow cells at The positive control group animals produced significant increases in chromosomal aberration frequencies.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: Sister chromatid exchange assay
Species: mouse Sex: male/female
Strain: B6C3F1
Route of admin.: i.p.
Exposure period: 24 to 26 hours
Doses: 3 Test groups: 0.4, 2.0 and 4.0 g/kg in corn oil. Positive
control group: 10 mg/kg cyclophosphamide. Negative control group: 10 mg/kg corn oil. Each group contained 5 male and 5 Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: Test Method
Test animals were given a single i.p. injection, 4 hours after implantation of a 50 mg agar–coated BrdUrd (5’–bromo–2’–deoxyuridine) pellet. The test substance was dissolved in corn oil. Bone marrow cells were arrested in metaphase with colchicine, 24 to 26 hours after implantation, and were examined microscopically for SCEs.
Result: Results were positive.
The test substance produced a small but significant dose–dependent increase in mouse bone marrow SCEs compared ______________________________________________________________________________ The positive control group gave the expected results.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
Type: Unscheduled DNA synthesis
Species: rat Sex: male
Strain: Fischer 344
Route of admin.: gavage
Exposure period: 2 to 12 hours
Doses: 3 Test groups: 50, 200 and 1000 mg/kg single dose. Positive
control group: 2–acetylaminofluorene in corn oil. Negative control group: corn oil. Each group contained 3 male animals.
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Remark: Animals were sacrificed 2 to 12 hours after treatment.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), API 81–15, CAS No.
5.7 Carcinogenicity
Species: mouse Sex: male/female
Strain: no data
Route of admin.: dermal
Exposure period: lifetime
Frequency of
treatment: no data
Post. obs.
period: no data
Doses: no data
Control Group: no data specified
Method: other
Year: GLP: no data
Test substance: other TS
Result: All lifetime skin–painting studies carried out with fuel oil
components have resulted in skin cancers in the majority of animals. Fuel oil components are potent dermal carcinogens, with cracked components generally more active Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Fuel oil components.
______________________________________________________________________________ Species: mouse Sex: male
Strain: other: C3H/HeJ
Route of admin.: dermal
Exposure period: lifetime
Frequency of
treatment: 3 times per week
Post. obs.
Doses: 4 Test groups: 25 ul. Negative control group: 25 ul
toluene. Positive control group: 25 ul of 3.3% catalytic cracked clarified oil (CCCO) in toluene. Each group contained Control Group: yes, concurrent no treatment
Method: other: procedure as detailed in Exxon paper (see Reference).
Year: GLP: no data
Test substance: other TS
Result: The TWO THERMALLY CRACKED RESIDUAL FUEL OILS were STRONG
DERMAL CARCINOGENS, producing TUMOURS in 16/20 and 26/50 animals with MEAN LATENCIES of 96 and 85 WEEKS respectively.
The BLENDED FUEL OIL was a STRONG DERMAL CARCINOGEN, producing TUMOURS in 30/50 animals with a MEAN LATENCY of 81 The STRAIGHT–RUN RESIDUAL FUEL OIL was a DERMAL CARCINOGEN, producing TUMOURS in 5/50 animals with a MEDIAN LATENCY of The positive and negative control groups gave the expected Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Four samples were tested:
2 samples of thermally cracked residual fuel oil 1 sample of a blend of straight–run and residual ______________________________________________________________________________ Species: mouse Sex: male
Strain: other: white albino
Route of admin.: dermal
Exposure period: lifetime
Frequency of
treatment: 3 times per week
Post. obs.
period: monthly
Doses: Test group: 15 mg (30 animals).
Control Group: no data specified
Method: other: procedure as detailed in paper by Smith, Sunderland and
Year: 1951 GLP: no data
Test substance: other TS
Remark: The study involved evaluation of the test substance and of
six fractions derived by distilling the steam–cracked tar.
This data was reconsidered by Dietz et al. in a review of the origin and composition of petroleum fractions that cause Result: The TEST SUBSTANCE was a DERMAL CARCINOGEN.
FRACTIONS DISTILLING ABOVE 370 degree C were the MOST Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Steam–cracked tar, CAS No. 64742–90–1 (note: CAS No. not
Species: mouse Sex: male
Strain: C3H
Route of admin.: dermal
Exposure period: lifetime
Frequency of
treatment: 3 times per week
Post. obs.
Doses: Test groups: 25 ul of solutions containing 1% to 50% (v/v) of
test substance in white oil. Negative control groups: 25 ul of white oil. Each group contained 40 or 50 animals.
Control Group: yes, concurrent vehicle
Method: other: procedure as detailed in paper by McKee et al. (see
Year: 1990 GLP: yes
Test substance: other TS
Result: The TEST SUBSTANCE was a STRONG DERMAL CARCINOGEN.
Concentrations of 5% of the TEST SUBSTANCE in white oil produced TUMOURS in MOST OF THE TREATED ANIMALS.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), CAS No. 64741–62–4.
______________________________________________________________________________ Species: mouse Sex: male/female
Strain: other: C3H/HeJ
Route of admin.: dermal
Exposure period: lifetime
Frequency of
treatment: 2 times per day
Post. obs.
period: no data
Doses: 3 Test groups: 50 ul of 0.1, 1.0 and 10% solutions in
toluene. Vehicle control group: 50 ul toluene. Each group contained 50 male and 50 female animals.
Control Group: yes, concurrent no treatment
Method: other: API procedure (see Reference).
Year: GLP: yes
Test substance: other TS
Result: The TEST SUBSTANCE was a STRONG DERMAL CARCINOGEN.
Animals treated with the 10% solution produced 48 MALIGNANT and 1 BENIGN TUMOUR with a MEAN LATENCY of 22 WEEKS.
Animals treated with the 1.0% SOLUTION produced 44 MALIGNANT and 1 BENIGN TUMOUR with a MEAN LATENCY of 72 WEEKS.
Animals treated with the 0.1% SOLUTION produced NO MALIGNANT AND 2 BENIGN TUMOURS with a MEAN LATENCY of 113 WEEKS.
The vehicle control group produced 4 malignant tumours Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytic cracked clarified oil (CCCO), CAS No. 64741–62–4.
5.8 Toxicity to Reproduction
–
______________________________________________________________________________ 5.9 Developmental Toxicity/Teratogenicity
Species: rat Sex: female
Strain: Sprague–Dawley
Route of admin.: dermal
Exposure period: 19 days (gestation)
Frequency of
treatment: once per day
Duration of test: 19 days
Doses: 5 Test groups: 4, 8, 30, 125 and 250 mg/kg/day. Negative
control group: no treatment. Each group contained 10 Control Group: yes, concurrent no treatment
NOAEL Maternalt.: = 4 mg/kg bw
NOAEL Teratogen.: = 4 mg/kg bw
Method: other: procedure as detailed in paper by Feuston et al. (see
Year: 1989 GLP: yes
Test substance: other TS
Remark: The test substance was applied directly to the test animals,
the rats were fitted with collars, and the exposure sites were left uncovered following treatment.
Result: SIGNS OF MATERNAL TOXICITY, seen at doses as low as 8
mg/kg/day, included VAGINAL BLEEDING, DECREASED BODYWEIGHT GAIN, REDUCED FOOD CONSUMPTION, DEATH, INCREASED RELATIVE LIVER WEIGHTS, ATROPHY OF THE THYMUS, and ABERRANT SERUM CHEMISTRY. The number of FOETAL RESORPTIONS/DEATHS was MARKEDLY INCREASED, and the number of VIABLE OFFSPRING DECREASED, by CCCO exposure at doses of 30 mg/kg/day and greater. THE GROUP RECEIVING 250 mg/kg/day CARRIED NO VIABLE OFFSPRING. Foetuses from pregnant females exposed to CCCO at doses greater than 8 mg/kg/day were smaller than those from the negative control and 4 mg/kg/day groups, and their skeletons showed decreased ossification. ABNORMAL EXTERNAL DEVELOPMENT and VISCERAL DEVELOPMENT WERE OBSERVED IN LIVING AND DEAD FOETUSES EXPOSED IN UTERO to CCCO at DOSE LEVELS of 8 mg/kg/day and greater.
Source: ELF ANTAR FRANCE PARIS La Defense
Test substance: Catalytically cracked clarified oil (CCCO), CAS No.
64741–62–4, used as a fuel oil component.
5.10 Other Relevant Information
–
5.11 Experience with Human Exposure
Remark: In its 1989 review of the carcinogenicity of fuel oils, IARC
considered the status of fuel oil No. 6, CAS No.
68553–00–4, residual fuel oil, CAS No. 68476–33–5 and clarified slurry oil, CAS No. 64741–62–4. It concluded that whilst there is sufficient evidence in animals for the carcinogenicity of residual fuel oils, there is inadequate evidence for the carcinogenicity of any type of fuel oil in ______________________________________________________________________________ Source: ELF ANTAR FRANCE PARIS La Defense
Remark: Epidemiological data for fuel oil components are not
Source: ELF ANTAR FRANCE PARIS La Defense
Remark: Epidemiological data for fuel oil components are not
Source: ELF ANTAR FRANCE PARIS La Defense
6. References Substance ID: 92045–14–2 ______________________________________________________________________________ (1) American Petroleum Institute, Petroleum process stream terms included in the Chemical Substances Inventory under TSCA, (2) American Society for Testing and Materials (ASTM), 1991 Annual Book of ASTM Standards. Section 5, Petroleum Products, Lubricants and Fossil Fuels, ASTM, Philadelphia, (3) CONCAWE, Review of the toxicity of catalytically cracked clarified oil, Report No. 89/56, CONCAWE, Brussels, 1989.
(4) Cruzan, G. et al., Systemic toxicity from subchronic dermal exposure, chemical characterization, and dermal penetration of catalytically cracked cycle oil (CCCO), Toxicol. Ind.
Health, vol. 2, no. 4, p. 429, 1986.
(5) McCullough, J.P., TSCA 8(e) Notification by Mobil Research & Development Corp., Letter to EPA, 21st November, 1985.
(6) International Agency for Research on Cancer (IARC), Monographs on the evaluation of the carcinogenic risks of chemicals to humans. Vol. 45, Occupational exposures in petroleum refining: crude oil and major petroleum fuels.
(7) Mobil Oil Corp., Material Safety Data Bulletin No.
(8) Log Pow Database, Pomona College, 1993.
(9) Atkinson, R., Gas–phase tropospheric chemistry of organic compounds: a review, Atmos. Environ., vol. 24A, pp. 1–41, (10) Harris, J.C., Rate of hydrolysis. In: Handbook of Chemical Property Estimation Methods, Environmental Behaviour of Organic Chemicals, Chapter 7, Lyman, W.J., Reehl, W.F. and Rosenblatt, D.H. (Eds.), McGraw–Hill, New York, 1982.
(11) Song, H., Wang, X. and Bartha, R., Bioremediation potential of terrestrial fuel spills, Appl. Environ. Microbiol., vol.
(12) Mackay, D., Patterson, S. and Shiu, W.Y., Generic models for evaluating the regional fate of chemicals, Chemosphere, (13) van Zandt, P.T.J. and van Leeuwen, C.J., A proposal for priority setting of existing chemical substances, Report prepared for the European Commission, September 1992.
6. References Substance ID: 92045–14–2 ______________________________________________________________________________ (14) Boehm, P.D. et al., A chemical investigation of the transport and fate of petroleum hydrocarbons in littoral and benthic environments: the ’Tsesis’ oil spill, Mar.
Environ. Res., vol. 6, pp. 157–188, 1982.
(15) Rashid, M.A., Degradation of Bunker C oil under different coastal environments of Chedabucto Bay, Nova Scotia, Estuarine and Coastal Mar. Sci., vol. 2, pp. 137–144, 1974.
(16) Vandermeulen, J.H., Keizer, P.D. and Penrose, W.R., Persistence of non–alkane components of Bunker C oil in beach sediments of Chedabucto Bay, and lack of their metabolism by molluscs. In: Proceedings of the 1977 Oil Spill Conference, pp. 469–473, 1977. Conference sponsored by the American Petroleum Institute (API), the Environmental Protection Agency (EPA) and the US Coast Guard (USCG), held 8–10 March 1977, New Orleans, Louisiana, USA.
(17) Walker, J.D., Petrakis, L. and Colwell, R.R., Comparison of the biodegradability of crude and fuel oils, Can. J.
Microbiol., vol. 22, no. 4, pp. 598–602, 1976.
(18) A number of bacterial species have been shown to be capable of degrading at least some constituents of Bunker C fuel (19) O’Neill, T.B., The biodegradation of oil in sea water for naval pollution control, Final Report 1974–1976, Office of (20) Sedita, S.J., Biodegradation of oil, Office of Naval (21) DSM Kunststoffen B.V., The acute toxicity of carbon black oil to Brachydanio rerio. Study conducted by TNO. Report No. R89/226, DSM, Beek, The Netherlands, 1989.
(22) Hollister, T.A., Ward, G.S. and Parrish, P.R., Acute toxicity of a No. 6 Fuel Oil to marine organisms, Bull.
Environ. Contam. Toxicol., vol. 24, pp. 656–661, 1980.
(23) Szaro, R.C., Bunker C fuel oil reduces Mallard egg hatchability, Bull. Environ. Contam. Toxicol., vol. 22, pp.
(24) Baker, J.L. et al., Long–term fate and effects of untreated thick oil deposits on salt marshes. In: Proceedings of the 1993 International Oil Spill Conference, pp. 395–399, 1993.
Sponsored by the American Petroleum Institute (API), the Environnmental Protection Agency (EPA) and the US Coast Guard (USCG), held 29 March – 1 April 1993, Tampa, Florida, 6. References Substance ID: 92045–14–2 ______________________________________________________________________________ (25) Chan, G.L., The five–year recruitment of marine life after the 1971 San Francisco oil spill. In: Proceedings of the 1977 Oil Spill Conference, pp. 543–545, 1977. Conference sponsored by the American Petroleum Institute (API), the Environmental Protection Agency (EPA) and the US Coast Guard (USCG), held 8–10 March 1977, New Orleans, Louisiana, USA.
(26) Linden, O., Elmgren, R. and Boehm, P.D., The ’Tsesis’ oil spill: its impact on the coastal ecosystems of the Baltic sea, Ambio, vol. 8, no. 6, pp. 244–253, 1979.
(27) Webb, J.W., Tanner, G.T. and Koerth, B.H., Oil spill effects on Smooth Cordgrass in Galveston Bay, Texas, Contributions in Marine Science, vol. 24, pp. 107–114, 1981.
(28) CONCAWE, Ecotoxicological testing of petroleum products: test methodology, Report No. 92/56, CONCAWE, Brussels, 1992.
(29) GESAMP Reports and Studies No. 35, Annex 9, Advice for aquatic toxicity testing of substances or of mixtures containing compounds of low solubility, International Maritime Organization (IMO), London, 1989.
(30) Whitehouse, P. and Mallet, M., Aquatic toxicity testing for notification of new substances. An advisory document for dealing with "difficult" substances, Water Research Centre (31) American Petroleum Institute. Acute toxicity tests, API 78–6. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32814, API, (32) American Petroleum Institute. Acute toxicity tests, API 78–7. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32774, API, (33) American Petroleum Institute. Acute toxicity tests, API 78–8. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32816, API, 6. References Substance ID: 92045–14–2 ______________________________________________________________________________ (34) American Petroleum Institute. Acute toxicity tests, API 79–2. Primary skin irritation study in rabbits. Primary eye irritation study in rabbits. Skin sensitization study in guinea pigs. Acute dermal toxicity study in rabbits.
Acute oral toxicity study in rats. Sub–acute dermal toxicity study in rabbits. Study conducted by Elars Bioresearch Laboratories. Report No. 27–32813, API, (35) American Petroleum Institute. Acute toxicity studies of catalytic cracked clarified oil, API Sample 81–15. Study conducted by Hazleton Raltech Inc. Report No. 30–31854, (36) DMS Kunststoffen B.V., Determination of the acute oral toxicity of carbon black oil in rats. Study conducted by TNO. Report No. V89.426, DSM, Urmond, The Netherlands, (37) Exxon Biomedical Sciences Inc., Acute oral toxicity (LD50) study in rats. Study conducted by International Research and Development Corporation. Exxon, in–house company data, (38) DSM Kunststoffen B.V., Determination of the acute dermal toxicity of carbon black oil in rats. Study conducted by TNO. Report No. V89.429, DSM, Urmond, The Netherlands, (39) The procedure used was very similar to that given in OECD Four male and four female New Zealand White rabbits were each exposed to a single dose of 5 ml/kg for 24 hours. The skins of 2 male and 2 female animals were abraded before exposure. The animals were observed for 14 days. No deaths resulted. Slight erythema was noted in the test area for a few animals. Gross necropsy revealed two animals with slightly congested livers that were considered to be Similar studies with two other samples of No. 6 Heavy Fuel Oil, designated API 78–7 and API 78–8, each gave LD50 values in excess of 5 ml/kg, no mortalities being observed.
(40) Exxon Biomedical Sciences Inc., Acute dermal toxicity (LD50) study in rabbits. Study conducted by International Research and Development Corporation. Exxon, in–house (41) Three animals were each treated for 4 hours, applying 0.5 ml of test substance to the shaved skin and covering with a semi–occluded patch. The 24–hour, 48–hour and 72–hour scores indicated that the test substance had caused moderate to well–defined erythema and slight oedema in the animals.
The effects cleared after 10 days in all the animals.
6. References Substance ID: 92045–14–2 ______________________________________________________________________________ (42) Six New Zealand White rabbits were each treated with 0.1 ml of test substance. An additional three animals were also treated with 0.1 ml of test substance, following which their eyes were rinsed with water. Effects on the eyes were monitored over 7 days with scoring according to the Draize scale. Corneal opacities of grade 1 and area 1 were seen in three animals at the 24 and 48–hour reading. No iridial inflammation was seen in any of the test animals.
Conjunctival irritation was seen in all of the rabbits at 24 and 48 hours post dosing. All rabbits were negative for irritation after 7 days. The averages for the eyes that were rinsed were slightly higher than the averages for the unrinsed group at 24 and 48 hours. However, at 72 hours, the unrinsed averages were higher. The test substance can be considered mildly irritating, with a 24–hour average of 7.50, and a score of zero at 7 days. The maximum possible Similar results were observed in studies on three further samples of No. 6 Heavy Fuel Oil, designated API 78–6, API (43) One eye from each animal in a group of 9 New Zealand White rabbits was treated with 0.1 ml of test substance, the other eye acting as control. The eyes of three of the animals were water washed almost immediately after treatment.
Scores were made 1, 24, 48 and 72 hours after treatment, according to the Draize scale. The presence of brown or light brown test material was noticeable during the scoring.
The highest scores were obtained at 24 hours, where both the washed and unwashed eyes scored 2.0 out of a maximum possible 110, indicating that the test substance was (44) Exxon Biomedical Sciences Inc., Eye irritation study in rabbits. Study conducted by International Research and Development Corporation. Exxon, in–house company data, (45) Each animal in a group of 3 albino rats was treated in one eye with 0.1 ml of test substance. Scores were taken at 24, 48 and 72 hours, comparing with the untreated eyes. The test substance caused slight inflammation and swelling of the conjunctivae in all animals. All the scores at 72 hours (46) The procedure used was a closed patch test closely following the Buehler method outlined in OECD Guideline 406.
Ten male Hartley guinea pigs were treated with 0.4 ml of neat test substance, once a week for three weeks. Two weeks after the final application, they were challenged on the opposite flank with neat test substance. Scores for erythema and oedema were made 24 and 48 hours after each application. The challenge treatment did not produce any significant irritation in the 10 test animals. A naive control group of 10 animals, treated in the challenge phase 6. References Substance ID: 92045–14–2 ______________________________________________________________________________ only, showed no reaction to the test substance. A positive control group of 20 animals was treated in both the sensitization and challenge phases with dilute solutions of 2,4–dinitrochlorobenzene, and all were sensitized.
(47) The closed patch test procedure was a variation of the Buehler method outlined in OECD Guideline 406.
Ten adult male albino guinea pigs were each treated with 0.5 ml of the test material, three times per week for three weeks. The patches were left in place for 6 hours before removal. Two weeks after final application, they were challenged with 0.5 ml of test material. Scores were taken at 24 hours according to the Draize scale. A naive control group of 10 animals and a positive control group of 10 animals were also included. The naive control group was treated with test substance in the challenge phase only.
The positive control group was treated with a 0.05% (w/v) dilution of dinitrochlorobenzene in both the sensitizing and challenge phases. A statistically significant difference between sensitizing and challenge treatments for erythema and oedema was noted among the test animals, but the challenge scores were less than the sensitizing average, indicating that the test substance was non–sensitizing.
Similar studies with three other samples of No. 6 Heavy Fuel Oil, designated API 78–6, API 78–7 and API 79–2, produced (48) Cruzan, G. et al., Systemic toxicity from subchronic dermal exposure, chemical characterization, and dermal penetration of CCCO, Toxicol. Ind. Health, vol. 2, no. 4, p. 429, 1986.
(49) American Petroleum Institute. Four–week dermal range–finding toxicity study in rats: catalytic cracked clarified oil, API Sample 81–15, CAS No. 64741–62–4. Study conducted by Tegeris Laboratories Inc. Report No. 33–30442, (50) American Petroleum Institute. Thirteen–week dermal toxicity study of a petroleum–derived hydrocarbon in rats: catalytic cracked clarified oil, API Sample 81–15, CAS No.
64741–62–4. Study conducted by Tegeris Laboratories Inc.
Report No. 32–32743, API, Washington DC, 1985.
(51) American Petroleum Institute. A 28–day dermal toxicity study of catalytic cracked clarified oil, API Sample 81–15.
Study conducted by Borriston Laboratories Inc. Report No.
30–32854, API, Washington DC, 1983.
(52) American Petroleum Institute, Information profile on clarified slurry oil, API, Washington DC, 1986.
6. References Substance ID: 92045–14–2 ______________________________________________________________________________ (53) American Petroleum Institute. Salmonella/mammalian microsome plate incorporation mutagenicity assay (Ames test). Study conducted by Microbiological Associates Inc.
Report No. 33–30599, API, Washington DC, 1986.
(54) American Petroleum Institute. CHO/HGPRT (Chinese hamster ovary/Hypoxyanthine–Guanine Phosphoribosyl Transferase) mammalian cell forward gene mutation assay. Catalytic cracked clarified oil, API Sample 81–15, CAS No. 64741–62–4.
Study conducted by Pharmakon Research International Inc.
Report No. 32–32118, API, Washington DC, 1985.
(55) American Petroleum Institute. Mutagenicity evaluation studies of catalytic cracked clarified oil, API Sample 81–15, in the rat bone marrow cytogenetic assay and in the mouse lymphoma forward mutation assay. Study conducted by Litton Bionetics Inc. Report No. 32–30534, API, Washington (56) American Petroleum Institute. Sister chromatid exchange (SCE) assay in Chinese hamster ovary (CHO) cells. Catalytic cracked clarified oil, API Sample 81–15, CAS No.
64741–62–4. Study conducted by Microbiological Associates Inc. Report No. 32–32750, API, Washington DC, 1985.
(57) American Petroleum Institute. An evaluation of the potential of RO–1, 81–15 and PS8–76D5–SAT to induce unscheduled DNA synthesis (UDS) in primary rat hepatocyte cultures. Study conducted by SRI International. Report No.
32–32407, API, Washington DC, 1985.
(58) American Petroleum Institute. Morphological transformation of BALB/3T3 mouse embryo cells. Catalytic cracked clarified oil, API Sample 81–15, CAS No. 64741–62–4. Study conducted by Microbiological Associates Inc. Report No. 32–32638, (59) American Petroleum Institute. In–vivo sister chromatid exchange (SCE) assay. Catalytic cracked clarified oil, API Sample 81–15, CAS No. 64741–62–4. Study conducted by Microbiological Associates Inc. Report No. 32–32754, API, (60) American Petroleum Institute. An evaluation of the potential of RO–1, 81–15 and PS8–76D5–SAT to induce unscheduled DNA synthesis (UDS) in the in–vivo/in–vitro hepatocyte DNA repair assay. Study conducted by SRI International. Report No. 32–32406, API, Washington DC, (61) The results were positive at 200 mg/kg (after 12 hours but not after 2 hours) and at 1000 mg/kg (after both 2 and 12 In this assay on primary rat liver cultures, unscheduled DNA synthesis (UDS) in the test groups, as measured by the amount of incorporated tritiated thymidine, was 6. References Substance ID: 92045–14–2 ______________________________________________________________________________ significantly elevated, in a dose–dependent manner, above the level found in the negative control group treated with The positive control group gave the expected results.
(62) CONCAWE, Heavy fuel oils, Product Dossier in preparation, (63) Exxon Biomedical Sciences Inc., Carcinogenicity of heavy fuel oils. Exxon, in–house company data, 1992.
(64) Dietz, W. et al., Properties of high–boiling petroleum products, Ind. Eng. Chem., vol. 44, pp. 1818–1827, 1952.
(65) Smith, W.E, Sunderland, D.A. and Sugivra, K., Experimental analysis of the carcinogenic activity of certain petroleum products, Arch. Ind. Hyg. Occup. Med., vol. 4, pp. 299–314, (66) McKee, R.H. et al., Estimation of epidermal carcinogenic potency, Fund. Appl. Toxicol., vol. 15, pp. 320–328, 1990.
(67) American Petroleum Institute. Lifetime dermal carcinogenesis bioassay of refinery streams in C3H/HeJ mice (AP–135R). Study conducted by Primate Research Institute, New Mexico State University. Report No. 36–31364, API, (68) Feuston, M.H. et al., Developmental toxicity of clarified slurry oil applied dermally to rats, Toxicol. Ind. Health, (69) International Agency for Research on Cancer (IARC), Monographs on the evaluation of the carcinogenic risks of chemicals to humans, Vol 45, Occupational exposures in petroleum refining: crude oil and major petroleum fuels, 7. Risk Assessment Substance ID: 92045–14–2 ______________________________________________________________________________ 7.1 Risk Assessment
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