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EC number: 265-051-5 | CAS number: 64741-50-0 A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985-12-23 to 1986-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 476 using the L5178Y cell line.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- Method: other: API procedure
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 64741-50-0
- Cas Number:
- 64741-50-0
- IUPAC Name:
- 64741-50-0
- Reference substance name:
- Unrefined light paraffinic distillate
- IUPAC Name:
- Unrefined light paraffinic distillate
- Test material form:
- other: oily liquid
- Details on test material:
- - Light paraffinic distillate, API 84-01, CAS No. 64741-50-0
- Test substance: Light paraffinic distillate
- Physical description: Clear yellow liquid
- Gravity API: 31.5
- Wt. % Sulphur: 0.2
- Nitrogen, ppm: 256
- Olefins: 39.7
- Naphthenes: 21.7
- Viscosity at 100°C, cSt: 2.67
- Flash Pt. (°F): 372
- Molecular Wt.: 296
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- PONA 37% by MS
Constituent 1
Constituent 2
Method
- Target gene:
- Thymidine kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 medium supplemented with pluronic solution, L-glutamine, sodium pyruvate, antibiotic, and horse serum (10% by volume)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- 50 to 1000 nL/mL; visibly insoluble above 100 nL/mL
- Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethansulphonate (EMS) for nonactivation conditions and 3-methylcholanthrene (MCA)
- Details on test system and experimental conditions:
- Mouse lymphoma forward mutation assay
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 10 to 14 days
SELECTION AGENT (mutation assays): 5-trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: not reported
NUMBER OF CELLS EVALUATED: 3 x 10^6 cells were suspended in selection medium to select for mutants
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The minimum criterion considered necessary to demonstrate mutagenesis for any given treatment will be a mutant frequency that is at least 150% of the concurrent background frequency plus 10X10-6. The background frequency is defined as the average mutant frequency of the solvent negative controls. A dose-related or toxicity-related increase in mutant frequency should be observed. If an increase of two times the minimum criterion or greater is observed for a single dose near the highest testable toxicity, the test material will be considered mutagenic. Treatments that induce less than 10% relative growth are included in the assay but are not used as primary evidence for mutagenicity. A test article is evaluated as nonmutagenic in a single assay only if the minimum increase in mutant frequency is not observed for a range of applied concentrations that extends to toxicity causing 10 to 20% relative growth or, in the case of relatively nontoxic materials, a range of applied concentrations routinely extending to the maximum of 5 mg/ml or 5 ul/ml unless limited by solubility.
- Statistics:
- The mutant frequency is calculated by dividing the total number of colonies in each set of three mutant selection dishes by the total count in the sent of three viable count dishes and multiplying by 2X10^-4.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data reported.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Without metabolic activation, the test material was assayed from 400 to 1000 nL/mL, and little or no toxicity was observed well into the insoluble range. No significant increases in the mutant frequency were observed. With metabolic activation, treatments from 50 to 1000 nl/ml induced significant increases in the mutant frequency at the thymidine kinase (TK+/-) locus. Increases ranged from 2.1-fold to 7.3-fold above background. It should be noted, however, that survival was 73% of control at 50 nl/ml, 33% of control at 200 nL/mL, and less than 20% of control at all higher levels. The mutation frequency did not increase with concentration at levels above 300 nL/mL.
Without S9 Activation | ||
Test material dose (nl/ml) | Relative Growth (%) | Mutant Frequency (10E-6 units) |
Solvent control | 100 | 34.4 |
EMS 0.25 μl/ml | 81.2 | 452.5 |
EMS 0.40 μl/ml | 47.2 | 694.5 |
400 | 109.4 | 26.3 |
500 | 99.5 | 37.1 |
600 | 114 | 30.9 |
800 | 110.4 | 28.1 |
1000 | 95.4 | 42.8 |
With S9 Activation | ||
Test material dose (nl/ml) | Relative Growth (%) | Mutant Frequency (10E-6 units) |
Solvent control | 100 | 34.9 |
MCA 2.5 μg/ml | 58.6 | 257.2 |
MCA 4.0 μg/ml | 35.8 | 331.4 |
50 | 72.6 | 73.4 |
200 | 32.8 | 142.6 |
300 | 15 | 230.1 |
500 | 15.6 | 215.5 |
600 | 14.7 | 164.2 |
800 | 7.3 | 155.4 |
1000 | 12.3 | 254.8 |
Note: Solvent control mutant frequency is the average of three solvent control plates.
EMS = ethylmethanesulphonate, positive control substance for nonactivated conditions
MCA = 3 -methylcholanthrene, positive control substance for activated conditions
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
The test material API 84-01 was active in the mouse lymphoma forward mutation assay only in the presence of metabolic activation. - Executive summary:
Under nonactivation conditions, the test material API 84 -01 was analyzed for mutant induction from 400 nL/mL to 1000 nL/mL, and little or no toxicity was observed (percent relative growths, 114.0% to 95.4%). None of the assayed treatments induced a mutant frequency that exceeded the minimum criterion of 61.7 x 10-6. Since there was no evidence for mutagenic activity well into the insoluble range, the test material was considered nonmutagenic without activation in this assay. In the presence of metabolic activation, the test material was analyzed for mutant induction from 50 nl/ml to 1000 nl/ml and a wide range of toxicities was induced (percent relative growths, 72.6% to 7.3%). The test material appeared to interact with the activation mix to convert the test material to a mutagenic form or forms. In order for a treatment to be considered mutagenic in this assay, a mutant frequency exceeding 62.3 x 10-6 was required. All of the assayed treatments induced mutant frequencies that exceeded the minimum criterion and the increases ranged from 2.1-fold to 7.3-fold above the background mutant frequency (average of solvent controls). The test material was therefore considered mutagenic with activation in this assay. In the assays used in this evaluation, the average cloning efficiencies for the solvent controls varied from 86.6% without activation to 87.4% with activation which demonstrated good cloning conditions for the assays. The negative control mutant frequencies were all in the expected range and the positive control compounds yielded mutant frequencies that were greatly in excess of the background.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 476 using the L5178Y cell line.
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