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Diss Factsheets
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EC number: 481-730-0 | CAS number: 848301-65-5
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
[Describe why the read-across can be performed (e.g. common functional group(s), common precursor(s)/breakdown product(s) or common mechanism(s) of action]
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
[Provide here, if relevant, additional information to that included in the Test material section of the source and target records]
3. ANALOGUE APPROACH JUSTIFICATION
[Summarise here based on available experimental data how these results verify that the read-across is justified]
4. DATA MATRIX
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Naphtha (petroleum), light alkylate
- EC Number:
- 265-068-8
- EC Name:
- Naphtha (petroleum), light alkylate
- Cas Number:
- 64741-66-8
- IUPAC Name:
- Naphtha (petroleum), light alkylate
- Details on test material:
- - Name of test material (as cited in study report): Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Test substance is closely related to Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear; it is defined as : 'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle used: corn oil
- Frequency of treatment:
- single treatment
- Post exposure period:
- 6, 24 and 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.3, 1.0, 3.0 g/kg
Basis: nominal conc.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Positive control(s):
- - Positive control group: 500 µg/kg of triethylenemelamine (TEM), group exposed for 24 hours.
- Negative control group: corn oil (5 ml/kg body weight).
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- Immediately after sacrifice bone marrow was obtained from the femurs of the animals. The marrow was washed and the cells were fixed before being spread on slides (at least 3 from each animal) for examination. Slides were scored for chromosomal aberrations. Where possible, a minimum of 50 metaphase cells from each animal were examined and scored for chromatid and chromosome gaps and breaks, fragments, structural rearrangements and ploidy (1-3). A mitotic index (= No. of cells in mitosis/500 counted X 100) was calculated and recorded.
- Evaluation criteria:
- The data were evaluated according to the following criteria:
For the test to be considered to be valid, the % of cells in the negative control group demonstrating aberrations of any type, other than gaps, must not exceed 4%. The % of cells with aberrations in the positive control group must be statistically increased (p=0.05) relative to the vehicle control using Chi-square statistics.
The test material is considered positive when the % of cells with aberrations in any treatment group is significantly increased (p = 0.05) relative to the vehicle control using Chi-square analysis and the number of aberrations per cell is also significantly increasd (p =0.05) relative to the vehicle control using t-test statistics. - Statistics:
- see "Evaluation criteria"
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the cytogenetics assay, 5 of 18 males and 4 of 18 females receiving 3 g/kg Light Alkylate Naphtha died within 3 days. At this dose level, there was a weight loss of 10% and 9% in males and females respectively within 48 hours of administration. Other signs of toxicity included piloerection, crusty eyes and noses and excess lacrimation. No sex-related differences were noted in the study and therefore the data for males and females were combined for the cytogenetics evaluation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Naphtha (petroleum), light alkylate (EC 265-068-8) did not induce bone marrow chromosomal aberrations in male or female Sprague-Dawley rats. - Executive summary:
Naphtha (petroleum), light alkylate (EC 265-068-8) was tested in a Sprague Dawley rat chromosome aberration assay [15/sex/group] at doses of 0.3, 1.0, and 3.0 g/kg in corn oil, administered intraperitoneally in a single dose. Two to four hours prior to sacrifice the rats were given a single intraperitoneal dose of colchicine (1 mg/kg). Animals [5/sex/group/time] were sacrificed at 6, 24 and 48 hrs post dose. A group of 5 animals of each sex to be used as positive controls was dosed with triethylenemelamine (TEM) at a level of 0.5 mg/kg and these animals were killed at 24 hours postdose. Deaths occurred in both male [5/18] and females [4/18] in the highest dose group and a 9-10% body weight loss was observed in surviving rats of both sexes. Other signs of toxicity included piloerection, crusty eyes and noses and excess lacrimation. Bone marrow was harvested from the femurs of treated rats, processed and stained for cytogenetic examination [a minimum of 50 metaphase spreads per animal]. No chromosome aberrations, rearrangements, or cell cycle disruption were observed in any dose group.
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