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EC number: 232-315-6 | CAS number: 8002-74-2 A complex combination of hydrocarbons obtained from petroleum fractions by solvent crystallization (solvent deoiling) or by the sweating process. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C20.
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2005-06-21 to 2005-08-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it closely adhered to OECD Test Guideline 476 using cell line L5178Y, with and without metabolic activation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 8002-74-2
- Cas Number:
- 8002-74-2
- IUPAC Name:
- 8002-74-2
- Reference substance name:
- Sasolwax 5203, hydrocarbon wax
- IUPAC Name:
- Sasolwax 5203, hydrocarbon wax
- Test material form:
- liquid: viscous
- Details on test material:
- 100% purity
Chemical name: aliphatic alkane
Other name: hydrocarbon wax
Appearance: solid, white, waxy
Batch/Lot Number: A053603
Molecular Formula: C(n)H(2n+2); Sasolwax 5203 contains alkanes ranging from C19 to C36. The man component is C26
Average Molecular Weight: 360
Melting point: 54°C
Supplier: Sasol Wax GmbH, Hamburg, Germany
TNO Test Substance Number: 0500A9
Just before use, the test material was melted and extracted once in dimethylsulphoxide (DMSO), at a concentration of 360 mg/ml (1: 1 w/w). The extraction was performed for approximately 60 minutes at 60 ± 5°C, under constant agitation. Thereafter, the clear extract (DMSO aliquot) was collected and used for the preparation of the serial dilutions in DMSO. Fifty microlitres of the stock concentration and its serial dilutions were added to a final volume of 5 millilitres culture medium.
- Viscosity (3.5 mm2/s at 100 oC)
- Congealing point (54 oC)
- Color saybolt ASTM D156 (30)
- Oil content (0.2%)
Constituent 1
Constituent 2
Method
- Target gene:
- Not applicable.
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham's F-12 with Glutamax-I supplemented with heat-inactivated foetal calf serum (10%), penicillin (100IU/ml medium), and streptomycin (100 μg/ml medium)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- The first chromosomal aberration assay used concentrations of 0.034, 0.069, 0.138, 0.277, 0.625, 1.25, 2.5, 5, or 10 mmol/l of the test material in final culture medium. The second chromosomal aberration test used concentrations of 2.78, 4.17, 5.56, 6.94, 8.33, or 10 mmol/l of the test material in final culture medium.
- Vehicle / solvent:
- Dimethyl sulphoxide was used as the vehicle because it is miscible with the test material and is a known extraction solvent for polyaromatic substances.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 50μl of extract at various concentrations was added to a final volume of 5 millilitres of culture medium.
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hours in the absence or presence of S9 in the first test; 4 hours in the presence of S9 or 18 hours in the absence of S9 in the second test
- Fixation time (start of exposure up to fixation or harvest of cells): 18 hours
At least 100 nuclei in each culture were examined to determine mitotic index. - Evaluation criteria:
- The study was considered valid because the positive controls gave the statistically significant increases in the number of aberrant cells and the negative controls were within the historical range. A response is considered to be positive if a concentration-related increase or a reproducible increase in the number of cells with structural chromosomal aberrations is observed.
A response is considered to be equivocal if the percentage of cells with structural chromosomal aberrations is statistically marginal higher than that of the negative control (0.05A test material is considered to be clastogenic if a concentration-related increase in the percentage of cells with structural chromosomal aberrations over the concurrent control frequencies is observed, or if a single positive test point is observed in both tests.
A test material is considered to be negative in the chromosomal aberration test if it produces neither a dose-related increase in the number of structural chromosomal aberrations nor a reproducible positive response at any of the test points. Cells with only gaps (achromatic lesions), heavily damaged cells (cells with multiple aberrations) and cells with polyploidy and endoreduplication were recorded separately and not included in the final assessment of clastogenic activity. - Statistics:
- Data were analysed statistically by Fisher's exact probability test (two-sided) to determine significant differences between treated and control cultures.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the second chromosomal aberration test, in the single treatment group with metabolic activation (S9-mix), the mitotic index of the highest extract concentration analysed (l00%) was slightly reduced to 82% of that of the concurrent control. The mitotic indices of the two lower extract concentrations analysed (83.3% and 69.4%) were not reduced when compared to the concurrent control. None of the extract concentrations analysed induced a statistically significant increase in the number of aberrant cells. In the continuous treatment group without metabolic activation (S9-mix), the mitotic indices of none of the extract concentration analysed (l00%, 83.3%, and 69.4 %) were reduced when compared to the concurrent control. None of the extract concentrations analysed induced a statistically significant increase in the number of aberrant cells. In both chromosomal aberration tests, the positive control substances mitomycin C (in the absence of a metabolic activation system) and cyclophosphamide (in the presence of a metabolic activation system) induced the expected statistically significant increases in the incidence of structural chromosomal aberrations.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The data obtained in both chromosomal aberration tests, support the conclusion that, under the conditions used in this study, the extract of SASOLWAX 5203 was not clastogenic for CHO cells. - Executive summary:
Two mammalian cell chromosome aberration tests were performed. In the first test, Chinese hamster ovary (CHO) cells were exposed to extracts of Sasolwax 5203 at concentrations of 0.034, 0.069, 0.138, 0.277, 0.625, 1.25, 2.5, 5, or 10 mmol/l for four hours with or without metabolic activation at 37°C under 5% CO2. In the second chromosome aberration test, extracts of Sasolwax 5203 were tested at concentrations of 2.78, 4.17, 5.56, 6.94, 8.33, or 10 mmol/l for 18 hours continuous treatment without metabolic activation or 4 hours pulse treatment with metabolic activation at 37°C under 5% CO2. None of the extract concentrations analysed induced a statistically significant increase in the number of aberrant cells with or without metabolic activation or at pulse or continuous exposure. In both chromosomal aberration tests, the positive control substances mitomycin C (in the absence of a metabolic activation system) and cyclophosphamide (in the presence of a metabolic activation system) induced the expected statistically significant increases in the incidence of structural chromosomal aberrations.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely adhered to OECD Test Guideline 476 using cell line L5178Y, with and without metabolic activation.
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