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EC number: 205-760-9 | CAS number: 150-46-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable, study with sufficient detailed documentation to demonstrate that study meets basic scientific principles and contains enough detail to be able to judge the results reliable as a contribution to the understanding of the genotoxic potential of this substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Mouse lymphoma L5178Y thymidine kinase locus assay of 50 compounds.
- Author:
- Wangenheim, J. and Bolcsfoldi, G.
- Year:
- 1 988
- Bibliographic source:
- Mutagen. 3(3):193-205.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Remarks:
- , no significant deviations noted
- Principles of method if other than guideline:
- Method: other: Clive et al. (Muta Res, 59, 61, 1979) with some minor modifications to reduce experiment time and plating efficiency. Study examined a large number of chemicals.
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- - Supplier AB Svenska Sprit (Sweden)
- Purity: highest available (not specified)
Constituent 1
Method
- Target gene:
- TK forward mutation
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fisher's medium with 10% horse serum, adjusted to pH 7.2
- Source: Boroughs Welcome Co, Research Triangle Park, NC, USA
- Periodically "cleansed" against high spontaneous background: yes by treatement with thymidine, hypoxanthine, methotrexate and glycine - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 from Sprague-Dawley rat livers, animals pre-treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 0.092, 0.184, 0.369, 0.553, 0.738 mol/l without activation; 0.414, 0.465 and 0.517 mol/l with activation
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Positive control substance:
- cyclophosphamide
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Positive control substance:
- 2-nitrofluorene
- Details on test system and experimental conditions:
- 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): no data
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: 3 per dose level but 6 for negative control.
DETERMINATION OF CYTOTOXICITY
- Mitotic index: Not strictly applicable. Total growth cf. controls were 88, 84, 53, 34 and 17% from lowest to highest concentrations in the absence of activation. With activation, total growth was 43, 24, and 6% from lowest to highest concentration. - Evaluation criteria:
- Two fold or greater increase in mutation frequency at 10% or greater total growth cf. controls.
- Statistics:
- Tested for normal distribution and then analysis of variance and 2-tailed Student's t-test against controls.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- None
ADDITIONAL INFORMATION ON CYTOTOXICITY: see table below
- Frequency of reversions etc: Without activation, mutation index values from lowest to highest dose were 1.3, 1.1, 1.2, 1.1 and 1.6. With metabolic activation these values were 1.1, 1.3 and 1.8.
- Dose-effect related observations: No dose-effect related observations were seen. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Only at the maximum concentration, with metabolic activation was total growth <10% control. Without activation, the lowest and highest concentrations of ethanol produced statistically significant increases in mutation frequency.
Without metabolic activation
Concentration (mols/litre) | Total growth | Mutation frequency | Mutation index |
0 | 100% | 80, 99 | 1.0 |
0.0922 | 88% | 118* | 1.3 |
0.184 | 84% | 94 | 1.1 |
0.369 | 53% | 104 | 1.2 |
0.553 | 34% | 101 | 1.1 |
0.738 | 17% | 140** | 1.6 |
With metabolic activation
Concentration (mols/litre) | Total growth | Mutation frequency | Mutation index |
0 | 100% | 63, 46 | 1.0 |
0.414 | 43% | 62 | 1. |
0.465 | 24% | 70 | 1.3 |
0.517 | 6% | 97** | 1.8 |
*significant, ** highly significant
Rates of spontaneous mutation frequencies in study: without metabolic activation 76 +/-25, with metabolic activation 86 +/-33.
Results are supported by those of Amacher, D., et al. (1980) Mutat. Res. 72:447 -474
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Ethanol is judged not to have significant mutagenic activity in this system. - Executive summary:
In a mammalian cell mutation study using mouse lymphoma lymphoma cells in the TK forward mutation assay, ethanol was found to be non mutagenic with and without metabolic activation at very high doses up to and including those that cause significant cytotoxicity (typically in the region 0.3 -0.5M.
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