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Diss Factsheets
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EC number: 200-578-6 | CAS number: 64-17-5
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Critical study for SIDS endpoint Published study but containing sufficient details to be able to judge it reliable for hazard assessment. Part of a programme of work by the NTP. Data tables available for results. TA102 not included.
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella mutagencity tests: V. Results from the testing of 311 chemicals.
- Author:
- Zeiger, E., Anderson, B., Haworth, S., Lawlor, T, Mortelamns, K.
- Year:
- 1 992
- Bibliographic source:
- Environ Mol Mut 19;2-141.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Preincubation as per method of Haworth (Env Mutagen, 5 suppl 1, 3-142, 1983)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse 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: US Industries
- Analytical purity: 91% pure
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.
- Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.
- Species / strain / cell type:
- S. typhimurium, other: TA104
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced male SD rat at 10 and 30% and male Syrian hamster liver S9 fraction, at 10 and 30%.
- Test concentrations with justification for top dose:
- 1; (3; 10; 33;)100; 333; 1,000; 3,333; 10,000 microgram/plate. Concentrations in brackets only tested with TA97 using 30% hamster S9.
- Vehicle / solvent:
- water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1342 2-aminoanthracene, used for all strains with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1342 4-nitro-o-phenylenediamine, used for TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 28 used for TA97 without metabolic activation.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2374 used for TA1535 and T100 without metabolic activation.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2072 used for TA104 without metabolic activation.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins at 37C
- Expression time (cells in growth medium): 2 days at 37C
NUMBER OF REPLICATIONS: 5 plus complete repeat of experiment.
DETERMINATION OF CYTOTOXICITY
- Dose range for main test assessed using TA100. Toxic concentrations defined as those producing a decrease in the background number of his+ colonies and/or a clearing in the background lawn. If no toxicity was seen, the maximum dose tested was 10000ug/plate
Evaluation criteria
Only considered non mutagenic if negative in all strains with and without activation and with both S9 extracts at both concentrations - Evaluation criteria:
- Combination of magnitude of increase in number of his+ revertants and shape of dose-response curve.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 104
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- None - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Dose-effected related observations: Ethanol at any dose did not produce a 2-fold increase in his+ revertants in the absence or presence of rat or hamster liver extracts.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Ethanol failed to induce reversions in any S. typhimurium
tester strain with or without metabolic activation over a
wide range of doses up to 10 mg/plate. - Executive summary:
In a reverse mutation assay in bacteria strains TA97, TA98, TA100, TA104 and TA1535 there was no evidence of mutation up to a maximum plate concentration of 10mg/plate with and without metabolic activation systems derived from two species (rat and hamster) used at two different concentrations.
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