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EC number: 943-886-2 | CAS number: -
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:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide
Data source
Reference
- Reference Type:
- publication
- Title:
- Detection of carcinogens as mutagens in the Salmonella/microsome terst: Assay of 300 chemicals.
- Author:
- McCann, J., Choi, E., Yamasaki, E., Ames, B.N.
- Year:
- 1 975
- Bibliographic source:
- Proc Nat Acad Sci 1975;72(12):5135-5139.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only two bacterial strains tested.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid
- Details on test material:
- -Name of test material (as cited in study report):Ethyl Alcohol.
-described as 'commercial solvent'.
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- Not specified for this compound but typically 10, 100, 500, 1000 microgram/plate. (10,000 known also to have been tested).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There were < 70 revertants per 10mg/plate tested.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Salmonella/microsome
Any other information on results incl. tables
There were < 70 revertants per 10mg/plate tested.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results :negative
As part of a study of the mutagenic potential of 300 chemicals, ethanol was evaluated in a bacterial reverse mutation (Ames) assay at a plate concentration of up to 10mg/plate in the presence of metabolic activation. There was no evidence of mutagenicity in either of the two strains examined (TA98, TA100). . It should be noted that only two of the normal four bacterial strains were evaluated, so the study cannot be regarded as complete or definitive.
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide - Executive summary:
As part of a study of the mutagenic potential of 300 chemicals, ethanol was evaluated in a bacterial reverse mutation (Ames) assay at a plate concentration of up to 10mg/plate in the presence of metabolic activation. There was no evidence of mutagenicity in either of the two strains examined (TA98, TA100). . It should be noted that only two of the normal four bacterial strains were evaluated, so the study cannot be regarded as complete or definitive.
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide
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