Registration Dossier
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EC number: 412-440-4 | 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:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium, TA98, TA100, TA1535, and TA1538
- Metabolic activation system:
- Liver microsomal enzymes from male Spraque-Dawley rats
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 667...10000 μg/plate
Concentration range in the main test (without metabolic activation): 667...10000 μg/plate - Vehicle / solvent:
- Solvent: Acetone
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 667 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >10000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >10000 μg/plate
- Additional information on results:
- Observations:
The vihicle control value for tester strain TA98 in the presence of microsomal enzymes was outside the acceptable range. Therefore, tester strain TA98 was retested in the presence of microsomal enzymes. - Remarks on result:
- other:
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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