Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Reverse mutation assay (Ames test + E. Coli). OECD Guideline n° 471 (1983) EEC Directive 84/449 (1984) - Annex V - Method B14
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538 Escherichia coli tryptophan auxotroph WP2uvrA
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation ): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation ): 100 ... 5000 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)
- Remarks on result:
- other: other: preliminary test
- 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
The test substance was found to be non-mutagenic under the condition of the test.
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