Registration Dossier
Registration Dossier
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EC number: 423-740-1 | CAS number: 10461-98-0
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 423-740-1
- EC Name:
- -
- Cas Number:
- 10461-98-0
- Molecular formula:
- C14H15N
- IUPAC Name:
- 2-cyclohexylidene-2-phenylacetonitrile
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102
- Metabolic activation system:
- Phenobarbital and beta-naphthoflavone-induced rat liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plate
Concentration range in the main test (without metabolic activation): .33 ... 333 μg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 100 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 333 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 333 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 333 μg/plate)
- Additional information on results:
- Observations:
Positive and negative controls responded as expected. There
was no increase in the numbers of revertants in any strain
at any dose level. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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