Registration Dossier
Registration Dossier
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EC number: 413-030-8 | CAS number: 1134-94-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (In Vitro Mammalian Cell Gene Mutation)
- GLP compliance:
- yes
- Type of assay:
- other: In vitro Mammalian Cell Gene Mutation
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster ovary
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 125 µg/ml
Concentration range in the main test (without metabolic activation): 5 ... 60 µg/ml - Vehicle / solvent:
- Dimethyl sulfoxide
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours
Expression time:
7 days
Selection time:
7 Days
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:
- ( 125 µg/ml)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 60 µg/ml)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 90 µg/ml)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 40 µg/ml)
- Additional information on results:
- Observations:
No significant or dose-related increases in mutant frequency
were seen in either the first or second experiment.
Negative control values were within the normal range. Ethyl
methane sulphonate and 20-Methylcholanthrene were used as
positive controls for non-activation and activation assays,
respectively. These controls induced significant increases
in mutant frequency. - 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
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