Registration Dossier
Registration Dossier
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EC number: 473-870-6 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, Method B13/B14 (Ames test).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA1535, TA1537, TA98 and TA100. E. coli: WP2uvrA-pKM101
- Metabolic activation system:
- Phenobarbitone/Beta-naphthoflavone induced, rat-liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethyl sulphoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1500 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Additional information on results:
- Observations:
A white precipitate (greasy in appearance) was observed at
and above 1500 micro.g/plate, this did not prevent the
scoring of revertant
colonies. - 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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