Registration Dossier
Registration Dossier
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EC number: 449-980-5 | 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 (Bacterial Reverse Mutation 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, and Escherichia coli strain WP2uvrA-.
- Metabolic activation system:
- ß-naphthoflavone/phenobarbitone 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 (DMSO)
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:
The vehicle (dimethyl sulphoxide) control plates gave counts
of revertant colonies within the normal range. All of the
positive control chemicals used in the test induced marked
increases in the frequency of revertant colonies, both with
and without metabolic activation. Thus, the sensitivity of
the assay and the efficacy of the S9-mix were validated.
The test material caused no visible reduction in the growth
of the bacterial lawn at any dose level. The test material
was, therefore, tested up to the maximum recommended dose
level of 5000 µg/plate. No test material precipitate was
observed on the plates at any of the doses tested in either
the presence or absence of S9-mix.
No significant increase in the frequency of revertant
colonies were recorded for any of the bacterial strains with
any dose of the test material, either with or without
metabolic activation.
The test material was considered to be non-mutagenic under
the conditions of this test. - 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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