Registration Dossier
Registration Dossier
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EC number: 467-290-2 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 2000/32, 4.D.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 100 and TA 98. Escherichia coli WP2 uvrA
- Metabolic activation system:
- S9 rat liver induced with Phenobarbital/.beta.Naphtoflavone.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide (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:
No toxic effects, evident as a reduction in the number of
revertants, occurred in the test groups with and without
metabolic activation.
No substantial increase in revertant colony numbers of any
of the five tester strains was observed following the
treatment with the test item at any dose level, neither in
the presence nor in the absence of metabolic activation.
No tendency of higher mutation rates with increasing
concentrations in the range below the generally acknowledged
border of biological relevance.
The test item did not induce gene mutations by base pair
changes or frameshits in the genome of the strains used, and
therefore was considered to be non-mutagenic. - 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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