Registration Dossier
Registration Dossier
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EC number: 434-770-8 | CAS number: 55314-16-4
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: Annex V (Bacterial gene mutation)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA1535, TA1537, TA100 and TA98. Escherichia coli: WP2uvrA
- 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): 3 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 3 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
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 substance did not induce a dose-related increase in the
number of revertant (His+) colonies in each of the four
tester strains (TA1535, TA1537, TA98 and TA100) and in the
number of revertant (Trp+) colonies in tester strain WP2uvrA
both in the absence and presence of S9-metabolic activation.
These results were confirmed in an independently repeated
experiment.
The compound was tested up to concentrations of 5000
µg/plate in the absence and presence of S9-mix. The
substance did not precipitate on the plates at this dose
level. The bacterial background lawn was not reduced at all
concentrations tested and no decrease in the number of
revertants was observed. - 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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