Registration Dossier
Registration Dossier
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EC number: 422-600-5 | CAS number: 73936-91-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat livers (S9 fraction)
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33.3 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 33.3 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: DMSO
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 333 μg/plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: other: preliminary and main 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
The substance was non mutagenic under the conditions of the test. - Executive summary:
The test susbtance was negative in an Ames test (bacterial reverse mutation assay according to EU Method B.13/14, GLP) with and without metabolic activation: No evidence of induction of point mutations in presence or absence of metabolic activation has been observed in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2.
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