Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
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:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames)
- 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 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- 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): 20 - 5120 μg/plate
Concentration range in the main test (without metabolic activation): 20 - 5120 μg/plate
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: ≥ 320 μg/plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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
- Additional information on results:
- Observations:
No increase in mutation rate was seen with the test substance in two independent experiments. Positive controls gave a satisfactory response. - Remarks on result:
- other: other: 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 Annex V, GLP) with and without metabolic activation: No increase in mutation rate was seen in two independent experiments (species/strains tested: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100).
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