Registration Dossier
Registration Dossier
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EC number: 428-410-9 | CAS number: 67014-36-2
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:
- other: not verifiable
- Rationale for reliability incl. deficiencies:
- other: no information given in SNIF-file
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.13, B.14 (Ames-Test); OECD 471, 472 (1983)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 428-410-9
- EC Name:
- -
- Cas Number:
- 67014-36-2
- Molecular formula:
- C8H9N3O
- IUPAC Name:
- 5-amino-6-methyl-2,3-dihydro-1H-1,3-benzodiazol-2-one
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation system:
- Aroclor 1254 induzierter Rattenleber S9-Mix
- 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: DMSO
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- other: see section "additional information on results"
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- other: see section "additional information on results"
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Additional information on results:
- Observations:
The substances precipitate in agar-agar.
Based on the results of this study it is concluded that the test item is mutagenic in the Salmonella thyphimurium reverse mutation assay and is not mutagenic in the Escherichia coli reverse mutation assay. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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