Registration Dossier
Registration Dossier
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EC number: 424-620-1 | CAS number: 13909-63-2 TUPH
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: data from ELINCS notification dossier approved by MSCA
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-phenyl-3-(p-toluenesulfonyl)urea
- EC Number:
- 424-620-1
- EC Name:
- 1-phenyl-3-(p-toluenesulfonyl)urea
- Cas Number:
- 13909-63-2
- Molecular formula:
- C14H14N2O3S
- IUPAC Name:
- 3-(4-methylbenzenesulfonyl)-1-phenylurea
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, 100, 1535, 1537, 1538
- Metabolic activation system:
- Aroclor induced, rat-liver S9
- Test concentrations with justification for top dose:
- Concentration range In the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: dimethylsulfoxide DMSO
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Additional information on results:
- Observations:
Solvent control plates gave counts of revertant colonies within the normal range.
All positive control chemicals gave increases in revertants, either with or without the metabolising system as apprppiate, within expected ranges. No statistically significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance, either with or without metabolic activation. The substance was found to be non-mutagenic under the conditions of this test. - 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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