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EC number: 216-407-3 | CAS number: 1576-35-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- A Compilation of Two Decades of Mutagenicity Test Results with the Ames Salmonella typhimurium and L5178Y Mouse Lymphoma Cell Mutation Assays
- Author:
- H. E. Seifried, R. M. Seifried, J. J. Clarke, T. B. Junghans, and R. H. C. San
- Year:
- 2 006
- Bibliographic source:
- Chem. Res. Toxicol. Vol. 19, No 5. 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- not specified
- Type of assay:
- other: Mouse lymphoma mutagenicity assay
Test material
- Reference substance name:
- Toluene-4-sulphonohydrazide
- EC Number:
- 216-407-3
- EC Name:
- Toluene-4-sulphonohydrazide
- Cas Number:
- 1576-35-8
- Molecular formula:
- C7H10N2O2S
- IUPAC Name:
- toluene-4-sulphonohydrazide
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- NA
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, male rat liver, Aroclor 1254 induced
- Test concentrations with justification for top dose:
- 100-2400 µg/mL
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Evaluation criteria:
- Mutant frequencies were expressed as mutants per 106 surviving cells. Although there are several different methods for evaluating mouse lymphoma data, results from this study were interpreted using a doubling of the mutant frequency over the concurrent solvent-treated control value as an indication of a positive effect, together with evidence of a dose-related increase. Only doses yielding total growth values of 10% were used in the analysis of induced mutant frequency. Doses yielding less than 10% total growth were used in determining dose response.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- At 1000 ug/mL
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- p-toluenesulfonic hydrazide (TSH) showed mutagenic effects in mouse lymphoma L5178Y at 1000 µg/mL without S9 metabolic activation system. The results were equivocal with S9 metabolic activation system
- Executive summary:
The genetic toxicity of p-toluenesulfonic hydrazide (TSH)was evaluation in a Mouse lymphoma mutagenicity assay. The study was performed in equivalence to OECD guideline 476.
TSH showed mutagenic effects in mouse lymphoma L5178Y at 1000 µg/mL without S9 metabolic activation system. The results were equivocal with S9 metabolic activation system.
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