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Toxicological information

Genetic toxicity: in vitro

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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:
2006
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

Constituent 1
Chemical structure
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

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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