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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.