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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication .

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. 2006, 19, 627-644

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of 2-amino-5-methylbenzolsulfonsäure(88-44-8) Salmonella typhimurium strains TA 98,TA 100,TA1535,TA 1537and TA 1538 by AMES test .
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-aminotoluene-3-sulphonic acid
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-aminotoluene-3-sulphonic acid
- Substance type: Organic
- Physical state: Solid

Method

Species / strain
Species / strain / cell type:
other: TA 98,TA 100,TA1535,TA 1537and TA 1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 from Hamster liver induced by AROCLOR 1254and Rat liver induced by AROCLOR 1254
Test concentrations with justification for top dose:
0,10-10000µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: Standard plate
Rationale for test conditions:
Not specified.
Evaluation criteria:
Evaluation was done considering a dose dependent increase in the number of revertants/plate.
Statistics:
Not specified.

Results and discussion

Test results
Species / strain:
other: TA 98,TA 100,TA1535,TA 1537and TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Not specified.
Remarks on result:
other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:
2-amino-5-methylbenzolsulfonsäure(88-44-8) was not considered to be mutagenic in Salmonella typhimurium strain TA 98,TA 100,TA1535,TA 1537and TA 1538 by AMES test.
Executive summary:

2-amino-5-methylbenzolsulfonsäure(88-44-8) was assessd for its possible mutagenic potential .For this purpose AMES test was performed on Salmonella typhimurium strain  TA 98,TA 100,TA1535,TA 1537and TA 1538 . The test material was exposed at the concentration of 0,10-10000µg/plate in the presence and absence of S9. . No mutagenic effect were observed in all strailin the presence and absence of metabolic activation. Therefore 2-amino-5-methylbenzolsulfonsäure was considered to be non mutagenic in Salmonella typhimurium strain  TA 98,TA 100,TA1535,TA 1537and TA 1538 by AMES test. Hence the test chemical cannot be classified as gene mutant in vitro.