2-amino-3,5-xylenesulphonic acid

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

4-aminotoluene-3-sulphonic acid

EC Number:

201-831-3

EC Name:

4-aminotoluene-3-sulphonic acid

Cas Number:

88-44-8

Molecular formula:

C7H9NO3S

IUPAC Name:

2-amino-5-methylbenzene sulfonic acid

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:

S. typhimurium, 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:

S. typhimurium, 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.