Benzenesulfonic acid, mono-C10-13-alkyl derivs., potassium salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

EC Number:

270-115-0

Cas Number:

68411-30-3

IUPAC Name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Purity: 91.3%

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Remarks:

+ S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Arochlor-induced S9 fraction

Test concentrations with justification for top dose:

0, 8, 40, 200, 1000 and 5000 μg/plate

Vehicle / solvent:

Aqueous

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

other: aminoacridine, aminoanthracene

Results and discussion

Test results

Key result

Species / strain:

other: S. typhimurium TA98, TA100, TA1535 and TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

S. typhimurium TA 1538 also tested negative. During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 μg/plate. No precipitation of the test substance was observed at any of the tested concentrations.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the substance was not mutagenic either in the presence or absence of metabolic activation in the bacterial reverse mutation assay.

Executive summary:

A study was conducted to evaluate the in vitro mutagenicity potential of the substance according to OECD Guideline 471 and EU Method B13/14, in accordance with GLP. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 were exposed to the test substance at concentrations of 0, 8, 40, 200, 1000 and 5000 µg/plate. Negative (vehicle) and positive controls were included in the experiment. The test substance induced cytotoxicity but no evidence of genotoxicity were observed in any of the tested strains. Under the study conditions, the substance was not mutagenic either in the presence or absence of metabolic activation in the bacterial reverse mutation assay (Schoeberl, 1993).