Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Unavailable - orginal study report date 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

Directive 84/449/EEC, B.14 Mutagenicity (Salmonella typhimurium - reverse mutation assay)" 1984; equivalent to OECD 471

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

EC Name:

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

Cas Number:

68411-30-3

Molecular formula:

Not applicable for UVCB

IUPAC Name:

sodium 4-undecylbenzenesulfonate

Method

Target gene:

Histidine locus

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Arochlor-induced S9 fraction

Test concentrations with justification for top dose:

8, 40, 200, 1000 and 5000 µg/plate

Vehicle / solvent:

Water solution at 50 g/L

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Positive controls:

yes

Remarks:

aminoanthracene

Positive control substance:

other: nitrofluorene, sodium azide and aminoacridine

Results and discussion

Test results

Key result

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100, TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

with and without activation

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 µg/plate. No precipitation of the product was observed at any concentration tested.

Applicant's summary and conclusion

Conclusions:

The substance was not mutagenic in Salmonella typhimurium strains (TA98, TA100, TA1535, TA1537 and TA1538) in the presence and absence of metabolic activation in bacterial reverse mutation assay.

Executive summary:

The potential of the substance to induce reverse mutations in several strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA1538) was evaluated in the presence or absence of an exogenous mammalian metabolic activation system (S9). The concentrations of the substance employed were 8, 40, 200, 1000 and 5000 µg/plate.

 

During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 µg/plate. No precipitate was observed at the maximum concentration tested. No positive responses were induced in any of the strains. Based on the results of this study, the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.