Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct. 7, 2010-Nov. 11, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

GLP study conducted on target substance, Benzenesulfonic acid, mono-C11-13-branched alkyl derivs. EC 271-807-5, CAS 68608-88-8.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.

EC Number:

271-807-5

EC Name:

Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.

Cas Number:

68608-88-8

Molecular formula:

C18H30O3S

IUPAC Name:

4-(1,3,5,7-tetramethyloctyl)benzenesulfonic acid

Specific details on test material used for the study:

Test Article I.D.: Sulfonic acid Branched Alkylate Derivative
Test Article Batch No.: MIBL008639
Test Article CAS No.: 68608-88-8
Test Article Purity: 100%
Test Article Description: Viscous brown liquid
Storage Conditions: Room temperature, protected from direct sunlight (in foil) without desiccant

Method

Target gene:

Tester strains TA98 and TA1537 are reverted from histidine dependence (auxotrophy) to histidine independence (prototrophy) by frameshift mutagens. Tester strain TA1535 is reverted by mutagens that cause basepair substitutions. Tester strain TA100 is reverted by mutagens that cause both frameshift and basepair substitution mutations. Specificity of the reversion mechanism in E. coli is sensitive to basepair substitution mutations, rather than frameshift mutations.

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 from rat livers induced with Aroclor 1254

Test concentrations with justification for top dose:

The dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate, based on initial toxicity-mutation assay, which was used to establish the dose-range for the confirmatory mutagenicity assay.

Vehicle / solvent:

Water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, 2-nitrofluorene, sodium azide, 9-aminoacridine, methyl methanesulfonate

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation
0.5 ml of S9 or Sham mix, 100 ul of tester strain, 50 ul of vehicle, and test article or positive control, will be added to 2.0 ml of agar at 45 +/- 2 degrees C.

DURATION
- Preincubation period: 12-14 hrs at 37 +/- 2 degrees C
- Exposure duration: 48-72 hrs at 37 +/- 2 degrees C
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):

SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):

NUMBER OF REPLICATIONS: 3

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: >50% reduction in number of revertants per plate relative to vehicle control

OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:

OTHER:

Evaluation criteria:

For strains TA1535 and TA1537 - positive if a 3-fold increase in mean revertants as compared to vehicle controls
For strains TA98, TA100, and WP2 uvrA - positive if a 2-fold increase in mean revertants as compared to vehicle controls

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 6

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance is negative for gene mutation.

Executive summary:

Benzenesulfonic acid, mono-C11-13-branched alkyl derivs. EC 271-807-5, CAS 68608-88-8 was assessed in an in vitro gene mutation study in bacteria according to OECD 471, the test substance was found to be negative with and without metabolic activation.