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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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 resultsopen allclose all
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
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
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
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
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
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.