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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP laboratory study
Justification for type of information:
Study is read-across from LAS. Please refer to section 13 for the read-across justification

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

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:
C16-19 H25-31 Na O3 S
IUPAC Name:
sodium 4-undecylbenzenesulfonate
Details on test material:
Marlon A 390 (CAS #68411-30-3) Sodium salts of C10-13 alkyl benzenesulphonic acid, average alkyl chain length = C11.6; activity 91.3%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
also 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 ug/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
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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:
TA 1538 also tested negative. During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 ug/plate. No precipitation of the product was observed at any concentration tested.

Applicant's summary and conclusion

Conclusions:
LAS is not mutagenic in the Ames test.
Executive summary:

A bacterial mutagenicity study (Ames test) was conducted on LAS and was found to be negative for mutagenicity.