Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across study

Justification for type of information:

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Refer to section 13 for read-across justification.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

EC Number:

939-529-5

Molecular formula:

not applicable, substance is a UVCB substance containing several constituents

IUPAC Name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from Aroclor 1254 pretreated rats

Test concentrations with justification for top dose:

4 up to 5000 microgram / plate

Vehicle / solvent:

Aqua bidest

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Evaluation criteria:

2-fold increase in mean number of revertants per plate
Dose-related increase in mean number of revertants per plate

Results and discussion

Test results

Key result

Species / strain:

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

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

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Based on the study results of this bacterial mutagenicity assay (Ames test), sodium methyl cocoyl taurate (SMCT) is not mutagenic with or without metabolic activation.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, the registration/target substance SMLT is not expected to be mutagenic with or without metabolic activation. Refer to section 13 for read-across justification.

Executive summary:

The read-across source substance sodium methyl cocoyl taurate (SMCT) was tested for mutagenicity with the strains TA 100, Ta 1535, TA 1537, and TA 98 of Salmonella typhimurium. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. The test substance was dissolved in Aqua bidest and a dose range of 6 different doses from 4 microgram/plate to 5000 microgram/plate was used. Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literaure. All the positve control compounds gave the expected increase in the number of revertant colonies. In the cytotoxicity tests, the test item proved to be toxic to most of the bacterial strains at doses of 2500 microgram/plate and above. In the mutagenicity study, 5000 microgram/plate was chosen as top dose level which did not result in any relevant (dose-dependent) increase in the number of revertants in any of the bacterial strains tested, neither in the preence nor in the absence of metabolic activation. On the basis of the results of this study, it can be stated that SMCT is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose levels investigated.

This study for the source substance SMCT is used as read-across to the registration/target substance SMLT. Hence, SMLT is not expected to be mutagenic in bacterial test systems with or without metabolic activation. Refer to section 13 for read-across justification.