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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The registration substance was not mutagenic in a guideline conform Salmonella typhimurium reverse mutation assay (Ames test) with and without metabolic activation (S9-mix from induced rat liver). Likewise, the submission substance was also not mutagenic in a guideline compliant mouse lymphoma assay and did not induce chromosome aberrations or clastogenic effects in a guideline conform micronucleus test in vitro with and without metabolic activation. Likewise, also negative mutagenicity data from an Ames-test, a mammalian cell gene mutation assay (HPRT) and a cytogentic study in V79 cells in vitro are abvailable for the structural analogue sodium methyl oleyl taurate, which do support the above conclusion.

Link to relevant study records

Reference

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:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

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

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

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

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
ambiguous without metabolic activation

Based on the study results of this bacterial mutagenicity assay (Ames test), sodium cocoyl taurate is not muatgenic neither in the presence or absence of metabolic activation.

Executive summary:

Sosium cocoyl taurate 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 sodium cocoyl taurate is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose lebvels investigated.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The registration substance was tested for potential point mutation in a guideline conform bacterial reverse mutation assay (Ames test) according to OECD TG 471 with and without metabolic activation. Independent experiments using several test concentrations up to the limit dose of 5000µg/platedid not cause gene mutations by base pair changes or frameshifts in the genome of any of the tester strains used. Therefore, the submission substance is considered to be non-mutagenic in this bacterial reverse mutation assay. This study was selected as key study.

The registration substance was tested for potential gene mutation in a guideline conform mouse lymphoma assay (HPRT locus) according to OECD TG 476 in L5178Y cells. Using independent experiments, no biologically relevant increase of mutants was found after treatment with the test item, neither with nor without metabolic activation. No dose-response relationship was observed. Therefore, the submission substance is considered to be non-mutagenic in the mouse lymphoma assay. This study was selected as key study.

The registration substance was tested for the potential to induce micronuclei in human lymphocytes in vitro in tha absence and presence of metabolic activation. Several dose levels up to 320 µg/mL and two exposure periods (4 and 20 hours) were tested. No biologically increase of micronuclei was found, either with or without S9 -mix. No dose-response relationship was observed. Therefore the submission substance is considered to be non-mutagenic in the micronucleus test in vitro. This study was selected as key study.

Additionally, supporting evidence concerning the absence of genotoxic / mutagenic properties is coming from study results with the structural analogue sodium methyl oleyl taurate, which was not muatgenic in the Ames test, the mammalian cell gen mutation assay (HPRT) and the cytogenetic in vitro test in V79 mammalian cells.

In conclusion, the registration substance is found to be not genotoxic / mutagenic in various test systems. This conclusion is further supported by read-across to data from a structural closely related compound.

Justification for selection of genetic toxicity endpoint
There are several key studies covering bacterial point mutation testing, testing for gen mutations in mammalian cells as well as chromosome mutations in mammalian cell systems. All studies are performed on the registration substance and representing guideline conform tests according to GLP with a Klimisch rating of 1. Additionally, study results from the read-across analogue sodium methyl oleyl taurate are in line and confirm above conclusions.

Justification for classification or non-classification

Based on the available data from three independent mutagenicity assays and supported by data from a structural analogous compound, a respective mutagenic potential of the test item can be excluded. Thus, the registration substance does not have to be classified for mutagenicity in accordance with the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) as well as in the EU Classification, Labellling and Packaging Regulation (1272/2008/EC).