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The substance Octadecanoic acid, sulfo-, potassium salt was tested in the Salmonella typhimurium Reverse Mutation Assay for the induction of reverse mutations in a bacterial test system. The assay was performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in two independent experiments, both with and without metabolic activation by S9-mix. Solutions of the test substance were prepared in aqua bidist. water and diluted with the same solvent just before use. No enhanced revertant rates compared to concurrent negative controls, induced by the test substance were observed in all tested strains, neither in the presence nor in the absence of metabolic activation. In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test substance did not induce gene mutations in Salmonella typhimurium strains.

The substance Octadecanoic acid, sulfo-, potassium salt was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro. Two independent experiments were carried out, both with and without the addition of liver S9 mix from phenobarbital- and β-naphthoflavone induced rats (exogenous metabolic activation).

Based on the results of the present study, the test substance did not cause any dosedependent increase in the mutant frequencies both without S9 mix and after the addition of a metabolizing system in two experiments performed independently of each other. Thus, under the experimental conditions of this study, the test substance Octadecanoic acid, sulfo-, potassium salt is not mutagenic in the HPRT locus assay under in vitro conditions in CHO cells in the absence and the presence of metabolic activation.

The substance Octadecanoic acid, sulfo-, potassium salt was assessed for its potential to induce micronuclei in V79 cells in vitro(clastogenic or aneugenic activity). Two independent experiments were carried out, both were carried out with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation).

On the basis of the results of the present study, the test substance did not cause any biologically relevant increase in the number of cells containing micronuclei either without S9 mix or after adding a metabolizing system. Thus, under the experimental conditions described, Octadecanoic acid, sulfo-, potassium salt is considered not to have a chromosome-damaging (clastogenic) effect nor to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.

In summary, the substance Octadecanoic acid, sulfo-, potassium salt does not have a genotoxic potential .


Short description of key information:
genetic toxicity in vitro (Ames test): negative
genetic toxicity in vitro (HPRT test): negative
micronucleus test in vitro (chromosome aberration): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification