Benzene, di-C10-14-alkyl derivs., sulfonated, sodium salts

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study was conducted to determine the genotoxicity of the test substance according to OECD Guideline 471 and EU Method B. 13/14 (Ames test). Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537, and Escherichia coli WP2 uvr A were exposed at concentrations ranging from 1.7 to 5,000 µg/plate (based on a dose range finding test). Several tests were performed: 1) a direct plate assay and 2) a pre-incubation assay. In the direct plate assay, precipitation of the test substance on the plates was observed at the start of the incubation period at the highest concentration of 5000 µg/plate. No precipitation was observed at the end of the incubation period. To determine the toxicity of the test substance, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed. Cytotoxicity, as evidenced by a decrease in the number of revertants was observed in tester strains TA100, TA1537 and TA98 in the absence of S9-mix at the highest tested concentration. No increase in the number of revertants was observed upon treatment with the test substance under all conditions tested. In the pre-incubation assay, precipitation of the test substance on the plates was observed at the start of the incubation period at the top concentration of 5000 µg/plate and at 1600 and 5000 µg/plate at the end of the incubation period. Cytotoxicity was only observed in strain TA100 in the absence of S9-mix at concentrations of 1600 and 5000 µg/plate. There was no reduction in the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all other tester strains in the absence and presence of S9-mix. No increase in the number of revertants was observed under all conditions tested. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. In conclusion, the test substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Under the study conditions, the test substance was not considered to be mutagenic with and without metabolic activation (Verspeek-Rip, 2016).