Decanedioic acid, compound with ethanolamine / Decanedioic acid, compound with 2-aminoethanol

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

In vitro gene mutation in Bacteria

The potential of the test material to cause mutagenic effects in bacteria was assessed in accordance with the standardised guideline OECD 471 under GLP conditions. The study was assigned a reliability score of 1 according to the criteria of Klimisch (1997)

Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537) and Escherichia coli strain WP2uvrA were tested with the test material, using the plate incorporation and pre-incubation methods at various dose levels, both with and without metabolic activation.

In the dose-range finding study, the test item was tested up to concentrations of 5000 µg/plate in the absence and presence of S-9 mix in strains TA100 and WP2uvrA. The test substance did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in teh number of revertants was observed.

Based on the results of the dose-range finding test, the test item was tested in the first mutation assay at a concentration range of 52 to 5000 µg/plate in the absence of S-9 mix in the tester strains TA1535, TA1537, TA98 and TA100 and in the presence of 5% (v/v) S-9 mix in the tester strains TA1535, TA1537 and TA98. The test substance did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the tested concentrations and no biologically relevant decreases in number of revertants was observed.

In a follow up experiment of the assay with additional parameters, the test substance was tested at a concentration range of 492 to 5000 µg/plate in the absence and presence of 10% (v/v) S-9 mix in tester strains TA 1535, TA 1537, TA98, TA100 and WP2uvrA. The test item did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at any of the concentrations tested and bo biologically relevant decreawse in the number of revertants was observed.

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 the tester strain Wp2uvrA both in the absence and presence of S9 -metabolic activation. The negative results were within the laboratory historical control data ranges.

In conclusion, based on the results of this study it is concluded that Sebacic Acid MEA salt is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.