Dodecyldimethylamine

Endpoint summary

Additional information

According to the key study, the substance was tested for mutagenicity with the strains TA100, TA1535, TA1537, TA1538, TA98 of Salmonella typhimurium and Escherichia coli. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different doses from 0.16 microgram/plate to 500 microgram/plate was used.Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compound gave the expected indrease in the number of revertant colonies. Toxicity: The test compound proved to be very toxic to the bacterial strains at 100 microgram/plate. 500 microgram/plate was chosen as top dose level for the mutagenicity study.Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the substance did not result in relevant increases in the number of revertant colonies. The substance is not mutagenic.

According to the supporting study, the material was examined for mutagenic activity in two histidine-dependent auxotrophs of Salmonella typhimurium, strains TA98 and TA100, using pour-plate assays. the studies which were conducted in the presence and absence of an activating system derived from rat liver (S-9 mix), employed a range of levels of the substance from 5 to 500µg plate, selected following a preliminary toxicity test in strain TA98. the tests included solvent (ethanol) controls with and without S-9 mix. It was concluded that the substance did not exhibit any mutagenic activity under the conditions of test.

According to the key study of Genetic toxicity in vivo, the micronucleus test was carried out with the substance. The test compound was dissolved in sesame oil and was given twice at an interval of 24 hours as orally doses of 120, 400 and 1200 mg per kg body weight to male and female mice, based on the results of a previous dose range finding assay. According to the test procedure the animals were killed 24 hours after administration. Under the conditions of the present study the results indicate that the substance is not mutagenic in the micronucleus test.

Short description of key information:
Full details of these endpoints are provided in the IUCLID dossier and they are considered reliable.
Results for the substance decyldimethylamine are presented below:
The results lead to the conclusion that the substance did not lead to a substantial increase of micronucleated polychromatic erythrocytes. The test material did not exhibit any mutagenic activity under the conditions of test.

Endpoint Conclusion: No adverse effect observed (negative)