Reaction mass of N, N'-hexane-1,6-diylbis [12-hydroxyoctadecanamide] and 12-hydroxy-N-[6-[1-oxoalkyl)amino] hexyl ] octadecanamide

Endpoint summary

Additional information

In a bacterial reverse mutation assay (e.g. Ames test), AD-1000 was tested with four strains of Salmonella typhimurium (TA1535, TA1537, TA100, TA98) and in the Escherichia coli WP2uvrA both in the presence and absence of metabolic activation according to OECD 471 and EC B.13/14 test guidelines. In a dose range finding test up to 5000 µg/l was tested, while in the main test up to 1000 µg/l was tested. In both tests precipitation of the substance was observed. AD-1000 did not induce a dose-related two-fold increase in the number of revertant colonies in any of the bacteria tested. The substance is therefore considered not mutagenic in the Ames test.

AD-1000 was tested in a chromosome aberration study with cultured peripheral human lymphocytes in the presence and absence of metabolic activation according to OECD 473 and EC B.10 test guidelines. Two assays were performed, in the first the substance was tested up to 33 µg/ml for a 3 hour exposure time with 24 h fixation time, while in the second test the substance was tested also up to 33 µg/ml but for a 24 hour and 48 hour exposure time with a 24 hour and 48 hour fixation time in the absence of S9 mix and for a 3 hour exposure time with a 48 fixation time in the presence of S9 mix. AD-1000 precipitated in the culture medium. The substance did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence or presence of metabolic activation. In addition, the substance did not have any effect on the number of polyploid cells and cells with endoreduplicated chromosomes and thus does not disturb mitotic processes and cell cycle progression. AD-1000 is not clastogenic in this study.

In a TK assay according to OECD 476 and EC B.17 test guidelines, mouse lymphoma L5178Y cells were exposed to AD-1000 with and without metabolic activation. Based on a dose-range finder, the main test consisted of two experiments, the first with 3 hours of exposure to the substance at concentrations up to 100 µg/ml with and without metabolic activation and the second experiment with 24 hours exposure up to 80 µg/ml and only without metabolic activation. Precipitation was observed at the highest concentrations. AD-1000 did not have a genotoxic effect in this assay.

Short description of key information:
In an Ames test, a chromosome aberration test and a TK assay, all according to current test guidelines, no genotoxicity was observed for AD-1000.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the studies available, AD-1000 does not have to be classified according to Directive 67/548/EEC and the CLP Regulation (EC) No 1272/2008 for genetic toxicity.