Amines, C12-16 alkyl dimethyl, reaction products with ethyl chloroacetate, 2-(2-aminoethylamino)ethanol and 2-propenoic acid

Endpoint summary

Additional information

Bacterial reverse mutation

The potential of the substance to induce gene mutations using theSalmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA was investigated. No substantial increase in revertant colony numbers of any of the fivetester strains was observed following treatment with the substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).

Based on the results of this study it is concluded that the substance is not mutagenic in theSalmonella typhimurium reverse mutation assay.

Mammalian cell gene mutation

In a mammalian cell gene mutation assay according to OECD guideline 467, L5178Y mouse lymphoma cells cultured in vitro were exposed to the substance in the following concentrations in the presence and absence of mammalian metabolic activation (S9 mix):

Test substance was tested up to cyctotoxic concentrations.The positive controls induced the appropriate response.There was no evidence of induced mutant colonies over background.

In the absence of S9 metabolic activation, the substance induced a 5.3-fold increase in the mutant frequency in the first experiment. Since this mutagenic effect was not confirmed by the additional assay nor in the short or prolonged treatment, this increase was considered to be not biologically relevant and the substance is considered to be not mutagenic in the absence of SS-mix.

In the presence of S9 -mix, the substance induced no significant increase in the mutant frequency in both independent experiments.

In conclusion, the substance is not mutagenic in the TK mutation test system under the experimental conditions described.

Mammalian chromosome aberration

The test item Rewoteric QAM 50 was investigated for a possible potential to induce structural chromosomal aberrations in CHO cells of the Chinese hamster in vitro in the absence and presence of metabolic activation with S9-mix. From the test results it is concluded that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test item did not induce structural chromosomal aberrations in the CHO Chinese hamster cell line.

Therefore, the test item is considered to be non-clastogenic.

Justification for selection of genetic toxicity endpoint
Data from four well documented studies with relialibilty 1 or 2. The full set of genotoxicity tests required by the REACH regulation is negative.

Short description of key information:
The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and the mammalian cell gene mutation assay using mouse lymphoma L5178Y cells. In an in vitro chromosomal aberration test the test item did not induce structural chromosomal aberrations in the CHO Chinese hamster cell line. Therefore, the test item is considered to be non-clastogenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance is not mutagenic in the bacterial reverse mutation assay and in the mammalian cell gen mutation assay. It did not induce structural chromosomal aberrations in mammalian cells and is therefore considered to be non-clastogenic.

In conclusion the full set of genotoxicity tests required by the REACH regulation is negative. According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 no classification and labelling for mutagenic toxicity is necessary.