N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide

Endpoint summary

Additional information

The test item was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster.

The study was performed in two independent experiments, using identical experimental procedures. In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. based on the results of the test, it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.

The test item was assessed for its potential to induce gene mutations in the plate incorporation test and in the pre-incubation test using the salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and the escherechia coli strain WP2 uvrA.

The assay was performed in two experiments both with and without liver microsomal activation. each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:1, 10, 22, 100, 333, 1000, 2500, and 5000 µg/plate.

Based on the results of the test, it can be stated that during the described mutagenicity test and under the experimental conditions reported in the robust study summary, the test item did not induce mutations by base pair change or frameshift in the genome of the strains used.

Therefore the registerd substance is considered to be non-mutagenic in the Salmonella typhimurium and Escherechia coli reverse mutation assay.

The test item , suspended in DMSO, was assessed for its potential to induce chromosomal aberrations in human lymphocytes in vitro in the absence and presence of metabolic activation by S9 mix. Two independent experiments were performed. In Experiment I the exposure period was 4 hours with and without S9 mix. In Experiment II the exposure periods were 4 hours with S9 mix and 22 hours without S9 mix. The chromosomes were prepared 22 hours (Exp. I & II) after the start of treatment with the test item. Based on the results of the test, it can be stated that under the experimental conditions reported, the test item did not induce structural chromosomal aberrations in human lymphocytes in vitro.

Therefore, the registered substance is considered to be non-clastogenic in this chromosome aberration test, when tested up to precipitating concentrations.

Justification for selection of genetic toxicity endpoint
Three key studies provide data to address the endpoint.

Short description of key information:
The genetic toxicity of N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide was assessed in 3 in vitro studies including, 1 bacterial reverse mutation assays, 1 mammalian chromosome aberration tests and a mammalian cells gene mutation assay. Negative results were reported in all the studies therefore N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide is not a genotoxic compound.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Genetic Toxicity: the substance is non-mutagenic under the conditions of the available in vitro studies. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.5.