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Key value for chemical safety assessment

Additional information

The test substance was examined for mutagenic activity in Salmonella typhimurium strains TA97a, TA98, TA100, TA1535 and E coli WP2uvrA (pKM101) in the presence and absence of exogenous metabolic activation system (S9) at concentrations up to 75% according to OECD Guideline 471. No mutagenic activity was observed in any bacterial strains at any concentration tested. It was concluded that the test substance was negative under the conditions of the test.An in vitro chromosome aberration assay in human lymphocytes was performed with the test substance at concentration up to 70% in one test in the presence of an exogenous metabolic activation system (S9) and in two tests in the absence of S9 according to OECD Guideline 473.In both the absence and presence of S9 mix, the test substance caused no statistically significant increase in the proportion of metaphase figures containing chromosomal aberrations, at any dose concentration. No increases in the proportion of polyploid cells were seen in the first test in the absence of S9 mix. However, in the presence of S9 mix a small statistically significant increase in the proportion of polyploid cells was seen at the highest treatment level. In the second test, both in the presence and absence of S9 mix, the test substance caused small significant increases in the proportion of polyploid metaphases at the highest level scored for chromosome aberrations only. Under the conditions of this test, it was concluded that the test substance has shown no evidence of clastogenic activity. The test substance was also examined for its potential to induce point mutations at the HPRT-locus of cultured Chinese hamster ovary (CHO) cells, in both the absence and the presence of a metabolic activation system (S9-mix) at concentrations up to 76% (the highest achievable concentration) according to OECD Guideline 476. In both the absence and presence of S9-mix the mean mutant frequency (MF) was not more than 20 mutants per 1E6 clonable cells at any concentration tested. It was concluded that the test substance was negative under the conditions of the test.


Justification for selection of genetic toxicity endpoint
For each endpoint, bacterial mutagenicity, mammalian mutagenicity and mammalian clastogenicity, a recent guideline and GLP compliant study is available.

Short description of key information:
DME was not mutagenic in a bacterial mutagenicity study (Ames test), induced no chromosomal aberrations in a study in human lymphocytes, and was not mutagenic in a mammalian mutagenicity study assessing the potential to induce point mutations at the HPRT-locus of cultured Chinese hamster ovary (CHO) cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance did not produce mutagenicity when evaluated in cell culture or animal systems. Further, the test substance was not carcinogenic in lifetime mammalian testing. The substance does not need to be classified for mutagenicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.