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Administrative data

Key value for chemical safety assessment

Additional information

Ethyl methyl carbonate has been assessed for genetic toxicity in vitro in two key studies: an Ames test mutagenicity assay and the human lymphocyte chromosomal aberration test. In a GLP-compliant study following OECD guideline 471, ethyl methyl carbonate was negative for mutagenicity when tested in Salmonella strains TA98, TA100, TA1535 and TA1537 and in E.coli strain WP2uvrA, in the presence and absence of metabolic activation (using S9 prepared from rat liver). In addition a GLP-compliant study following OECD guideline 473 assessed the clastogenic potential of ethyl methyl carbonate; no significant increases in chromosomal aberration in human lymphocytes were observed either in the presence or absence of metabolic activation (using S9 prepared from rat liver).

The close chemical analogue dimethyl carbonate was tested in a mouse fibroblast comet assay: this investigation of non-specific DNA damage (DNA strand breaks) found no evidence of induced DNA damage. It is reasonable to conclude that ethyl methyl carbonate would give similarly negative results if tested in this assay system.

The predicted pathway for hepatic metabolism of ethyl methyl carbonate (elimination via formation of ethanol, methanol and carbon dioxide) suggests no potential for formation of genotoxic metabolites.

Overall, it is concluded that ethyl methyl carbonate also has shown no potential to damage DNA or induce mutation, and should be considered non-genotoxic.

Short description of key information:
Three key studies have been identified, adequately assessing the mutagenicity of ethyl methyl carbonate. These are in vitro mutagenicity assays:
- bacterial gene mutation (Ames test)
- chromosome aberration test with human lymphocytes
- comet assay conducted in cultured mammalian cells, using the close analogue dimethyl carbonate.
Thus the endpoints of localised (gene) mutation, larger-scale chromcome damage and non-specific DNA damage (strand breaks) have all been assessed. In all cases, negative results were obtained.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the mutagenicity studies, ethyl methyl carbonate is:

- Not classified in accordance with the criteria given in Regulation 1272/2008 (EU CLP GHS).

- Not classified in accordance with the criteria given in Directive 67/548/EEC (DSD).      

No classification for mutagenicity is applied to ethyl methyl carbonate in Annex VI of the CLP Regulation No. 1272/2008.