Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 433-480-9 | CAS number: 623-53-0
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
