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EC number: 203-311-1 | CAS number: 105-58-8
Diethyl carbonate was tested negative in an Ames test with Salmonella typhimurium strains TA 100, TA 1535, TA 1537 and TA 98, with and without metabolic activation, at doses up to 6666 ug/plate.
Concerning genotoxicity, the database for diethyl carbonate (DEC) is limited as only one negative Ames test with S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 is available. Therefore, data for dimethyl carbonate (DMC) are taken into further consideration (read across). The two compounds differ with regard to the length of their ester side chain. DEC contains two ethyl and DMC contains two methyl groups. Structural similarity can be calculated by using different models/algorithms and will then result in a percentage of similarity. Using the mathematical model “Yule” from the OECD toolbox (v 2.3) a structural similarity of 88.89% is calculated (15 out of 28 possible atom pairs match to DEC, 4 out of 6 topological torsions and 4 out of 8 atom centred fragments). Although the calculated value has only an indicative character, it confirms the high structural similarity of both compounds.
In a Comet assay with L 929 mice fibroblasts, dimethyl carbonate gave no indications for a DNA damage at concentrations of up to 150 mg/mL.
In an in vivo cytogenetic test for detection of chromosome aberrations in spermatogonial mitoses (study design comparable to OECD Guideline 483), male mice were dosed once orally with 0, 0.99, 1.99 or 3.97 g/kg bw of dimethyl carbonate. The results of this study gave no indications for an increase in chromosome aberrations.
Also the main metabolite ethanol gave no indications for a genotoxic/mutagenic potential. In the OECD SIDS for Ethanol (http://www.inchem.org/documents/sids/sids/64175.pdf) it was stated:
“The balance of evidence is that ethanol is not genotoxic. Negative results from a number of bacterial mutation assays appear to be reliable. Of the mammalian cell mutation assays a weak mutagenic effect in mouse lymphoma cells occurred only at very high ethanol concentrations. In vivo tests for chromosome aberrations in both rats and Chinese hamsters have given negative results. There is very little evidence to suggest that ethanol is genotoxic in somatic cells and it may have a very limited capacity to induce genetic changes in vivo but under very specific circumstances and at very high doses achievable in humans only by deliberate oral ingestion.”
Although the database concerning genotoxicity/mutagenicity for diethyl carbonate is limited, the read across with data from dimethyl carbonate (high structural similarity of both compounds) and also from the main metabolite ethanol is not indicating a significant genotoxic/mutagenic potential for diethyl carbonate. Therefore, no classification according to EU and GHS criteria is required.
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