Ethylformiat
MAK-Begründung, Nachtrag
Andrea Hartwig1 (Vorsitz der Ständigen Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Deutsche Forschungsgemeinschaft)MAK Commission2
1 Institut für Angewandte Biowissenschaften, Abteilung Lebensmittelchemie und Toxikologie, Karlsruher Institut für Technologie (KIT), Adenauerring 20a, Geb. 50.41, 76131 Karlsruhe, Deutschland
2 Ständige Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Deutsche Forschungsgemeinschaft, Kennedyallee 40, 53175 Bonn, Deutschland
Abstract
The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and re-evaluated the data for ethyl formate [109-94-4] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value) considering all toxicological end points. Relevant studies were identified from a literature search. The critical effects of ethyl formate are irritation of the eyes and nose in humans and irritation of the olfactory mucosa in rats; neurotoxic effects were observed in animals at higher concentrations. Based on the lowest observed adverse effect concentration (LOAEC) of 330 ml/m3 for irritation in a study with volunteers, a NAEC was extrapolated and the previous MAK value of 100 ml/m3 has been retained. This concentration provides protection also against neurotoxic effects. The MAK value of ethyl formate is thus higher than that of its metabolite formic acid (5 ml/m3), which is consistent with the analogous situation of ethyl acetate (MAK value 200 ml/m3) and acetic acid (MAK value 10 ml/m3). The assignment to Peak Limitation Category I with an excursion factor of 1 has been retained. Taking into consideration the data for the metabolites formic acid and ethanol, damage to the embryo or foetus is unlikely if the MAK value of ethyl formate is observed. Ethyl formate is not mutagenic in bacteria or yeasts. No other genotoxicity or carcinogenicity studies are available, but the structure of ethyl formate does not give reason to expect these types of effects. Ethyl formate remains designated with “H” for substances which can be taken up via the skin in toxicologically relevant amounts. There is no structural alert for sensitization.



