2025/06/29 by Hartwig, Andrea, MAK Commission
#571.95 Toxicology #571.95 Toxikologie #616.9803 Betriebs- und Arbeitsmedizin #616.9803 Industrial and occupational medicine #Ameisensäureethylester #Analogiebetrachtung #Auge #Ethyl formate #Ethylformiat #Formic acid ethyl ester #Hautresorption #Luft #MAK value #MAK-Wert #Nase #Reizwirkung #Spitzenbegrenzung #air #ethyl formiate #eye #irritation #maximale Arbeitsplatzkonzentration #maximum workplace concentration #nose #peak limitation #read across #skin absorption
paper · doi:10.34865/mb10994d10_2ad
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.