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2-(Propyloxy)ethyl acetate: MAK Value Documentation, addendum - Translation of the German version from 2024
1Institute of Applied Biosciences, Department of Food Chemistry and Toxicology, Karlsruhe Institute of Technology (KIT) Adenauerring 20a, Building 50.41 76131 Karlsruhe Germany.
None:
The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) re-evaluated the occupational exposure limit value (maximum concentration at the workplace, MAK value) for 2-(propyloxy)ethyl acetate (2-propoxyethyl acetate) [20706-25-6] considering all toxicological end points. 2-(Propyloxy)ethyl acetate is a haemolytic and irritant glycol ether acetate. Relevant studies were identified from a literature search. The haemolytic activity of 2-(propyloxy)ethyl acetate in vivo and data from other glycol ether acetates suggest that it is probably metabolized to 2-(propyloxy)ethanol. The haemolytic activity of both compounds is mediated by the corresponding alkoxy acid; in vitro, it was lower in human erythrocytes than in rat erythrocytes. The critical effect identified in a subchronic study in rats was irritation. A NOAEC (no observed adverse effect concentration) was not obtained. The systemic NOAEC relevant for humans is 211 ml/m3. In analogy to 2-(propyloxy)ethanol, the MAK value of 2-(propyloxy)ethyl acetate has been lowered to 10 ml/m3. This exposure limit protects workers also against systemic toxicity. The substance remains assigned to Peak Limitation Category I with an excursion factor of 2. The Commission has re-evaluated a prenatal toxicity study in rats, deriving a NOAEC for developmental toxicity of 200 ml/m3. The margin between the NOAEC and the MAK value is sufficient even after considering the increased respiratory volume at the workplace. Therefore, damage to the embryo or foetus is unlikely if the MAK value is not exceeded and 2-(propyloxy)ethyl acetate remains assigned to Pregnancy Risk Group C. Studies investigating the genotoxic and carcinogenic potential are not available. Percutaneous absorption can contribute significantly to systemic toxicity and 2-(propyloxy)ethyl acetate remains designated with the "H" notation. In a screening study with guinea pigs, no evidence of a skin sensitizing potential was observed.
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