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Ethyl acetate [MAK Value Documentation, 2017]


Hartwig, A; MAK Commission; Arand, Michael; et al (2019). Ethyl acetate [MAK Value Documentation, 2017]. The MAK Collection for Occupational Health and Safety, 4(4):2027-2044.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the maximum concentration at the workplace (MAK value) of ethyl acetate [141‐78‐6] of 400 ml/m3, considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. The critical effect of ethyl acetate is irritation of eye and nose in humans and of the olfactory mucosa in rats; in addition, neurotoxic effects are observed in animals at high concentrations. In three studies with volunteers exposed to 400 ml ethyl acetate/m3, slight irritation in the nose, throat and eye were observed, however the physiological parameters blinking frequency and nasal resistance, both indicators of irritation were not affected. Overall, 400 ml ethyl acetate/m3 is not an unequivocal NOAEC. Accordingly, the MAK value has been lowered to 200 ml/m3. As local effects are critical, the assignment to Peak Limitation Category I and the excursion factor of 2 are confirmed. Taking into consideration the data for the metabolites acetic acid and ethanol, damage to the embryo and fetus is unlikely when the MAK value for ethyl acetate is observed. Therefore, ethyl acetate remains classified in Pregnancy Risk Group C. Ethyl acetate is not genotoxic and there are no carcinogenicity studies. Skin contact is not expected to contribute significantly to systemic toxicity. Skin sensitization is not expected from the limited data. There are no data concerning the potential for respiratory sensitization.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the maximum concentration at the workplace (MAK value) of ethyl acetate [141‐78‐6] of 400 ml/m3, considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. The critical effect of ethyl acetate is irritation of eye and nose in humans and of the olfactory mucosa in rats; in addition, neurotoxic effects are observed in animals at high concentrations. In three studies with volunteers exposed to 400 ml ethyl acetate/m3, slight irritation in the nose, throat and eye were observed, however the physiological parameters blinking frequency and nasal resistance, both indicators of irritation were not affected. Overall, 400 ml ethyl acetate/m3 is not an unequivocal NOAEC. Accordingly, the MAK value has been lowered to 200 ml/m3. As local effects are critical, the assignment to Peak Limitation Category I and the excursion factor of 2 are confirmed. Taking into consideration the data for the metabolites acetic acid and ethanol, damage to the embryo and fetus is unlikely when the MAK value for ethyl acetate is observed. Therefore, ethyl acetate remains classified in Pregnancy Risk Group C. Ethyl acetate is not genotoxic and there are no carcinogenicity studies. Skin contact is not expected to contribute significantly to systemic toxicity. Skin sensitization is not expected from the limited data. There are no data concerning the potential for respiratory sensitization.

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Item Type:Journal Article, not_refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Pharmacology and Toxicology
07 Faculty of Science > Institute of Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Language:German
Date:13 November 2019
Deposited On:04 Feb 2020 15:20
Last Modified:29 Jul 2020 12:26
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb14178e6319

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