Ethylenoxid
MAK-Begründung, Nachtrag
Andrea Hartwig1MAK 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 Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated ethylene oxide [75‐21‐8] considering all toxicological endpoints.
Ethylene oxide is an alkylating agent that is mutagenic and carcinogenic in animals. A number of epidemiological studies have indicated a carcinogenic potential, but others showed no excess cancer risk upon exposure to ethylene oxide. Re‐evaluation has shown that a maximum concentration at the workplace (MAK value) cannot be derived. Accordingly, ethylene oxide remains classified in Carcinogen Category 2.
Nevertheless, the Commission has derived an excess risk of lymphoid tumours for both men and women. Forty‐year exposure to 0.1 ml/m3 ethylene oxide at the workplace thus results in a risk of 1.4 or 4 per 100 000.
Ethylene oxide is a mutagen in vitro and in vivo and a known germ cell mutagen. Accordingly, it remains classified in Germ Cell Mutagen Category 2. Ethylene oxide can be taken up via the skin in toxicologically relevant amounts. Therefore, the designation “H” is retained. The published reports do not indicate a relevant potential for sensitization of skin and airways in humans.
