Ethylene glycol dinitrate
MAK Value Documentation, addendum – Translation of the German version from 2017
Andrea Hartwig1 (Chair of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft)MAK Commission2
1 Institute of Applied Biosciences, Department of Food Chemistry and Toxicology, Karlsruhe Institute of Technology (KIT), Adenauerring 20a, Building 50.41, 76131 Karlsruhe, Germany
2 Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft, Kennedyallee 40, 53175 Bonn, Germany
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 ethylene glycol dinitrate [628‐96‐6] of 0.05 ml/m3, considering all toxicity endpoints. A detailed description of the underlying studies is given.
The critical effect in volunteers after a 25‐minute exposure to 0.05 ml/m3 of a mixture of ethylene glycol dinitrate and nitroglycerin was vasodilation, as indicated by the development of headaches or decreases in blood pressure. The effects were very slight. In occupational situations it is very difficult to assess the levels of exposure to ethylene glycol dinitrate that induce symptoms and effects, not only because exposure is usually to mixtures of organic nitrate esters, but also because of both respiratory tract and skin absorption of ethylene glycol dinitrate vapours. In workers, headaches were reported at nitroglycerin concentrations of 0.03 to 0.11 ml/m3 with a NOAEC below 0.01 ml/m3 nitroglycerin. Based on this data, the MAK value for nitroglycerin was established at 0.01 ml/m3. Because of the same mode of action and the similar LOAEC of the two substances, the MAK value for ethylene glycol dinitrate has been lowered to 0.01 ml/m3. The MAK value also applies to the sum of the concentrations of the two substances in the air. As systemic effects are critical, the assignment to Peak Limitation Category I and the excursion factor of 1, due to the short half‐life, are retained. Although there are no studies on developmental toxicity, ethylene glycol dinitrate is assigned to Pregnancy Risk Group C in analogy to nitroglycerin. No data are available for genotoxicity or carcinogenicity. Skin contact may contribute significantly to systemic toxicity and ethylene glycol dinitrate continues to be designated with an “H”. Sensitization is not expected from the limited data.
