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Diethylene glycol monomethyl ether: MAK Value Documentation - 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.
Abstract:
The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for diethylene glycol monomethyl ether [111-77-3] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value) considering all toxi-cological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. Diethylene glycol monomethyl ether is not irri-tating to the skin or eyes of rabbits. At the maximum vapour concentration of 216 ml/m3, diethylene glycol monomethyl ether induced no effects in a 13-week inhalation study in rats. The NOAEC is therefore 216 ml/m3 or higher. Taking into account the longer half-life of its toxic metabolite methoxyacetic acid in humans compared to rats, a MAK value of 10 ml/m3 has been derived from this study. Peak Limitation Category II with an excursion factor of 8 have been assigned because of the critical systemic effect and the long half-life of methoxyacetic acid. Diethylene glycol monomethyl ether is not clastogenic or mutagenic in vitro. Studies investigating its genotoxic or carcinogenic potential in vivo are not available. However, there is no corresponding structural alert. The critical end point of diethylene glycol monomethyl ether is developmental toxicity observed in rats and rabbits independent of maternal toxicity. The malformations are thought to be caused by the metabolite methoxyacetic acid. As the margins between the derived NOAELs and the MAK value are not sufficiently large, diethylene glycol monomethyl ether has been assigned to Pregnancy Risk Group B. Based on an in vitro skin absorption study, percutaneous absorption is expected to contribute significantly to systemic toxicity and diethylene glycol monomethyl ether has been designated with an "H". A sensitizing potential is not expected based on the available data.
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