2-Methoxyethanol, 2-methoxyethyl acetate, methoxyacetic acid, diethylene glycol dimethyl ether, diethylene glycol monomethyl ether – Addendum: evaluation of a pregnancy risk group for the BAT values with the parameter methoxyacetic acid
Assessment Values in Biological Material – Translation of the German version from 2024
Sandra Michaelsen1Rüdiger Bartsch1
Britta Brinkmann1
Gerlinde Schriever-Schwemmer1
Hans Drexler2 (Head of the working group “Assessment Values in Biological Material” of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft)
Andrea Hartwig1 (Chair of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft)
MAK Commission3
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 Friedrich-Alexander-Universität Erlangen-Nürnberg, Institute and Outpatient Clinic of Occupational, Social, and Environmental Medicine, Henkestraße 9–11, 91054 Erlangen, Germany
3 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 Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for prenatal toxicity and derived a methoxyacetic acid concentration in urine at which damage to the embryo or foetus is unlikely (“prerequisite for Pregnancy Risk Group C”) for 2-methoxyethanol [109-86-4], 2-methoxyethyl acetate [110-49-6], methoxyacetic acid [625-45-6], diethylene glycol dimethyl ether [111-96-6], and diethylene glycol monomethyl ether [111-77-3]. These substances are classified in Pregnancy Risk Group B because adhering to the biological tolerance value (BAT value) of 15 mg methoxyacetic acid/g creatinine cannot exclude a risk to the developing foetus. This classification was based on embryo-/foetotoxic and teratogenic effects in rats, mice, rabbits and monkeys. The effects are caused by methoxyacetic acid, the metabolite of all substances. From the lowest NOAEC (no observed adverse effect concentration) for developmental toxicity in rabbits of 3 ml 2-methoxyethanol/m3, a concentration of 0.15 ml 2-methoxyethanol/m3 at the workplace was derived for which damage to the embryo or foetus is unlikely. This external concentration corresponds to a urine concentration of 2.5 mg methoxyacetic acid/g creatinine. Therefore, an internal exposure not higher than this concentration would be the prerequisite for an assignment to Pregnancy Risk Group C.
