White mineral oil, pharmaceutical
MAK Value Documentation, addendum – Translation of the German version from 2018
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) and the Pregnancy Risk Group of pharmaceutical white mineral oil [8042‐47‐5].
Critical effect is lung toxicity which is observed as microgranulomas in two long‐term studies with rats and dogs at a respirable aerosol concentration of 100 mg/m3 with a NOAEC of 5 mg/m3. A MAK value of 5 mg/m3 had been set as the respirable fraction (R). This value is now reaffirmed even considering the increased respiratory volume at the workplace (see List of MAK and BAT Values, Sections I b and I c).
Pharmaceutical white mineral oil had been classified in Pregnancy Risk Group C because the NOAEC for developmental toxicity is 1000 mg/m3 in rats. There is no new data on developmental toxicity. This classification is retained even considering the increased respiratory volume at the workplace.
