White mineral oil, pharmaceutical
MAK Value Documentation – Translation of the German version from 2015
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, Geb. 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 evaluated pharmaceutical white mineral oil which is a grade of white mineral oil [8042‐47‐5] considering all toxicological endpoints. Available publications are described in detail. In addition to studies with white mineral oils, studies with other highly refined mineral oils are used. 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 has been set as the respirable fraction (R). Since the critical effect is a long‐term effect on the lung, Peak Limitation Category II is designated, with an excursion factor of 4. The NOAEC and the oral NOAEL for developmental toxicity of white mineral oil in rats are 1000 mg/m3 and 5000 mg/kg body weight, respectively. The differences between the MAK value and the NOAEC and that of the oral NOAEL scaled to a concentration at the work place are sufficiently large, so that damage to the embryo or foetus is unlikely when the MAK value is not exceeded. Pharmaceutical white mineral oil is therefore classified in Pregnancy Risk Group C. Highly refined mineral oils are neither genotoxic nor carcinogenic. Skin contact is not expected to contribute significantly to systemic toxicity. Numerous studies where purified mineral oil and petrolatum are used as a vehicle show no sensitization in humans and animals. The same is expected for pharmaceutical white mineral oil.
