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White mineral oil, pharmaceutical [MAK Value Documentation, 2015]


Hartwig, A; MAK Commission; et al; Arand, Michael (2017). White mineral oil, pharmaceutical [MAK Value Documentation, 2015]. The MAK Collection for Occupational Health and Safety, 2(3):1177-1191.

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.

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.

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Additional indexing

Item Type:Journal Article, not_refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Pharmacology and Toxicology
07 Faculty of Science > Institute of Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Language:English
Date:26 July 2017
Deposited On:17 Oct 2019 12:22
Last Modified:17 Oct 2019 12:23
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb804247kske5917

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