Di(2‐propylheptyl) phthalate
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 di(2‐propylheptyl) phthalate [ 53306‐54‐0] considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. Critical effect is the peroxisome proliferating activity in the liver which has also been observed with other phthalates. Di(2‐propylheptyl) phthalate is less potent as a peroxisome proliferator than the structurally very similar di(2‐ethylhexyl) phthalate, which is a rat liver carcinogen. No carcinogenicity study has been performed on di(2‐propylheptyl) phthalate but due to the similarity to di(2‐ethylhexyl) phthalate, liver carcinogenicity cannot be excluded. Therefore, di(2‐propylheptyl) phthalate is classified in Category 3B for suspected carcinogens. Di(2‐propylheptyl) phthalate is not genotoxic in vitro; in vivo data are missing. Only a 5‐day inhalation study has been performed. Possible long‐term effects on larynx, trachea or goblet cell hyperplasia which are target organs of di(2‐propylheptyl) phthalate and of other phthalates cannot be evaluated based on this study. No maximum concentration at the workplace (MAK value) can be derived. Di(2‐propylheptyl) phthalate shows no developmental toxicity in rats up to an oral dose of 1000 mg/kg body weight and day which is toxic to the dams. Skin contact is not expected to contribute significantly to systemic toxicity. Limited data show no sensitization.
