Diisotridecyl phthalate, ditridecyl phthalate
MAK Value Documentation – Translation of the German version from 2019
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 evaluated diisotridecyl phthalate (a mixture of various isomers) [27253‐26‐5] and ditridecyl phthalate [119‐06‐2] considering all toxicological endpoints. Available publications and unpublished study reports are described in detail. The critical effect is centrilobular hepatocyte hypertrophy following prolonged oral exposure of rats. There are signs of peroxisome proliferating activity which has also been observed with other phthalates like di(2‐ethylhexyl) phthalate. Diisotridecyl phthalate and ditridecyl phthalate are not genotoxic. No carcinogenicity study has been performed, but due to the similarity to di(2‐ethylhexyl) phthalate, liver carcinogenicity cannot be excluded. Therefore, diisotridecyl phthalate and ditridecyl phthalate are classified in Category 3B for suspected carcinogens.
Both phthalates cause at most minimal irritation to the eyes and skin of rabbits. As no inhalation study has been performed, possible long‐term effects on larynx and nasal goblet cells, the targets of other phthalates, cannot be evaluated. Therefore, no maximum concentration at the workplace (MAK value) can be derived.
Ditridecyl phthalate does not cause developmental toxicity in rats up to an oral dose of 100 mg/kg body weight and day, the highest dose tested. Skin contact is not expected to contribute significantly to systemic toxicity. Limited data show no sensitization.
