Benzophenon-3
MAK-Begründung
Andrea Hartwig1 (Vorsitz der Ständigen Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Deutsche Forschungsgemeinschaft)MAK Commission2
1 Institut für Angewandte Biowissenschaften, Abteilung Lebensmittelchemie und Toxikologie, Karlsruher Institut für Technologie (KIT), Adenauerring 20a, Geb. 50.41, 76131 Karlsruhe, Deutschland
2 Ständige Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe, Deutsche Forschungsgemeinschaft, Kennedyallee 40, 53175 Bonn, Deutschland
Abstract
The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for benzophenone-3 [131-57-7] considering all toxicological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. Benzophenone-3 is not genotoxic. A carcinogenicity study in mice was negative. A special carcinogenicity study was carried out in which rats were exposed in utero beginning on gestation day 6 with continuous exposure of the F1 animals for up to 2 years. Male rats developed meningiomas without statistical significance: in the brain one at the low dose, three at the middle dose and one in the spine at the middle dose. The mid dose animals belonged to two different litters. The mechanism underlying the formation of meningiomas has not been identified, nor is it known whether benzophenone-3 plays any role in this process. As it is unclear whether the in-utero exposure triggered the development of meningiomas in rats, benzophenone-3 has been classified in Category 3 for carcinogens. A MAK value cannot be derived. The data for developmental toxicity and endocrine disruption do not indicate that there is a risk for the unborn child. Benzophenone-3 yielded positive results for hormonal activity in different in vitro assays. By contrast, negative results were obtained for benzophenone-3 in several in vivo studies, such as six uterotrophic assays in rats and mice that tested doses up to 1000 mg/kg body weight (bw) and day for 3 or 4 days. However, one uterotrophic assay yielded positive results in rats at 1525 mg/kg bw and day exposed for 4 days. In a one-generation study in rats, benzophenone-3 did not exhibit estrogenic, androgenic or antiandrogenic activity up to 2700 mg/kg bw and day. Benzophenone-3 has therefore been evaluated as a weak endocrine disruptor at high doses. Benzophenone-3 can provoke contact allergic reactions in humans and has therefore been designated with “Sh”. Light may increase the severity of the contact allergic reactions and may result also in photocontact allergic reactions. Benzophenone-3 penetrates the skin in toxicologically relevant amounts and has therefore been designated with “H”.
