Fettsäuren, C14–18-gesättigt und C16–18-ungesättigt
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 Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated fatty acids, C14–18 saturated and C16–18 unsaturated [67701-06-8], considering all toxicological end points. It is a UVCB substance (substances of Unknown or Variable composition, Complex reaction products or Biological materials). There are no data for humans or from repeated dose studies in animals for fatty acids, C14–18 saturated and C16–18 unsaturated, that can be used to derive a maximum concentration at the workplace (MAK value). No data are available for the irritation potential of the UVCB substance. The systemic oral NOAEL of behenic acid (C22), a structurally similar fatty acid, was found to be 1000 mg/kg body weight and day in a study carried out in rats according to OECD Test Guideline 422. The fatty acids, C14–18 saturated and C16–18 unsaturated, are non-ionic surfactants; therefore, effects on the pulmonary surfactant are likely to occur. A MAK value cannot be established because no data for inhalation toxicity are available. In vitro studies of the fatty acids, C14–18 saturated and C16–18 unsaturated, or acids of similar length and similar degree of unsaturation showed no genotoxic potential. No in vivo genotoxicity studies and no carcinogenicity studies have been carried out with the fatty acids, C14–18 saturated and C16–18 unsaturated. Limited studies of fatty acids of similar length and similar degree of saturation did not find effects of developmental toxicity. A sensitizing potential is not expected based on the available data. The substance does not penetrate the skin in toxicologically relevant amounts.
