Fatty acids, C_14–18 saturated and C_16–18 unsaturated

MAK Value Documentation – Translation of the German version from 2023

  Andrea Hartwig¹ (Chair of the Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft)
  MAK Commission<sup>2

1</sup> 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 Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for fatty acids, C_14–18 saturated and C_16–18 unsaturated [67701-06-8] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value), considering all toxicological end points. Relevant studies were identified from a literature search. 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, C_14–18 saturated and C_16–18 unsaturated, that can be used to derive a MAK value. No data are available for the irritation potential of the 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, C_14–18 saturated and C_16–18 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, C_14–18 saturated and C_16–18 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, C_14–18 saturated and C_16–18 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.

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