2024/09/29 by Hartwig, Andrea, MAK Commission
#571.95 Toxicology #571.95 Toxikologie #616.9803 Betriebs- und Arbeitsmedizin #616.9803 Industrial and occupational medicine #Atemtrakt #C14–18 gesättigte und C16–18 ungesättigte Alkylcarboxylsäuren #C14–18 saturated and C16–18 unsaturated #C14–18 saturated and C16–18 unsaturated alkylcarboxylic acids #C14–18-gesättigt und C16–18-ungesättigt #Fatty acids #Fettsäuren #Luft #Reizwirkung #UVCB Substanz #UVCB substance #air #irritation #nicht ionisches Tensid #non-ionic surfactant #respiratory tract
paper · doi:10.34865/mb6770106e9_3or
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, C14–18 saturated and C16–18 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, C14–18 saturated and C16–18 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, 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.