Fatty alcohol ethoxylates, C16–18 and C18 unsaturated
MAK Value Documentation – Translation of the German version from 2022
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 Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) summarized and evaluated the data for fatty alcohol ethoxylates, C16–18 and C18 unsaturated [68920-66-1] 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 Relevant studies were identified from a literature search and also unpublished study reports were used. It is a UVCB substance (substances of Unknown or Variable composition, Complex reaction products or Biological materials). There are no human data or inhalation studies in animals performed with fatty alcohol ethoxylates, C16–18 and C18 unsaturated to derive a maximum concentration at the workplace (MAK value). A fatty alcohol ethoxylate, C16–18 and C18 unsaturated with < 2.5 ethoxylate units, is not irritating to skin or eyes of rabbits, but C16–18 and C18 unsaturated with 10 ethoxylate units is irritating in the forestomach of rats in a 13-week gavage study at 500 mg/kg body weight and day. The systemic NOAEL for this substance is 100 mg/kg body weight and day. Fatty alcohol ethoxylates are non-ionic surfactants, therefore an effect on the pulmonary surfactant can be assumed after inhalation. As no data on inhalation toxicity are available, a MAK value cannot be established. In vitro and in vivo studies with alcohol ethoxylates of similar length and similar grade of unsaturation showed no genotoxic potential. Data with similar fatty alcohol ethoxylates do not point to a carcinogenic potential for fatty alcohol ethoxylates, C16–18 and C18 unsaturated. Investigations with alcohol ethoxylates of similar length and similar degree of saturation do not show an effect on developmental toxicity. Fatty alcohol ethoxylates, C16–18 and C18 unsaturated are not sensitizing to the skin; investigations on airway sensitization are lacking. The substance does not penetrate the skin in toxicologically relevant amounts.
