Oleylsarkosin
MAK-Begründung, Nachtrag
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 re‐evaluated the maximum concentration at the workplace (MAK value) of oleoyl sarcosine [110‐25‐8].
Critical effects are lung fibrosis and inflammation at the epiglottis in rats in a 28‐day study at an aerosol concentration of 6 mg/m3, the lowest concentration tested. A BMDL05 of 1.3 mg/m3 as surrogate for a NOAEC for fibrosis had been calculated. For inflammation at the epiglottis an NAEC of 2 mg/m3 was estimated. Taken together, a MAK value of 0.1 mg/m3 had been set. Since the NAEC for inflammation at the epiglottis is similar to the BMDL05 for lung toxicity, the MAK value had been established for the inhalable fraction (I). The MAK value is now lowered to 0.05 mg/m3 (I) considering the increased respiratory volume at the workplace (see List of MAK and BAT Values, chapters I b and I c).
Oleoyl sarcosine remains assigned to Peak Limitation Category II because the fibrosis is considered not to result from an immediate irritation. As the half‐life in the lung is not known, the default excursion factor of 2 is retained.
There are still no data on sensitization of the airways, no clinical evidence and only an equivocal result from a maximization test for skin sensitization.
