N′‐(3‐Aminopropyl)‐N′‐dodecylpropan‐1,3‐diamin
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 N‐(3‐aminopropyl)‐N‐dodecylpropane‐1,3‐diamine [2372‐82‐9] to derive a maximum concentration at the workplace (MAK value), considering all toxicity endpoints. Available unpublished study reports and publications are described in detail. Critical effects are degeneration of heart muscle cells and lympho‐histiocytic infiltrations in the skeletal muscles of male rats. No NOAEL could be derived for these effects. The LOAEL is 4 mg/kg body weight. A NAEL of 1.3 mg/kg body weight was extrapolated and a MAK value of 0.05 mg/m3 for the inhalable fraction could be derived. The derivation of the MAK value is conservative because the determined oral absorption is very low and for the inhalative absorption a default value of 100 % is assumed due to a lack of experimental data. N‐(3‐Aminopropyl)‐N‐dodecylpropane‐1,3‐diamine is basic and therefore corrosive to rabbit skin, hence an irritation potential for the respiratory tract has to be assumed. No inhalation studies are available. Compared to several primary, secondary and tertiary amines which have MAK values between 1 and 13 mg/m3, the basicity of N‐(3‐aminopropyl)‐N‐dodecylpropane‐1,3‐diamine is almost the same or less. Therefore, a MAK value of 0.05 mg/m3 should protect against local irritating effects. As the critical effect is systemic, the substance has been classified in Peak Limitation Category II. An excursion factor of 8 is set as the half‐life in blood is at least 28.5 hours. The NOAELs for developmental toxicity in rats and rabbits are 22.5 and 9 mg/kg body weight and day, respectively, which can be scaled to concentrations of 1 and 0.66 mg/m3 at the workplace. Thus, there is no reason to fear damage to the embryo or foetus when the MAK value is observed and the substance is classified in Pregnancy Risk Group C. N‐(3‐Aminopropyl)‐N‐dodecylpropane‐1,3‐diamine is not genotoxic or carcinogenic. The potential of contact sensitization in humans cannot be definitely assessed because of the corrosive character. The substance is not a contact sensitizer in guinea pigs. Skin contact is not expected to contribute significantly to systemic toxicity
