N‐Vinyl‐2‐pyrrolidone
MAK Value Documentation, addendum – Translation of the German version from 2018
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 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) and the Pregnancy Risk Group of N‐vinyl‐2‐pyrrolidone [88‐12‐0].
N‐Vinyl‐2‐pyrrolidone is a non‐genotoxic carcinogen in liver, nose and larynx of rats. In 28‐day inhalation studies it was shown that cell proliferation in liver and hyperplasia in the nasal epithelia of rats is increased at 0.5 ml/m3 with a NOAEC of 0.2 ml/m3. The former MAK value of 0.02 ml/m3 was derived from this concentration, the MAK value is now lowered to 0.01 ml/m3. This takes into account the increased respiratory volume at the workplace, because the blood:air partition coefficient of N‐vinyl‐2‐pyrrolidone is > 5 (see List of MAK and BAT Values, Sections I b and I c). Since a systemic effect is critical, Peak Limitation Category II is retained. As the critical metabolite is not known, the default excursion factor of 2 for systemically acting compounds is confirmed.
For rats, the NOAEC for developmental toxicity after inhalation is 5 ml N‐vinyl‐2‐pyrrolidone/m3, where reduced maternal body weight gain occurred. At 20 ml/m3 reduced foetal bodyweight and an increase of variations were observed. Taking into account the increased respiratory volume at the work place the NOAEC for developmental toxicity is 250 times higher than the MAK‐value. Therefore, N‐vinyl‐2‐pyrrolidone remains assigned to Pregnancy Risk Group C.
