Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

n-Vinylpyrrolidone (nVP) is not expected to cause skin or respiratory sensitisation. In an OECD 406 guideline study (Buehler test) performed according to GLP, no skin reactions were observed in any of the 20 test animals or the 10 control animals (BASF, 1996). In addition, nVP does not significantly bind to proteins (Digenis, G.A., 1990). These data are supported further by the absence of findings suggestive of a severe respiratory sensitising potential following inhalation exposures in a 2 -year inhalation study with rats (BASF, 1992).


Migrated from Short description of key information:
not sensitising

Justification for classification or non-classification

Sensitisation

Based on an OECD 406 guideline study (Buehler test) performed according to GLP, no skin reactions were observed in any of the 20 test animals or the 10 control animals (BASF, 1996). In addition, nVP does not significantly bind to proteins (Digenis, G.A., 1990). These data are supported further by the absence of findings suggestive of a severe respiratory sensitising potential following inhalation exposures in a 2 -year inhalation study with rats (BASF, 1992). Therefore,

N-vinyl-2-pyrrolidone (NVP) should not be classified under the EU DSD criteria (EU Directive 67/548/EEC) nor under the EU CLP criteria (Regulation (EC) 1272/2008) for sensitisation.