Registration Dossier
Registration Dossier
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EC number: 201-800-4 | CAS number: 88-12-0
Endpoint summary
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.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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