Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

N-Vinyl-2 -pyrrolidone has not been specifically examined for toxicity to reproduction but is not expected to be a specific hazard in this regard based on negative pathological reproductive organ findings observed in a 2 -year inhalation cancer study (BASF, 1992)

and a key guideline Developmental/teratogenicity study (BASF, 2001).

The substance is classified as a Catergory 2 carcinogen and, therefore, exposures should be prevented / minimized to as low a reasonably achievable.

Short description of key information:
N-Vinyl-2-pyrrolidone has not been specifically examined for toxicity to reproduction. The substance is classified as a Catergory 2 carcinogen. Exposures should be prevented / minimized to as low as reasonably achievable.

Effects on developmental toxicity

Description of key information
Not expected to be a developmental toxicant in the absence of maternal toxicity.
Additional information

In an OECD 414 Prenatal Development Toxicity study performed according to GLP guidelines (BASF AG, 2001), Wistar rats exposed daily by inhalation (whole body) for 6 hours per day for 20 days (exposure period from day 6 post coitum to day 19 pos coitum) to either 0, 1, 5 or 20 ppm, effects on fertility and fetal development were only present at doses that were clearly maternally toxic. The examinations revealed no difference in the sex distribution between treated and control groups. The placental weights were similar for all groups. In contrast, the mean body weight of the fetuses within the group treated with 20 ppm of test substance was significantly reduced below the control value and was considered to be substance-related. The fetuses showed neither external nor soft tissue malformations. Skeletal malformations were observed at low incidences in all groups including control, but the significantly higher rate of incomplete ossification of supraoccipital or hyoid bones and wavy ribs observed within the highest treated group clearly indicates a substance-dependency.

Justification for classification or non-classification

N-vinylpyrrolidone (NVP) should not be classified as a reproductive or developmental hazard under either the EU DSD classification criteria (Directive 67/548/EEC) or the EU CLP classification criteria (Regulation (EC) 1272/2008) on the basis of negative pathological reproductive organ findings observed in key chronic study (BASF, 1992) and a key guideline Developmental/teratogenicity study (BASF, 2001).