Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

n-Vinylpyrrolidone (nVP) has not produced genotoxic, mutagenic, or clastogenic activity in any of the various in vivo and in vitro GLP guideline and reliable non-guideline studies that have been performed.

The the following in vitro studies with nVP produced negative results:

- Ames test with or without activation (S9 mix) in the strains TA1535, TA98 or TA100 (BASF, 1978)

- Ames test with or without activation (S9 mix) in the strains TA 1535, TA 1537, TA 98 and TA 100 (HRC, 1978)

- TK locus tests in L5178Y mouse lymphoma cells with and without metabolic activation (GAF, 1980)

- Cell transformation test without S9 mix (BALB/3T3 mouse cells) (GAF, 1980)

- Unscheduled DNA Synthesis test in rat hepatocytes (GAF, 1980)

- Chromosome Aberration test in human lymphocyte cultures (with and without S9 mix) (BASF, 1987)

The following in vivo studies with nVP also produced negative results:

A mouse micronucleus assay (male/female NMRI mice) following a single oral administration of 150, 300, or 600 mg/kg bw (nominal) doses (BASF, 1993). Under the conditions of the study the test substance did not increase the number of micronuclei and Erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was not inhibited. Thus, there was neither a clastogenic effect nor any impairment of chromosome distribution.

 

A study of DNA binding in rat liver after i.p. injection of single doses of 150 or 300 mg/kg body weight with liver tissue biopsy after 1 and 5 hours and doses on 5 consecutive days with liver biopsy 1 hour after the last injection (BASF, 1986). In preliminary experiments the test substances appeared to be strongly associated with the rat liver DNA fractions, especially after 5 days of dosing. But upon further purification of the DNA samples, the highly purified DNA showed no association of the test substances or their metabolites. There was evidence of other major binding molecules such as glycogen.


Short description of key information:
Not genotoxic, mutagenic, or clastogenic in vitro or in vivo.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

n-Vinylpyrrolidone (nVP) should not be classified as mutagenic 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 results in all in vivo and in vitro GLP guideline and reliable non-guideline studies that have been performed.