Registration Dossier

Administrative data

Description of key information

Skin: Not irritating
Eyes: May cause irreversible effects.
Respiratory: Irritating to respiratory system

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation / Corrosion

Skin irritation/corrosion of N-Vinyl-2-pyrrolidone (nVP) has been examined in 2 well documented and reliable non-GLP non-guideline studies. In a test conducted using Draize methodology, only slight erythema (individual scores of 1 out of a possible 4) was observed in each animal 24 and 72 hours after exposure of intact skin of six New Zealand White rabbits to 0.5 ml of undiluted test substance for 24-hours under occlusive dressing and there was no evidence of edema (BASF AG, 1978). These data are supported by an earlier study which showed only slight erythema (highest score of 1.67 out of possible 4 observed in 1 animal) after exposure to intact skin of eight Vienna White rabbits to 2.5 ml of undiluted test substance under occlusive wrap for 20 hours followed by an 8-day observation period (BASF AG, 1963). Edema was evident in only one animal, resulting in a score of 1.67 out of a possible 4. In addition, several animals died during the test and is presumed to be the result of treatment-related toxicity.

 

Eye Irritation / Corrosion

Eye irritation/corrosion of N-Vinyl-2-pyrrolidone (nVP) has been examined in 2 well documented and reliable non-GLP non-guideline studies. In a test conducted using Draize methodology, one eye of each of 6 New Zealand White rabbits was exposed to 0.1 ml of undiluted test substance and effects were scored at 1, 24, 48, and 72 hours (BASF AG, 1978). Mean scores for individual animals during the 24-72 hour time period were as follows: corneal opacity (2.0 out of a possible 4.0 for 3 of the 6 animals and 1.7 or less for the remaining 3 animals), iritis (1.0 out of a possible 2.0 for each of the 6 animals), conjunctivae redness (2.0 out of a possible 3.0 in 5 of the 6 animals and 1.7 in the remaining animal), conjunctivae chemosis (2.0 or greater out of a possible 4.0 in all 6 animals). There were no signs of reversibility during the 7 days following exposure. These data are supported by an earlier study where 0.05 ml of undiluted test substance was applied to one eye of each of 2 Vienna White Rabbits and effects scored at 1, 3, 24, 48 and 72 hours and 4, 7 and 9 days following treatment (BASF AG, 1963). Mean scores for individual animals during the 24-72 hour time period were as follows: corneal opacity (2.0 and 2.33 out of a possible 4.0), iritis (1.0 in both animals out of a possible 2.0), conjunctivae redness (1.0 in both animals out of a possible 3.0), and conjunctivae chemosis (0.00 and 0.33 out of a possible 4.0). Effects on the cornea and iris were not reversible.

Conclusion

Based on these results, nVP should be regarded as capable of causing serious irreversible damage to the eye but should not be regarded as a skin irritant.


Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin irritation

Based on the finding of no significant irritation in the key study (BASF AG, 1978), 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).

Eye irritation

Based on evidence of serious and irreversible eye damage in the key study (BASF AG, 1978), N-vinyl-2-pyrrolidone (NVP) should be classified as R41 (Risk of serious damage to eyes) under the EU DSD criteria (EU Directive 67/548/EEC) and assigned to Category 1 (Irreversible effects on the eye) under the EU CLP criteria (Regulation (EC) 1272/2008).

 

Respiratory irritation

Based on pathological observations of respiratory effects in the key study (lung with acute congestion hyperemia, partially edematic) in rats exposed to NVP (nose only, aerosol) at a concentrations up tp of 5.63 mg/L for 4-hours (BASF, 1979), NVP is classified as R37 (Irritating to respiratory system under the EU DSD criteria (EU Directive 67/548/EEC) and Specific Target Organ Toxicity - Single Exposure (STOT-SE), Category 3 (Transient target organ effects) under the EU CLP criteria (Regulation (EC) 1272/2008).