Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
Absoprtion: expected to be rapid by oral and inhalation routes, slow by the dermal route
Distribution: primarily liver, kidney, and small intestine (including contents) in rats and dogs
Excretion/Elimination: rapid primarily in urine and feces in rats and dogs
Clearance from plasma: expected to be rapid
Protein binding: low in the rat and dog
Short description of key information on absorption rate:
Dermal Absorption Rate (Estimated): 0.067 mg/cm2-hr.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Based on available information in SD rats and Beagle dogs, N-Vinyl-2-pyrrolidone (nVP) is expected to be rapidly absorbed following inhalation and oral exposures, and slowly following dermal exposures; is expected to distribute primarily to the liver, kidneys, and small intestine (including contents); and is expected to be excreted primarily in urine and eliminated as feces. The major metabolites have not been reliably determined.

Discussion on bioaccumulation potential result:

The absorption, disposition, and metabolism of radiolabelled 1-ethenyl-2-pyrrolidinone (N-vinyl-2-pyrrolidinone; NVP) has been studied in a series of experiments in male Sprague-Dawley rats and female beagle dogs (McClanahan, et. al., 1987; McClanahan, et. al., 1983; Digenis, G.A. et. al., 1982; Digenis, G.A. et. al., 1990; and BASF AG, 1992).  From these experiments, it can be concluded that NVP is rapidly absorbed by the oral and inhalation routes and slowly by the dermal route; is distributed primarily to the liver, kidneys and small intestine (including its contents); and is excreted primarily in urine and eliminated via feces. In addition, clearance from plasma following single i.v. injections was determined to follow a biphasic/biexponential pattern in rats with a half-life of 3.8 hours and a monophasic/monoexponential pattern in dogs with a half-life of 0.3 hours. Based on urine analysis by radiomonitored reversed phase HPLC, the two major metabolites, accounting for 50% and 33% of both the 3H- and 14C-excreted activity, could not be identified but eluted at 14.0 and 52.5 min, respectively. Minor metabolites were, however, believed to include N-acetyl-gamma-amino butyric acid, 2-pyrrolidinone, and N-vinyl succinimide. Finally, NVP shows low protein binding in the rat and the dog.

Discussion on absorption rate:

Using U.S. EPA DERMWIN v1.43a, the dermal absorption rate of n-Vinylpyrrolidone (nVP) is estimated to be 0.067 mg/cm2 -hr, which equates to a permeation coefficient (Kp) of 0.000769 cm/hr (ISP, 2010). No measured data, of sufficient reliability, are available. However, the clinical observations made during acute toxicity studies via the dermal route (BASF, 1979) and measurement of low levels (near analytical detection) of nVP in blood (Beagle dods) following dermal administration (BASF, 1992) suggest that nVP can be absorbed through the skin and partition to blood though much more slowly than by inhalation and oral routes.