Priority Existing Chemical Assessment Reports -

1-Vinyl-2-pyrrolidine

 

1. Chemical Identity

1.1. Chemical name (IUPAC)

• 1-vinyl-2-pyrrolidone

1.2. Registry numbers

NVP is listed on the Australian Inventory of Chemical Substances (AICS).

• CAS number 88-20-1

• EINECS number 201-800-4

1.3. Other names

• 1-Ethenylpyrrolidin-2-one

• 1-Vinyl-2-pyrrolidinone

• 1-Vinyl-2-pyrrolidone

• 2-Pyrrolidinone, 1-ethenyl-

• 2-Pyrrolidinone, 1-vinyl-

• N-Vinyl-2-pyrrolidinone

• N-Vinyl-2-pyrrolidone

• N-Vinylpyrrolidinone

• N-Vinylpyrrolidone

• Vinylbutyrolactam

• Vinylpyrrolidon

• Vinylpyrrolidone

• 1-Ethenyl-2-pyrrolidone

• Vinyl butylolactam

• V-Pyrol

1.4. Trade names

• V-Pyrol

• 1-Vinyl-2-pyrrolidinone

2. Applicants

BASF Australia Ltd
PO Box 84ALTONA
VIC 3018

Bio-Scientific Pty Ltd
PO Box 78GYMEA
NSW 2227

Crown Scientific Pty Ltd
144 Moorebank Ave
MOOREBANK
NSW 2170

ISP (Australasia) Pty Ltd
PO Box 6564
SILVERWATER
NSW 2128

3M Australia Pty Ltd
PO Box 144
St MARYS
NSW 2760

Sigma Aldrich Pty Ltd
PO Box 970
CASTLE HILL
NSW 2154

3. N-vinyl-2-pyrrolidone Overview

N-vinyl-2-pyrroloidone (NVP) was declared a PEC on 7th April 1998 due to the potential for high occupational and environmental exposure and potential adverse health effects such as severe eye irritation and in particular, possible carcinogenic effects.

In Australia, NVP is mainly used in manufacturing of ultraviolet (UV) curing inks and paper coating products. Small amounts of NVP are also used in laboratories for research purposes. A NVP containing polymer, polyvinyl pyrrolidone (PVP) is used widely in industries such as cosmetics, pharmaceuticals, and agricultural formulations.

Occupational and environmental exposures may occur from any of the above uses and also during transportation and disposal. Exposure to the general public may occur from use of PVP products.

Adverse health effects following short-term or prolonged exposure to NVP in humans have not been reported.

NVP exhibits acute toxicity by oral, dermal and inhalational routes in animals. Liquid NVP has been shown to cause severe eye irritation in animals. Signs of respiratory tract irritation were observed in a range of animal species following a single exposure to NVP aerosol and repeated inhalation of NVP vapour.

The target organs after repeated inhalational exposure to NVP in animal studies were the liver and nasal cavity. Liver effects included enlarged hepatocytes with clear cell areas, degenerative changes of the nucleus, centrilobular necrobiosis, fatty infiltration, cellular proliferation, cirrhosis-like metaplasia and glycogen accumulation within centrilobular hepatocytes in the liver. Cell hyperplasia and inflammatory changes in the olfactory and respiratory epithelia in the nasal cavity were observed. A no observed adverse effect level (NOAEL) of 1 ppm (1mg/kg) has been identified in a 3 month study in rats. However, it is not certain whether the NOAEL is applicable to longer or lifetime exposures as there are indications that at 5 ppm (5 mg/kg), the lowest observed adverse effect level (LOAEL), hepatotoxicity takes longer than 3 months to develop in rats. Administration of NVP by the oral route results in damage only to the liver and the dose required to produce histopathological changes is much higher than that required by inhalation. A NOAEL of 3.6 mg/kg has been identified in a drinking water study in rats. There are no data relating to the effects of repeated dermal exposure to NVP.

Carcinogenicity studies in rats by the inhalation route indicate the principal tumour sites are the liver, nasal cavity and larynx. A NOAEL could not be identified from these studies as tumours occurred at 5 ppm (5 mg/kg) which was the lowest dose tested. NVP is not a mutagen and the exact mechanism of tumour formation in animals is not known.

Currently NVP is not listed on the National Occupational Health and Safety Commission (ASCC) List of Designated Hazardous Substances (ASCC, 1999b).

The occupational risk assessment concluded that a risk of acute eye effects is likely during formulation of NVP products due to accidental contact with liquid NVP. In the absence of monitoring data for workers involved in formulation of NVP products and use of UV curing inks containing NVP, estimates for NVP exposure were obtained using modelling. Results from this modelling indicate that the atmospheric levels of NVP likely during these operations are of concern.

Environmental risk assessment indicates that NVP does not cause adverse effects on the aquatic compartment. Adverse effects on aquatic organisms or on microbial activity during formulation or end use of NVP is not likely in Australia.

The public health risk assessment concluded that laboratory use of NVP in small quantities and industrial use in UV curing inks and paper coating are not considered to present a significant hazard to public health. The highest consumer exposure is likely to be associated with cosmetics containing PVP with high levels of NVP (more than 200 ppm). It is therefore prudent to limit the allowable contamination of PVP to 200 ppm NVP, in order to provide an adequate margin of exposure for the general public using such products.

Based on the assessment of health effects and in accordance with the ASCC Approved Criteria for Classifying Workplace Hazardous Substances (ASCC, 1999a), it is recommended that NVP be classified as 'Harmful by inhalation, in contact with skin and if swallowed' [risk phrase (R) 20/21/22], 'Irritating to respiratory system' (R37), 'Possible risk of irreversible effects, Carcinogen Category 3' (R40), 'Risk of serious damage to eyes' (R41), 'Harmful: danger of serious damage to health by prolonged exposure through inhalation' (R48/20).

Suppliers of NVP and products containing NVP for workplace uses should review their MSDS and labels in accordance with ASCC requirements. It is recommended that employers implement specific workplace control measures for uses identified in Australia where necessary. In addition, atmospheric monitoring should be conducted, in conjunction with engineering controls, to ensure that the levels of NVP are low, as a safe level has not been identified.

In the absence of analytical data on the level of NVP in cosmetic products and reliable dermal absorption data, it is recommended that the Department of Health and Age Care establish a maximum level of 200 ppm NVP present in PVP for cosmetic use.

It is recommended that the final PEC report on NVP be forwarded to relevant authorities for consideration of the public health impact of NVP in pharmaceuticals, food and agricultural formulations respectively.