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EC number: 201-800-4 | CAS number: 88-12-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
N-vinylpyrrolidone (NVP) is currently classified according to EU DSD criteria (EU Directive 67/548/EEC) as R40: Limited evidence of a carcinogenic effect, Carc. Cat. 3 and under the EU CLP criteria (Regulation (EC) 1272/2008) as Carc. 2. These classifications are supported by the key study (BASF, 1992) which clearly shows that NVP (with 3 ppm Kerobit as stabilizer) is carcinogenic in rats, causing hepatocellular carcinomas, nasal adenomas and adenocarcinomas and squamous cell carcinomas in the larynx. Furthermore, 3 haemangiosarcomas in liver were noted in 3 animals of the top dose.
Additional information
BASF (1992) reported a two-year inhalation study (whole-body exposure). Male and female Sprague-Dawley rats were offered vapour concentrations of 5, 10 or 20 ppm for 6 hours per working day. The following results were obtained:
No treatment-related mortality occurred.
Neoplastic changes first became evident after 12 months. No animals in this group died prematurely. Although no macroscopic changes could be detected at this time, microscopic examinations revealed the presence of a hepatocellular adenoma in one top dose male and adenomas of the nasal cavity in one low dose male and one male and female from the top dose group. These adenomas arose from the respiratory epithelium or from the submucosal glands in the anterior part of the nasal cavity. Metaplasia of respiratory epithelium into squamous epithelium was also seen at this time in rats from the top dose group.
In rats exposed for 18 months and allowed a 6 month recovery period, macroscopical masses in the liver of 2 low dose males and one male and two females from the high dose group. Microscopically, hepatocellular carcinomas were found in 3 male and 2 females and in the nasal cavity, adenomas were seen in one mid dose group male and 2 males and 2 females from the high dose group. Findings occurred both in animals surviving until study termination and in those dying prematurely. A total of 141 males and 106 females survived until the end of the study (24 months). The incidence of macroscopically detectable masses in the liver was clearly dose-related. In males, masses could be seen in 23 animals and in females, masses were visible in 36 animals. Masses were also evident in the nasal cavities of 1 male in the 10 ppm group and 2 males and 2 females in the 20 ppm group. Most macroscopically visible masses in the liver were identified microscopically as hepatocellular carcinomas. In males the incidence of microscopically detectable hepatocellular carcinoma was 29 and in females 36. The following table shows the tumor incidences:
NVP concentration (ppm) | Sex | 0 | 5 | 10 | 20 |
No. of animals/group | 70 | 60 | 60 | 60 | |
Liver: liver cell carcinoma | male | 1 | 6 | 5 | 17 |
female | 1 | 3 | 6 | 26 | |
Nasal cavity: adenoma | male | 8 | 9 | 10 | |
female | 2 | 8 | 12 | ||
Nasal cavity: adenocarcinoma | male | 4 | 6 | ||
female | 4 | ||||
Larynx: squamous cell carcinoma | male | 4 | |||
female | 4 |
This study clearly shows that NVP (with 3 ppm Kerobit as stabilizer) is carcinogenic in rats, causing hepatocellular carcinomas, nasal adenomas and adenocarcinomas and squamous cell carcinomas in the larynx. Furthermore, 3 haemangiosarcomas in liver were noted in 3 animals of the top dose. It was not possible to identify a NOAEL from this study, increased tumour incidences being produced at 5 ppm, the lowest dose used.
Klimisch et al. (Food and Chemical Toxicology 35, 1997) reported about the long-term inhalation toxicity of N-Vinylpyrrolidone-2 vapours. Female Sprague-Dawley rats were offered a vapour concentration of 45 ppm for 6 hours per day and 5 days per week over a study period of 3 months. The animals were killed at 3 or 12 and 24 months post-exposure. The effect of NVP on body weight evident at 3 months disappeared before 1 year, but effects on liver pathology persisted throughout the subsequent 21-month exposure-free period, and a few liver tumours were seen at 2 years.
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