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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
Endpoint summary
Administrative data
Description of key information
Oral LD50: 834 to 1314 mg/kg bw (male/female rat); 1022 mg/kg bw (male/female rat);
Dermal LD50: between 1043 and 4127 mg/kg bw (male/female rat) in a reliable study, less reliable study result: LD50=560 mg/kg bw (male/female rabbit); Inhalation LC50 = 3070 mg/m3 (male/female rat).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 022 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 3 070 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 350 mg/kg bw
Additional information
n-Vinylpyrrolidone (nVP) has been adequately characterized for acute toxicity via oral, dermal, and inhalation routes. In various non-GLP guideline-equivalent studies, oral LD50 values (male/femal rats) include 834 to 1314 mg/kg bw (European Commission, 2003) and 1022 mg/kg bw (BASF, 1963), dermal LD50 values (male/female rabbits) of >400 mg/kg bw (BASF, 1979) and > 1000 mg/kg bw (HRC, 1978), and the inhalation LC50 (male/female rats) was determined to be 3070 mg/m3 (BASF, 1979).
Justification for classification or non-classification
Acute oral toxicity
Based on a weight of the evidence of the results of acute oral toxicity testing (LD50, rat = 834 to 1314 mg/kg bw), the substance should be classified as Xn; R22 (Harmful if swallowed) under the EU DSD classification criteria (EU Directive 67/548/EEC) and Acute Toxicity, Oral-Category 4 under the EU CLP classification criteria (Regulation (EC) 1272/2008).
Acute inhalation toxicity
Based on the results of acute inhalation toxicity testing (LC50, rat = 3070 mg/m3), the substance should be classified as Xn; R20 (Harmful by inhalation) under the EU DSD classification criteria (EU Directive 67/548/EEC) and Acute Toxicity, Inhalation-Category 4 under the EU CLP classification criteria (Regulation (EC) 1272/2008).
Acute dermal toxicity
The study with rabbits (LD50 = 560 mg/kg bw; FDRL, 1975; cited in EU RAR) lacks important data on conditions of exposure and information on local skin effects or systemic toxicity. Consequently, this study was given reliability 4 (not assignable).
The BASF study with no mortality at 400 mg/kg bw does not provide for sufficient evidence for an LD50 > 1000 mg/kg bw. However, the third study with rats shows indeed that the LD50 is > 1000 mg/kg (2350 mg/kg) when both sexes are combined. Females appeared to be more sensitive with 50% mortality at 1000 mg/kg, but due to the low number per replicate (2) this remains equivocal. A higher sensitivity of female rats is also observed in the inhalation study (Key Study - BASF AG (1979) - Acute toxicity: inhalation, rat).
Based on a weight of evidence of the results of acute dermal toxicity testing (LD50, rabbit of 560 mg/kg-bw and LD50, rat of 1043 to 4127 mg/kg bw), the substance should be classified as Xn; R21 (Harmful in contact with skin) under the EU DSD classification criteria (EU Directive 67/548/EEC). Giving more weight to the two studies with an assignable reliability, CLP classification appears fall in Acute Toxicity, Dermal-Category 4 (EC Regulation 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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