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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
- Reference Type:
- publication
- Title:
- Long-term Inhalation Toxicity of N-Vinylpyrrolidone-2 Vapours. Studies in Rats
- Author:
- Klimisch, et. al.
- Year:
- 1 997
- Bibliographic source:
- Food and Chemical Toxicology, Volume 35, Issues 10-11, October-November 1997, Pages 1041-1060
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1-vinyl-2-pyrrolidone
- EC Number:
- 201-800-4
- EC Name:
- 1-vinyl-2-pyrrolidone
- Cas Number:
- 88-12-0
- Molecular formula:
- C6H9NO
- IUPAC Name:
- 1-ethenylpyrrolidin-2-one
- Details on test material:
- - Name of test material (as cited in study report): N-Vinylpyrrolidone-2 (NVP)
- Physical state: liquid, colorless to yellowish
- Analytical purity: 99.8%
- Storage condition of test material: room temperature (protected from light)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld
- Weight at study initiation: mean weight of about 28 g
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: for the duration of about one week the animals were housed in groups of 5 separately according to sex; before the start or the treatment the animals were transferred and housed individually under the same conditions until the end of the test
- Diet: standardized pelleted feed (Kliba diet, Klingentalmühle AG, Switzerland) ; assayed for chemical and microbiological contaminants
- Water: ad libitum; assayed for chemical contaminants
- Acclimation period: about one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: all test substance formulations were prepared immediately before administration
- Duration of treatment / exposure:
- 24 hrs (additionally: 16 and 48 hrs in the 600 mg/kg bw N-Vinylpyrrolidone-2 treatment)
- Frequency of treatment:
- single administration (10 ml/kg bw)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
150, 300, 600 mg/kg bw (15, 30, 60 mg/ml)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
16.1, 33.2, 57.7 mg/ml
Basis:
analytical conc.
- No. of animals per sex per dose:
- 5 (negative control, N-Vinylpyrrolidone-2)
positive controls: cyclophosphamide (2 male, 3 female), vincristine (3 male, 2 female) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide, vincristine
- Justification for choice of positive control(s): cyclophosphamide: positive control for clastogenicity; vincristine positive control for spindle poison effects
- Route of administration: cyclophosphamide: orally; vincristine: intraperitoneal
- Doses / concentrations: cyclophosphamide: 20 mg/kg bw, vincristine: 0.15 mg/kg bw
Examinations
- Tissues and cell types examined:
- 1000 polychromatic erythrocytes were evaluated per animal and investigated for micronuclei. The normocytes with and without micronuclei occuring per 1000 polychromatic erythrocytes were also registered.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
In a pretest for the determination of the acute oral toxicity one death each was still observed down to doses of 681 mg/kg bw and 562 mg/kg body weight; therefore a dose of 600 mg/kg bw was selected as the highest dose in the present cytogenetic study; 300 and 150 mg/kg bw were administered as further doses.
- Statistics:
- a statistical evaluation was not necessary to perform
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Clinical examinations:
The administration of the vehicle was tolerated by all animals without any signs or symptoms.
The administration of N-vinylpyrrolidone-2 led to the following clinical signs:
600 mg/kg bw group: irregular respiration, piloerection and squatting posture were found about 15 minutes after treatment. Some of these signs were still observed two days after treatment and the general state of the animals was poor.
300/150 mg/kg bw group: irregular respiration and piloerection were found about 15 minutes after treatment; squatting posture was additionally observed after one hour. Some of these signs were still observed the day after treatment.
Both positive controls did not cause any evident signs of toxicity.
Substance |
Dose (mg/kg) |
Sex |
post exposure period (h) |
PCE with micronuclei |
NCE with micronuclei |
Ratio PCE/NCE |
vehicle |
solvent |
male |
24 |
2.80 |
0.6 |
4.67 |
female |
24 |
1.60 |
1.0 |
1.60 |
||
test substance |
150 |
male |
24 |
2.60 |
1.0 |
2.60 |
female |
24 |
0.80 |
1.0 |
0.80 |
||
test substance |
300 |
male |
24 |
1.60 |
0.6 |
2.67 |
female |
24 |
1.40 |
0.6 |
2.33 |
||
test substance |
600 |
male |
16 |
1.00 |
1.0 |
1.00 |
female |
16 |
2.80 |
1.2 |
2.33 |
||
test substance |
600 |
male |
24 |
3.20 |
0.8 |
4.00 |
female |
24 |
1.80 |
1.2 |
1.50 |
||
test substance |
600 |
male |
48 |
1.60 |
0.0 |
|
female |
48 |
1.80 |
0.6 |
3.00 |
||
positive ctrl |
20 |
male |
24 |
14.50 |
0.5 |
29.00 |
female |
24 |
11.77 |
0.7 |
17.57 |
||
positive ctrl |
0,15 |
male |
24 |
129.67 |
2.0 |
64.84 |
female |
24 |
112.50 |
2.0 |
56.25 |
||
PCE = polychromatic erythrocytes (1000 were scored for micronuclei) |
||||||
NCE = normochromatic erythrocytes |
||||||
The PCE/NCE ratio is based on the scoring of 1000 erythrocytes |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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