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EC number: 218-787-6 | CAS number: 2235-00-9
- 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
The test item is not irritating to skin but irritating to eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 2.16 kg
ENVIRONMENTAL CONDITIONS
not reported - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: unchanged (melted by 34°C), ca. 1 mL
- Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cmx2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing: no - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: scaling, not reversible within 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: scaling, not reversible within 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: scaling, not reversible within 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: scaling, not reversible within 8 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. One drop of the test substance was applied to the conjunctival sac of one eye of 2 animals. The NaCl-treated adjacent eye served as a control.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 2.29 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The NaCl-treated adjacent eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): one drop undiluted
(melted by 34°C), which is equivalent to ca. 50 µL - Duration of treatment / exposure:
- Treatment was once. The eye was left unwashed.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Descriptive scores of the raw data have been converted to Draize numerical scores.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Skin irritation was tested using an internal standard method (BASF test). The study meets scientific standards with acceptable restrictions (limited documentation). Two white rabbits were treated for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the undiluted test substance. The test substance induced slight erythema after 20 h occlusive exposure in 1/2 animals, which was reversible within 6 d. No oedema was present, however slight scaling was noted from 24 h onwards which was not reversible within 8 days. Mean scores were 0.35 for erythema and 0 for edama. Thus, the test item is not considered skin irritating.
According to this result, Cosumser Product Testing applied 0.5 g of the test substance to the skin of New Zealand white rabbits for 24 to abraded as well as intact skin and measured erytheme and edema 24 and 72 h post-application (occlusive conditions). An overall irritation score of 0.23 was noted, indicating that the substance is not irritating to the skin.
Eye irritation:
Eye irritation was tested using an internal method (BASF test). The study meets scientific standards with acceptable restrictions (limited documentation, application amount not defined). One drop of the test substance was applied to the conjunctival sac of one eye of 2 rabbits. Reversible corneal opacity, conjunctivae redness and chemosis were observed. Mean scores were 2 for cornea, 0 for iris, 3 for conjunctivae and 0.65 for chemosis. Thus the test item is irritating to eye.
Furthermore, Consumer Product testing evaluated the potential of the test item to induce eye irritation. Therefore, 100 mg of the test substance was instilled in the right eye of New zealand White rabbits (6 rabbits in total); the left untreated eye served as control. Treated eyes of all rabbits remained unwashed for 24 h. Readings were taken 1, 2, 3 and 7 days post-application. The total irritation score (mean, 24, 48, 72 h all animals) was 17.4; in two animals, corneal opacity was still visible after 7 days. Ths, the test article is moderately irritating.
Justification for selection of skin irritation / corrosion endpoint:
The Key study was selected (study with acceptable restrictions).
Justification for selection of eye irritation endpoint:
The Key study was selected (study with acceptable restrictions).
Effects on eye irritation: irritating
Justification for classification or non-classification
Classification for skin irritation is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.
N-Vinylcaprolactam is considered as irritating to eye (EU: R36 and GHS: Cat. 2, H319) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 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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