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EC number: 220-250-6 | CAS number: 2687-91-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- other: Amendment
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-ethylpyrrolidin-2-one
- EC Number:
- 220-250-6
- EC Name:
- 1-ethylpyrrolidin-2-one
- Cas Number:
- 2687-91-4
- Molecular formula:
- C6H11NO
- IUPAC Name:
- 1-ethylpyrrolidin-2-one
- Details on test material:
- purity: 99.8 corr. area-%
pH-value: ca. 7 (undiluted test substance)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. Deviations from these specifications that would have had an adverse effect on the test results did not occur. Illumination period was 12 h light (6.00 a.m. - 6 .00 p.m.) and 12 h darkness (6.00 p.m. - 6.00 a.m. Stainless steel wire mesh cages with grating were used; the animals were housed singly. The diet was Kliba Labordiät and water was available ad libitum. Acclimatization period was at least 5 days before the beginning of the study.
Before the beginning of application both eyes were investigated for signs of pre-existing irritation. Only animals with intact cornea and conjunctiva were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single ocular application
- Observation period (in vivo):
- The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 28.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- About 24 hours after application the eye was rinsed with tap water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: within 28 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- within 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 14 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.9
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 14 d
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
||||
1 h |
01 |
0 |
0 |
0 |
3 |
3 |
3 |
49 |
02 |
0 |
0 |
0 |
2 |
3 |
3 |
49 |
|
03 |
0 |
0 |
0 |
2 |
3 |
3 |
49 |
|
24 h |
01 |
1 |
2 |
0 |
2 |
1 |
1 |
PC, 48 |
02 |
1 |
4 |
1 |
3 |
2 |
2 |
PC, DB, 49 |
|
03 |
1 |
4 |
1 |
3 |
3 |
2 |
PC, DB, 49 |
|
48 h |
01 |
1 |
1 |
0 |
2 |
1 |
1 |
PC, 48 |
02 |
1 |
4 |
1 |
3 |
2 |
2 |
PC, DB, 48 |
|
03 |
1 |
4 |
1 |
3 |
3 |
1 |
PC, DB, 49 |
|
72 h |
01 |
1 |
1 |
0 |
2 |
1 |
0 |
PC, 48 |
02 |
2 |
4 |
0 |
3 |
2 |
1 |
PC, DB, 48 |
|
03 |
2 |
4 |
1 |
3 |
2 |
1 |
PC, DB, 49 |
|
7 d |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
SD |
02 |
1 |
3 |
0 |
1 |
0 |
0 |
PC, 48 |
|
03 |
2 |
1 |
0 |
2 |
2 |
1 |
S, PC, 44, 49 |
|
14 d |
02 |
1 |
1 |
0 |
0 |
0 |
0 |
44, 48 |
03 |
1 |
1 |
0 |
0 |
0 |
0 |
44, 48 |
|
21 d |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
SD |
03 |
1 |
1 |
0 |
0 |
0 |
0 |
45, 48 |
|
28 d |
03 |
1 |
1 |
0 |
0 |
0 |
0 |
45, 48 |
Mean |
01 |
1.0 |
|
0.0 |
2.0 |
1.0 |
|
|
02 |
1.3 |
|
0.7 |
3.0 |
2.0 |
|
|
|
03 |
1.3 |
|
1.0 |
3.0 |
2.7 |
|
|
|
Mean |
|
1.2 |
|
0.6 |
2.7 |
1.9 |
|
|
Explanation of findings:
S = Suppuration
PC = Pupil contracted
DB = Discharge of blood
SD = Study discontinued because the animal was free of findings
44 = Vascularization of the cornea, circumscribed area, marginal
45 = Vascularization of the cornea, circumscribed area, into the central part
48 = Scleral vessels injected, circumscribed area
49 = Scleral vessels injected, circular
Applicant's summary and conclusion
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, N-Ethyl-2-pyrrolidon shows a severe eye irritation potential under the test conditions chosen.
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