Registration Dossier
Registration Dossier
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EC number: 201-800-4 | CAS number: 88-12-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP, guideline-equivalent study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, et. al.
- GLP compliance:
- not specified
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 (Code no. 77/757)
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, untreated eye of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: n/a
SCORING SYSTEM: Draize and Kelley (1952)
-Cornea
Opacity: 0 - 4
Area Involved: 1 - 4
Total = (Opacity + Area) x 5
-Iris
Value: 0 - 2
Total = Value x 5
-Conjuntivae
Redness: 0 - 3
Chemosis: 0 - 4
Discharge: 0 - 3
Total = (Redness + Chemosis + Discharge) x 5
-Total = Cornea + Iris + Conjuntivae
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24 to 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 2, 4, and 6, individually
- Time point:
- other: 24 to 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 3 and 5, individually
- Time point:
- other: 24 to 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 thru 6, individually
- Time point:
- other: 24 to 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals 1, 2, 3, 5, and 6, individually
- Time point:
- other: 24 to 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 4
- Time point:
- other: 24 to 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1, 3, 4, and 5, individually
- Time point:
- other: 24 to 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24 to 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6
- Time point:
- other: 24 to 72 hours
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
Any other information on results incl. tables
Reading |
Animal |
Cornea |
Iris |
Conjunctiva Redness |
Conjunctiva Chemosis |
1 hour |
1/2/3/4/5/6 |
0/0/0/1/0/0 |
0/0/0/1/0/1 |
1/1/1/1/1/1 |
1/2/1/1/2/2 |
24 hours |
1/2/3/4/5/6 |
1/2/1/2/1/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/3/2/2/2/3 |
48 hours |
1/2/3/4/5/6 |
1/2/2/2/2/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/3/2/2/2/2 |
72 hours |
1/2/3/4/5/6 |
2/2/2/2/2/2 |
1/1/1/1/1/1 |
2/2/2/1/2/2 |
2/2/2/2/2/2 |
Mean, Each Animal |
1/2/3/4/5/6 |
1.3/2.0/1.7/2.0/1.7/2.0 |
1.0/1.0/1.0/1.0/1.0/1.0 |
2.0/2.0/2.0/1.7/2.0/2.0 |
2.0/2.7/2.0/2.0/2.0/2.3 |
Mean, all animals |
---- |
1.78 |
1.0 |
1.95 |
2.17 |
- Effects were not reversible in any animals after 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: Risk of serious damage to eyes (R41) / Category 1 (Irreversible effects on the eyes)
- Remarks:
- Criteria used for interpretation of results: EU
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