Registration Dossier
Registration Dossier
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EC number: 201-800-4 | CAS number: 88-12-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraided or unabraided
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours. If distinct reading observed after 72 hours, a final reading is taken 7 days later.
- Number of animals:
- 6 abraded skin, 6 intact skin
- Details on study design:
- TEST SITE
- Area of exposure: 1 in. x 1 in.
- % coverage: not stated
- Type of wrap if used: surgical patch wrapped with impervious wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a
SCORING SYSTEM:
- Erythema: 0 - 4
- Edema: 0 - 4
- Total: 8 (4 + 4)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.8
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
Any other information on results incl. tables
Intact Skin |
||||
Rabbit No. |
24-hours |
72-hours |
||
Erythema |
Edema |
Erythema |
Edema |
|
6792 |
1 |
0 |
1 |
0 |
6793 |
1 |
0 |
1 |
0 |
6794 |
1 |
0 |
0 |
0 |
6795 |
1 |
0 |
1 |
0 |
6796 |
1 |
0 |
1 |
0 |
6797 |
1 |
0 |
1 |
0 |
Mean |
1 |
0 |
0.8 |
0 |
Abraded Skin |
||||
Rabbit No. |
24-hours |
72-hours |
||
Erythema |
Edema |
Erythema |
Edema |
|
6786 |
4 |
1 |
4 |
1 |
6787 |
4 |
2 |
4 |
1 |
6788 |
4 |
1 |
4 |
1 |
6789 |
4 |
1 |
4 |
1 |
6790 |
4 |
1 |
4 |
1 |
6791 |
4 |
1 |
4 |
0 |
Mean |
4 |
1.2 |
4 |
0.8 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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