Registration Dossier
Registration Dossier
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EC number: 213-382-0 | CAS number: 941-69-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD 405 but non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- N-phenylmaleimide
- EC Number:
- 213-382-0
- EC Name:
- N-phenylmaleimide
- Cas Number:
- 941-69-5
- Molecular formula:
- C10H7NO2
- IUPAC Name:
- 1-phenyl-2,5-dihydro-1H-pyrrole-2,5-dione
- Details on test material:
- Purity:>99.9%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 other: gram - Duration of treatment / exposure:
- 0.5 minute(s)
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h, 96 h, and 168 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: rinsed after (see exposure time)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 24 h
- Score:
- 57
- Max. score:
- 57
- Reversibility:
- not fully reversible within: 168 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 48 h after dosing
- Score:
- 58.3
- Max. score:
- 59
- Reversibility:
- not fully reversible within: 168 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 72 h
- Score:
- 57.7
- Max. score:
- 59
- Reversibility:
- not fully reversible within: 168 h
- Remarks on result:
- other: Unwashed group
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unwashed group
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0.44
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unwashed group
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 3.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unwashed group
- Irritant / corrosive response data:
- Total Scores Hours after dosing
1h 24h 48h 72h 96h 168h
Eye washed #1 12 57 57 57 55 55
#2 12 57 59 57 57 57
#3 12 57 59 59 59 57
Average 12.0 57.0 58.3 57.7 57.0 56.3
Eye non-washed #4 12 57 61 46 44 42
#5 12 44 44 44 40 40
#6 12 42 42 40 42 42
Average 12.0 47.7 49.0 43.3 42.0 41.3 - Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Eye Irritation test: serious eye damage when non eye-washing after exposure and moderately irritating when eye-washing after exposure
- Executive summary:
Eye Irritation test: serious eye damage when non eye-washing after exposure and moderately irritating when eye-washing after exposure
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