Registration Dossier
Registration Dossier
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EC number: 204-354-9 | CAS number: 119-84-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Coumarin
- EC Number:
- 202-086-7
- EC Name:
- Coumarin
- Cas Number:
- 91-64-5
- Molecular formula:
- C9H6O2
- IUPAC Name:
- 2H-chromen-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six New Zealand White rabbits weighing between 1 and 2 Kg and aged 7-9 weeks,in good general health,are used for testing each material. Only one eye of each rabbit is used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 50mg of powder as supplied.
- Observation period (in vivo):
- 5d
- Number of animals or in vitro replicates:
- six
- Details on study design:
- Test substances are applied to one eye of each of six rabbits by gently pulling the lower lid away from the eye ball and placing 50mg in the sac so formed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritant / corrosive response data:
- Coumarin caused slight conjunctivitis in four animals. Two animals healed within 48 hours of treatment, two by day 4. Two animals were unaffected 24 hours after treatment.
Any other information on results incl. tables
Coumarin caused slight conjunctivitis in four animals. Two animals healed within 48 hours of treatment, two by day 4. Two animals were unaffected 24 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, Coumarin(50mg) is not eye irritant.
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