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EC number: 229-390-2 | CAS number: 6505-30-2
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
- EC Number:
- 229-390-2
- EC Name:
- Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
- Cas Number:
- 6505-30-2
- Molecular formula:
- C43H48N3O6S2.Na
- IUPAC Name:
- hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
Constituent 1
- Specific details on test material used for the study:
- Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- White New Zealand rabbits (3-4 kg) of both sexes, individual housing.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 7 days (eyes were not washed).
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals
- Details on study design:
- A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours), conjunctiva score was 2 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.
Based on the conjunctiva score of 2 (24, 48 and 72 hours) a classification as Category 2 (irritating to eyes) based on GHS criteria is justified. - Executive summary:
A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days. Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.
Based on the conjunctiva score of 2 (24, 48 and 72 hours) a classification as Category 2 (irritating to eyes) based on GHS criteria is justified.
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