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EC number: 203-815-1 | CAS number: 110-91-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03. Jan 1967 - 11. Jan 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- BASF-Test, see details in remarks on material and methods.
- GLP compliance:
- no
Test material
- Reference substance name:
- Morpholine
- EC Number:
- 203-815-1
- EC Name:
- Morpholine
- Cas Number:
- 110-91-8
- Molecular formula:
- C4H9NO
- IUPAC Name:
- morpholine
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.82 and 2.97 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as saline control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
Any other information on results incl. tables
Findings animal1/animal2 (50 µL):
| Time | Opacity | Iritis | Erythema | Chemosis |
| 1h | 1/1 | 0/0 | 2/2 | 2/2 |
| 24h | 1/1 | 0/0 | 2/2 | 0/0 |
| 48h | 1/1 | 0/0 | 1/2 | 0/0 |
| 72h | 2/1 | 0/0 | 1/2 | 0/0 |
| 8d | 2/0 | 0/0 | 1/3 | 0/0 |
Mean values over 24 h, 48 h and 72 h:
Animal1: Opacity: 1.3; Chemosis: 0; Erythema: 1.3; Iritis: 0
Animal2: Opacity: 1; Chemosis: 0; Erythema: 2; Iritis: 0
The application of 50 µL test substance caused initially chemosis and moderate opacity and erythema. The corneal opacity and erythema effects were not reversible within the 8 day observation period. One animal developed ingrowing vessels at the end of the observation period.
Findings animal1/animal2 (100 µL):
| Time | Opacity | Iritis | Erythema | Chemosis |
| 1h | 1/1 | 0/0 | 2/2 | 2/2 |
| 24h | 2/2 | 0/0 | 2/2 | 2/2 |
| 48h | 2/2 | 2/2 | 2/2 | 2/2 |
| 72h | 2/2 | 2/2 | 2/2 | 2/2 |
| 8d | 3/3 | 2/2 | 2/2 | 2/2 |
Mean values over 24 h, 48 h and 72 h:
Animal1: Opacity: 2; Chemosis: 2; Erythema: 2; Iritis: 1.3
Animal2: Opacity: 2; Chemosis: 2; Erythema: 2; Iritis: 1.3
The applicaton of 100 µL test substance caused moderate to severe corneal opacity, erythema and chemosis. After 48 hours iritis and after 6 days staphyloma was noted. The effects were not reversible within the 8 day observation period Severe corneal opacity and iritis are considered to be irreversible effects to ophthalmic tissue.
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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