Registration Dossier
Registration Dossier
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EC number: 203-142-3 | CAS number: 103-76-4
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (only 50 µL of the test substance were used and the observation period was 8 days)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-piperazin-1-ylethanol
- EC Number:
- 203-142-3
- EC Name:
- 2-piperazin-1-ylethanol
- Cas Number:
- 103-76-4
- Molecular formula:
- C6H14N2O
- IUPAC Name:
- 2-piperazin-1-ylethanol
- 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: 3.28 and 3.24 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as saline-control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL undiluted test ietm - Duration of treatment / exposure:
- Single application, eyes were not washed out.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. The report describes findings after 1 and 24 hours and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
Findings: animal1/animal2
| Time | opacity | iritis | erythema | chemosis |
| 1 h | 3/3 | 2/2 | 2/2 | 1/2 |
| 24 h | 3/3 | 2/2 | 2/2 | 1/1 |
| 48 h | 3/3 | 2/2 | 2/2 | 1/1 |
| 72 h | 3/3 | 2/2 | 2/2 | 1/1 |
| 8 d | 3/3 | 2/2 | 2/2 | 0/0 |
The original BASF grading was converted into the numerical grading according the OECD Draize system.
Mean values over 24, 48, and 72 h
Animal 1: Erythema: 2 ; Opacity: 3; Chemosis: 1; Iritis: 2
Animal 2: Erythema: 2 ; Opacity: 3; Chemosis: 1; Iritis: 2
Additional observations: discharge with blood, staphyloma, marginal vascularization of the cornea, small retraction in the eyelid.
Severe corneal opacity and staphyloma formation are regarded as irreversible damage to ophthalmic tissue.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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