Registration Dossier
Registration Dossier
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EC number: 203-057-1 | CAS number: 102-81-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented report which meets basic scientific principles.
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)
- Deviations:
- yes
- Remarks:
- (BASF test, 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-dibutylaminoethanol
- EC Number:
- 203-057-1
- EC Name:
- 2-dibutylaminoethanol
- Cas Number:
- 102-81-8
- Molecular formula:
- C10H23NO
- IUPAC Name:
- 2-(dibutylamino)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Dibutylaethanolamin
- Analytical purity: >99%
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: 2.96, 2.91 kg
No further data.
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 - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.35
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days in one of the two animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.65
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h -72 h
- Score:
- 1.65
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h -72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days in one of the two animals
Any other information on results incl. tables
Findings: animal 1/ animal 2
Time |
corneal opacity |
erythema |
chemosis |
iritis |
1 h |
1/1 |
2/2 |
2/2 |
0/0 |
24 h |
1/1 |
3/3 |
2/2 |
0/0 |
48 h |
2/1 |
3/2 |
2/1 |
0/0 |
72 h |
2/1 |
3/2 |
2/1 |
1/1 |
8 d |
3/0 |
3/1 |
0/0 |
2/0 |
| mean | 1.7/1 | 3/2.3 | 2/1.3 | 0.3/0.3 |
Mean values over 24, 48 and 72 h.
Bleedings of the mucous membrane were observed in both animals at the 24 and 48 h readings.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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