Registration Dossier
Registration Dossier
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EC number: 291-445-1 | CAS number: 90411-68-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited data
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hexanoic acid, 2-ethyl-, C16-18-alkyl esters
- EC Number:
- 291-445-1
- EC Name:
- Hexanoic acid, 2-ethyl-, C16-18-alkyl esters
- Cas Number:
- 90411-68-0
- Molecular formula:
- from C24H48O2 to C26H52O2
- IUPAC Name:
- Hexanoic acid, 2-ethyl, C16-18 alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: not reported
- Lot/batch No.: 2403 L
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- other: the untreated eye served as control
- Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
Any other information on results incl. tables
Results:
|
|
Cornea |
Iris |
Conjunctiva |
|||
Reading time |
Animal No. |
Opacity |
Area of opacity |
Redness |
Chemosis |
Discharge |
|
1 h |
6599 |
0 |
0 |
1 |
2 |
0 |
2 |
6600 |
0 |
0 |
0 |
2 |
1 |
2 |
|
6601 |
0 |
0 |
1 |
2 |
1 |
2 |
|
24 h |
6599 |
0 |
0 |
0 |
1 |
0 |
0 |
6600 |
0 |
0 |
0 |
1 |
0 |
0 |
|
6601 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
6599 |
0 |
0 |
0 |
1 |
0 |
0 |
6600 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6601 |
0 |
0 |
0 |
1 |
0 |
0 |
|
72 h |
6599 |
0 |
0 |
0 |
1 |
0 |
0 |
6600 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6601 |
0 |
0 |
0 |
0 |
0 |
|
|
mean 24-48-72 h |
6599 |
0.0 |
0.0 |
0.0 |
1.0 |
0.0 |
0.0 |
6600 |
0.0 |
0.0 |
0.0 |
0.3 |
0.0 |
0.0 |
|
6601 |
0.0 |
0.0 |
0.0 |
0.7 |
0.0 |
0.0 |
|
mean |
0.0 |
0.0 |
0.0 |
0.7 |
0.0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- CLP: not classified
DSD: not classified
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