Registration Dossier
Registration Dossier
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EC number: 253-087-4 | CAS number: 36528-28-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Dec - 21 Dec 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : only basic data given, lack of details on test substance
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-ethylhexyl laurate
- EC Number:
- 243-697-9
- EC Name:
- 2-ethylhexyl laurate
- Cas Number:
- 20292-08-4
- Molecular formula:
- C20H40O2
- IUPAC Name:
- 2-ethylhexyl laurate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- At the 1-hour reading time point slight to well-defined conjunctivae (score 1-2) was noted in 3/3 animals, which persisted as slight conjunctivae (score 1) until 24 h after installation. The eye irritation effects had cleared completely within 48 h. All the scores for both rabbits were 0 for corneal and iridial effects. No scoring was performed for chemosis.
Any other information on results incl. tables
Table 1: Results of eye irritation test
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
1 / m |
1 |
0 |
0 |
1 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
2 / m |
1 |
0 |
0 |
2 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
3 / m |
1 |
0 |
0 |
2 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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