Registration Dossier
Registration Dossier
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EC number: 306-248-9 | CAS number: 96690-53-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, number 405 “Acute Eye
Irritation / Corrosion”, adopted April 24, 2002.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sunflower oil, ester with sorbitol
- EC Number:
- 306-248-9
- EC Name:
- Sunflower oil, ester with sorbitol
- Cas Number:
- 96690-53-8
- IUPAC Name:
- sunflower seed oil sorbitol esters
- Test material form:
- liquid
- Details on test material:
- Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single application into the left eye
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: observation in three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: observation in three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: observation in three animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: observation in three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Eye Irritation Scores |
||||||
Reading time |
Animal |
Opacity |
Iris |
Conjunctivae |
Sclera |
|
Redness |
Chemosis |
|||||
1h |
1 |
0 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
1 |
1 |
1 |
|
3 |
0 |
0 |
1 |
1 |
1 |
|
24 hours |
1 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritation property of the registration substance was investigated in rabbits according to the Guideline OECD 405. No significant effect was found.
- Executive summary:
The eye irritation property of the registration substance was investigated in rabbits according to the Guideline OECD 405. Three rabbits were treated by applying 0.1 ml of undiluted substance into left eyes. Redness of conjunctivae was observed immediately after treatment, which disappered within 48 hours. In addition, chemosis and sclera were observed immediately after treatment but were reversible within 24 hours. No significant eye irritating property was obtained for the registration substance.
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