Registration Dossier
Registration Dossier
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EC number: 472-170-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01/03/2006 - 02/05/2006
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Rabbit Enucleated Eye Test
- GLP compliance:
- not specified
Test material
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of undiluted substance was applied as evenly as possible oto the surface of the cornea.
- Duration of treatment / exposure:
- Application during 10 seconds. After that the cornea was washed off with a minimum of 20 ml of saline solution.
Immediately following washing, the treated eye was returned to the superfusion chamber. - Observation period (in vivo):
- Every hour up to 4 hours following the treatment.
- Number of animals or in vitro replicates:
- 3 eyes, 2 additional eyes remained untreated for control purposes.
- Details on study design:
- 0.1 ml of the test material was applied onto the cornea of each of the three enucleated eyes which had been maintained at a temperature of 32 °C +/- 1.5 within the superfusion chamber.
A further 2 enucleated eyes were treated, for control purposes, with saline solution (0.9% sodium chloride).
Results and discussion
Any other information on results incl. tables
Maximal ocular irritation observation for the test eyes were as follows:
Corneal irritancy: 1 X 3 = 3
Fluorescein Uptake: 3 X 2 = 6
Corneal Swelling: > 25%
Corneal Epithelium: Normal
The maximum fluorescein uptake and the corneal swelling are 2 endpoints exceeding the REET cutt-off values. As a consequence, the test material was considered to have the potential to cause severe ocular irritancy in vivo.
Corneal Opacity |
Fluorescein |
Corneal Swelling (%) |
Condition of |
|||||||
Test Eyes a |
Control Eyes b |
|||||||||
Cloudiness |
Area |
Intensity |
Area |
60 min |
120 min |
240 min |
60 min |
120 min |
240 min |
|
1 |
3 |
2 |
3 |
13.5 |
39.7 |
66.5 |
2.7 |
5.4 |
3.1 |
Normal |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The substance is considered to have the potential to cause severe ocular irritancy in vivo.
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