Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No detailed information upon Guideline followed. No GLP. Sufficient documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit was not treated with the test substance and served as a control.
- Amount / concentration applied:
- 0,01 g
- Duration of treatment / exposure:
- 1 dose was administered into the right eye of each rabbit. After 20 seconds the eyes of one rabbit were washed with water. The eyes of the other rabbit remained unchanged.
- Observation period (in vivo):
- 3 d
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 and 2
- Time point:
- other: 1 H - 3 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1 and 2
- Time point:
- other: 1 H - 3d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 and 2
- Time point:
- other: 1 H - 3d
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
The test substance produced no irritation in either the treated washed eye or in the eye washed after treatment. Fluorescein stain examinations were negative for corneal injury in the treated eyes of both rabbits. No clinical signs were observed, and no biologically important body weight loss occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, H-25285 was not an eye irritant. According to EU guidelines H-25285 probably should not be classified as irritant unless additional testing proves otherwise.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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