Registration Dossier
Registration Dossier
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EC number: 944-574-9 | 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: Pre-GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Hazardous Substances Labeling Act
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Six rabbits were used in this study, 0.1g of the test material was instilled into the right eyes of the animals, the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1,2 and 3 days following instillation.
- GLP compliance:
- no
- Remarks:
- Prior to GLP
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No details on test animals and environment provided
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Days 1, 2, 3
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Illustrated Guide for Grading Eye Irritation by Hazardous Substances
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, & 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effect observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effect observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: No effect observed
- Irritant / corrosive response data:
- No effects shown
- Other effects:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not an irritant to the eyes of rabbit under the conditions of the study. The test item is not classifiable under CLP.
- Executive summary:
Introduction
The study was performed in accordance with the US Federal Hazardous Substances Labelling Act.
Method
A volume of 0.1g of the test item was placed into one eye of six rabbits. The eyes were left unwashed and observations were perfomed on day 1 and then daily for a period of 3 days. Assessment of ocular damage/irritation was made according to the Illustrated gide for Grading Eye Irritation by Hazardous Substances
Results
A single application of the test item to the non-irrigated eye of six rabbits produced no effects.
Conclusion
The test material is not an irritant in the eye of rabbits. The test item is not classifiable under CLP.
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