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EC number: 908-381-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD Guideline n° 405 and in compliance with UK GLP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of the test material
- Duration of treatment / exposure:
- the test material was not removed
- Observation period (in vivo):
- 1, 24, 48, 72 hours and after 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 16.3
- Max. score:
- 17
- Reversibility:
- fully reversible
- Remarks:
- All treated eyes appeared normal at the 7-day observation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 15.7
- Max. score:
- 29
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 9.7
- Max. score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 7.7
- Max. score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to Commission Directive 93/21/EEC.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance should not be classified for eye irritation/corrosion using the criteria of Directive 67/548/EEC (DSD) or the criteria of Regulation No 1272/2008 (CLP).
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