Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD GUIDELINE 405 (1987) EEC Directive 84/449 (1984) - Annex V - method B5 EPA n° 798.4500 (1990) MAFF n° 4200 (1985)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Score:
- 0.56
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Score:
- 0.22
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Score:
- 0.06
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Score:
- 0.33
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
Any other information on results incl. tables
Reversibility of any observed effect: Changes fully reversible within 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was found to be not irritating to eye under the condition of the test.
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