Registration Dossier
Registration Dossier
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EC number: 700-097-6 | CAS number: 847565-09-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2008
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 substance name:
- (1R,2S,5R)-5-methyl-2-(propan-2-yl)-N-[2-(pyridin-2-yl)ethyl]cyclohexanecarboxamide
- EC Number:
- 700-097-6
- Cas Number:
- 847565-09-7
- Molecular formula:
- C18H28N2O
- IUPAC Name:
- (1R,2S,5R)-5-methyl-2-(propan-2-yl)-N-[2-(pyridin-2-yl)ethyl]cyclohexanecarboxamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- The test substance was instilled in the right eye of each rabbit
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 3.3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Reversibility:
- other: no effects were observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Reversibility:
- other: no effects were observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Reversibility:
- other: no effects were observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Reversibility:
- other: no effects were observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 13.3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 10.7
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 6
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 2
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance did not require labelling with the risk phrase R36, "irritating to eyes" in accordance with Commission Directive 2001/59/EEC
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