Registration Dossier
Registration Dossier
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EC number: 408-050-9 | CAS number: 76855-69-1 4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, B5
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
- EC Number:
- 408-050-9
- EC Name:
- (2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
- Cas Number:
- 76855-69-1
- Molecular formula:
- C13H25NO4Si
- IUPAC Name:
- (2R,3R)-3-[(1R)-1-[(tert-butyldimethylsilyl)oxy]ethyl]-4-oxoazetidin-2-yl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- White powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Amount / concentration applied:
- 100 mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: Overall at 24, 48 and 72h
- Score:
- 0.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: Overall at 24, 48 and 72h
- Score:
- 2
- Remarks on result:
- other: Max duration: 6h; Max value at end of observatio period: 2 (related to all animals)
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: Overall at 24, 48 and 72h
- Score:
- 2
- Remarks on result:
- other: Max duration: 6h; Max value at end of observatio period: 2 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.67
- Remarks on result:
- other: Max duration: 6h; Max value at end of observatio period: 1 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48 and 72 h
- Score:
- 1.67
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Remarks on result:
- other: Max duration: 6h; Max duration at end of observation period: 2 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0.67
- Max. score:
- 2
- Remarks on result:
- other: Max duration: 6h; Max duration at end of observation period: 2 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Remarks on result:
- other: Max duration: 6h; Max duration at end of observation period: 1 (related to all animals)
- Other effects:
- Additional signs of irritation included Harderian discharge and erythema and oedema of the eyelids in one animal, and additionally in another animal, included irregular corneal surface, haemorrhage of the nictitating membrane, raised corneal opacity, bulging and ulceration of the cornea and neovascularistaion. The latter animal was killed due to irritation 6 days after dosing.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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