Registration Dossier
Registration Dossier
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EC number: 421-830-3 | CAS number: 49805-30-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 421-830-3
- EC Name:
- -
- Cas Number:
- 49805-30-3
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 2-azabicyclo[2.2.1]hept-5-en-3-one
Constituent 1
- Specific details on test material used for the study:
- Nature of substance: Fine powder
Test animals / tissue source
- Species:
- other: Rabbit (New Zealand White)
Test system
- Amount / concentration applied:
- 70 MG
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Max. score:
- 3
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 14 days
- Other effects:
- There were no signs of toxicity or ill health in any animal
during the observation period.
Two animals developed corneal opacities with iridial
inflammation, while all three animals showed a diffuse
crimson or beefy red colouration of the conjunctivae, in one
animal only one hour after instillation. These reactions
were accompanied by swelling with partial eversion of the
eyelids.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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