Registration Dossier
Registration Dossier
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EC number: 458-670-9 | 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 2004/73/EG, B.5
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- other: rbt, NZW Crl:KBL(NZW)
Test system
- Amount / concentration applied:
- 100 MG
- 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: mean value including 24, 48, 72 h observation
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean value including 24, 48, 72 h observation
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean value including 24, 48, 72 h observation
- Score:
- > 1 - < 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean value including 24,48,72 h observation
- Score:
- > 0 - < 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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