Registration Dossier
Registration Dossier
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EC number: 249-227-9 | CAS number: 28797-48-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
- EC Number:
- 249-227-9
- EC Name:
- 11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
- Cas Number:
- 28797-48-0
- Molecular formula:
- C14H10ClN3O2
- IUPAC Name:
- 11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 2 - 3 kg- Diet (e.g. ad libitum): Conventional feeding ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 - 23 - Humidity (%): 30 - 70 - Photoperiod (hrs dark / hrs light): 12 :12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g
- Observation period (in vivo):
- 17 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 2 + 3
- Time point:
- other: 1 hour - 17 days
- Score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 1 hour - 17 days
- Score:
- 1.66
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 1 hour - 17 days
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 1 hour - 17 days
- Score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- other: Inflammation score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 1 hour - 17 days
- Score:
- 2
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- other: Inflammation score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 1 hour - 17 days
- Score:
- 2.66
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- other: Inflammation score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 1 hour - 17 days
- Score:
- 3
- Reversibility:
- fully reversible within: 17 days
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 according CLP
- Conclusions:
- Chloracetyl ( Phase 6 Gastrozepin ) is irritant to the eyes of the rabbits under the conditions of this study.
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