Registration Dossier
Registration Dossier
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EC number: 812-545-9 | CAS number: 93173-05-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- 5,11-dihydro-11-((4-methyl-1-piperazinyl)acetyl)-6H-pyrido(2,3-b)(1,4)benzodiazepin-6-one monohydrochloride
- EC Number:
- 812-545-9
- Cas Number:
- 93173-05-8
- Molecular formula:
- C19H21N5O2 x HCl
- IUPAC Name:
- 5,11-dihydro-11-((4-methyl-1-piperazinyl)acetyl)-6H-pyrido(2,3-b)(1,4)benzodiazepin-6-one monohydrochloride
- Test material form:
- solid: bulk
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):
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- animal: all animals
- Time point:
- other: overall
- Score:
- 0
- Max. score:
- 0.33
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: "not classified" according CLP
- Conclusions:
- Not important eyes lesion cause
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