Registration Dossier
Registration Dossier
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EC number: 604-776-7 | CAS number: 151213-15-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- May-June 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid
- EC Number:
- 604-776-7
- Cas Number:
- 151213-15-9
- Molecular formula:
- C20 H21 F2 N3 O3
- IUPAC Name:
- 7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid
- Details on test material:
- Bay Z 7906, white-yellowish powder, batch 501779, purity 99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Polyethylene glycol 400
- Doses:
- 2000 mg/kg with an administration volume of 10 ml/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
No deaths occurred and no clinical signs, no deviations in weight development and no gross pathological findings at sacrifice were observed.
Applicant's summary and conclusion
- Executive summary:
The acute oral toxicity to male and female Wistar rats of Bay Z 7906 was assessed. The test compound was formulated in polyethylene glycol, the administration volume was 10 ml/kg body weight.
The LD50 of Bay Z 7906 in male and female rats is above 2000 mg/kg.
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