Registration Dossier
Registration Dossier
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EC number: 606-396-7 | CAS number: 198904-86-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- tert-butyl 2-{(2S,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-4-phenylbutyl}-2-[4-(pyridin-2-yl)benzyl]hydrazinecarboxylate
- EC Number:
- 606-396-7
- Cas Number:
- 198904-86-8
- Molecular formula:
- C32H42N4O5
- IUPAC Name:
- tert-butyl 2-{(2S,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-4-phenylbutyl}-2-[4-(pyridin-2-yl)benzyl]hydrazinecarboxylate
- Test material form:
- solid
- Details on test material:
- - Appearance: Off-white powder
- Storage condition of test material: At room temperature protected from light
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on exposure:
- Male rats were dosed at 2000, 600, and 200 mg/kg/day once per day on three consecutive days via oral gavage at a volume of 10 mL/kg. Forty eight hours after a second dose was adminstrated
- Duration of treatment / exposure:
- 48hrs
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Control animals:
- yes, concurrent vehicle
- other: Positive Control
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test article BMS-233101-01 was evaluated as negative under the conditions of this study.
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