Registration Dossier
Registration Dossier
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EC number: 454-450-1 | CAS number: 429659-01-8 BIBR 1048 MANAMIDE
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March April 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
- EC Number:
- 454-450-1
- EC Name:
- Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
- Cas Number:
- 429659-01-8
- Molecular formula:
- C18 H20 N4 O5
- IUPAC Name:
- ethyl 3-{1-[4-(methylamino)-3-nitrophenyl]-N-(pyridin-2-yl)formamido}propanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- 30% DMSO / 70%corn oil
- Post exposure period:
- 24 h and 48 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- 24 h preperation interval
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- 48 h preparation interval
- No. of animals per sex per dose:
- 24 h post treatment
Male: 500 mg/kg; No. of animals: 5
Male: 1000 mg/kg; No. of animals: 5
Male: 2000 mg/kg; No. of animals: 5
Female: 500 mg/kg; No. of animals: 5
Female: 1000 mg/kg; No. of animals: 5
Female: 2000 mg/kg; No. of animals: 5
48 h post-treatment
Male: 2000 mg/kg; No. of animals: 5
Female: 2000 mg/kg; No. of animals: 5 - Control animals:
- yes
- Positive control(s):
- Negative control
Male: No. of animals: 5
Female: No. of animals: 5
Positive control
Male: No. of animals: 5
Female: No. of animals: 5
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Doses producing toxicity: > 2000 mg/kg
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- It can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse.
Therefore, BIBR 1048 Manamide is considered to be non-mutagenic in this micronucleus assay.
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