Registration Dossier
Registration Dossier
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3-{5-[3-(4-{1-[3-(dimethylammonio)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo}benzamido)phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(dimethyl)ammonium di(acetate); 3-{5-[4-(3-{1,6-dihydro-2-hydroxy-4-methyl-1-[3-(methylammonio)propyl]-6-oxo-3-pyridylazo}benzamido]phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(dimethyl)ammonium di(acetate); reaction mass of: 3-{5-[3-(4-{1,6-dihydro-2-hydroxy-4-methyl-1-[3-(methylammonio)propyl]-6-oxo-3-pyridylazo}benzamido)phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(methyl)ammonium di(acetate)
EC number: 431-440-5 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 431-440-5
- EC Name:
- -
- IUPAC Name:
- (3-{5-[(E)-2-(3-{4-[(E)-2-{1-[3-(dimethylazaniumyl)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)dimethylazanium (3-{6-hydroxy-5-[(E)-2-(3-{4-[(E)-2-{2-hydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)(methyl)azanium (3-{6-hydroxy-5-[(E)-2-(4-{3-[(E)-2-{2-hydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)dimethylazanium hexaacetate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Deionised water
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200 mg/kg b.w.
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
670 mg/kg b.w.
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2000 mk/kg b.w.
Basis:
actual ingested
- No. of animals per sex per dose:
- Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 670 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours Female: 200 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 670 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
- Positive control(s):
- cyclophosphamide
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- not specified
- Toxicity:
- yes
- Remarks:
- Doses producing toxicity: In the pretest: 2000 mg/kg
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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