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EC number: 437-930-5 | CAS number: 51553-03-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-01-2002 - 20-05-2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Version / remarks:
- 21st July 1997
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- -
- EC Number:
- 437-930-5
- EC Name:
- -
- Cas Number:
- 51553-03-8
- Molecular formula:
- Hill formula: C22H23N7O5 CAS formula: C22H23N7O5
- IUPAC Name:
- N-{5-[bis(2-methoxyethyl)amino]-2-[2-(2,6-dicyano-4-nitrophenyl)diazen-1-yl]phenyl}acetamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 26 male rats
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 1% (w/v) carboxymethylcellulose, suspension
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was suspended in 1 % (w/v) carboxymethylcellulose. The suspensions were treated with ultrasonic waves to obtain a homogeneous suspension. - Duration of treatment / exposure:
- 2 - 4 h or 12 - 16 h
- Frequency of treatment:
- single dosing
- Post exposure period:
- 2 - 4 h or 14 - 18 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Male: 2000 mg/kg; No. of animals: 3; Sampling time: 2 - 4 hours
Male: 1500 mg/kg; No. of animals: 3; Sampling time: 2 - 4 hours
Male: 1000 mg/kg; No. of animals: 3; Sampling time: 2 - 4 hours
Male: 2000 mg/kg; No. of animals: 3; Sampling time: 12 - 16 hours
Male: 1500 mg/kg; No. of animals: 3; Sampling time: 12 - 16 hours
Male: 1000 mg/kg; No. of animals: 3; Sampling time: 12 - 16 hours - Control animals:
- yes
- Positive control(s):
- 2-acetylaminofluorene (12 - 16 h treatment time):
- Route of administration: oral
- Doses / concentrations: 50 mg/kg bw, administered in corn oil
N-dimethylnitrosamine (2 - 4 h treatment time):
- Route of administration: oral
- Doses / concentrations: 10 mg/kg bw, administered in water
Examinations
- Tissues and cell types examined:
- liver; hepatocytes (living parenchymic liver cells)
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
The net nuclear grain count in the solvent-treated control cultures were within the historical control data range and the positive control cultures showed responses within the expected range. The viability of liver cells was at least 51%.
Applicant's summary and conclusion
- Conclusions:
- BDF 054-1 is not genotoxic in the DNA-repair assay using hepatocytes obtained from male rat liver following in vivo exposure for 2 - 4 or 12 - 16 hours to the test substance up to concentrations of 2000 mg/kg bw.
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