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EC number: 604-075-6 | CAS number: 138401-24-8
- 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 vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 July 1996 to 19 September 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test follows standard guidelines. GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- [1,1’-Biphenyl]-2-carbonitrile, 4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-
- IUPAC Name:
- [1,1’-Biphenyl]-2-carbonitrile, 4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-
- Reference substance name:
- 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile
- EC Number:
- 604-075-6
- Cas Number:
- 138401-24-8
- Molecular formula:
- C25H27N3O
- IUPAC Name:
- 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): SR 47563
- Lot/batch No.: 6R00003
- storage: at room temperature
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- primary culture, other: Human lymphocytes
- Details on mammalian cell type (if applicable):
- - type and identity of media:
RPMI 1640 containing 20% fetal calf serum, L-glutamine (2 mM), Penicillin (100 U/ml), Streptomycin (100 µg/ml), and 3.6% Phytohaemagglutinin. The culture was then placed at 37°C for 48 hours.
- stable karyotype with 46 chromosomes and an average cell cycle time of 12-14 hours
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- First experiment: 31.25, 62.5, 125, 250, 500, 1000µM
Second experiment: 3.906, 7.8125, 15.625, 31.25, 62.5, 125µM, without S9 mix for both harvest times
7.8125, 15.625, 31.25, 62.5, 125, 250 µM, with S9 mix for both harvest times - Vehicle / solvent:
- - Justification for choice of solvent/vehicle: selected according to the results of solubility trials approximately 50 to 500 fold the final dose-level, depending on the vehicle. The preparations will be made immediately before use.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- DURATION
- Preincubation period: 48h
- Exposure duration: 20 and 44h
NUMBER OF CELLS EVALUATED: 1000 cells
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- A reproducible and statistically significant increase in the frequency of cells with structural chromosome aberrations for at least one of the dose-levels and one of the two harvest times will be considered as a positive result. Reference to historical data or other considerations of biological relevance may be taken into account in the evaluation of the findings.
- Statistics:
- For each test and for each harvest time, the frequency of cells with structural chromosome aberrations (excluding gaps) in treated cultures will be compared to that of the vehicle control cultures. the comparison will be performed using the χ² test, in which p=0.05 will be used as the lowest level of significance.
Results and discussion
Test results
- Species / strain:
- primary culture, other: Human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test substance did not induce chromosome aberrations neither with nor without S9 mix, for both harvest times.
The frequency of cells with structural chromosomes aberrations in the vehicle and positive controls were as specified in acceptance criteria.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the experimental conditions, the test substance SR 47563 did not induce chromosome aberrations in cultured human lymphocytes.
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