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Diss Factsheets
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EC number: 229-102-5 | CAS number: 6410-32-8
- 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
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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:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 473) and according to GLP.
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 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- EC Number:
- 229-245-3
- EC Name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- Cas Number:
- 6448-95-9
- Molecular formula:
- C24H18N4O4
- IUPAC Name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)diazenyl]-N-phenyl-2-naphthamide
- Test material form:
- not specified
- Details on test material:
- Name of test material (as cited in study report): Chromosomal Abberation Test with Cultured Mammalian Cells: C.I. Pigment Red 22
Analytical purity: 99.8 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung cells (CHL/IU)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: no data
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from phenobarbital and 5,6-benzoflavone induced rats
- Test concentrations with justification for top dose:
- cell growth inhibition test: 0, 8.4, 16.8, 33.6, 67.2, 134.4, 268.8, 537.5, 1075, 2150, 4300 µg/mL
chromosomal abberation test: 0, 37.5, 75, 150, 300, 600 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: test substance is insolube in water, DMSO and acetone
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- for continuous treatment and short treatment in absence of metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: dimethylnitrosamine
- Remarks:
- for short treatment method in the presence of metabolic activation
- Details on test system and experimental conditions:
- DURATION
- Exposure duration:
continuous treatment: 24 or 48 h
short treatment: 6 h
- Expression time (cells in growth medium):
short treatment: 18 h
- Fixation time (start of exposure up to fixation or harvest of cells):
continuous treatment: 24 or 48 h
short treatment: 24h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (2 h before completion of incubation)
STAIN (for cytogenetic assays): Giemsa solution
NUMBER OF REPLICATIONS: Doubling time: 16.2 h
NUMBER OF CELLS EVALUATED: 200 cells per concentration
DETERMINATION OF CYTOTOXICITY
- Method: cell survival ratio
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- The final judgement on the outcome of the test was made as follows: when the incidence of cells with numerical or structural aberrations induced by the test article was lower than 5, the result was assessed as negative; from 5-10% (exclusive of 10%), equivocal; and 10% or higher with a concentration-dependent rise, positive. The incidence of cells having structural abberations with gaps and of cells without gaps were calculated separately, and cells without gaps were assessed for chromosomal aberrarions.
- Statistics:
- No significance tests were performed, since the incidence of cells with chromosomal aberrations was assessed according to the evaluation criteria described above.
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster lung cells (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation occurred at concentrations of 268.8 µg/mL and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation occurred at concentrations of 268.8 µg/mL and higher
ADDITIONAL INFORMATION ON CYTOTOXICITY:
in the cell growth inhibition test no cytotoxicity was noted. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item is not clastogenic in Chinese hamster lung fibroblast (CHL/IU) cells under the experimental conditions described in the study. - Executive summary:
In a guideline study (OECD 473) the test item, suspended in ethanol, was assessed for its potential to induce structural chromosome aberrations in Chinese hamster lung fibroblasts (CHL/IU) with and without metabolic activation.
Prior to the chromosomal aberration test, a cell growth inhibition test was performed to determine test concentrations for the chromosomal aberration test. No cytotoxicity was noted at 4300 µg/mL, the highest concentration tested. Precipitations were noted at concentrations of 268.8 µg/mL and higher.
In the chromosomal aberration test, concentrations of 0, 37.5, 75, 150, 300 and 600 µg/mL were tested. A continuous exposure (24 or 48 h) and a short time exposure (6 h with 18 h expression time) in the presence and absence of S9-mix were performed.
At least 200 metaphases per culture were evaluated for structural chromosome aberrations.
Appropriate mutagens were used as positive controls. They produced markedly positive results.
It was concluded that the test substance is not clastogenic in Chinese hamster lung fibroblast cells (CHL/IU) under the experimental conditions described in the report.
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