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EC number: 235-628-6 | CAS number: 12392-64-2
- 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 gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012-06-13 to 2012-09-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study performed on the analogue substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 260-906-9
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Cas Number:
- 57693-14-8
- Molecular formula:
- C40H20CrN6O14S2.3Na
- Test material form:
- other: solid and liquid preparations
Constituent 1
Method
- Target gene:
- hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- -Type and identity of media: MEM- Properly maintained: yes- Periodically checked for Mycoplasma contamination: yes- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Sprague Dawley Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- All concentrations used referred to the active components of the test item.Pre-experiment for experiment I without metabolic activation: 3.16, 10.0, 31.6, 100, 316, 1000, 2500, 5000 µg/mLwith metabolic activation: 1.0, 2.5, 5.0, 10.0, 31.6, 100, 316, 1000, 2500, 5000 µg/mLExperiment Iwithout metabolic activation: 0.025, 0.05, 0.10, 0.25, 0.50, 1.0, 2.5, 5.0, 10 and 20 µg/mLwith metabolic activation: 10, 25, 50, 100, 150, 175, 200, 225, 250, and 275 µg/mLExperiment IIwithout metabolic activation: 10, 20, 40, 50, 60, 70, 80, 90 and 100 µg/mLwith metabolic activation: 30, 60, 140, 220, 240, 250, 260, 270, 280 and 290 µg/mL
- Vehicle / solvent:
- Vehicle (Solvent) used: cell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment). The test item was dissolved in cell culture medium and diluted prior to treatment
Controlsopen allclose all
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activationMigrated to IUCLID6: 300 µg/mL
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activationMigrated to IUCLID6: 1 µg/mL and 1.5 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: suspended in mediumDURATION: 4 h (short-term exposure), 20 h (long-term exposure)Expression time (cells in growth medium): 48-72 hSelection time (if incubation with selection agent): about one weekSELECTION AGENT ( mutation assay) 11 µg/mL 6-thioguanine (TG)NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; 5 individual flasks were seeded and evaluatedNUMBER OF CELLS EVALUATED: 400000 cells per flaskDETERMINATION OF CYTOTOXICITY: Method: relative growth
- Evaluation criteria:
- A test is considered to be negative if there is no biologically relevant increase in the number of mutants.There are several criteria for determining a positive result:-a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations; -a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of the mutant frequency is not observed;-if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I without S9: ≥ 5.0 μg/mL; experiment I with S9: ≥ 225 μg/mL; Experiment II without S9: ≥ 60 μg/mL; Experiment II with S9:≥ 220 μg/mL
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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):negativeIn vitro cell gene mutagenicity test was performed on the analogue substance following OECD 476 (HPRT-test). Under the experimental conditions reported, the analogue substance is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
- Executive summary:
In a mammalian cell gene mutation assay (HPRT locus],V79 cells cultured in vitro were exposed to the analogue substance dissolved in cell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment) at concentrations of
- 0.025, 0.05, 0.10, 0.25, 0.50, 1.0, 2.5, 5.0, 10 and 20 µg/mL (without metabolic activation, Experiment I)
- 10, 25, 50, 100, 150, 175, 200, 225, 250 and 275 µg/mL (with metabolic activation, Experiment I)
- 10, 20, 40, 50, 60, 70, 80, 90 and 100 µg/mL (without metabolic activation, Experiment II)
- 30, 60, 140, 220, 240, 250, 260, 270, 280 and 290 µg/mL µg/mL (with metabolic activation, Experiment II).
Analogue substance was tested up to cytotoxic concentrations.
Biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation. In experiment I without metabolic activation the relative growth was 5.1% for the highest concentration (20 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 275 µg/mL with a relative growth of 19.5%. In experiment II without metabolic activation the relative growth was 20.1% for the highest concentration (100 µg/mL) evaluated. The highest concentration evaluated with metabolic activation was 290 µg/mL with a relative growth of 10.1%.
In experiment I without metabolic activation the highest mutation rate (compared to the negative control values) of 0.80 was found at a concentration of 0.025 µg/mL with a relative growth of 76.4%.
In experiment I with metabolic activation the highest mutation rate (compared to the negative control values) of 2.60 was found at a concentration of 250 µg/mL with a relative growth of 31.7%.
In experiment II without metabolic activation the highest mutation rate (compared to the negative control values) of 1.33 was found at a concentration of 100 µg/mL with a relative growth of 20.1%.
In experiment II with metabolic activation the highest mutation rate (compared to the negative control values) of 1.98 was found at a concentration of 140 µg/mL with a relative growth of 83.1%.The positive controlsdidinduce the appropriate response.
There was no evidence of a concentration related positive response of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.
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