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EC number: 203-187-9 | CAS number: 104-23-4
- 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 / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- European Commission
- Year:
- 2 008
- Bibliographic source:
- SCCS
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guideline 487 and 473
- Version / remarks:
- Draft
- Principles of method if other than guideline:
- In vitro mammalian chromosome aberration test was carried out using Chinese hamster V79 cells.
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- EC Number:
- 269-944-0
- EC Name:
- [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 68391-32-2
- Molecular formula:
- ClN5O3
- IUPAC Name:
- 8-[(4-amino-3-nitrophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride
- Reference substance name:
- (8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride
- IUPAC Name:
- (8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride
- Test material form:
- other: Dark brown powder
- Details on test material:
- - Name of test material : (8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride
- Molecular formula : C19H20N5O3.Cl
- Molecular weight : 401.852 g/mol
- Smiles notation :[N+](c1cc(\N=N\c2c3cc([N+](C)(C)C)ccc3ccc2O)ccc1N)([O])=O.[ClH]
- InChl : 1S/C19H19N5O3.ClH/c1-24(2,3)14-7-4-12-5-9-18(25)19(15(12)11-14)22-21-13-6-8-16(20)17(10-13)23(26)27;/h4-11H,1-3H3,(H2-,20,21,22,25);1H
- Structural formula attached as image file (if other than submission substance): No data available
- Substance type: Organic
- Physical state: Solid
- Analytical purity: No data available
- Impurities (identity and concentrations): No data available
- Composition of test material, percentage of components: No data available
- Isomers composition: No data available
- Purity test date: No data available
- Lot/batch No.: No data available
- Expiration date of the lot/batch: No data available
- Radiochemical purity (if radiolabelling): No data available
- Specific activity (if radiolabelling): No data available
- Locations of the label (if radiolabelling): No data available
- Expiration date of radiochemical substance (if radiolabelling): No data available
- Stability under test conditions: No data available
- Storage condition of test material: No data available
- Other: No data available
Constituent 1
Constituent 2
Method
- Target gene:
- No data available
Species / strain
- Species / strain / cell type:
- other: Chinese hamster V79 cells
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 fraction from phenobarbital/βnaphthoflavone-induced rats was used as exogenous metabolic activation system.
- Test concentrations with justification for top dose:
- Experiment IA: 128.1, 256.3, 2050.0 and 4100.0 μg/ml without S9-mix
Experiment IA: 128.1, 256.3, 1025.0 and 2050.0 μg/ml with S9-mix
Experiment IB: 31.3, 62.5, and 125.0 without S9-mix
Experiment IIA: 128.1, 256.3 and 512.5 μg/ml without S9-mix
Experiment IIA: 128.1, 256.3, 512.5 and 1025.0 μg/ml with S9-mix
Experiment IIB: 100.0, 150.0, 200.0, 250.0, 300.0 and 350.0 μg/ml without S9-mix
Experiment IIB: 100.0, 200.0, 400.0, 600.0 and 800.0 μg/ml with S9-mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Deionised water
- Justification for choice of solvent/vehicle: The test chemical was soluble in Deionised water
Controls
- Untreated negative controls:
- yes
- Remarks:
- as per OECD guideline
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- as per OECD guideline
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: No data available
- Exposure duration:
Experiment I (without & with S9-mix): 4 hr
Experiment II (with S9-mix): 4 hr
Experiment II (without S9-mix): 20 hrs
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: For assessment of cytotoxicity a XTT test was performed
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: On the basis of pre-test (range finding study) and the occurrence of precipitation of test chemical, 4100 μg/ml (≈ 10 mM the prescribed maximum concentration) was chosen as top concentration in experiment IA. To corroborate the data of this experiment in the absence of S9-mix, a confirmatory experiment (experiment IB) was performed with a top dose of 500 μg/ml. Dose selection in experiment IIA was influenced by toxicity and precipitation observed in experiment I. Due to the steep dose toxicity curve, a repeat experiment (experiment IIB) was performed with narrower dilution steps to proof if genotoxicity observed at highly toxic concentrations far below the 40% of control level was an artificial finding.
Harvest time was 24 h or 48 h (experiment II with S9-mix only) after the beginning of culture.
For assessment of cytotoxicity a XTT test was additionally carried out in parallel to the main micronucleus test. - Rationale for test conditions:
- No data available
- Evaluation criteria:
- The cell line was observed for micronucleated cells
- Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster V79 cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: A pretest on cell growth inhibition (XTT assay) with 4 h treatment was performed in order to determine the toxicity of test substance, the solubility during exposure and thus the test concentrations for the main micronucleus test.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes, In experiment IIA, in the absence and the presence of S9-mix, a statistically significant increase in the number of micronucleated cells exceeding the range of the historical control data was observed at the highest doses (512.5 and 1025 μg/ml, respectively). These concentrations were strongly cytotoxic indicated as by cell numbers of 7.9% and 12.9% of control, respectively.
Due to the steep dose-toxicity curve a repeat experiment, designated experiment IIB, was performed with narrower dilution steps to prove if the genotoxicity observed could have been an artefact induced by general test item toxicity. In the absence of S9-mix, at a cytotoxic level of about 40% of control the number of micronucleated cells (2.05% and 2.00%) slightly exceeded the historical control data range (0.0 – 1.8% micronucleated cells). Therefore, the test item was regarded as non-genotoxic in the absence of metabolic activation.
In the presence of S9-mix, at cytotoxic test item levels and associated with precipitation from doses equal or exceeding 200 μg/ml, the number of micronucleated cells (2.68% and 2.33%) slightly exceeded the range of the historical control data (0.0 – 1.8% micronucleated cells). Due to the high value of the respective solvent control (1.80% micronucleated cells), these two slight increases have to be regarded as biologically irrelevant.
The observations of experiment IIA in the absence and the presence of metabolic activation were not confirmed in the repeat experiment IIB with narrower dilution steps. Therefore, it has to be considered that the findings in both parts of experiment IIA were artefacts induced by general test item toxicity.
Other: In all experiments clear toxic effects indicated by reduced cell numbers below 40% of control were observed at least at the highest concentrations scored after treatment with test chemical except in experiment IB in the absence of S9-mix. In experiment IA, in the absence of S9-mix, a statistically significant but non-dose-related increase in the rate of micronucleated cells was observed at the lowest and highest dose. The values of highest dose were at the laboratory’s control data range (0.0 – 1.8% micronucleated cells). Concerning the lowest dose, in the confirmatory experiment IB this finding was not confirmed. Consequently, the positive finding was considered not biologically relevant. In experiment IA, in the presence of S9-mix no biologically relevant increase in the percentage of micronucleated cells was observed after treatment with the test item.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available - Remarks on result:
- other: No mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not induce an increase in micronucleated cells in the V79 cell line in the presence and absence of S9 metabolic activation system and thus, the test was considered to be negative.
- Executive summary:
In vitro mammalian chromosome aberration test was carried out using Chinese hamster V79 cells to determine the mutagenic nature of the test chemical.
Different conc. of test chemical was used in the various experiment. They are-
Experiment IA:128.1, 256.3, 2050.0 and 4100.0 μg/ml without S9-mix
Experiment IA:128.1, 256.3, 1025.0 and 2050.0 μg/ml with S9-mix
Experiment IB:31.3, 62.5, and 125.0 without S9-mix
Experiment IIA:128.1, 256.3 and 512.5 μg/ml without S9-mix
Experiment IIA:128.1, 256.3, 512.5 and 1025.0 μg/ml with S9-mix
Experiment IIB:100.0, 150.0, 200.0, 250.0, 300.0 and 350.0 μg/ml without S9-mix
Experiment IIB:100.0, 200.0, 400.0, 600.0 and 800.0 μg/ml with S9-mix
Deionised water was used as a vehicle.
Liver S9 fraction from phenobarbital/β-naphthoflavone-induced rats was used as exogenous metabolic activation system.
A pretest on cell growth inhibition (XTT assay) with 4 h treatment was performed in order to determine the toxicity of test substance, the solubility during exposure and thus the test concentrations for the main micronucleus test.
On the basis of pre-test (range finding study) and the occurrence of precipitation of test chemical, 4100 μg/ml (≈ 10 mM the prescribed maximum concentration) was chosen as top concentration in experiment IA. To corroborate the data of this experiment in the absence of S9-mix, a confirmatory experiment (experiment IB) was performed with a top dose of 500 μg/ml. Dose selection in experiment IIA was influenced by Basic Brown 17 toxicity and precipitation observed in experiment I. Due to the steep dose toxicity curve, a repeat experiment (experiment IIB) was performed with narrower dilution steps to proof if genotoxicity observed at highly toxic concentrations far below the 40% of control level was an artificial finding.
The treatment period in the main test was 4 h in experiment I (without and with S9-mix) and in experiment II (with S9-mix) or 20 h in experiment II (without S9-mix). Harvest time was 24 h or 48 h (experiment II with S9-mix only) after the beginning of culture.
For assessment of cytotoxicity a XTT test was additionally carried out in parallel to the main micronucleus test.
Under the experimental conditions, the test chemical did not induce an increase in micronucleated cells in the V79 cell line in the presence and absence of S9 metabolic activation system and thus, the test was considered to be negative.
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