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EC number: 241-806-4 | CAS number: 17852-98-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- first experiment 4 hours treatment with and without metabolic activation
second experiment 24 hours treatment without metabolic activation - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- Physical state: Solid
- Purity test date: Certificate of Analysis AZ 353/e1, dated December 10, 2007
- Expiration date of the lot/batch: October 31, 2017
- Storage condition of test material: Room temperature
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
Method
- Target gene:
- 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
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO;
- Justification for choice of solvent/vehicle: solubility properties
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- Migrated to IUCLID6: ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours with and without metabolic activation in experiment 1, 24 hours without metaoblic activation in experiment 2
- Expression time (cells in growth medium): 72 hours
- Selection time (if incubation with a selection agent): 10 days
SELECTION AGENT (mutation assays): Thioguanine
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: >1,5x10exp.6
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
- Evaluation criteria:
- A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered to be non-mutagenic in this system.
A mutagenic response is described as follows:
The test item is classified as mutagenic if it induces reproducibly with one of the concen¬trations a mutation frequency that is three times higher than the spontaneous mutation fre¬quency in the experiment.
The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
In a case by case evaluation this decision depends on the level of the correspon¬ding solvent control data. - Statistics:
- Linear regression analysis (least squares) .
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Precipitation: precipitation occurred at 125 µg/mL and 1000 µg/mL in experiment I with and without metabolic activation (4 h treatment), and at
62.5 µg/mL, 125 µg/mL, and 1000 µg/mL in experiment II without metabolic activation (24 h treatment)
RANGE-FINDING/SCREENING STUDIES: determination of plating efficiency, concentration range 7.8 to 1000 µg/mL.
Cytotoxicity at 500 µg/mL and above without metabolic activation at 4 h treatment.
Precipitation at 4 h treatment without metabolic activation: at 125 µg/mL and 1000 µg/mL
Precipitation at 4 h treatment with metabolic activation: at 62.5 µg/mL, 125 µg/mL, and 1000 µg/mL
Precipitation at 24 h treatment without metabolic activation: at 125 µg/mL and 1000 µg/mL
COMPARISON WITH HISTORICAL CONTROL DATA: all mutant frequencies within historical control data
Any other information on results incl. tables
Summary Table
relative | relative | mutant | relative | relative | mutant | |||||
conc. | S9 | cloning | cloning | colonies/ | induction | cloning | cloning | colonies/ | induction | |
µg/mL | mix | efficiency 1 | efficiency 2 | 106 cells | factor | efficiency 1 | efficiency 2 | 106 cells | factor | |
% | % | % | % | |||||||
column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Experiment I | culture I | culture II | ||||||||
Solvent control DMSO | - | 100.0 | 100.0 | 11.9 | 1.0 | 100.0 | 100.0 | 15.2 | 1.0 | |
Pos. contr. with EMS | 150.0 | - | 86.5 | 76.2 | 87.2 | 7.3 | 82.8 | 66.8 | 237.9 | 15.6 |
Test item | 7.8 | - | 100.6 | culture was not continued# | 89.6 | culture was not continued# | ||||
Test item | 15.6 | - | 103.5 | 91.9 | 11.3 | 0.9 | 99.0 | 90.3 | 26.4 | 1.7 |
Test item | 31.3 | - | 103.8 | 80.2 | 13.5 | 1.1 | 93.2 | 98.2 | 16.1 | 1.1 |
Test item | 62.5 | - | 97.0 | 93.8 | 7.9 | 0.7 | 95.1 | 88.6 | 19.3 | 1.3 |
Test item | 125.0 (p) | - | 101.3 | 84.1 | 9.1 | 0.8 | 90.6 | 91.2 | 24.9 | 1.6 |
Test item | 1000.0 (p) | - | 98.0 | 79.1 | 17.0 | 1.4 | 82.8 | 87.2 | 20.6 | 1.4 |
Solvent control DMSO | + | 100.0 | 100.0 | 5.4 | 1.0 | 100.0 | 100.0 | 27.5 | 1.8 | |
Pos. contr. with DMBA | 1.1 | + | 75.1 | 54.9 | 898.8 | 165.3 | 74.1 | 61.9 | 247.0 | 16.2 |
Test item | 7.8 | + | 97.8 | 83.4 | 19.8 | 3.6 | 96.7 | 81.4 | 8.8 | 0.6 |
Test item | 15.6 | + | 100.8 | 70.9 | 18.0 | 3.3 | 94.9 | 86.7 | 4.3 | 0.3 |
Test item | 31.3 | + | 95.7 | 70.0 | 13.0 | 2.4 | 103.6 | 79.1 | 3.9 | 0.3 |
Test item | 62.5 (p) | + | 98.7 | 77.2 | 9.2 | 1.7 | 93.9 | 86.0 | 11.4 | 0.7 |
Test item | 125.0 (p) | + | 97.0 | culture was not continued## | 95.7 | culture was not continued## | ||||
Test item | 1000.0 (p) | + | 88.6 | 67.7 | 21.9 | 4.0 | 68.0 | 83.9 | 7.4 | 0.5 |
Experiment II | culture I | culture II | ||||||||
Solvent control DMSO | - | 100.0 | 100.0 | 19.4 | 1.0 | 100.0 | 100.0 | 20.4 | 1.0 | |
Pos. contr. with EMS | 150.0 | - | 98.4 | 43.0 | 710.5 | 36.6 | 82.1 | 89.3 | 400.3 | 19.6 |
Test item | 7.8 | - | 97.6 | 83.2 | 26.8 | 1.4 | 86.4 | 112.7 | 12.1 | 0.6 |
Test item | 15.6 | - | 98.1 | 105.1 | 7.7 | 0.4 | 84.4 | 129.4 | 15.2 | 0.7 |
Test item | 31.3 | - | 98.8 | 107.9 | 11.6 | 0.6 | 95.8 | 116.8 | 18.4 | 0.9 |
Test item | 62.5 (p) | - | 99.1 | 107.0 | 20.3 | 1.0 | 84.7 | 91.5 | 17.0 | 0.8 |
Test item | 125.0 (p) | - | 94.6 | culture was not continued## | 87.2 | culture was not continued## | ||||
Test item | 1000.0 (p) | - | 93.6 | 103.8 | 13.0 | 0.7 | 89.7 | 109.7 | 11.1 | 0.5 |
# culture was not continued since a minimum of only four analysable concentrations is required
## culture was not
continued to avoid analysis of too many precipitating concentrations
p precipitation or turbidity
visible to the unaided eye
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.
The substance is considered to be non-mutagenic in this HPRT assay. - Executive summary:
Study design
The study was performed to investigate the potential of Graphtol-Rubine 6BP to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster.
The assay was performed in two independent experiments, using two parallel cultures each. Experiment I was performed with and without metabolic activation and a treatment period of 4 hours. Experiment II was performed without metabolic activation and a treatment time of 24 hours.
Results
The highest applied concentration (1000 µg/mL) was limited by the solubility properties of the test item in DMSO and aqueous media. The concentration range of the main experiments was based on the results of the pre-experiment, regarding the toxicity data and the occurrence of precipitation.
No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments.
Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies confirming the sensitivity of the test system and the activity of the S9 mix.
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