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EC number: 277-552-6 | CAS number: 73612-29-0
- 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:
- other: 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:
- - Name of test material (as cited in study report): Graphtol-Rubine 6BP
- Substance type: pigment
- Physical state: red solid
- Expiration date of the lot/batch: October 31, 2017
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: stability > 72 hours in DMSO and 1,2 - propylene glycol at room temperature
- Analytical purity: 84.34/ (w/w)
- Composition: 7.73 % Pigment Red 63:1
- Lot/batch No.: KRON 792014
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
- Specific details on test material used for the study:
- - 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
- Name of test material (as cited in study report): Graphtol-Rubine 6BP
- Composition of test material: C.I. Pigment Red 57:1; 84.34 % (w/w); C.I. Pigment Red 63:1; 7.73 % (w/w)
- Lot/batch No.: KRON 792014
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:
- 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 corresponding solvent control data. - Statistics:
- Linear regression analysis (least squares) .
Results and discussion
Test results
- Key result
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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