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EC number: 204-934-1 | CAS number: 129-17-9
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of Arylmethane dyes in Salmonella
- Author:
- Antonio M. Bonin, Janice R. Farquharson And Robert S.U. Baker
- Year:
- 1 981
- Bibliographic source:
- Mutation Research, 89 (1981) 26-34
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Patent Blue V was tested in the Salmonella/ mammalian microsome mutagenicity assay to check for its mutagenic potential.
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- EC Number:
- 204-934-1
- EC Name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Cas Number:
- 129-17-9
- Molecular formula:
- C27H32N2O6S2.Na
- IUPAC Name:
- hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Details on test material:
- - Name of test material: Patent Blue V- Molecular formula: C27H31N2O6S2.NaC27H32N2O6S2.Na - Molecular weight (if other than submission substance): 566.672 g/mol- Substance type: Organic- Physical state: Solid- Purity: No data available- Impurities (identity and concentrations): No data available
Constituent 1
Method
- Target gene:
- Salmonella/mammalian microsome mutagenicity assay
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 0, 32, 100, 320, 1000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2- acetylaminoflourene, β- propiolactone
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: No data available- Exposure duration: 72 hrs- Expression time (cells in growth medium): 72 hrs- 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 availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data availableOTHER EXAMINATIONS:- Determination of polyloidy: No data available- Determination of endoreplication: No data available- Other: No data availableOTHER: No data available
- Evaluation criteria:
- Criteria for mutagenicity were (a) a dose-response and, (b) reproducibility of the result. Dose-responses were not always evident at concentratrations selected for initial testing.
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538
- 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:
- RANGE-FINDING/SCREENING STUDIES: Dose ranges for mutagenesis were determined first by preliminary pour-plate toxicity tests at 10, 1, 0.1, 0.01 mg/plate.
- 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 with and withoutThe given test material is negative to induce mutagenicity in the Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 strains in the presence and absence of S9 mix.
- Executive summary:
Salmonella/ mammalian microsome mutagenicity assay was performed to study the mutagenic potential of Patent Blue V both in the presence and absence of metabolic activator S9 mix. To each 2 ml of top agar at 42°C was added 100 µL bacterial broth culture, 100 µL test compound dissolved in DMSO various concentrations, and 500 µL S9 mix as required. Plates were incubated at 37°C for 72 hrs before counting his+revertant colonies and each dose point was determined from at least two plates, unless indicated otherwise. Criteria for mutagenicity were (a) a dose-response and, (b) reproducibility of the result. Dose-responses were not always evident at concentratrations selected for initial testing. Since no mutagenicity was detected, Patent Blue V is negative for the induction of gene toxicity in vitro. Hence the test chemical is not likely to classify for gene mutation in vitro..
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