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EC number: 221-831-7 | CAS number: 3248-91-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from SCCS report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion on Basic Violet 2 Colipa N° B115
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 011
- Bibliographic source:
- European Commission, SCCS/1340/10, 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Ames assay was performed to determine the mutagenic nature of Basic violet 2
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride
- EC Number:
- 221-831-7
- EC Name:
- 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride
- Cas Number:
- 3248-91-7
- Molecular formula:
- C22H24ClN3
- IUPAC Name:
- 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride
- Details on test material:
- - Name of test material: Basic Violet 2
- IUPAC name: 4,4'-[(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methylene]bis(2-methylaniline) hydrochloride
- Molecular formula: C22H23N3ClH
- Molecular weight: 365.906 g/mol
- Substance type: Organic
- Physical state: No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Basic Violet 2
- IUPAC name: 4,4'-[(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methylene]bis(2-methylaniline) hydrochloride
- Molecular formula: C22H23N3ClH
- Molecular weight: 365.906 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: HPLC: 94.2%; NMR: 96.8%
- Impurities (identity and concentrations): No data
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA102, TA1535, TA1537
- Details on mammalian cell type (if applicable):
- Not applicable
- 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 Aroclor 1254-induced rats was used as exogenous metabolic activation system.
- Test concentrations with justification for top dose:
- Experiment 1: 1, 10, 100, 300, 1000 and 5000 μg/plate with and without S9-mix
Experiment 2: 3, 10, 30, 100, 300, 1000 and 3000 μg/plate with and without S9-mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- in accordance with the OECD guideline
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- in accordance with the OECD guideline
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: triplicates in two independent experiments
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS: No data
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for a dose dependent doubling of an increase in the number of revertants
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: No data
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: No data
- Negative (solvent/vehicle) historical control data: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: No data
- Other observations when applicable: Cytotoxicity observed as growth inhibition and clearing of the background lawn was found in the first experiment in the absence of S9-mix for TA98 and TA102 (1000 and 5000 μg/plate), TA100, TA1535 and TA1537 (100, 1000 and 5000 μg/plate); in the presence of S9-mix for TA98 (5000 μg/plate), TA100 and TA1535 (100, 1000 and 5000 μg/plate) and TA1537 and TA102 (1000 and 5000 μg/plate). This toxicity was observed also in the second experiment. - Remarks on result:
- other: No mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- Basic violet 2 did not induce gene mutation in Salmonella typhimurium strains TA98, TA100, TA102, TA1535, TA1537 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
Ames assay was performed to determine the mutagenic nature of Basic violet 2. The study was performed using Salmonella typhimurium strains TA98, TA100, TA102, TA1535, TA1537 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose levels of 1, 10, 100, 300, 1000 and 5000 μg/plate in experiment 1 and 3, 10, 30, 100, 300, 1000 and 3000 μg/plate in experiment 2. Direct plate incorporation method with 48 h incubation without and with S9-mix was performed. Toxicity observed as growth inhibition, clearing of the background lawn and strong reduction in the number of spontaneous revertants, was found in the first experiment in the absence of S9-mix for TA98 and TA102 (1000 and 5000 μg/plate), TA100, TA1535 and TA1537 (100, 1000 and 5000 μg/plate); in the presence of S9-mix for TA98 (5000 μg/plate), TA100 and TA1535 (100, 1000 and 5000 μg/plate) and TA1537 and TA102 (1000 and 5000 μg/plate). This toxicity was observed also in the second experiment. An increase in the number of revertants was observed on TA102 strain only in the presence of S9-mix at non-toxic concentrations. However, the effect never reached a factor of 2 compared to the control. This effect was therefore not considered biologically relevant. Under the experimental conditions used Basic Violet 2 was not mutagenic in this gene mutation tests in bacteria.
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