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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- European Commission (EC) - Scientific Committee on Consumer Safety (SCCS)
- Year:
- 2 011
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS, COLIPA n° B115, 13-14 December 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- In vivo Mammalian Erythrocytes Micronucleus Test was performed ot determine the mutagenic nature of Basic violet 2
- GLP compliance:
- not specified
- Type of assay:
- other: In vivo Mammalian Erythrocytes Micronucleus Test
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%
- Impurities (identity and concentrations): No data
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Remarks:
- CD-1
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Sterile distilled water
- Justification for choice of solvent/vehicle: The test chemical was soluble in sterile distilled water
- Concentration of test material in vehicle: 0, 3, 6 and 12 mg/kg bw
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- For oral route
PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in sterile distilled water at dose levels of 0, 3, 6 and 12 mg/kg bw
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data - Duration of treatment / exposure:
- 24 and 48 hrs
- Frequency of treatment:
- No data
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- 0, 3, 6 and 12 mg/kg bw
- No. of animals per sex per dose:
- Total: 20 males and 20 females
0 mg/Kg bw: 5 males and 5 females
3 mg/Kg bw: 5 males and 5 females
6 mg/Kg bw: 5 males and 5 females
12 mg/Kg bw: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- In accordance with the OECD guideline
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Test doses were based on acute toxicity in a pretest
with 2 animals per sex/group.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 24 and 48h control and high dose group only
DETAILS OF SLIDE PREPARATION: Bone marrow cells were collected 24 h or 48 h (control and highest dose only) after dosing and stained with May-Gruenwald and Giemsa.
METHOD OF ANALYSIS: Toxicity and thus exposure of the target cells was determined by measuring the ratio between polychromatic and total erythrocytes (PCE/PCE+NCE) over the negative control value.
OTHER: No data - Evaluation criteria:
- Toxicity and thus exposure of the target cells was determined by measuring the ratio between polychromatic and total erythrocytes (PCE/PCE+NCE) over the negative control value.
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 3.91, 15.6, 125 mg/Kg bw
- Solubility: No data
- Clinical signs of toxicity in test animals: swollen abdomen, ataxia, hunched posture, lethargy, reduced activity, semi closed eyes and piloerection
- Evidence of cytotoxicity in tissue analyzed: No data
- Rationale for exposure: No data
- Harvest times: No data
- High dose with and without activation: >125 mg/Kg bw
- Other:
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data
- Induction of micronuclei (for Micronucleus assay): No data
- Ratio of PCE/NCE (for Micronucleus assay): a reduction in the PCE/(PCE+NCE) ratio was observed for both sexes and both time points
- Appropriateness of dose levels and route:
Dose level: 0, 3, 6 and 12 mg/kg bw
Route: Intraperitoneal injection
- Statistical evaluation: No data
Applicant's summary and conclusion
- Conclusions:
- Basic Violet 2 did not induce an increase in bone marrow cells with micronuclei and, consequently, Basic Violet 2 is not genotoxic (clastogenic and/or aneugenic) in bone marrow cells of mice.
- Executive summary:
In vivo mammalian erythrocytes micronucleus test was performed to determine the mutagenic nature of Basic violet 2. The study was performed using 5 males and 5 females Swiss CD-1 Mice at dose levels of 0, 3, 6 or 12 mg/Kg bw for 24 and 48 hrs. Three toxicity studies with decreasing doses were performed in order to identify the doses to be used in the main study. Animals were inspected for signs of reaction to treatment daily throughout the study. Bone marrow cells were collected 24 h or 48 h (control and highest dose only) after dosing and stained with May-Gruenwald and Giemsa. Toxicity and thus exposure of the target cells was determined by measuring the ratio between polychromatic and total erythrocytes (PCE/PCE+NCE) over the negative control value. In the micronucleus test no animals died. Animals from the 6 mg/Kg bw treatment group showed piloerection; those from the high dose group hunched posture, swollen abdomen, closed eyes, piloerection and pink spots in the cage litter indicative for excretion of coloured urine. A reduction in the PCE/(PCE+NCE) ratio was observed for both sexes and both time points. Biological relevant increases in the number of bone marrow cells with micronuclei compared to the concurrent vehicle controls were not found at any dose tested, either 24 or 48 h after treatment or for males and females.Basic Violet 2 did not induce an increase in bone marrow cells with micronuclei and, consequently, Basic Violet 2 is not genotoxic (clastogenic and/or aneugenic) in bone marrow cells of mice.
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