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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 safety assessment report.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion of the Scientific Committee on Consumer Safety on Basic Violet 2 (B115)
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 011
- Bibliographic source:
- The Scientific Committee on Consumer Products, SCCS/1340/10,2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Buehler method
- Principles of method if other than guideline:
- To determine the skin sensitization potential of (4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1 ylidene)methyl]-o-toluidine monohydrochloride) by Buehler method
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Not specified
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:
- -[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride/ 3248-91-7
/ 221-831-7
Commen name-Basic Violet 2
mol.formula:C22H23N3 .HCl
smiles:C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
InChI:1S/C22H23N3.ClH/c1-13-10-16(4-7-19(13)23)22(17-5-8-20(24)14(2)11-17)18-6-9-21(25)15(3)12-18;/h4-12,23H,24-25H2,1-3H3;1H
Physical state: Solid Green crystalline powder
molecular weight:365.906 g/mol
Constituent 1
- Specific details on test material used for the study:
- 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride/ 3248-91-7
/ 221-831-7
Commen name-Basic Violet 2
mol.formula:C22H23N3 .HCl
smiles:C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
InChI:1S/C22H23N3.ClH/c1-13-10-16(4-7-19(13)23)22(17-5-8-20(24)14(2)11-17)18-6-9-21(25)15(3)12-18;/h4-12,23H,24-25H2,1-3H3;1H
purity: 94%
molecular weight:365.906 g/mol
Physical state: Solid Green crystalline powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75%
- Day(s)/duration:
- 16 Days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- The test group consisted of 20 female Guinea pigs
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Not specified
- Exposure period: 6 hrs
- Test groups:20 animals
- Control group: 20
- Site: left flank
- Frequency of applications: Not specified
- Duration: 16 hrs
- Concentrations: 75%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 hrs
- Test groups: 20
- Control group:20
- Site: Not specified
- Concentrations: 50%
Evaluation (hr after challenge): 24 and 48 hrs
OTHER: vehicle alone on the contralateral flank was applied - Challenge controls:
- two control groups of ten female Guinea
pigs each - Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs appered.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Non skin sensitizing
- Conclusions:
- The Basic Violet 2 was considered skin non sensitizing as no differences between values of the test group compared to values of the control group were apparent
- Executive summary:
Basic Violet 2 was assessed for its skin sensitizing potential by Buehler test on Dunkin-Hartley guinea pig The test group consisted of 20 female Guinea pigs, two control groups of ten female Guinea pigs each. During the induction phase, the test group was treated with the test substance in sterile water at 75% at the left flank. The negative control groups were treated with the vehicle (sterile water) in the same manner. The gauze patches with test substance or vehicle under occlusive dressing were removed after 6 hours. Approximately 24 hours after removal of the patches, skin reactions were scored. These procedures were repeated at weekly intervals (days 8/9 and 15/16 of the study). On study day 29, sensitisation reactions were challenged in the test as well as in one negative control group by topical administration of the test substance in sterile water (50% on one side and vehicle alone on the contralateral flank) under occlusive dressing for 6 hours.
Twenty-four and 48 hours after removal of the patches the skin reactions were scored. Following the 48 hour examination at challenge, skin fold thickness of the treated sites was measured using a digital micrometer. Body weights were recorded on days 1 and 31 (termination of the study). Body weights were not affected by the test compound.
The Basic Violet 2 was considered skin non sensitizing as no differences between values of the test group compared to values of the control group were apparent.
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