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EC number: 235-437-8 | CAS number: 12227-62-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 16185:1.
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitization to reactive textile dyes in patients with contact dermatitis
- Author:
- Bianca Maria Manzini, Alberico Motolese, Andrea Conti, Graziella Ferdani and Stefania Seidenari.
- Year:
- 1 996
- Bibliographic source:
- Contact Dermatitis, 1996, 34,172-175
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of C.I. Reactive Violet 5 was performed by human Maximization test in human
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
- EC Number:
- 235-434-1
- EC Name:
- Copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
- Cas Number:
- 12226-38-9
- Molecular formula:
- C20H18CuN3Na3O15S4
- IUPAC Name:
- copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: C.I. Reactive Violet 5
IUPAC name: copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
Molecular formula: C20H18CuN3Na3O15S4
Molecular weight: 799.1324 g/mol
SmilesNotation:c1(S(=O)(=O)CCOS(=O)(=O)[O-])cc2O[Cu]OC3=C(N=Nc2cc1)C(=C[C@@H]1[C@@H]3C(=CC(=C1)S(=O)(=O)[O-])NC(=O)C)S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChI: 1S/C20H21N3O15S4.Cu.3Na/c1-10(24)21-15-8-13(40(29,30)31)6-11-7-17(41(32,33)34)19(20(26)18(11)15)23-22-14-3-2-12(9-16 (14)25)39(27,28)5-4-38-42(35,36)37;;;;/h2-3,6-9,11,18,25-26H,4-5H2,1H3,(H,21,24)(H,29,30,31)(H,32,33,34)(H,35,36,37);;;;/q;+2;3*+1/p-5/b23-22+;;;;
Substance Type: Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: C.I. Reactive Violet 5
IUPAC name: copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
Molecular formula: C20H18CuN3Na3O15S4
Molecular weight: 799.1324 g/mol
SmilesNotation:c1(S(=O)(=O)CCOS(=O)(=O)[O-])cc2O[Cu]OC3=C(N=Nc2cc1)C(=C[C@@H]1[C@@H]3C(=CC(=C1)S(=O)(=O)[O-])NC(=O)C)S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChI: 1S/C20H21N3O15S4.Cu.3Na/c1-10(24)21-15-8-13(40(29,30)31)6-11-7-17(41(32,33)34)19(20(26)18(11)15)23-22-14-3-2-12(9-16 (14)25)39(27,28)5-4-38-42(35,36)37;;;;/h2-3,6-9,11,18,25-26H,4-5H2,1H3,(H,21,24)(H,29,30,31)(H,32,33,34)(H,35,36,37);;;;/q;+2;3*+1/p-5/b23-22+;;;;
Substance Type: Organic
Physical State: Solid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Source: Allergological Department, University of Modena, Italy
Age: from 3 to 73 years
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5.0%
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5.0%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1813 patients
- Details on study design:
- Details on study design
RANGE FINDING TESTS: Final concentration of 5% in petrolatum was chosen after preliminary tests with 4% and 10%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period:3 days
- Test groups:1813
- Control group: No data available
- Site: The allergens applied on back with Finn Chamber (Epitest Finland ) on Scanpor tape(Norgesplaster, Norway)
- Frequency of applications: No data available
- Duration:3 days
- Concentrations:5.0% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: at day 4
- Exposure period: No data available
- Test groups:1813
- Control group: No data available
- Site: The allergens applied on back with Finn Chamber (Epitest Finland ) on Scanpor tape(Norgesplaster, Norway)
- Frequency of applications: No data available
- Duration: 3 days
- Concentrations:5.0%
- Evaluation (hr after challenge):3 hr later at 4days.
OTHER: no data available - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 5.0%
- No. with + reactions:
- 5
- Total no. in group:
- 1 813
- Clinical observations:
- 5 out of 1813 patients showed positive effect
- Remarks on result:
- other: positive indication of skin sensitisation observed in 5 out of 1813 patients
In vivo (LLNA)
- Cellular proliferation data / Observations:
- 5 patients showed positive reaction when observed after 3 hr later at 4days.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- C.I. Reactive Violet 5 (12226-38-9) was considered to be not sensitizing to humans.
- Executive summary:
In skin sensitization study, 1813 patients were tested by maximization test to ascertain the degree of sensitization caused by C.I. Reactive Violet 5 (12226-38-9).
1813 patients aged 3 to 73 years underwent patch tests in the Allergological Department, University of Modena, Italy with the GIRDCA standard series. The dye was dispersed in 5% petrolatum, chosen after preliminary studies with 4% and 10%. Patches were applied to healthy skin of the back with Finn Chambers on Scanpor tape. The patches were removed after 3 days and reactions were read 3 hours later at 4 days. Reactions were evaluated according to ICDRG Guidelines.
However it was not known whether the sensitizing components of the reactive dye molecules are the same as those responsible for occupational IgE- mediated and contact allergy, or if they are new groups derived by the end of the dying process. Also no particular association was found between sensitization to reactive dye and sensitization to standard allergens.
Hence. C.I. Reactive Violet 5(12226-38-9)was considered to be not sensitizing to humans.
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