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EC number: 249-670-8 | CAS number: 29508-47-2
- 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 SCCNFP on basic red 51
- Author:
- Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers
- Year:
- 2 003
- Bibliographic source:
- Opinion of the SCCNFP on Basic red 51 during the 25th plenary meeting 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- To evaluate the skin sensitization potential of 77061-58-6 (2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride) by Magnusson and Kligman Guinea pig maximisation test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- EC Number:
- 278-601-4
- EC Name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Cas Number:
- 77061-58-6
- Molecular formula:
- C13H18N5.Cl
- IUPAC Name:
- 2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- IUPAC name: 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride
- Commen name: Basic Red 51
- Molecular formula: C13H18ClN5
- Molecular weight : 279.6 g/mol
- Substance type: organic
- Physical state: Powder
- InChI :1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
- Smiles :c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]
Constituent 1
- Specific details on test material used for the study:
- IUPAC name: 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride
- Name of test material (as cited in study report): Basic Red 51
- Molecular formula (if other than submission substance): C13H18ClN5
- Molecular weight (if other than submission substance): 279.6 g/mol
- Substance type: organic
- Physical state: Powder
- Purity : >98%
- Impurities (identity and concentrations): approx 2%
InChI :1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
Smiles :c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous solution with and without Freund’s Complete Adjuvant
- Day(s)/duration:
- 48 hrs
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 48 hrs
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% aqueous dilution
- Day(s)/duration:
- 24 hrs
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 15 females
Test-10
Control-5 - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: 48 hrs ( epicuteneous induction)
- Test groups: 10
- Control group: 5
- Site: no data
- Frequency of applications: not specified
- Duration: not specified
- Concentrations:
Intradermal induction :5%aqueous solution with and without Freund’s Complete Adjuvant
Epicuteneous induction : 50 %
B. CHALLENGE EXPOSURE
- No. of exposures: not specified
- Day(s) of challenge: 1 day
- Exposure period: 24 hrs
- Test groups: 10
- Control group: 5
- Site: Not specified
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48 hrs
OTHER: challenge treatment was provided 14 days after induction treatment - Challenge controls:
- Controls received vehicle only.
- 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:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No positive skin allergic reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No positive skin allergic reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was subjected to albino guinea pig by intradermal and topical application in induction and challenge treatment . None of the animal produced positive skin allergic reactions . Hence, 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not sensitizing to guinea pig skin.
- Executive summary:
2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was used as a test material to evaluated its skin sensitization potential by Magnusson and Kligman Guinea pig maximisation test The test was performed according to OECD guideline 406.
The test material was subjected to the guinea pig by intadermal and topical induction . In intradermal induction 5% aqueous solution with and without
Freund’s Complete Adjuvant was subjected to test animal whereas, in topical induction ,50% preparation of test material under
occlusion for 48 hours. Controls received vehicle only.
After 14 days of induction challenge dode was introduced on the guinea pigs by exposing 25% aqueous dilution of the test substance for 24 hours under occlusion. Animals were observed after 24 and 48 hrs
None of the animals of the control or test group were observed with skin reactions after challenge with a non-irritating preparation of 25% of the test material . Hence,2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not sensitizing to guinea pig skin.
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