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EC number: 947-405-7 | CAS number: -
- 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 is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Pigmented contact dermatitis from azo dyes -I
- Author:
- TAKEHITO KGZUKA et. al
- Year:
- 1 980
- Bibliographic source:
- Contact Dermatitis, 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A study was performed in human volunteers to determine the degree of allergic reactions caused by the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 1-(4-methyl-2-nitrophenylazo)-2-naphthol
- EC Number:
- 219-372-2
- EC Name:
- 1-(4-methyl-2-nitrophenylazo)-2-naphthol
- Cas Number:
- 2425-85-6
- Molecular formula:
- C17H13N3O3
- IUPAC Name:
- 1-(4-Methyl-2-nitrophenylazo)-2-naphthol
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Toluidine Red- Molecular formula: C17H13N3O3- Molecular weight : 307.308g/mol- Substance type:Organic- Physical state:Solid-Smiles: c12c(\N=N\c3c(cc(C)cc3)[N+](=O)[O-])c(ccc1cccc2)O : c12c(\N=N\c3ccc(\N=N\c4ccccc4)cc3)c(ccc1cccc2)O- InChI: 1S/C17H13N3O3/c1-11-6-8-14(15(10-11)20(22)23)18-19-17-13-5-3-2-4-12(13)7-9-16(17)21/h2-10,21H,1H3/b19-18+
Constituent 1
In vivo test system
Test animals
- Species:
- other: human
- Strain:
- other: Not applicable
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 2
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 2
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 8
- Details on study design:
- The tests were performed with Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). The application was performed on the back for 2 days. Readings were made according to the ICDRG classification 24 h after the patches were removed.
- Challenge controls:
- 28 healthy female volunteers
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- Skin sensitizing effects were not observed.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Skin sensitizing effects were not observed.None of the control volunteers gave a positive reaction
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No dermal reactions were observed in all treated patients. Thus the test material was not considered to be a potent sensitizer in human patients suffering from pigmented contact dermatitis.
- Executive summary:
A study was performed in human volunteers to determine the degree of allergic reactions caused by the test chemical.
The test chemical 1% in petrolatum was applied onto the back of 8 healthy patients for 24 hours by using Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days. Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.
No dermal reactions were observed in all treated patients. Thus the test material was not considered to be a potent sensitizer in human patients suffering from pigmented contact dermatitis.
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