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EC number: 220-701-7 | CAS number: 2871-01-4
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 5 March 1984 to 12 June 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The entire study extended over a six weeks period with three phases: induction, rest and challenge. The induction phase consisted of 10 consecutive applications of the test material. The patches were removed 24 hours after application and evaluated each 48 hours. The challenge phase was initiated during the sixth week of the study, with identical patches applied to a unexposed site to the test material. Patches were removed after 48 hours. The sites were graded 48 and 72 hours after removal.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(4-amino-2-nitroanilino)ethanol
- EC Number:
- 220-701-7
- EC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Cas Number:
- 2871-01-4
- Molecular formula:
- C8H11N3O3
- IUPAC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Product No. 1431282
- Expiration date of the lot/batch:not specified
- Purity test date: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: keep unused in refrigerator
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The samples were prepared at a level of 3.0% with : Tween 80 (2.0%), Natrosol (2.0%), Sodium Sulfite (0.05%), Carbitol (6.0%), Hexyleneglycol (4.0%), Water (q.s. 100)
Method
- Type of population:
- not specified
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 115 enrolled ; 100 completed cases
- Sex: male & female
- Age: 19-79
- Race: not designated
- Demographic information: Causaian; Negroid, Hispanic and Other (no more details) - Controls:
- No control was used in the study
- Route of administration:
- inhalation
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
- Type of application: semi-occlusive
- Description of patch: A 1.4cm square blotting paper affixed with Scanpor tape
- Vehicle / solvent: Formulation : The samples were prepared at a level of 3.0% with : Tween 80 (2.0%), Natrosol (2.0%), Sodium Sulfite (0.05%), Carbitol (6.0%), Hexyleneglycol (4.0%), Water (q.s. 100)
- Concentrations: 3%
- Volume applied: 0.1 mL
- Testing/scoring schedule: 48 hours after patch application
- Removal of test substance: 48 and 72 hours after application
EXAMINATIONS
Grading/Scoring system
-No reaction
- Doubtful response, barely perceptible erythema, only slighty different from surrounding skin
- Definite erythema (minimal or doubtful edema)
- Minimal or doubful edema
- Definite erythema
- Definite edema
- Definite erythema (definite edema and vesiculation)
-Statistical analysis : not specified
Results and discussion
- Results of examinations:
- There were neither irritation nor sensitisation reactions in the study.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of the study, the test substance H.C. Red No. 3 did not induce sensitization effect on voluntary subjects in a Human Repeated Insult Patch Test.
- Executive summary:
The purpose of the non GLP-compliant study was to evaluate the potential sensitizer effect of the test item H.C. Red No. 3 on human with a Human Repeated Insult Patch Test.
115 subjects were used in this study. The entire study extended over a six weeks period with three phases: induction, rest and challenge. The induction phase consisted of 10 consecutive applications of the test material. The patches were removed 48 hours after application and skin evaluated each 48 hours. The challenge phase was initiated during the sixth week of the study, with identical patches applied to sites on the opposite site previously unexposed to the test material. Patches were removed after 48 hours. The sites were grades 48 and 72 hours after removal.
Under the experimental conditions of the study, the test substance H.C. Red No. 3 in hayr dye base did not induce sensitization effect on voluntary subjects in a Human Repeated Insult Patch Test.
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