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EC number: 283-144-9 | CAS number: 84540-50-1
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 04.03.2011 - 16.02.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 428: Skin Absorption: In Vitro Method
- GLP compliance:
- yes (incl. QA statement)
Test material
- Specific details on test material used for the study:
- Unlabelled test material:
3-amino-2-chloro-6-methylphenol
Radiolabelled test material:
Name: [14C]-labelled test substance (test item)
Chemical name: 5-Amino-6-chloro-o-cresol, [U-^14C]-phenol
Molecular mass: 159.6 g/mol at 2294 MBq/mmol
Purity: 99 % (HPLC)
Appearance: Pale pink solid
Results and discussion
Applicant's summary and conclusion
- Executive summary:
The test substance, A094, is intended to be used as an ingredient in hair dye formulations. As part of the safety evaluation of this ingredient, a study was required to assess the extent of its dermal bioavailability following topical application of three formulations, with radiodiluted [14C]-A094 concentrations of 1, 2 and 3% (w/w), to excised dermatomed pig skin. Immediately prior to application, the formulations were mixed 1:1 (w/w) with developer without hydrogen peroxide (Test Preparations 1, 3 and 5) and with developer with hydrogen peroxide (6%, w/w) (Test Preparations 2, 4 and 6). The final applied concentration of A094 in Test Preparations 1 and 2 was 0.5% (w/w). The concentration of A094 in Test Preparations 3 and 4 was (1.0%, w/w). The concentration of A094 in Test Preparations 5 and 6 was 1.5% (w/w). The skin surface was washed at 30 min, for each test preparation, to reflect the in-use conditions. The skin was again washed at 24 h post dose as a final wash off before test run termination.
Previously frozen dermatomed pig skin (12 replicates per test run of 4 individual pigs in total) was mounted into static diffusion cells containing receptor fluid (phosphate buffered saline, ca 10 mL) in the receptor chamber. The skin surface temperature was maintained at 32°±1°C throughout the experiment. An electrical resistance barrier integrity test was performed and any pig skin sample exhibiting a resistance <4 kΩ was excluded from subsequent dermal bioavailability measurements.
The hair dye formulation was applied at an application volume of ca 20 mg/cm2, to dermatomed pig skin mounted into static diffusion cells in vitro.
Dermal bioavailability was assessed by collecting receptor fluid aliquots at 0.5, 1, 2, 4, 6 and 24 h post dose. At 30 min post dose, for both test preparations, exposure was terminated by washing the skin surface with a mild shampoo solution and drying the skin surface with tissue paper (tissue swabs). At 24 h post dose, the washing procedure was repeated. The skin was then removed from the static diffusion cells, dried and divided into exposed and unexposed skin. The stratum corneum was removed from the exposed skin with 20 successive
D-Squame® discs. The exposed and unexposed skin was solubilised with Solvable® tissue solubiliser. Bulk receptor fluid was removed from the receptor chamber and retained for future interest. All samples were analysed by liquid scintillation counting.
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