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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5 December 2004 to 6 June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- yes
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:
- solid: particulate/powder
- Remarks:
- Crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplied by Procter&Gamble, Batch No. L35939
- Expiration date of the lot/batch: 8 July 2006
- Purity test date: 8 July 2003
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: 99.5% (by HPLC method)
- Specific activity: 57 mCi/mmol ; 2.109GBq/mmol ; 10.7MBq/mg
- Locations of the label: ethanolamine-1.2-14C-
- Expiration date of radiochemical substance: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature in the dark
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: 0.75mg/ml
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
58.6 mg HC Red 3 was weighed into a glass round bottomed vial and dissolved in an ethanolic solution containing 18MBq[14C]-HC Red 3. The solution was mixed then blown to dryness in a stream of nitrogen. 39.82 mg of water and 1898.76 mg"Loving Care" blank tint were added, and the solution mixed.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Hair dye cream formulation containing 3% HC Red 3 (Loving Care Tint used as formulation) - Radiolabelling:
- yes
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: Hair dye cream formulation : Loving Care Tint
- Duration of exposure:
- 30 minutes
- Doses:
- - Nominal doses: 20 mg/cm2
- No. of animals per group:
- 12 replicates were used
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: 58.6 mg HC Red 3 was weighed into a glass round bottomed vial and dissolved in an ethanolic solution containing 18MBq[14C]-HC Red 3. The solution was mixed then blown to dryness in a stream of nitrogen. 39.82 mg of water and 1898.76 mg"Loving Care" blank tint were added, and the solution mixed.
- Method of storage: Not specified
APPLICATION OF DOSE: Since the test material was a gel, the doses were applied to the skin and spread over the surface using small glass rods and the weight of the applied dose recorded after spreading
VEHICLE
- Justification for use and choice of vehicle (if other than water): to mimic a hair dye cream formulation
- Amount(s) applied (volume or weight with unit): 20mg/cm2 (600µg/cm2 of HC Red 3)
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: gently swabbing with a series of sponge pre-wetted with 3% Teepol
- Time after start of exposure: 0.5 hours (30minutes)
ANALYSIS
- Method type(s) for identification Liquid scintillation counting
- Liquid scintillation counting results (cpm) converted to dpm as follows: not specified - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Human skin samples from female donors (post-mortem)
- Ethical approval if human skin: not specified
- Type of skin: Information not available
- Preparative technique: Extraneous tissue was removed from human whole skin samples obtained from post mortem. Skin membranes were cut from whole skin samples at a thickness setting of 400 µm using an electric dermatome
- Thickness of skin (in mm): 400 µm
- Membrane integrity check: Performed by measurement of the electrical resistance across the skin membrane
- Storage conditions: stored at -20 °C on aluminium foil
PRINCIPLES OF ASSAY
- Diffusion cell: glass diffusion cell
- Receptor fluid: containing 4% polyoxyethylene 20 oleyl ether solution in phosphate
- Solubility of test substance in receptor fluid: 0.75 mg/mL
- Static system: Yes
- Flow-through system: No
- Test temperature: 32±1°C
- Humidity: not specified
- Occlusion: No, skin samples were unoccluded
- Reference substance(s): not specified
Results and discussion
- Absorption in different matrices:
- - Receptor fluid, receptor chamber, donor chamber (in vitro test system): The mean penetrated amount of HC Red 3 at 0.5 hours was 0.001µg/cm2 which increased to 0.006µg/cm2 at 1 hour, 0.036 µg/cm2 at 6 hours and was 0.436 µg/cm2 (0.072%) at the end of exposure. The mean residual amount in the remaining epidermis/dermis after tape strapping was 0.612 µg/cm2 (1,01%), thus the mean systemically available proprtion of the dose (amount penetrated + remaining epidermis.dermis) was 1.05µg/cm2.
- Stratum corneum (in vitro test system): (i.e tape strips) The mean proportion of the dose recovered from tape strips representing the stratum corneum, was 0.480 µg/cm2 (0.079%). - Total recovery:
- - Total recovery: 98.7%
- Recovery of applied dose acceptable: Yes
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 48 h
- Dose:
- 3%
- Parameter:
- amount
- Absorption:
- 1.53 other: µg/cm2
- Key result
- Time point:
- 48 h
- Dose:
- 3%
- Parameter:
- percentage
- Absorption:
- 0.252 %
Any other information on results incl. tables
Table1 :SUMMARY OF HC Red 3 DISTRIBUTION IN THE TEST SYSTEM
Test Compartment |
Amount Recovered (µg/cm²) |
|||
Mean |
SD |
SEM |
n |
|
Flange |
0.203 |
0.369 |
0.107 |
12 |
Donor Chamber |
0.313 |
0.217 |
0.063 |
12 |
Skin Wash @ 0.5h |
594 |
8.58 |
2.48 |
12 |
Skin Wash @ 48h |
1.79 |
1.01 |
0.290 |
12 |
StratumCorneum |
0.480 |
0.404 |
0.116 |
12 |
Remaining Epidermis/Dermis |
0.612 |
0.355 |
0.103 |
12 |
Receptor Fluid |
0.436 |
1.77 |
0.051 |
12 |
Systemically Available* |
1.05 |
1.29 |
0.154 |
12 |
TOTAL |
598 |
7.5 |
2.17 |
12 |
Test Compartment |
Percent of Dose Recovered (%) |
|||
Mean |
SD |
SEM |
n |
|
Flange |
0.034 |
0.063 |
0.018 |
12 |
Donor Chamber |
0.02 |
0.036 |
0.010 |
12 |
Skin Wash @ 0.5h |
98.0 |
1.42 |
0.409 |
12 |
Skin Wash @ 48h |
0.296 |
0.166 |
0.048 |
12 |
StratumCorneum |
0.079 |
0.067 |
0.019 |
12 |
Remaining Epidermis/Dermis |
0.101 |
0.059 |
0.017 |
12 |
Receptor Fluid |
0.072 |
0.029 |
0.08 |
12 |
Systemically Available * |
0.173 |
0.088 |
0.025 |
12 |
TOTAL |
98.3 |
1.24 |
0.36 |
12 |
* Systemically Available = Sum of Remaining Epidermis and Receptor Fluid data
TABLE 2 :PENETRATION OF HC Red 3 FROM THE FORMULATION
Hours |
Amount penetrated |
|
µg/cm2 |
% of applied dose |
|
0.5 |
0.001 |
0.000 |
1 |
0.006 |
0.001 |
2 |
0.012 |
0.002 |
4 |
0.022 |
0.004 |
6 |
0.036 |
0.006 |
24 |
0.218 |
0.036 |
29 |
0.269 |
0.044 |
48 |
0.436 |
0.072 |
Applicant's summary and conclusion
- Conclusions:
- Under experimental condition of this study, the results obtained in this study indicate that the penetration of HC Red 3 through human skin is very slow, only 0.25% (1.52μg/cm2) of the applied HC Red 3 was regarded as available. Washing the formulation from the skin surface at 0.5h removed the vast majority of the test substance.
- Executive summary:
The purpose of this study was to determine the in vitro percutaneous penetration of HC Red 3 through human skin over a 48 hour exposure period with a formulation containing HC Red 3 at aconcentration of 3% according to OECD Guideline 428 Method.
The penetration and distribution of HC Red 3 has been measured in vitro through human skin, following the incorporation of [14C]-HC Red 3. The mixed formulation was applied to 12 human dermatomed skin membranes (nominally 400μm thick), mounted in glass diffusion cells, at a nominal rate of 20mg/cm2. After a contact period of 30 minutes, the dose was washed from the surface of the skin using natural sponges soaked in 3% Teepol. Samples of the receptor fluid (4% polyoxyethylene 20 oleyl ether solution in phosphate buffered saline) were taken at recorded intervals over a 48h period, during which time the applications remained unoccluded. At the end of the experiment, the surface of the skin was washed again and layers of stratum corneum removed using a tape stripping technique. The receptor fluid samples, sponges, tape strips, residual skin and donor chambers were analysed for radioactivity, which was representative of the HC Red 3 content. Penetration rates and distribution of the Test Item in the test system were calculated.
Under experimental condition of this study, the results obtained in this study indicate that the penetration of HC Red 3 through human skin is very slow, only 0.25% (1.52μg/cm2) of the applied HC Red 3 was regarded as available. Washing the formulation from the skin surface at 0.5h removed the vast majority of the test substance.
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