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EC number: 251-410-3 | CAS number: 33229-34-4
- 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:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 428 (draft) and in compliance to GLP.
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)
- Version / remarks:
- (Draft)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
- EC Number:
- 251-410-3
- EC Name:
- 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
- Cas Number:
- 33229-34-4
- Molecular formula:
- C12H19N3O5
- IUPAC Name:
- 2-({4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl}amino)ethan-1-ol
- Details on test material:
- Non-radiolabelled test substance
Test substance : HC Blue No 2
EC number : 251-410-3
Batch number : 114B5
Purity : 98.7%
Radiolabelled substance
Test substance : [ring-U-14C]-HC Blue No 2
Batch number : CFQ13908 batch 1
Radiochemical purity : 98.1% (HPLC), 98.3% (TLC)
Constituent 1
- Radiolabelling:
- yes
Administration / exposure
- Duration of exposure:
- 30 minutes
- Details on in vitro test system (if applicable):
- The study was designed to examine the in vitro percutaneous absorption of the hair dye HC Blue No 2 through human dermatomed skin membranes using [14C]-HC Blue No 2. The compound was tested as a semi-permanent hair dye under 'in-use' conditions in one formulation with a target concentration of 2.8w/w% (actual concentration 2.7w/w%). An amount of 20 mg/cm2 of formulation was applied on the skin surface. The contact time was 30 minutes after which the skin was rinsed following a well-standardised washing procedure. The post exposure time was 23.5 hours. In addition to the radioactivity in the receptor fluid, the residues remaining in/on the skin membranes and in the stratum corneum (after 24 hours of application) was determined.
Human skin membranes were prepared from frozen abdominal skin samples obtained from four female donors. The tissue was obtained directly after surgery. After thawing of the skin, this was dermatomed to a recorded thickness of approximately 400um. The integrity of the skin membranes was established by determination of the permeation coefficient for tritiated water, which was <2.5x10-3 cm/hour for all selected skin membranes.
The study was performed in flow-through diffusion cells. The temperature of the cells was approximately 32 deg C at ambient humidity. The receptor fluid was pumped at a rate of ca. 1.6 mL/hour and consisted of phosphate buffered saline containing 0.01% sodium azide (w/v). The solubility of the test substance, HC Blue No 2, was 425 ug/mL, which is considered sufficient.
Results and discussion
Percutaneous absorption
- Dose:
- 20 mg/cm2 of formulation containing 2.7w/w% test item
- Parameter:
- percentage
- Absorption:
- 0.004 %
- Remarks on result:
- other: 24 hours
- Remarks:
- mean total absorption (dermal delivery)
Any other information on results incl. tables
The percutaneous absorption of HC Blue No 2 was evaluated on 8 skin preparations from 4 different donors. None of the cells was rejected. The results, obtained under the present experimental conditions, are summarised in the table below (mean +/- SD).
% of dose applied | ugeq/cm2 | |
Skin wash | 103.0 +/- 4.4 | 585.0 +/- 33.2 |
Dislodgeable dose | 103.1 +/- 4.4 | 585.0 +/- 33.2 |
Receptor fluid | 0.001 +/- 0.001 | 0.006 +/- 0.005 |
Stratum corneum | 0.007 +/- 0.005 | 0.039 +/- 0.027 |
Skin (epidermis and dermis) | 0.003 +/- 0.001 | 0.014 +/- 0.008 |
Unabsorbed dose | 103.1 +/- 4.4 | 585.0 +/- 33.1 |
Absorbed dose | 0.004 +/- 0.002 | 0.020 +/- 0.009 |
Total recovery | 103.1 +/- 4.4 | 585.1 +/- 33.2 |
Dislodgeable dose is defined as the amount of test substance removable from the application site (skin wash, cotton swabs and donor compartment wash). Unabsorbed dose is defined as the dislodgeable dose including the amount recovered in the stratum corneum. Absorbed dose (dermal delivery) is defined as the amount in the receptor fluid, the receptor compartment wash and skin membrane, excluding strips.
The mean recovery of HC Blue No 2 was 103.1%. Most of the HC Blue No 2 was recovered in the skin wash after 30 minutes of exposure. The skin wash represented 103.0% of the applied dose and the dislodgeable dose 103.1% of the dose applied. After 24 hours, 0.007% of the applied dose was retained in the stratum corneum; those amounts are not considered to percutaneously absorbed. At the end of the experiment, 0.003% of the dose applied was found in the skin (epidermis and dermis) showing the absence of skin storage.
Virtually no penetration of HC Blue No 2 into the receptor fluid after 24 hours was observed (0.006 ug/cm2, 0.001% of the dose applied). The mean total absorption (dermal delivery), defined as the compound related radioactivity present in the receptor fluid, the receptor compartment wash and the skin (excluding tape strips) was 0.004% of the applied dose.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions, the mean recovery of HC Blue No2 was 103.1%. Most of the test item was recovered in the skin wash after 30 minutes of exposure. Virtually no penetration of the test item into the receptor fluid after 24 hours was observed (0.006 ug/cm2, 0.001% of the dose applied). The mean total absorption defined as the compound related radioactivity present in the receptor fluid, the receptor compartment wash and the skin (excluding tape strips) was 0.020 ug/cm2, 0.004% of the dose applied.
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