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Diss Factsheets
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EC number: 619-856-7 | CAS number: 1056196-56-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 33470-153 FK
- Expiration date of the lot/batch: 30 Apr 2009.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: The sponsor guarantees the storage stability at least until 30 Apr 2009.
- Solubility and stability of the test substance in the solvent/vehicle: Because the test substance is applied undiluted or minimally moistened with doubly distilled
water, no analysis of the test substance in a vehicle is required.
FORM AS APPLIED IN THE TEST (if different from that of starting material): minimally moistened with doubly distilled water.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Skin model: Epi-200, Supplier: MatTek Corp., Ashland MA, USA
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: human - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epiderm model (Epi-200)
- Tissue batch number(s): Lot No. Kit 9450
- Date of initiation of testing: 18.07.2007
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1
- Observable damage in the tissue due to washing: Skin more or less detached from supporting diaphragm in all reaction chambers before washing. Washing resulted in full detatchment and ripping skin in pieces.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ mL assay medium.
- Incubation time: 3 hours.
- Spectrophotometer: Image Reader Spectra SL T.
- Wavelength: 570 nm.
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: killed tissue.
- Procedure used to prepare the killed tissues (if applicable): killed by twice freezing at -20°C and thawing at room temperature.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL - Duration of treatment / exposure:
- 3 min, 1 hour
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1, mean of 2 replicate tissues/ 3 min exposure period
- Value:
- 105
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1, mean of 2 replicate tissues/ 1 hour exposure period
- Value:
- 112
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Skin more or less detached from supporting diaphragm in all reaction chambers before washing. Washing resulted in full detatchment and ripping of skin in pieces. However, validity of the study was indicated by fullfillment of acceptance criteria.
- Direct-MTT reduction: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Table 1: Individual and mean OD570 values, individual and mean viability values after 3 min exposure.
OD570 tissue 1 |
OD570 tissue 2 |
mean OD570 |
viability [% of NC] |
|
NC | 1.759 | 1.583 | 1.671 | 100 |
Test material | 1.796 | 1.709 | 1.752 | 105 |
PC | 0.263 | 0.203 | 0.233 | 14 |
NC: negative control
PC: positive control
Table 2: Individual and mean OD570 values, individual and mean viability values after 1 hour exposure.
OD570 tissue 1 |
OD570 tissue 2 |
mean OD570 |
viability [% of NC] |
|
NC | 1.641 | 1.683 | 1.662 | 100 |
Test material | 1.779 | 1.933 | 1.856 | 112 |
PC | 0.223 | 0.293 | 0.258 | 15 |
NC: negative control
PC: positive control
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material showed no skin corrosion potential in the EpiDerm™ in vitro Corrosivity-Test under the test conditions chosen.
- Executive summary:
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 10 mg of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
Two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The following results were obtained in the EpiDerm™ Corrosivity-Test:
The test substance is not able to directly reduce MTT.
The mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 105 % and it was 112 % after an exposure period of 1 hour.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test material shows no skin corrosion potential in the EpiDerm™ in vitro Corrosivity-Test under the test conditions chosen.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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