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EC number: - | CAS number: -
- 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:
- February - May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
- Details on test material:
- Storage: room temperature
Form: liquid
Colour: colorless to yellowish
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Reconstructed Human Epidermis Model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not applicable
- Source strain:
- other: Not applicable
- Justification for test system used:
- Following the REACH bottom-up strategy, as the result of the OECD test guideline No. 439 was positive, the epiCS® Reconstructed Human Epidermis Model method was used to assess skin corrosion as recommended in the OECD test guideline No. 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: 0.60 cm2 reconstituted epidermis (epiCS®)
EXPOSURE
- The test item was applied as supplied, at the dose of 50 μL, to 2 living and 2 killed Human skin model surfaces (epiCS®, CellSystems®) during 3 minutes and 1 hour.
REMOVAL OF TEST MATERIAL AND CONTROLS
- 3 minutes and 1 hour after the test item application, the human epidermis was washed with 20 mL of PBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
The cell viability is quantified by measurement of the cellular mitochondrial dehydrogenases activity. These enzymes are responsible for the MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; EINECS number 206-069-5, CAS number 298-93-1)] reduction into blue formazan in the viable cells. The skin sample is placed in MTT solution of appropriate concentration (e.g. 0.3 or 1 mg/mL) for 3 hours at 37°C ± 1°C. The precipitated blue formazan product is then extracted using a solvent (e.g. isopropanol), and the concentration of formazan is measured by determining the Optical Density (OD) at a wavelength between 540 and 600 nm (preferably 570 nm). The measured absorbances are proportional to the number of living cells.
The measurement of OD was performed using the ELx800 absorbance microplate reader supplied by BioTek and the validated software Gens ELISA V1.05.11 supplied by BioTek.
VIABILITY
Viability = (OD test item / OD negative control) x 100
For each tissue, OD values and calculated percentage cell viability data for the test item, positive and negative controls, should be reported in tabular form, including data from replicate repeat experiments as appropriate, mean and individual values. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 2 living skin model surfaces (epiCS®, CellSystems®) for test item; 2 lived skins each for positive and negative controls
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 at 3 minutes
- Value:
- 47.94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 at 1 hour
- Value:
- 3.63
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- VIABILITY
- 3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 47.94 and 3.63%, respectively, versus 6.08% and 0.39%, respectively, with the positive control item (potassium hydroxide 8N).
Any other information on results incl. tables
Table 7.3.1/1: Skin corrosion assay: Results
Skin |
OD |
Mean OD / disc (#) |
Mean OD / product |
Viability % |
Mean viability % |
Viability difference between replicates % |
|
Treatment: 3 min |
|||||||
Negative control |
1 |
0.669 |
0.686 |
0.0691 |
99.35 |
100 |
1.3 |
0.688 |
|||||||
0.701 |
|||||||
2 |
0.715 |
0.695 |
100.65 |
||||
0.652 |
|||||||
0.717 |
|||||||
Positive control |
3 |
0.025 |
0.025 |
0.042 |
3.62 |
6.08 |
4.9 |
0.025 |
|||||||
0.024 |
|||||||
4 |
0.059 |
0.059 |
8.54 |
||||
0.058 |
|||||||
0.059 |
|||||||
Test item |
7 |
0.232 |
0.233 |
0.331 |
33.74 |
47.94 |
28.4 |
0.231 |
|||||||
0.235 |
|||||||
8 |
0.440 |
0.429 |
62.13 |
||||
0.428 |
|||||||
0.419 |
|||||||
Treatment: 1 hour |
|||||||
Negative control |
11 |
0.856 |
0.842 |
0.771 |
109.28 |
100 |
18.6 |
0.384 |
|||||||
0.835 |
|||||||
12 |
0.710 |
0.699 |
90.72 |
||||
0.676 |
|||||||
0.711 |
|||||||
Positive control |
13 |
0.004 |
0.004 |
0.003 |
0.52 |
0.39 |
0.3 |
0.004 |
|||||||
0.004 |
|||||||
14 |
0.002 |
0.002 |
0.26 |
||||
0.002 |
|||||||
0.002 |
|||||||
Test item |
17 |
0.026 |
0.026 |
0.028 |
3.37 |
3.63 |
0.5 |
0.027 |
|||||||
0.024 |
|||||||
18 |
0.030 |
0.030 |
3.89 |
||||
0.029 |
|||||||
0.029 |
#: mean of 3 values
OD: optical density
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item has to be classified in Category 1B/1C “Corrosive”.
The corresponding hazard statement is “H314: Causes severe skin burns and eye damage” with the signal word “Danger - Executive summary:
An in vitro skin corrosion study was performed according to OECD Guideline 431 and in compliance with GLP to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (epiCS®, CellSystems®).
The test item was applied as supplied, at the dose of 50 μL, to 2 living Human skin model surfaces (epiCS®, CellSystems®) during 3 minutes and 1 hour, followed by a rinse with 20 mL of DPBS. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 47.94% and 3.63% versus 6.08% and 0.39%, respectively, with the positive control item (potassium hydroxide 8N).
Under the test conditions, in accordance with the Regulation (EC) No. 1272/2008, the results obtained enable to conclude that the test item has to be classified in Category 1 “Corrosive”. The corresponding hazard statement is “H314: Causes severe skin burns and eye damage” with the signal word “Danger
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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