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Diss Factsheets
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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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 15 Aug 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Details on test material:
- - Name of test material (as cited in study report): trade name given
- Substance type: white, crystalline powder
- Analytical purity: 99.5%
- Solubility: water: < 0.1 g/L
- Lot/batch No.: 1592ZG-076
- Expiration date of the lot/batch: Aug 2015
- Storage condition of test material: at room temperature 20 ± 5 °C
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EpiDermTM
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
TEST METHOD
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The test consists of a topical exposure of the neat test item to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential.
ADAPTATION TO CELL CULTURE CONDITIONS
Tissues were transferred into 6-well plates (three per plate, upper row) containing 900 µL assay medium per well and preincubated in an incubator for 1 h (37 °C, 5% CO2). After the preincubation, every tissue was transferred into a well of the lower row containing 900 µL fresh assay medium . All 6-well-plates were set into the incubator at 37 °C and 5% CO2 for 18 hours.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37
- CO2 gas concentration (%): 5
Test system
- Type of coverage:
- other: open, in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Concurrent control tissues treated with DPBS buffer served as negative controls, positive controls were exposed to 5% SDS.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 24.9 mg (mean)
The tissues were wetted with 25 µL DPBS buffer before applying the test item and spreading it to match the tissue size.
POSITIVE CONTROL SUBSTANCE
- Positive control substance: SDS, 5%
NEGATIVE CONTROL SUBSTANCE
- Negative control substance: DPBS buffer - Duration of treatment / exposure:
- 60 min (35 min at 37°C and 25 min at RT)
- Observation period:
- Not applicable.
Post-treatment incubation period: 42 ± 2 h - Number of animals:
- Not applicable.
The test was performed in triplicates for each treatment and control group. - Details on study design:
- TEST SITE
- Area of exposure: 0.63 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: The test item was washed from the skin surface with DPBS buffer.
- Time after start of exposure: 60 min
- Post-treatment incubation period: 42 ± 2 h
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed 42 ± 2 h h after the incubation period. Therefore, tissues were incubated in 300 µL freshly prepared MTT-reagent for 3 h ± 5 min at 37 ± 1 °C and 5% CO2. After aspiration of the MTT reagent, tissues were washed several times in DPBS buffer followed by tissue drying. Extraction of the formazan product was carried out in 2 mL isopropanol for 2 h. The optical density was measured at 570 nm wave length in a plate spectral photometer.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of negative controls (DPBS buffer). Time point: 60 min. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 2.2
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of positive controls (5% SDS). Time point: 60 min. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 101.8
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the test item. Time point: 60 min. Reversibility: other: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).
After the treatment with the test substance, the relative absorbance values increased compared to the negative control to 101.8 %. This value is well above the threshold for irritation potential (50%).
Any other information on results incl. tables
Table 4. MTT assay after 60 min exposure.
|
Negative control |
Positive control |
Test substance |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD570 |
2.079 2.072 |
2.213 2.195 |
1.917 1.921 |
0.082 0.082 |
0.086 0.082 |
0.081 0.079 |
2.040 2.020 |
2.046 2.211 |
2.180 2.120 |
OD570 (mean-blank) |
2.039 |
2.167 |
1.882 |
0.045 |
0.045 |
0.043 |
1.993 |
2.092 |
2.113 |
Relative SD (%) |
7.0 |
3.1 |
4.4 |
||||||
OD570(mean values of replicates) |
2.029 |
0.045 |
2.066 |
||||||
Viability (%) |
100 |
2.2 |
101.8 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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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