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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Clariant Plastics and Coatings (Deutschland) GmbH, BU Additives
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- The assessment of skin irritation has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals.
One of the validated in vitro test methods adopted by the OECD TG 439 makes use of reconstructed human epidermis (RhE) which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. - Details on test system:
- SKIN DISC PREPARATION
- Procedure used: EpiSkin is an in vitro reconstructed human epidermis (RHE) from normal human keratinocytes cultured on a collagen matrix at the air liquid interface. This is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Differentiated and stratified epidermis model comprises the main basal, supra basal, spinous and granular layers and a functional stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo.
- Quality control for skin discs: The human keratinocytes come from mammary samples obtained from healthy consenting donors during plastic surgery. HIV 1 & 2, B and C hepatitis tests were carried out on the donor bloods as well as verification of the bacteriological and fungal sterility of the cells and absence of mycoplasma.
The technical data, safety sheet and certificate of analysis of the EpiSkin kit used in this study
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: The epidermis units were transferred to 12-well plates containing 2 mL of pre-warmed maintenance medium and incubated in a CO2 incubator for approximately 3 hours.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: After the 15 minutes exposure at room temperature, the epidermis units were removed from the wells and thoroughly rinsed with PBS to remove residual matters, if any, from the epidermal surface.
After rinsing each of these epidermal units were gently tapped on an absorbent paper to remove the remaining PBS. The surface gently swabbed with a cotton swab and then placed in a 12-well plate pre-filled with 2 mL pre-warmed assay medium to rinse. After rinsing, all the epidermis units were placed on an absorbent paper to remove excess assay medium and then placed back to the same 12-plate pre-filled with pre-warmed maintenance medium.
DYE BINDING METHOD
- Dye used in the dye-binding assay: [MTT:] After incubation, the epidermis units were dried carefully to remove excess medium and were transferred into a 12-well plate prefilled with 2 mL MTT-solution (0.3 mg/mL) and the plates were incubated for 3-hr at 37°C in a carbon dioxide incubator with 5% CO2
- Spectrophotometer: 200 μL sample from each tube was transferred into the wells of a labeled 96-well flat bottom plate (2 wells/epidermis unit) and the amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Microplate Reader, using acidified isopropanol solution as the blank.
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement) - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Ten microliters (10 μL) of Phosphate Buffered Saline (PBS)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): Ten milligram (10 mg) of 98.5% pure Sodium Dodecyl Sulfate (SDS) in powder form - Duration of treatment / exposure:
- The epidermis units were dried carefully to remove excess medium and were transferred into a 12-well plate prefilled with 2 mL MTT-solution (0.3 mg/mL) and the plates were incubated for 3-hr at 37°C in a carbon dioxide incubator with 5% CO2.
- Number of replicates:
- Three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- The relative mean tissue viability obtained after 15 minutes treatment with the test item compared to the negative control tissues was 145.54 %.
- Value:
- > 145.54
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The test item was checked for possible direct MTT reduction by exposing it in direct contact with the MTT solution.
A quantity of 10 mg of the test item was mixed in a glass tube with 2 mL of MTT solution (0.3 mg/mL) along with water as control and mixed. The resulting mixture was incubated for 3 hours in a carbon dioxide incubator at 37°C protected from light. After the incubation period, the color of the MTT solution was checked.
- Colour interference with MTT: The test item was evaluated for its intrinsic color or ability to become colored in contact with water (simulating a tissue humid environment).
A quantity of 10 mg of the test item was mixed with 90 µL water in a glass tube, kept for 15 minutes at room temperature and then visually observed for color development, if any.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: It is considered that the NC meets the acceptance, if the mean OD value of the 3 tissues is > 0.6 and the Standard Deviation value (SD) of the % viability is < 18.
- Acceptance criteria met for positive control: It is considered that the Positive Control (SDS) meets the acceptance if the mean viability expressed as % of the NC, is < 40% and the SD is < 18.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean relative tissue viability for the test item, Licocare RBW 300 FL TP was 145.54 % and hence, in according with UN GHS it is predicted to be non-irritant under the experimental conditions described in this report.
- Executive summary:
The test item, Licocare RBW 300 FL TP was tested for its possible skin irritation potential using a three dimensionalReconstructed Human Epidermis model,EpiSkin, through topical application for 15 minutes.
The test item is in solid form and was applied directly on the top of the skin tissues at 10 mg/tissue, followed by moistening with 5 µL of the negative control, and exposed for 15 minutes. Ten microliters (10 µL) of PBS and 10 mg of SDS were used as the negative and positive controls, respectively.
After a 42 hour post-incubation period, irritation potential of Licocare RBW 300 FL TP was evaluated by assessing the cytotoxic (irritancy) effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Skin irritation is expressed as the ability of the test item to reduce the cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 minutes treatment with the test item was compared to the negative control tissues.
The absolute mean OD570(optical density at 570 nm) of the negative control tissues was 0.557287. The test item had a mean cell viability of 145.54 % after 15 minutes exposure. The positive control had a mean cell viability of 14.09567 % after 15 minutes exposure, indicating that the test system functioned properly.
The study indicated that the test item Licocare RBW 300 FL TP is in accordance with UN GHS predicted to be non-irritant in this In Vitro Skin Irritation Test using Reconstructed Human Epidermis under the conditions of testing employed.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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