Registration Dossier
Registration Dossier
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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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - May 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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:
- solid: particulate/powder
- Details on test material:
- - odour: odourless
- color: colourless
- expiration date: 16 October 2020
Constituent 1
- Specific details on test material used for the study:
- - Storage conditions: Controlled room temperature (15-25°C, ≤70% relative humidity), protected from light and humidity (stored in a tightly closed container)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: no data
- Details on animal used as source of test system:
- EpiDerm™ Model (EPI-200-SCT) (Source: MatTek, Bratislava, Slovakia, Batch No.: 30859, Expiry date: 24 April 2020) units consist of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis (0.63 cm2). It’s 3D structure consisting of organized and proliferative basal cells, spinous and granular layers, and cornified epidermal layers are mitotically and metabolically active. Its use for skin corrosivity testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability.
- Justification for test system used:
- The EpiDerm™ Model (EPI-200-SCT) has been validated for corrosivity testing in an international validation study [2] and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 431); therefore, it was considered to be suitable for this study.
- Vehicle:
- water
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- The plates with the treated epidermis units were incubated for the exposure time of 3 minutes and 1 hours at 37°C in an incubator with 5 % CO2, in a >95% humidified atmosphere.
- The plates with the treated epidermis units were incubated for the exposure time of 25 minutes (± 0.5 minute) at room temperature (23.5-23.8°C).
REMOVAL OF TEST MATERIAL AND CONTROLS
- After the incubation times the EpiDerm™ units were removed and rinsed thoroughly with DPBS solution (= insert was filled and emptied 20 times in a constant soft stream of DPBS in a glass beaker filled with at least 100 mL DPBS solution) to remove all of the test item from the epidermal surface. The rest of the DPBS was removed from the epidermal surface using a pipette (without touching the epidermis).
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT ((3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1))
- Wavelength: 570 nm
- Spectrophotometer: standard apparatus
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be non-corrosive to skin if the relative tissue viability after 3-minute treatment with a test item is above 50%.and 1 hour >= 15% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied in this original form; no formulation was required. 25 mg test item was applied to the epidermal surfaces in each exposure time point and 25 μL of distilled water was added for wetting of the test item (to increase tissue surface contact).
- Duration of treatment / exposure:
- 3 and 60 minutes
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- In this assay, two replicates for the test item were used. Two negative controls and two positive controls were also run. Furthermore, as the test item was coloured, two additional test item-treated living tissues were used for the non-specific colour optical density (OD) evaluation.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 100.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 89.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Following exposure to the LZ 61000 test item the mean cell viability after 3 minutes of treatment was 89.2 %, the mean cell viability after 1 hour of treatment was 100.9% compared to the negative control. These are above the threshold values in both cases, therefore the test item was considered to be non-corrosive to skin under the conditions of this assay. The experiment met the validity criteria, and therefore the study was considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be non-corrosive in this in-vitro test.
- Executive summary:
An in vitro skin corrosivity test was conducted on the test item in a reconstructed human epidermis model according to OECD test guideline 431 and EU-method. B40. Following exposure to the test item the mean cell viability after 3 minutes of treatment was 100.9 %, the mean cell viability after 1 hour of treatment was 89.8% compared to the negative control. These are above the threshold values in both cases, thereforethe test item was considered to be non-corrosive to skin under the conditions of this assay. The experiment met the validity criteria, and therefore the study was considered to be valid. In conclusion, under the conditions of this in vitro EpiDerm™ SCT Model corrosivity assay, the results indicate that the test item is non-corrosive.
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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