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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:
- 15 - 19 Jan 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted in Jul 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted in Jul 2012
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Mainz, Germany
Test material
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue batch number: 25874
- Production date: 15 Jan 2018
- Delivery date: 16 Jan 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 °C
- Temperature of post-treatment incubation: 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: After treatment the tissues were rinsed immediately in 1-minute-intervals.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Anthos Reader 2010 Flexi
- Wavelength: 570 nm
- Filter: no reference filter was used
- Linear OD range of spectrophotometer: 0.1 - 2.5
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm™ tissue was assessed by undertaking a MTT cell viability test. The OD (540 - 570 nm) was 1.71 ± 0.09 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 μL of 1% Triton X-100. The ET-50 value was determined to be 5.28 h.
- Contamination: The cells for EpiDerm™ tissue were screened for potential biological contaminants, such as HIV-1-virus, Hepatitis B virus, Hepatitis C virus, bacteria, yeast and other fungi. No contamination was detected.
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test substance did not directly reduce MTT.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive or irritant to skin if the viability is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µL
NEGATIVE CONTROL
- Amount(s) applied: 30 µL
POSITIVE CONTROL
- Amount(s) applied: 30 µL - Duration of treatment / exposure:
- 35 min
- Duration of post-treatment incubation (if applicable):
- 23 h and 25 min
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 35 min of exposure with the test item
- Value:
- 90
- Vehicle controls validity:
- not applicable
- 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 tested for the ability of direct MTT reduction. Since the MTT solution did not change its colour within 1 hour, direct MTT reduction by the test item had not taken place and no data correction was necessary.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control OD values were 1.677, 1.863 and 1.746 and, thus, in the range of ≥ 0.8 and ≤ 2.8.
- Acceptance criteria met for positive control: The mean viability value was 1.9% and, thus, ≤ 20%.
- Acceptance criteria met for variability between replicate measurements: The standard deviation of the three tissues treated with the test substance was 1.1%, treated with the negative control was 5.3% and treated with the positive control was 0.1% and, thus all standard deviations were ≤ 18%.
Any other information on results incl. tables
Table 1: Mean Absorbance Values (OD 570 nm)
Designation | Negative Control | Reaction mass of potassium sodium phosphotartrate and potassium sodium tartrate and potassium sodium ortho-phosphate (aqueous solution) | Positive Control |
Mean – blank (tissue 1) | 1.677 | 1.563 | 0.034 |
Mean – blank (tissue 2) | 1.863 | 1.592 | 0.033 |
Mean – blank (tissue 3) | 1.746 | 1.602 | 0.036 |
Mean of the three tissues | 1.762 | 1.586 | 0.034 |
Table 2: Tissue Viability (%)
Designation | Reaction mass of potassium sodium phosphotartrate and potassium sodium tartrate and potassium sodium ortho-phosphate (aqueous solution) | Positive Control |
% Tissue viability (tissue 1) | 88.7% | 1.9% |
% Tissue viability (tissue 2) | 90.4% | 1.9% |
% Tissue viability (tissue 3) | 90.9% | 2.0% |
% Tissue viability (mean) | 90.0% | 1.9% |
± SD of mean tissue viability (%) | 1.1% | 0.1% |
Applicant's summary and conclusion
- Interpretation of results:
- other: no irritating potential according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the conditions of the conducted test, the test substance did not show irritating properties in the EpiDerm™ model. The RhE-based test methods are able to identify Cat. 2 and No Cat. chemicals and can thus serve as stand-alone skin irritation methods for non-corrosives.
CLP: 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.
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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