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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:
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18.6.2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid
- Details on test material:
- Test material was sublimed for purification.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- EpiDerm™ tissues derived from MatTek Corporation, Lot# 30863, keratinocyte strain 00267
- Justification for test system used:
- The skin corrosion test refers to the production of irreversible tissue damage following the application of a test material on a reconstructed human skin model. It allows the identification of corrosive chemical substances and mixtures.
The test item is applied topically to a three-dimensional human skin model, comprising of non-transformed, 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 representing main lipid classes analogous to those found in vivo.
The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion and are cytotoxic to the underlying cell layers.
Corrosive chemicals are identified by their ability to decrease cell viability. The viability is measured by enzymatic conversion of the vital dye MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide) into a blue formazan salt, that is quantitatively measured after extraction from tissues. - Vehicle:
- water
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
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 EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava (Designation of the kit: EPI-200-SCT, Batch: 30863) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- in the 3 minute exposure experiment two tissues were tested with 25.9 mg and 25.2 mg test substance; for the 1 hour exposure experiment also two tissues were exposed to 26.2 mg and 26.3 mg test substance, respectively.
- Duration of treatment / exposure:
- 3 minutes and 1 hour exposure
- Duration of post-treatment incubation (if applicable):
- After the respective incubation time (“3 minutes” and “1 hour”) at 37 ± 1 °C and 5.0 ±1% CO2, the inserts were removed from the plates using sterile forceps. The inserts were thoroughly rinsed with DPBS, blotted with sterile cellulose tissue and set into the respective holding plate, using the wells containing assay medium. After transfer of all inserts, they were immediately moved to the wells containing MTT medium, blotting the bottom with cellulose tissue again before setting the insert into the MTT well. The tissues were incubated with MTT solution for 3 hours at 37 ±1 °C and 5.0 ±1% CO2.
After this time, the MTT solution was aspirated and replaced by DPBS. This was then aspirated, too, and replaced several times. At last, each insert was thoroughly dried and set into the empty, pre-warmed 24-well-plate. Into each well, 2 mL isopropanol were pipetted, taking care to reach the upper rim of the insert. The plate was then shaken for 2 hours at room temperature. - Number of replicates:
- Two tissues per exposure time were tested
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item, 3 minutes incubation
- Value:
- 109
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive control, 3 minutes incubation
- Value:
- 20.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item, 1 hour incubation
- Value:
- 79.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive control, 1 hour incubation
- Value:
- 4.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Validity
The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.6 (3 minutes) resp. 1.7 (1 hour).
The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 4.9%.
The values for negative control and for positive control were within the range of historical data of the test facility.
Therefore, the experiment is considered valid.
Any other information on results incl. tables
Measured Values
As blank, the optical density of isopropanol was measured in 12 wells of the 96-well-plate. The measured values and their mean are given as follows:
Absorbance: 0.035, 0.036, 0.035, 0.038, 0.035, 0.035, 0.035, 0.035, 0.035, 0.034, 0.034, 0.035, Mean of 12 values: 0.035
The absorbance values of negative control, test item and positive control are given in the following table:
Absorbance Values (OD 570 nm)
Incubation |
Negative Control |
Test Item |
Positive Control |
|||
|
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
3 min |
1.575 |
1.686 |
1.753 |
1.798 |
0.354 |
0.376 |
1.574 |
1.689 |
1.736 |
1.793 |
0.353 |
0.377 |
|
1.567 |
1.668 |
1.747 |
1.794 |
0.351 |
0.379 |
|
1 h |
1.760 |
1.623 |
1.397 |
1.302 |
0.118 |
0.114 |
1.748 |
1.619 |
1.385 |
1.299 |
0.117 |
0.115 |
|
1.750 |
1.616 |
1.381 |
1.294 |
0.118 |
0.114 |
From the measured absorbances, the mean absorbance of isopropanol was subtracted. The corrected mean and relative standard deviation (RSD) of the two tissues were also calculated.
Mean Absorbance Values of the 3 Minutes Experiment
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.537 |
1.710 |
0.318 |
Mean – blank (tissue 2) |
1.646 |
1.760 |
0.342 |
Mean of the two tissues |
1.591 |
1.735 |
0.330 |
RSD |
4.8% |
2.0% |
5.3% |
Mean Absorbance Values of the 1 h Experiment
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.718 |
1.353 |
0.083 |
Mean – blank (tissue 2) |
1.584 |
1.263 |
0.079 |
Mean of the two tissues |
1.651 |
1.308 |
0.081 |
RSD |
5.7% |
4.8% |
2.9% |
Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of mean tissue viability were calculated in comparison to the mean of the negative controls:
% Tissue Viability
Test Item |
Positive Control |
Incubation |
109.0% |
20.7% |
3 min |
79.2% |
4.9% |
1 h |
Corrosivity of the Test Item
The mean value of relative tissue viability of the test item was increased to 109.0% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1 hour treatment, the mean value of relative tissue viability of the test item was reduced to 79.2%, lying above the threshold for corrosivity (15%). Therefore, the test item is considered as non-corrosive to skin in this study.
Applicant's summary and conclusion
- Interpretation of results:
- other: substance is non-corrosive to skin
- Conclusions:
- The test item AM(pfa)4 is considered non-corrosive to skin.
- Executive summary:
One valid experiment was performed.
Two tissues of the human skin model EpiDerm™ were treated with the test item for 3 minutes and 1 hour, respectively. The test item was applied to each tissue and spread to match the tissue size.
Demineralised water was used as negative control and 8 M KOH was used as positive control.
After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan. Formazan production was evaluated by measuring the optical density (OD) of the resulting solution.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals; thus, showing the quality of the tissues. The OD was 1.6 (3 minutes experiment) and 1.7 (1 hour experiment).
The positive control showed clear corrosive effects for both treatment intervals. The mean relative tissue viability value was reduced to 4.9% for the 1 hour treatment.
After 3 minutes treatment with the test item, the mean value of relative tissue viability was increased to 109.0 %. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, the mean value of relative tissue viability was reduced to 79.2%. This value too is above the threshold for corrosion potential (15%).
Thus, under the conditions of this study, the test item AM(pfa)4 is considered non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test method.
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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