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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:
- From 30 March 2020 to 17 April 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study is conducted in accordance with the relevant OECD test guideline and GLP. All validity criteria were met.
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:
- other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
- Details on test material:
- Storage conditions: At room temperature protected from light
Physical description: Light orange liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model
- Source species:
- other: human-derived epidermal keratinocytes
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes, purchased or derived from tissue obtained by MatTek Corposation from accredited institutions
- Source strain:
- other: Keratinocyte strain 00267
- Details on animal used as source of test system:
- N/A
- Justification for test system used:
- The test is based on the experience that corrosive chemicals show cytotoxic effects following short-term exposure to the stratum corneum of the epidermis. The test is designed to predict and classify the skin corrosion potential of a test item by assessment of its effect on a three-dimensional human epidermis model (1-4).
The test consists of topical application of the test item on the skin tissue for 3-minute and
1-hour. After exposure the skin tissue is thoroughly rinsed to remove the test item followed by immediate determination of the cytotoxic (corrosive) effect.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): 33008 kit G+B and 33018 kit G+F
- Production date: Not specified
- Shipping date: Not specified
- Delivery date: Not specified
- Date on Certificate of Analysis: 1 April 2020
- Date of initiation of testing: Not specified
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C ± 1.0°C
- Temperature of post-treatment incubation (if applicable): 37°C ± 1.0°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test item. The skin inserts were carefully dried. Rinsed tissues were kept in 24 well plates on 300 µL DMEM until 6 tissues (= one application time) were dosed and rinsed
- Observable damage in the tissue due to washing: Not specified
- Modifications to validated SOP: Not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 5 mg/mL diluted (1:5) with MTT diluent (supplemented DMEM)
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 4
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1, although initially the tissues treated for 3 minutes with the test item did not fulfill the acceptability criteria. This part of the experiment was rejected and repeated.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: N/A - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 minutes, 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 4
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute application
- Value:
- 74
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% tissue viability
- Positive controls validity:
- valid
- Remarks:
- 8.2% tissue viability
- Remarks on result:
- other: no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour application
- Value:
- 27
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% tissue viability
- Positive controls validity:
- valid
- Remarks:
- 8.8% tissue viability
- Remarks on result:
- other: no indication of corrosion
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: The solutions did not turn blue/purple nor a blue/purple precipitate was observed so it was concluded that the test item did not interfere with the MTT endpoint
- Colour interference with MTT: The solutions did not turn blue/purple nor a blue/purple precipitate was observed so it was concluded that the test item did not interfere with the MTT endpoint
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes - the absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit 2.8) and the laboratory historical control data range.
- Acceptance criteria met for positive control: Yes - the mean relative tissue viability following the 1-hour exposure to the positive control was 8.8%.
- Acceptance criteria met for variability between replicate measurements: Yes - in the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was 27%, indicating that the test system functioned properly
Any other information on results incl. tables
Table 1
Mean Absorption in the in vitro Skin Corrosion Test with
N-Phenyl-diethanolamine, reaction products with formaldehyde EC:
942-131-4
|
3-minute application |
1-hour application |
||||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
|||
Negative control |
1.769 |
1.737 |
1.753 |
± |
0.022 |
1.733 |
1.616 |
1.674 |
± |
0.083 |
Test item |
1.398 |
1.189 |
1.294 |
± |
0.148 |
0.383 |
0.527 |
0.455 |
± |
0.102 |
Positive control |
0.155 |
0.134 |
0.144 |
± |
0.015 |
0.124 |
0.169 |
0.147 |
± |
0.032 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0436 and 0.0424 for the 3-minute and 1 hour application, respectively).
Isopropanol was used to measure the background absorption.
Table 2
Mean Tissue Viability in the in vitro Skin Corrosion Test with
N-Phenyl-diethanolamine, reaction products with formaldehyde EC:
942-131-4
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Test item |
74 |
27 |
Positive control |
8.2 |
8.8 |
Table 3
Coefficient of Variation between Tissue Replicates
|
3 minute |
1 hour |
Negative control |
1.8 |
6.8 |
Test item |
15 |
27 |
Positive control |
14 |
27 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Individual OD Measurements at 570 nm
|
3-minute application (OD570) A B |
1-hour application (OD570) A B |
||
Negative control OD570 measurement 1 OD570 measurement 2 OD570 measurement 3 |
|
|
||
1.8317 |
1.7845 |
1.8072 |
1.6497 |
|
1.8198 |
1.7895 |
1.7597 |
1.6520 |
|
1.7851 |
1.7682 |
1.7583 |
1.6720 |
|
Test item OD570 measurement 1 OD570 measurement 2 OD570 measurement 3 |
|
|
||
1.4371 |
1.2239 |
0.4353 |
0.5674 |
|
1.4380 |
1.2386 |
0.4108 |
0.5683 |
|
1.4499 |
1.2365 |
0.4292 |
0.5719 |
|
Positive control OD570 measurement 1 OD570 measurement 2 OD570 measurement 3 |
|
|
||
0.1972 |
0.1786 |
0.1699 |
0.2097 |
|
0.1992 |
0.1761 |
0.1654 |
0.2136 |
|
0.1987 |
0.1771 |
0.1645 |
0.2121 |
OD = Optical density
Duplicate exposures are indicated by A and B.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
The objective of this study was to evaluate the test item for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of the test item was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
The test item was a light orange liquid. The test item was applied undiluted (50 µL) directly on top of the skin tissue. At the end of the treatment period. Cell viability was assessed using the MTT assay.
The positive control had a mean relative tissue viability of 8.8% after the 1-hour exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤27%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 74% and 27%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive.
In conclusion, the test item is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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