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EC number: 221-309-9 | CAS number: 3063-94-3
- 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:
- 17 October 2017 - 20 October 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate
- EC Number:
- 221-309-9
- EC Name:
- 2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate
- Cas Number:
- 3063-94-3
- Molecular formula:
- C7H6F6O2
- IUPAC Name:
- 2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 449935-248
- Expiration date of the lot/batch: 30 March 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: IN refrigerator (2-8ºC)
- Stability under test conditions: Stable under test conditions
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model (EPI-200, Lot no.: 27161 Kit J and Kit K)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cells were purchased or derived from tissue obtained by MatTek Corporation from acredited institutions.
- Source strain:
- other: Keratinocyte strain: 4F1188
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1ºC (actual range 36.7 - 37.4°C).
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
- 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.
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 4 per test item / 2 per control
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the relevant mean tissue viability obtained after 3-minute tretment compared to the negative control tissues is decreased by below 50%. In addition, a test item considered nn-corosive (viability >=50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15.
- The test substance is considered to be non-corrosive to skin if the relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%. In addition, the relative tissue viabilty after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50μl
NEGATIVE CONTROL
- Amount(s) applied: 50µl
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50µl
- Concentration (if solution): 8N - Duration of treatment / exposure:
- 3 minutes / 1 hour
- Number of replicates:
- 2 per exposure time
For the negative and positive controls, 2 tissues
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute application
- Value:
- 101
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1-hour application
- Value:
- 90
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
RESULTS
2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test item did not interfere with the MTT endpoint.
The mean absorption at 570 nm measured after treatment with the test item and controls are presented inAppendix 1, Table1. The individual OD570 measurements are presented in table 1.
Table 2 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 101% and 90% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues waswithin the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit<=2.8) and the laboratory historical control data range. The mean relative tissue viability following the 1-hour exposure to the positive control was 7.7%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was < 8%, indicating that the test system functioned properly.
Table 1
Mean Absorption in the in vitro skin corrosion test with 2,2,2 -trifluoro-1 -(trifluoromethyl)ethyl methacrylate
3 -minute application (Mean) | 1 -hour application (Mean) | ||||||
A (OD570) | B (OD570) | Mean (OD570) SD | A (OD570) | B (OD570) | Mean (OD570) SD | ||
Negative control | 2.085 | 1.936 | 2.010±0.106 | 2.183 | 2.371 | 2.277± 0.133 | |
Test Item | 2.063 | 1.988 | 2.025± 0.053 | 2.063 | 2.045 | 2.054± 0.013 | |
Positive control | 0.131 | 0.143 | 0.137± 0.009 | 0.187 | 0.162 | 0.175± 0.018 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are correct for background absorption (0.0430). Isopropanol was used to measure the background absorption.
Table 2
Mean tissue viability in the in vitro skin corrosion test with 2,2,2 -trifluoro-1 -(trifluoromethyl)ethyl methacrylate
3 -minute application viability (percentage of control) | 1 -hour application viability (percentage of control) | |
Negative control | 100 | 100 |
Test Item | 101 | 90 |
Positive control | 6.8 | 7.7 |
Table 3
Coefficient of variation between tissue replicates
3 -minute | 1 -hour | |
Negative control | 7.2 | 7.9 |
Test item | 3.6 | 0.9 |
Positive control | 8.7 | 13 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, 2,2,2 -trifluoro-1-(trifluoromethyl)ethyl methacrylate 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 2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate for its ability to induce skin corrosion onon 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.
Batch 449935-248 of the test item was a clear colourless liquid. The test item was applied undiluted (50 µl) directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 7.7% 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 < 8%, 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 101% and 90%, 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, 2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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