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EC number: 251-528-5 | CAS number: 33454-82-9
- 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 31-August-2016 to 24-October-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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)
- Version / remarks:
- Adopted 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Except for the Test Item characterisation which was conducted in an ISO 9000 environment.
Test material
- Reference substance name:
- Lithium trifluoromethanesulphonate
- EC Number:
- 251-528-5
- EC Name:
- Lithium trifluoromethanesulphonate
- Cas Number:
- 33454-82-9
- Molecular formula:
- CHF3O3S.Li
- IUPAC Name:
- lithium trifluoromethanesulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- See confidential details on test material
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL:
- At room temperature container flushed with nitrogen, desiccated
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:
- Not applicable
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model EPI-200
- Tissue batch number(s): 24364 Kit M and L
- Source: MatTek Corporation, Ashland, MA, USA
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: All incubations, with the exception of the test item incubation of 3 minutes at room temperature, were carried out at 37.0 ± 1.0°C (actual range 35.6 - 37.3°C).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/ml) diluted (1:5) with MTT diluent (supplemented DMEM)
- Incubation time: 3 hours (37°C)
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD (540-570) = 1.496+/-0.034 [1.0 - 3.0]
- Barrier function: ET-50 = 6.52 hrs [4.77 - 8.72 hrs]
- Morphology: Functional stratum corneum, viable basal cell layer, and intermediate spinous and granular layers
- Contamination: No contamination (absence of bacteria, fungus and mycoplasma)
NUMBER OF REPLICATE TISSUES: 4 tissues per test item together with a negative control and positive control (2 tissues were used for a 3-minute exposure to Lithium Trifluoromethanesulfonate and two for a 1-hour exposure)
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
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%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 35.6 to 48.6 mg of the solid test item with 25 µl Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test item to the tissue.
NEGATIVE CONTROL
- Amount applied: 50 µl Milli-Q water
POSITIVE CONTROL
- Amount applied: 50 µl KOH
- Concentration: 8N - Duration of treatment / exposure:
- 3-minute and 1-hour exposures
- Number of replicates:
- 4 tissues per test item together with a negative control and positive control (2 tissues were used for a 3-minute exposure to Lithium Trifluoromethanesulfonate and two for a 1-hour exposure)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean values
- Run / experiment:
- 3-minute application
- Value:
- 90
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 11%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean values
- Run / experiment:
- 1-hour application
- Value:
- 63
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 11%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
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 (3-minute treatment: 1.324-2.615 / 1-hour treatment: 1.361-2.352).
The mean relative tissue viability following the 3-minute or 1-hour exposure to the positive control was 11%.
In the range 20-100% viability, the Coefficient of Variation (cut-off value <= 30%) between tissue replicates was <= 10% for the negative control and the 3-minute treatment with the test item, indicating that the test system functioned properly. For the 1-hour treatment with the test item the coefficient of variation was 69%, but because the individual results of the mean relative tissue were 30% and 97%, both above 15%, this does not affect the study outcome.
Any other information on results incl. tables
Preliminary tests
Lithium Trifluoromethanesulfonate was checked for colour 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 Lithium Trifluoromethanesulfonate did not interfere with the MTT endpoint.
Main test
The mean absorption at 570 nm measured after treatment with Lithium Trifluoromethanesulfonate and controls are presented in the following Table. The individual OD570 measurements are presented in an other Table below.
Mean absorption in the in vitro skin corrosion test with Lithium Trifluoromethanesulfonate
3 -minute application | 1 -hour application | |||||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
|
SD |
A (OD570) |
B (OD570) |
Mean (OD570) |
|
SD |
|
Negative control |
1.526 |
1.586 |
1.556 |
+/- |
0.042 |
1.770 |
1.588 |
1.679 |
+/- |
0.129 |
Lithium Trifluoromethanesulfonate |
1.440 |
1.372 |
1.406 |
+/- |
0.048 |
0.502 |
1.626 |
1.064 |
+/- |
0.795 |
Positive control |
0.180 |
0.155 |
0.167 |
+/- |
0.018 |
0.205 |
0.163 |
0.184 |
+/- |
0.030 |
SD= Standard deviation
Duplicate exposures are indicated by A and B
In this table the values are corrected for background absorption (0.0420). Isopropanol was used to measure the background absorption.
Individual OD measurements at 570 nm
3-minute application (OD570) AB |
1-hour application (OD570) AB |
|||
Negative control |
|
|
||
OD570 measurement 1 |
1.5361 |
1.6025 |
1.7973 |
1.6268 |
OD570 measurement 2 |
1.5801 |
1.6369 |
1.8098 |
1.6275 |
OD570 measurement 3 |
1.5880 |
1.6449 |
1.8278 |
1.6348 |
Lithium Trifluoromethanesulfonate |
|
|
|
|
OD570 measurement 1 |
1.5015 |
1.4262 |
0.5481 |
1.6941 |
OD570 measurement 2 |
1.4688 |
1.4062 |
0.5456 |
1.6541 |
OD570 measurement 3 |
1.4750 |
1.4106 |
0.5380 |
1.6556 |
Positive control |
|
|
|
|
OD570 measurement 1 |
0.2226 |
0.2013 |
0.2484 |
0.2051 |
OD570 measurement 2 |
0.2199 |
0.1948 |
0.2513 |
0.2053 |
OD570 measurement 3 |
0.2221 |
0.1934 |
0.2425 |
0.2051 |
OD = Optical density
Duplicate exposures are indicated by A and B.
The following Table shows the mean tissue viability obtained after 3-minute and 1-hour treatments with Lithium Trifluoromethanesulfonate compared to the negative control tissues.
3-minute application Viability, percentage of control |
1 -hour application Viability, percentage of control |
|
Negative control |
100 (98 and 102) / SD: 3.8 |
100 (105 and 95) / SD: 10.3 |
Lithium Trifluoromethanesulfonate |
90 (93 and 88) / SD: 4.7 |
63 (30 and 97) / SD: 69.1 |
Positive control |
11 (12 and 10) / SD: 13.9 |
11 (12 and 10) / SD: 20.6 |
SD= Standard deviation
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 Lithium Trifluoromethanesulfonate compared to the negative control tissues was 90% and 63% respectively. Because the mean relative tissue viability for Lithium Trifluoromethanesulfonate was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, Lithium Trifluoromethanesulfonate is considered to be not corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Lithium Trifluoromethanesulfonate is not corrosive in the in vitro skin corrosion test (OECD Guideline No. 431, adopted 29 July 2016) under the experimental conditions described in this report.
The substance is not classified as corrosive to skin according to GHS criteria. - Executive summary:
The assessment of the corrosive potential to skin of Lithium Trifluoromethanesulfonate was carried out, under GLP compliance, using an in vitro skin corrosive test based on the guidelines described in: OECD No. 431 (adopted 29 July 2016) and EU Method B.40 BIS.
The test consisted of topical application of Lithium Trifluoromethanesulfonate (35.6 to 48.6 mg of the solid test item with 25 µl Milli-Q water) on the skin tissue for 3-minute and 1-hour. After exposure the skin tissue was 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.
The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with Lithium Trifluoromethanesulfonate compared to the negative control tissues was 90% and 63% respectively.
Because the mean relative tissue viability for Lithium Trifluoromethanesulfonate was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, Lithium Trifluoromethanesulfonate is considered to be non-corrosive in the performed experiment. The substance is not classified as corrosive to skin according to GHS criteria.
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