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EC number: 207-005-9 | CAS number: 421-50-1
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation / corrosion: corrosive to skin (OECD 431, GLP compliant, Key Rel. 1)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 September 2016 - 21 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
- 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)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspection dates: 7 - 11, 14 and 16 September 2015. Date of the certificate: 03 November 2015.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL:
- At room temperature
FORM AS APPLIED IN THE TEST
- The liquid test item was applied undiluted (400 µl; excess amount) directly on top of the tissue.
- Since the test item is highly volatile for the 1-hour exposure an excess amount (400 µl) of the test item was applied every 15 minutes.
OTHER SPECIFICS:
- No correction was made for the purity/composition of the test item. - 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 test item and two for a 1-hour exposure)
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
A test item is considered corrosive in the skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (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%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability 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
- Due to the high volatility of the test item an excess amount (400 µl) of the undiluted test item was added into the 6-well plates on top of the skin tissues for the 3-minute exposure. For the one hour incubation, the tissues were re-treated every 15 minutes with an excess amount (400 µl) of the undiluted test item.
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 Test item and two for a 1-hour exposure)
- 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:
- 7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 11%
- Remarks on result:
- other: Corrosive
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not specified
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, mean OD570 (3-minute exposure): 1.556 and mean OD570 (1-hour exposure): 1.679.
- Acceptance criteria met for positive control: Yes, mean relative tissue viability following 1-hour exposure: 11%.
- Acceptance criteria met for variability between replicate measurements: Yes, all coefficients of variation between tissue replicates were below 30%.
- Range of historical values if different from the ones specified in the test guideline: see section "Any other information on results incl. tables". - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- 1,1,1-trifluoroacetone is 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 should be classified as corrosive to skin subcategories 1B and 1C according to UN GHS criteria. - Executive summary:
The assessment of the corrosive potential to skin of 1,1,1-trifluoroacetone 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 1,1,1-trifluoroacetone ( 400 µl; excess amount, every 15 minutes for the 1 -hour exposure) 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 1,1,1-trifluoroacetone compared to the negative control tissues was 90% and 7% respectively.
Because the mean relative tissue viability for 1,1,1-trifluoroacetone was not below 50% after 3 minutes treatment but was below 15% after 1 hour treatment, 1,1,1-trifluoroacetone is considered to be corrosive. The substance should be classified as corrosive to skin subcategories 1B and 1C according to UN GHS criteria.
Reference
Preliminary tests
1,1,1-trifluoroacetone 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 1,1,1-trifluoroacetone did not interfere with the MTT endpoint.
Main test
The mean absorption at 570 nm measured after treatment with 1,1,1-trifluoroacetone 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 1,1,1-trifluoroacetone
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 |
1.417 |
1.393 |
1.405 |
+/- |
0.016 |
0.137 |
0.108 |
0.122 |
+/- |
0.021 |
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.
The following Table shows the mean tissue viability obtained after 3-minute and 1-hour treatments with 1,1,1-trifluoroacetone compared to the negative control tissues.
3-minute application Viability, percentage of control |
1 -hour application Viability, percentage of control |
|
Negative control |
100 / SD: 3.8 |
100 / SD: 10.3 |
Lithium Trifluoromethanesulfonate |
90 / SD: 1.6 |
7 / SD: 21.4 |
Positive control |
11 / SD: 13.9 |
11 / SD: 20.6 |
SD= Standard deviation
Skin corrosion is expressed as the remaining cell viability after exposure to the test item.
Historical control data for in vitro skin corrosion studies
Negative control | Positive control | Positive control | ||||
3 -minute treatment (OD570) |
1 -hour treatment (OD570) |
3 -minute treatment (OD570) |
1 -hour treatment (OD570) |
3 -minute treatment (% viability) |
1 -hour treatment (% viability) |
|
Range | 1.324 - 2.615 | 1.361 - 2.352 | 0.172 - 0.56 | 0.057 - 0.277 | 6 - 22 | 3 - 12 |
Mean | 1.86 | 1.86 | 0.18 | 0.13 | 10.67 | 7.17 |
SD | 0.24 | 0.22 | 0.10 | 0.05 | 3.9 | 2.36 |
n | 65 | 67 | 64 | 61 | 30 | 30 |
SD= Standard deviation
n= Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of December 2012 to December 2015.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
One key study was identified for skin irritation / corrosion.
The assessment of the corrosive potential to skin of 1,1,1-trifluoroacetone 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 1,1,1-trifluoroacetone (400 µl; excess amount, every 15 minutes for the 1 -hour exposure) 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 was 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 1,1,1-trifluoroacetone compared to the negative control tissues was 90% and 7% respectively.
Because the mean relative tissue viability for 1,1,1-trifluoroacetone was not below 50% after 3 minutes treatment but was below 15% after 1 hour treatment, 1,1,1-trifluoroacetone is considered to be corrosive. The substance should be classified as corrosive to skin subcategories 1B and 1C according to UN GHS criteria.
Eye irritation
No study available. However based on the result of the corrosivity assessment to skin, the study does not need to be conducted according to the point 8.2 of the column 2 of Annex VII of REACH regulation.
Respiratory irritation
No study available.
Justification for classification or non-classification
Skin irritation / corrosion
Based on the available information, 1,1,1 -trifluoroacetone should be classified corrosive to skin categories 1B and 1C according the Regulation 1907/2006 (CLP) and the UN GHS Regulation.
Eye irritation
Based on the classification of the substance for skin irritation / corrosion and due to the physico-chemical properties (vapour pressure) of the substance, 1,1,1-trifluoroacetone should be classified corrosive to eye.
Respiratory irritation
Based on the classification of the substance for skin irritation / corrosion and due to the physico-chemical properties (vapour pressure) of the substance, 1,1,1-trifluoroacetone should be classified corrosive to the respiratory tract.
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