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EC number: 200-913-6 | CAS number: 75-89-8
- 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
A study was identified as the key study (Griffon, 2004). This study was performed according to the OECD guideline No. 429 and in compliance with the GLP. 2,2,2-trifluoroethanol (TFE) was administered to mice and the lymph node proliferative responses were measured as described by Kimber and Dearman (1991). No clinical signs and no mortality were observed during the study. Furthermore, no irritation of the skin was noted following the application of the test item. The LLNA gave negative results with SI lower than 1 in all the animals whatever the TFE concentration. Under the test conditions, the 2,2,2-trifluoroethanol is not considered as a dermal sensitizer in the murine Local Lymph Node Assay.
This study is considered as acceptable as it satisfies the criteria of the OECD guideline No.429.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-09-16 to 2003-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source : Janvier, Le GEnest-Saint-Isle, France
- Age at study initiation: 9 weeks old
- Weight at study initiation: 20 g (+/- 1.0 g)
- Housing: in individual crystal polystyrene cages (22 cm x 8.5 cm x 8 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 2°C)
- Humidity (%): 30-70%
- Air changes (per hr): approximately 12 cycles per hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: To: no data - Vehicle:
- dimethylformamide
- Remarks:
- Batch No. 06743LA (Aldrich, Saint-Quantin-Fallavier, France)
- Concentration:
- For the preliminary test the concentrations were 10, 25, 50 and 100% of the test item.
For the main test the concentrations were 0, 5, 10, 25, 50 and 100% of the test item. - No. of animals per dose:
- For the preliminary test: 2 females/dose (no controls): Right and left ear were treated with different concentrations.
For the main test: 4 females/dose, 4 females for the negative control and 4 females for the positive control
See details on table 7.4.1/1 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil), Dimethylformamide was chosen among the other proposed vehicles. A homogeneous dosage form preparation was obtained whatever the proportion.
- Irritation: Measurement of the ear thickness (using a micrometer) was performed each day before treatment and 24 hours after the last application. The test item was non-irritant in the preliminary test, whatever the concentration. The highest concentration retained for the main test was therefore the maximal practicable concentration (100%).
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node cell proliferative responses were measured as described by Kimber and Dearman (1991).
- Criteria used to consider a positive response: The results were expressed as disintegration per minute (dpm) per group. Stimulation indices (SI) were calculated according to the following formula: SI = dpm of treated group / dpm of control group. The test item was considered as a skin sensitizer when the SI for a dose group is higher than or equal to 3. Other relevant criteria such as cellularity (amount of cells in treated group compared to the amount in control vehicle group), radioactivity levels and ear thickness were also taken into account for the interpretation of results.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was prepared in the vehicule at the chosen concentrations. All dosage form preparations were made freshly on the morning of the administration and any unused material was discarded that same day. On days 1, 2 and 3, a dose-volume of 25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration. No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no data
- Positive control results:
- In the positive control group given HCA at the concentration of 25%, a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI=4.77) were noted.
The study was therefore considered valid. - Key result
- Parameter:
- SI
- Value:
- < 1
- Variability:
- Lymph nodes pooled
- Test group / Remarks:
- concentration 5 % - 4 females/group
- Key result
- Parameter:
- SI
- Value:
- < 1
- Variability:
- Lymph nodes pooled
- Test group / Remarks:
- Concentration 10 % - 4 females /group
- Key result
- Parameter:
- SI
- Value:
- < 1
- Variability:
- Lymph nodes pooled
- Test group / Remarks:
- Concentration 25 % - 4 females per group
- Key result
- Parameter:
- SI
- Value:
- < 1
- Variability:
- Lymph nodes pooled
- Test group / Remarks:
- Concentration 50 % - 4 females /group
- Key result
- Parameter:
- SI
- Value:
- < 1
- Variability:
- Lymph nodes pooled
- Test group / Remarks:
- Concentration 100 % - 4 females/group
- Key result
- Parameter:
- SI
- Value:
- ca. 4.77
- Variability:
- Lymph nodes pooled
- Test group / Remarks:
- Positive control (HCA) - concentration 25 % - 4 females /group
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item 2,2,2-trifluoroethanol does not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay (stimulation index < 1).
- Executive summary:
A dermal sensitization study was performed according to the OECD guideline No.429 and in compliance with the GLP. 2,2,2-trifluoroethanol (99.95%) diluted in Dimethylformamide at the doses of 0, 5, 10, 25, 50 and 100% was administered to CBA/J mice after a preliminary study to determine main test useful concentrations. The Lymph node proliferative responses were measured as described by Kimber and Dearman (1991).
The positive control used was HCA (α-hexylcinnamaldehyde) which presented a Stimulation index of 4.77. Therefore, the positive control gave acceptable positive results and the study was considered as valid.
No clinical sign and no mortality were observed during the study. Furthermore, no skin irritation was noted following the application of the TFE even at the highest tested concentration (100%). The LLNA gave negative results, as the SI is lower than 1 in the animals treated whatever the concentration of the test item.
Under the test conditions, the 2,2,2-trifluoroethanol is not classified as a dermal sensitizer in the murine Local Lymph Node Assay.
This study is considered as acceptable as it satisfies the criteria of the OECD guideline No.429.
Reference
No clinical signs and no mortality were observed during the study. The body weight gain of the treated animals was similar to that of the control animals. No cutaneaous reactions and no increase in ear thickness were observed at any of the tested concentrations.
Table 7.4.1/3:Results of the main test for the dermal irritation level and the sensitisation
Treatment |
Concentration (%) |
Irritation level |
Stimulation Index (SI) |
TFE |
5 |
Non-irritant |
0.95 |
TFE |
10 |
Non-irritant |
0.95 |
TFE |
25 |
Non-irritant |
0.58 |
TFE |
50 |
Non-irritant |
0.47 |
TFE |
100 |
Non-irritant |
0.42 |
HCA |
25 |
- |
4.77 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available according to the Regulation (EC) No 1272/2008.
Self classification:
2,2,2 Trifluoroethanol is not classified for skin sensitisation according to the criteria of the Annex VI to the Regulation (EC) No 1272/2008 (CLP).
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