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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-06-28 to 1999-7-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- May 1981
- Deviations:
- yes
- Remarks:
- : no detail on animals and environmental conditions. A 7 day observation period after the completion of exposure instead of 14 days.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2,2-trifluoroethanol
- EC Number:
- 200-913-6
- EC Name:
- 2,2,2-trifluoroethanol
- Cas Number:
- 75-89-8
- Molecular formula:
- C2H3F3O
- IUPAC Name:
- 2,2,2-trifluoroethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 2,2,2 trifluoroethanol (TFEA)
- Physical state: no data
- Lot/batch No.: 905033
- Expiration date of the lot/batch: no data
- Stability under test conditions: assumed to be stable during the test (sponsor responsibility)
- Storage condition of test material: no data
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: vapor generator ; model GEL-1A, Shibata Scientific Technology LTD). The test substance was introduced from the top part of the inhalation chamber through a pre-filter and HEPA filter after mixing and dilution with the air inside the breathing chamber and then ejected normally from the lower part (one pass method). The concentration of the test substance was adjusted by changing the mix ratio of the test substance gas and the dilution air.
- Exposure chamber volume: 384L
- Method of holding animals in test chamber: no data
- Source and rate of air: Airflow, 100L/min
- Method of conditioning air: The ejected test substance was processed through an activated charcoal filter, diluted through a dilution tank and then released into the atmosphere.
- System of generating particulates/aerosols: no data
- Method of particle size determination: no data
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: see details in table 7.2.2/1.
TEST ATMOSPHERE
- Brief description of analytical method used: Sampling of the animal-breathing chamber was taken and the concentration was measured by equipment analysis (see details in Table 7.2.2/2). Sampling was conducted using a sampling rate if approximately 1.0 L/min at 60 and 80 minutes from the start of exposure.
- Samples taken from breathing zone: yes
VEHICLE
No data
TEST ATMOSPHERE (if not tabulated)
Not applicable - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- see Table 7.2.2/3
- Duration of exposure:
- 4 h
- Concentrations:
- Low, Middle and high dose: 150; 450 and 1350 ppm (0.62; 1.87 and 5.6 mg/L)
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: the animals were observed for clinical signs and to see if death occured at 1, 2, 3, and 4 hours after exposure completion and then each day up to day 7. The animals are weighed at day 1, 3, 5 and 7.
- Necropsy of survivors performed: yes - Statistics:
- no data
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 784 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: corresponding to 3.25 mg/L (1 ppm= 4.16 µg/mL)
- Mortality:
- yes - See details in Table 7.2.2/4.
- Clinical signs:
- other: At the low dose, no abnormalitie were detected in male and female rats. At the middle (males only) and the high doses (males and females) decreased spontaneous locomotion, decreased respiratory rate, ptosis, and staining around anus were observed.
- Body weight:
- At the middle dose, the animals survived at day 7 but they presented clinical signs of suffering.
The body weight gain at day 7 was less than for the animals exposed to the low dose.
See details in Table 7.2.2/5. - Gross pathology:
- At the high dose, staining around nose and mouth (only for one female rat), pale kidney, dark reddish change of the lung, reddish region of mucosa of the glandular stomach and cecum were observed.
- Other findings:
- no other findings
Any other information on results incl. tables
Table 7.2.2/4: Mortality after an inhalation exposure for 4h
Sex |
Exposure group |
Mortality (Number of dead animals/Number of animals) |
Time of death |
LD50 (ppm) |
Male |
Low dose |
0/5 |
- |
784 |
Middle dose |
0/5 |
- |
||
High dose |
5/5 |
Day 1 (4 rats), Day 2 (1 rat) |
||
Female |
Low dose |
0/5 |
- |
784 |
Middle dose |
0/5 |
- |
||
High dose |
5/5 |
Day 1 (2 rats), Day 2 (3 rats) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- With a 4h LC50 between 2 and 10 mg/L (vapour), under the test conditions, 2,2,2 Trifluoroethanol is classified in category 3 (Toxic if inhaled, H331) according to the criteria of Annex VI of the Regulation (EC) No 1272/2008.
- Executive summary:
In an acute inhalation toxicity study, performed according to the OECD guideline No. 403 with acceptable restrictions, groups of Crj: CD (SD) male and female rats (5 animals/sex/dose) were exposed by inhalation route by whole body exposure to 2,2,2 Trifluoroethanol for 4 hours at concentrations of 0.62; 1.87; 5.6 mg/L (150, 450 and 1350 ppm). Animals then were observed for 7 days. Clinical signs (at 1, 2, 3, 4 hours and each day after exposure completion), body weight (at day 0, 1, 3, 5, and 7) and gross pathology (at the sacrifice or death of animal) were observed.
LC50Males = 3.25 mg/L
Females = 3.25 mg/L
At the middle (only for male rats) and high doses (for male and female rats), a decreased spontaneous locomotion, a decreased respiratory rate, ptosis, a staining around anus were observed. At the middle dose, the surviving animals presented clinical signs of suffering at day 7 and showed a body weight gains lower than those of the animals exposed to the low dose. At the high dose, a staining around nose and mouth (only for one female rat), a pale kidney, a dark reddish change of the lung, a reddish region of mucosa of the glandular stomach and cecum were observed.
Under the test conditions, 2,2,2 Trifluoroethanol is classified in category 3 (Toxic if inhaled, H331) according to the criteria of Annex VI of the Regulation (EC) No 1272/2008.
This study is considered as acceptable as the main criteria of the guideline are respected.
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