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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2010-04-30 to 2010-06-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Trifluoroethanol
- Physical state: colorless liquid
- Storage condition of test material: in a sealed container, at room temperature in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: approximately 8 to 9 weeks old on Day 1
- Weight at study initiation: 220 to 312 g (males) and 166 to 194 g (females) on Day 1
- Fasting period before study:
- Housing: During the acclimatisation period, up to five rats of the same sex were accommodated in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). From the day prior to dosing (Day –1), each rat was individually housed in a similar cage. After completion of the Day 3 observations animals allocated to the main study were returned to group housing.
- Diet: SQC(E) Rat and Mouse Maintenance Diet No 1, from Special Diets Services Ltd, Witham, UK ad libitum
- Water: ad libitum
- Acclimation period: 7 to 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24°C
- Humidity: 45 to 65%
- Air changes: 15 to 20 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: on the clipped dorsum of the rat
- % coverage: at least 10% of the total body surface
- Type of wrap if used: A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression bandage
REMOVAL OF TEST SUBSTANCE
- Washing: The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool before the animal was returned to the holding cage.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration (if solution): 1.43 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period.
Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes. The necropsy procedure included inspection of external surfaces and orifices, the dermal test site, all viscera and tissue within the abdominal, thoracic and cranial cavities, and free hand sectioning of the dermal test site, liver and kidneys - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died following a single dermal application of Trifluoroethanol at 2000 mg/kg.
- Clinical signs:
- other: There were no clinical signs after a single dermal application of Trifluoroethanol.
- Gross pathology:
- Macroscopic examination on Day 15 revealed reddening to the thymus (bilateral), green kidneys (bilateral) and kidney pelvic dilatation (unilateral). These macroscopic findings were limited to two animals only. There were no abnormalities seen in the remaining animals.
- Other findings:
- There were no dermal reactions.
Any other information on results incl. tables
Table 7.2.3/1: Individual body weights and weekly increments
Dose level (mg/kg) |
Animal number and sex |
Body weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
2000 |
10M |
227 |
230 |
225 |
231 |
236 |
1 |
5 |
11M |
220 |
222 |
212 |
212 |
217 |
-10 |
5 |
|
12M |
266 |
265 |
264 |
280 |
297 |
15 |
17 |
|
13M |
246 |
249 |
244 |
259 |
281 |
10 |
22 |
|
14M |
301 |
312 |
304 |
322 |
341 |
10 |
19 |
|
2000 |
15F |
166 |
170 |
163 |
169 |
175 |
-1 |
6 |
16F |
193 |
194 |
190 |
197 |
210 |
3 |
13 |
|
17F |
181 |
175 |
177 |
179 |
191 |
4 |
12 |
|
18F |
180 |
185 |
181 |
183 |
193 |
-2 |
10 |
|
19F |
191 |
188 |
189 |
192 |
199 |
4 |
7 |
Table 7.2.3/2: Dermal reactions
Day |
Dermal reaction |
Animal number and sex |
||||
10M |
11M |
12M |
13M |
14M |
||
2 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
5 to 15 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Day |
Dermal reaction |
Animal number and sex |
||||
15F |
16F |
17F |
18F |
19F |
||
2 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
5 to 15 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With a dermal acute DL50 above 2000 mg/Kg and no mortality at this dose, under the test conditions, 2,2,2 Trifluoroethanol is not classified for acute dermal toxicity according to the GHS criteria.
- Executive summary:
In a limit acute dermal toxicity study performed according to the OECD test guideline No. 402 and in compliance with GLP, groups of young adult HsdHan:WIST rats (5/sex) were dermally exposed toTrifluoroethanol (99.9 %) at doses of 2000 mg/kg bw. The treated areas of dorsum (10%) were covered by a semi-occlusive dressing for 24 hours. Animals then were observed for 14 days.
Dermal LD50Combined > 2000 mg/kg bw.
No animal died and there were no clinical signs of reaction to treatment. No overt dermal changes were noted at the test site following a single application at 2000 mg/kg.
All rats achieved body weight gains during the second weeks of the study. One male and two females lost weight during the first week of the study.
Macroscopic examination on Day 15 revealed reddening to the thymus (bilateral), green kidneys (bilateral) and kidney pelvic dilatation (unilateral). These macroscopic findings were limited to two animals only. There were no abnormalities seen in the remaining animals.
Under the test conditions, Trifluoroethanol is not classified according to the Directive 67/548/EEC and according to the CLP Regulation (1272/2008).
This study was considered as acceptable as it satisfied the main criteria of the OECD guideline.
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