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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-09-23 to 2003-10-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 404 (17 July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- 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): 2,2,2 trifluoroethanol (TFE)
- Physical state: colorless liquid
- Lot/batch No.: 02 092 01
- 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: at room temperature
- Other: the pH of the undiluted test item, measured at CIT, was approximately 4.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 2.7 kg (+/- 0.2 kg)
- Housing: in individual polystyrene cages (48.2 cm x 58 cm x 36.5 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (+/- 3°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
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
VEHICLE: not applicable
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- The test item was first evaluated on a single animal. The duration was 3 minutes on one flank and 4 hours on the other flank. Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals.
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after the removal of the dressing. Since there were persistent irritation reactions at 72 hours, the observation period was extended. In the absence of complete reversibility of skin reactions on day 15, the study was ended.
- Number of animals:
- 3 animals (male rabbit)
- Details on study design:
- TEST SITE
- Area of exposure: the flanks of animals
- % coverage: no data
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no residual test item was observed on removal of the dressing
- Time after start of exposure: 3 minutes or 4 hours
SCORING SYSTEM: according to the OECD guideline No. 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- For the 3-minute exposed animal (only one animal), except for a very slight erythema (grade 1) observed one hour after the removal of the dressing, no cutaneous reactions were noted (mean score 0.0)
See details in Table 7.3.1/1 for an exposure of 4 hours. - Other effects:
- Dryness of the skin up to the end of the study and presence of crusts up to day 11 for the rabbit No. 936 (the rabbit the most affected by the treatment).
Any other information on results incl. tables
Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (4h)
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
1/1/2 |
0/0/0 |
24 h |
0/1/2 |
0/0/0 |
48 h |
0/0/2 |
0/0/0 |
72 h |
0/0/2 |
0/0/0 |
Average 24h, 48h, 72h |
0.0/0.3/2.0 |
0.0/0.0/0.0 |
Reversibility*) |
c |
- |
Average time (day) for reversion** |
11 |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**): correspond to the last day for which skin irritation signs in the last animal were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item 2,2,2-trifluoroethanol is not classified as skin irritant when applied topically to rabbits according to the Annex VI of the CLP regulation 1278/2000/EC.
- Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404 (1992) 3 male New Zeland White rabbits, were dermally exposed to 0.5 mL of undiluted 2,2,2,-trifluoroethanol (TFE) (purity of 99.5%) to the shaved skin of the right flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days for edema and erythema.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.
The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.3/2.0 for erythema and 0.0/0.0/0.0 for edema.
Under the test conditions, the test item 2,2,2-trifluoroethanol is not classified as skin irritant when applied topically to rabbits according to the CLP Regulation 1278/200/EC.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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