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EC number: 206-851-6 | CAS number: 383-63-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed similarly to OECD guideline with some restrictions (6 animals instead of 3. No data on the age of the animals at the beginning) and no compliance with the GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 6 animals instead of 3. No data on the age of the animals at the beginning
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethyl trifluoroacetate
- EC Number:
- 206-851-6
- EC Name:
- Ethyl trifluoroacetate
- Cas Number:
- 383-63-1
- Molecular formula:
- C4H5F3O2
- IUPAC Name:
- ethyl 2,2,2-trifluoroacetate
- Details on test material:
- - Name of test material (as cited in study report): Trfluoroacétate d'éthyle
- Physical state: incolor liquid
- Stability under test conditions: no data. Assume to be stable (sponsor responsibility)
- Storage condition of test material: no data
- Other: pH measurement was impossible (instable measure)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino New-Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Roucher (86700, Couhé); EGAV (61350 Passais la conception); Elevage scientifique des Dombes (01400 Chatillon sur Chalaronne); Gwen Meur (22200 Trégonneau)
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (+/- 200 g)
- Housing: individual polystyrene cages (540 x 360 x 315 mm) with a perforated polystyrene floor.
- Diet (e.g. ad libitum): 150 g of complete maintenance food (granulés lapin Entretien "112" UAR, 91360 Villemoisson/Orge) is provided per rabbit and per day.
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: yes for 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 times per hour
- Photoperiod (hrs dark / hrs light): 12hrs / 12 hrs
IN-LIFE DATES: From: To: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the test item is applied on the skin as supplied by the sponsor
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable
VEHICLE
not applicable - Duration of treatment / exposure:
- 4h
- Observation period:
- 1h, 24, 48 and 72 hrs after the removal of the patch. The observation time may be extended (maximum 14 days) in order to show an eventual corrosive action of the test item, characterized by the irreversibility of the lesions observed.
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: the flanks
- % coverage: 2.5 cm²
- Type of wrap if used: the gauze pad is held in contact with the skin with a semi-occlusive patch: 4 cm wide adhesive tape, applied on a hydrophilic gauze pad (20 cm x 15 xm) covering the whole clipped surface and wound arounbd the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess of the test item which has not penetrated is wiped with a gauze pad moistened with deionized wtaer (or a non-irritant solvent).
- Time after start of exposure: 4h
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: erythema larger than the application site area
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean individual score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of the 6 animals score
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0.71
- Max. score:
- 8
- Remarks on result:
- other: slightly irritating
- Irritant / corrosive response data:
- Ethyl trifluoroacetate is slightly irritating to the skin but these effects are fully reversible (see details in Table 7.3.1/1).
- Other effects:
- no data
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 |
2$/0/1/1/1$/1 |
0/0/0/0/0/0 |
24 h |
2$/0/1/0/0/1 |
0/0/0/0/0/0 |
48 h |
2$/1/1/0/0/0 |
0/0/0/0/0/0 |
72 h |
2$/1/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
1.83 |
0.0 |
Reversibility*) |
c |
- |
Average time (day) for reversion** |
7 |
- |
*) 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
$) : erythema larger than the application site area
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Ethyl trifluoroacetate is not classified as skin irritant when applied topically to rabbits according to the Annex I of the Regulation (EC) 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EEC.
- Executive summary:
In a dermal irritation study performed in a similar manner to the OECD guideline No. 404, 6 male New Zealand Albino rabbits, were dermally exposed to 0.5 mL of undiluted Ethyl trifluoroacetate (purity of 97.3%) to the clipped skin of the 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 scores calculated within 3 scoring times (24, 48 and 72 hrs) were 1.83 for erythema and 0.0 for edema among the six animals.
Under the test conditions, the test item Ethyl trifluoroacetate is not classified as skin irritant when applied topically to rabbits according to the Regulation (EC) 1272/2008 (CLP) and to the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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