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EC number: 200-913-6 | CAS number: 75-89-8
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- 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
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- 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
- Skin irritation: Not irritating (OECD 404, Kr: 1)
- Eye irritation: Corrosive (OECD 405, Kr: 1)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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. - 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).
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-10-01 to 2003-11-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study is performed according to the OECD No 405 (1987) and EC (92/69/EEC, B.5) guidelines and is in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 405 (24 February 1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 3.2 kg (+/- 0.3 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye, which remained not treated served as negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
VEHICLE: not applicable - Duration of treatment / exposure:
- the eye was not rinsed after administration of test item up to the end of the study.
- Observation period (in vivo):
- Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until the end of the observation period (21 days).
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM: ocular reactions were scored according to the numerical scale described in the OECD guideline No.405
TOOL USED TO ASSESS SCORE: For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- ca. 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- day 7
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- ca. 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- day 10
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- ca. 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 5
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 6
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 18
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- ca. 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- day 11
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- ca. 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: day 21
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: day 21
- Irritant / corrosive response data:
- Very slight to severe conjunctival reactions, including a very slight to severe chemosis (grades 1 to 4), a very slight to moderate redness of the conjunctiva (grades 1 to 3) and a clear to whitish purulent discharge, were observed in all animals from day 1 up to day 11 (1/3 animals) or 21 (end of the observation period, 2/3 animals).
A slight iritis, which could have been masked by a corneal opacity between day 1 and day 2 in all animals and between days 9 and 18 in 1/3 animal, was noted in all animals from day 3 up to day 5, 6 or 8.
A very slight to severe corneal opacity (grades 1 to 4), which sometimes covered the area of the eye, was recorded in all animals from day 1 (2/3 animals) or 2 (1/3 animals) up to day 7, 10 or 22 (end of the observation period).
Whitish and/or brownish areas were observed on the conjunctiva of all animals from day 4 (2/3 animals) or 5 (1/3 animals) until day 10, 18 or 22 (end of the observation period).
Neovascularization was noted in 1/3 animals from day 10 until the end of the observation period (day 22).
Mean scores calculated for each animal over 24, 48 and 72 hours were 3.7, 2.7 and 4.0 for chemosis, 3.0, 3.0 and 3.0 for redness of the conjunctiva and 2.7, 2.7 and 2.3 for corneal opacity. Due to the corneal opacity which sometimes masked details of the iris, the mean scores for iris lesions could not be calculated.
See details in tables 7.3.2/1 and 7.3.2/2 - Other effects:
- Withish and/or brownish area on the conjonctiva, neovascularisation and withish purulent disharge.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions, the 2,2,2-trifluorethanol is classified in Category 1 (Irreversible effects on the eye, H318) according to the Annex VI of the CLP Regulation 1272/2008/EC.
- Executive summary:
In an eye irritation study performed according to the OECD No. 405 (1987) and EC (92/69/EEC, B.5) guidelines and in compliance to the GLP, 0.1 mL of undiluted 2,2,2-trifluoroethanol (TFE) was instilled into the conjunctival sac of left eye of 3 male New Zeland White Rabbit. After the instillation the substance was not remained. Animals were then observed for 21 days for eye edema and erythema of the conjunctive, corneal opacity and iris lesion.
Eye rritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the instillation of the substance. The mean individual score were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean individual scores were 3.7/2.7/4.0 for chemosis, 3.0/3.0/3.0 for conjunctival erythema, 2.7/2.7/2.3 for corneal opacity which were not completely reversible within the end of the study (21 days). The corneal opacity covered sometimes the whole area of the eye. Slight iridial lesions (mean individual score 1.0/1.0/1.0) were observed but were completely reversible in all animals.
Under the test conditions, the 2,2,2-trifluorethanol is classified in Category 1 (Irreversible effects on the eye, H318) according to the Annex VI of the CLP Regulation 1272/2008/EC.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Reference
Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/4/3 |
0/OP/OP |
2/3/3 |
3/3/3 |
24 h |
3/4/3 |
OP/OP/OP |
3/3/3 |
4/3/4 |
48 h |
3/2/2 |
1/1/1 |
3/3/3 |
4/3/4 |
72 h |
2/2/2 |
1/1/1 |
3/3/3 |
3/2/4 |
Average 24h, 48h, 72h |
2.7/2.7/2.3 |
Not calculated |
3.0/3.0/3.0 |
3.7/2.7/4.0 |
Reversibility*) |
c/c/n |
c/c/c |
c/n.c/n |
c/n.c/n.c |
Average time (day) for reversion |
7/10/- |
5/6/18 |
11/-/- |
11/-/- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
OP: Scoring masked by marked corneal opacity
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
1- Skin irritation:
A study was identified as the key study (Griffon, 2003). This study was performed according to the OECD guideline No. 404 and in compliance with the GLP.
Male New Zeland White rabbits were dermally exposed to undiluted 2,2,2-trifluoroethanol for 4 hours using a semi-occlusive patch. On the treated intact skin, 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. Therefore under the test conditions, the 2,2,2-trifluoroethanol was not a skin irritant.
2- Eye irritation:
A study was identified as the key study (Griffon, 2004). This study was performed according to the OECD guideline No. 405 and in compliance with the GLP.
0.1 mL of undiluted 2,2,2-trifluoroethanol was instilled into the conjunctival sac of male New Zeland White rabbits. Under the test conditions, 2,2,2-trifluoroethanol induced severe chemosis (mean individual scores of 3.7/2.7/4.0), moderate conjunctival redness (mean individual scores of 3.0/3.0/3.0), and moderate corneal lesions (mean individual scores of 2.7/2.7/2.3) which were not completely reversible within the end of the study (21 days). The corneal opacity covered sometimes the whole area of the eye. Slight iridial lesions (mean individual scores of 1.0/1.0/1.0) were observed but were completely reversible in all animals.
Under
the test conditions, 2,2,2-trifluoroethanol was highly irritating to
eyes and induced irreversible effects.
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available according to the Regulation (EC) No 1272/2008.
Self-classification:
Based on the available data, 2,2,2-Trifluoroethanol is not classified for skin irritation according to the criteria of the Annex VI to Regulation (EC) No 1272/2008.
2,2,2-Trifluoroethanol is self-classified in Category 1 (H318: Irreversible effects to eyes) according to the Regulation (EC) No 1272/2008 (CLP).
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