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Diss Factsheets

Administrative data

Description of key information

Skin Irritation:

The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively.

Based on the scores, methyl trifluoroacetate can be considered not irritating to rabbit skin.

Eye Irritation:

When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours. The mean values of Chemosis, edema, iris and corneal opacity were 1.55, 1.45, 0.83 and 1.61 respectively.

Methyl trifluoroacetate (TFAM) was considered according to Annex VI of Directive 83/467 published in the Official Journal of the European Communities as Not Irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
To assess the dermal irritation potential of methyl trifluoroacetate in rabbits according to OECD 404 Guidelines
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of the test chemical: methyl trifluoroacetate
- Molecular formula: C3H3F3O2
- Molecular weight: 128.05 g/mol
- Smiles notation: O=C(OC)C(F)(F)F
- InChl: 1S/C3H3F3O2/c1-8-2(7)3(4,5)6/h1H3
- Substance type: Organic
- Physical state: Liquid
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- sex: Male
- Source: Charles river
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (200g)
- Fasting period before study: no data
- Housing: The rabbits were kept in individual polystyrene cages, measuring 540×360×315mm with a perforated polystyrene flour in ventilated and air conditioner room.
- Diet (e.g. ad libitum): 150gm of complete maintenance food (granules Lapin Entration “112” UAR, 91360 – Villemoisson/Drge) is provided per rabbit per day.
- Water: ad libitum (softened and filtered water-15 µ)
- Acclimation period: 8 days
Rabbits were vaccinated against Myxomatosis (Lyomyxovax, institut Merleux)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12 to 14 times per hours (pre-filtered air: 5- 10 µ)
- Photoperiod (hrs dark / hrs light): artificial lighting for 12 hrs (7.30am to 7.30pm)

IN-LIFE DATES: From: To: No data available
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
24,48, 72 hours.The observation period may be extended to 7 or 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: whole clipped surface (back 14cm×14cm)
- % coverage:6 square centimeter area
- Type of wrap if used: bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): If necessary the excess of the test substance which has not penetrated, the gauze pad moisten with deionized water (or non-irritant solvent)
- Time after start of exposure: No data available

SCORING SYSTEM: The mean values for erythema and edema were calculated for 6 rabbits examined at 1,24,48 and 72 hours after removal of the semi occlusive patches.
The cutaneous reactions were scored according to the following scale:
Erythema or Eschar formation:
no erythema =0
very slight erythema(barely perceptible) = 1
well defined erythema = 2
moderate to severe erythema = 3
severe erythema [beet redness] to slight eschar formation [injuries in depth] = 4
Edema formation:
No edema formation = 0
very slight edema(barely perceptible) = 1
slight edema [edges well defined by definte raising] = 2
moderate edema [edges raised approx 1mm] = 3
severe edema [raised more than 1mm and extending the area of exposure] = 4



Other effects / acceptance of results:
no data available
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hr
Score:
0.17
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 and 72hr
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr
Score:
0.17
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively

Table 1: Evaluation of cutaneous irritation potential after removal of patches

Rabbit number

1263

1264

1265

1266

1267

1268

Total

Mean

 

 

 

 

 

 

 

 

 

 

Erythema

 

 

 

 

 

1 hour

1

1

0

0

0

0

3

0.50

24 hours

0

1

0

0

0

0

1

0.17

48 hours

0

0

0

0

0

0

0

0

72 hours

0

0

0

0

0

0

0

0

 

Erythema mean = 24+48+72 hours

0.06

 

Rabbit number

1263

1264

1265

1266

1267

1268

Total

Mean

 

 

 

 

 

 

 

 

 

 

Edema

 

 

 

 

 

1 hour

0

1

0

0

0

0

1

0.17

24 hours

0

0

0

0

0

0

0

0

48 hours

0

0

0

0

0

0

0

0

72 hours

0

0

0

0

0

0

0

0

 

Edema mean = 24+48+72 hours

0.00

 

Interpretation of results:
other: not irritating
Conclusions:
The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively.
Based on the scores, methyl trifluoroacetate can be considered not irritating to rabbit skin.

Executive summary:

The dermal irritation potential of methyl trifluoroacetate was assessed in rabbits. The study was performed according to OECD 404 Guidelines. Six male albino New Zealand rabbits were used for the study. The six rabbits are carefully clipped on the back and on the flanks with a fine toothed electronic clipper (Asaculap – type V 42 947), to bare a surface 14cm×14cm (cutting height: 1/20thmm). The skin must be perfectly clean shaven often clipping. 0.5 ml of the undiluted sterile test substance was applied with a sterile polypropylene syringe(Becton Dickson) of 2 ml, on a Codex hydrophilic eight layer gauze pad, about 2.5 square cms. The test substance and the gauze pad are held in contact with the skin using a semi- occlusive patch: 10 cm wide adhesive perforation tape applied on a crimped gauze covering the whole clipped surface and wrapped around the animal. The test substance is kept in contact with the skin for 4 hours and the animals are retained in plastic restrainers. After 4 hours the patches were removed and the excess material was wiped with a gauze pad moistened with deionized water. The animals were observed for signs of irritation (erythema and edema formation) 1, 24, 48 and 72 hours after patch removal. The observation may be extended to 7 or 14 days to determine the corrosive nature of the test chemical.

The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively.

Based on the scores, methyl trifluoroacetate can be considered not irritating to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To assess the ocular irritation potential of methyl trifluoroacetate according to OECD 405 Guidelines
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of the test chemical: methyl trifluoroacetate
- Molecular formula: C3H3F3O2
- Molecular weight: 128.05 g/mol
- Smiles notation: O=C(OC)C(F)(F)F
- InChl: 1S/C3H3F3O2/c1-8-2(7)3(4,5)6/h1H3
- Substance type: Organic
- Physical state: Liquid
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Details on test animals
- sex: Male
- Source: Charles river
- Age at study initiation: No data
- Weight at study initiation: 2.5 kg (200g)
- Fasting period before study:
- Housing: The rabbits were kept in individual polystyrene cages, measuring 540×360×315mm with a perforated polystyrene flour in ventilated and air conditioner room.
- Diet: 150gm of complete maintenance food (granules Lapin Entration “112” UAR, 91360 – Villemoisson/Drge) is provided per rabbit per day.
- Water: ad libitum (softened and filtered water- 15 µ)
- Acclimation period: 8 days

Or Test Tissue
- Source: Not applicable
- Type: Not applicable
- Acclimation: Not applicable
- Housing conditions: Not applicable

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3
- Humidity (%):30 to 70 %
- Air changes (per hr): 12 to 14 times per hours (pre-filtered air: 5- 10 µ)
- Photoperiod (hrs dark / hrs light): artificial lighting for 12 hrs (7.30am to 7.30pm)

IN-LIFE DATES: From: To: No data available
Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye of six rabbits serves as control
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
The upper and lower eyelids are held together for 10 seconds to avoid any loss of test substance.
Observation period (in vivo):
1, 24, 48 and 72 hours post instillation. The observation period can be extended to 7 and 14 days to study the corrosive potential of test substance
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
TEST SITE
- Area of exposure: conjunctival sac

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Ocular examinations are carried out for each rabbit and rated according to the following scale
Conjunctival lesions:
Chemosis (lids and/or nictating membranes)
No swelling =1
Any swelling above normal (including nictating membrane) = 1
Obvious swelling with partial eversion of lids = 2*
Swelling with lids about half closed = 3*
Swelling with lids more than half closed = 4*

Redness:
Blood vessels normal = 0
Some blood vessels definitely hyperemic = 1
Diffuse, crimson color, individual vessels not easily discernible = 2*
Diffuse beefy red = 3*

Iris:
Normal = 0
Markedly deepened rugae, congestion, swelling moderate circumcorneal hyperaemia, or injection [any of these or combination of any thereof], iris still positively reacting to light = 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) = 2*

Corneal lesions
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity = 0
Scaterred or diffuse areas of opacity(other than slight dulling of normal luster) details of iris clearly visible = 1*
Easily discernible transcluent area, details of iris slightly obscured = 2*
Nacreous area, no details of iris visible, size of pupil barely discernible = 3*
Opaque cornea, iris not discernible through the opacity = 4*

Area of cornea affected
One quarter (or less) but not zero = 1
Greater than one quarter, but less than half = 2
Greater than one half, but less than three quarters = 3
Greater than three quarters, up to whole area = 4

*-figures indicate positive effect
A qualitative evaluation of any ulceration of cornea was conducted to determine the irritative capacity of test substance
Ulceration (loss of substance with or without swelling of the eyes)
No ulceration = 0
Presence of ulceration = U
The mean values are respectively calculated for each lesion evaluated on the 6 rabbits examined for conjunctivae, iris and the cornea at 24,48 and 72 hours after instillation of the test chemical.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.55
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
edema
Basis:
mean
Time point:
24/48/72 h
Score:
1.45
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.61
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours.

Table for scoring of ocular lesions:

Readings

Rabbits

Conjunctivae

Iris

Cornea

Chemosis

Edema

Reflex

Congestion

Degree of opacity

Surface area

Ulceration

1 hour

 

 

 

 

 

1275

1

1

N

1p

2

1

U

1276

2

2

N

1p

2

1

U

1277

2

2

N

1p

2

2

U

1278

1

2

N

1p

2

1

U

1279

2

1

N

1p

2

1

U

1280

2+

2

N

1p

2

2

U

24 hours

1275

1

0

N

0

0

0

0

1276

2

2

N

1p

2

2

U

1277

2

2

N

1p

2

2

U

1278

1

2

N

1p

2

1

U

1279

2

2

N

1p

2

1

U

1280

2+

2

N

1p

2

2

U

Mean

1.83

1.67

 

0.83

1.67

 

 

48 hours

1275

1

0

N

0

0

0

0

1276

2

2

N

1p

2

2

U

1277

1

2

N

1p

2

1

U

1278

1

2

N

1p

2

1

U

1279

1

1

N

1p               

2

1

U

 

1280

2

2

N

1p

2

2

U

Mean

1.50

1.50

 

0.83

1.83

 

 

72 hours

1275

0

0

N

0

0

0

0

1276

1

1

N

1p

2

1

U

1277

2

2

N

1p

2

3

U

1278

2

2

N

1c

0

0

0

1279

1

0

N

1p

2

1

U

1280

2

2

N

1p

2

2

U

Mean

1.33

1.17

 

0.83

1.83

 

 

Mean

24+48+72

 

1.55

1.45

 

0.83

1.61

 

 

Observations

+ -Edema of the palpebral conjunctiva and nictitating membrane

+/- -Permanent myosis with conservation of reflex direct photometer

p- Circumcorneal injections + iris congestion

c- circumcorneal injections

 

 

 

 

Table of average values, for each type of lesion, calculated with 6 rabbits for readings at 24, 48 and 72 hours

 

 

Readings

Mean

24+48+72 hours

24 hours

48 hours

72 hours

Conjunctivae

 

 

 

 

Chemosis

1.83

1.50

1.33

1.55

Edema

1.67

1.50

1.17

1.45

Iris

Congestion

0.83

0.83

0.83

0.83

Cornea

Opacity

1.67

1.83

1.33

1.61

 

 

Interpretation of results:
other: not irritating
Conclusions:
When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours. The mean values of Chemosis, edema, iris and corneal opacity were 1.55, 1.45, 0.83 and 1.61 respectively.
Methyl trifluoroacetate (TFAM) was considered according to Annex VI of Directive 83/467 published in the Official Journal of the European Communities as Not Irritant.
Executive summary:

The ocular irritation potential of methyl trifluoroacetate was assessed in rabbits. The study was performed according to OECD 405 Guidelines. 0.1 ml of the test substance was deposited in the conjunctival sac of 6 male albinoNew Zealand rabbits with a hundredth graduated sterile polypropylene syringe (Becton Dickinson) of 1ml. Each rabbit was immobilized in a plastic restraining box. The test chemical is introduced into the inferior conjunctival sac of the right eye, left serves as control. The eyelids are held together for 10 seconds to avoid material loss. The animals are restrained for one hour and then replaced in cages. The eyes remained unrinsed throughout the test. The eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours post instillation. The observation period can be extended to 7 and 14 days to study the corrosive potential of test substance. The mean values are respectively calculated for each lesion evaluated on the 6 rabbits examined for conjunctivae, iris and the cornea at 24, 48 and 72 hours after instillation of the test chemical.

When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours.

The mean values of Chemosis, edema, iris and corneal opacity were1.55, 1.45, 0.83 and 1.61 respectively.

Methyl trifluoroacetate (TFAM) was considered according to Annex VI of Directive 83/467 published in the Official Journal of the European Communities as Not Irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:        

In different studies,methyl trifluoroacetatehas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its functionally similar read across substances, diethyl malonate [CAS: 105-53-3] and dimethyl adipate [CAS: 627-93-0]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

The dermal irritation potential of methyl trifluoroacetate was assessed(OTS0571344, NTRL report, last updated 1992) in rabbits. The study was performed according to OECD 404 Guidelines. Six male albino New Zealand rabbits were used for the study. The six rabbits are carefully clipped on the back and on the flanks with a fine toothed electronic clipper (Asaculap – type V 42 947), to bare a surface 14cm×14cm (cutting height: 1/20thmm). The skin must be perfectly clean shaven often clipping. 0.5 ml of the undiluted sterile test substance was applied with a sterile polypropylene syringe(Becton Dickson) of 2 ml, on a Codex hydrophilic eight layer gauze pad, about 2.5 square cms. The test substance and the gauze pad are held in contact with the skin using a semi- occlusive patch: 10 cm wide adhesive perforation tape applied on a crimped gauze covering the whole clipped surface and wrapped around the animal. The test substance is kept in contact with the skin for 4 hours and the animals are retained in plastic restrainers. After 4 hours the patches were removed and the excess material was wiped with a gauze pad moistened with deionized water. The animals were observed for signs of irritation (erythema and edema formation) 1, 24, 48 and 72 hours after patch removal. The observation may be extended to 7 or 14 days to determine the corrosive nature of the test chemical. The mean score for erythema and edema formation after 72 hours was 0.06 and 0.00 respectively.Based on the scores, methyl trifluoroacetate can be considered not irritating to rabbit skin.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin irritation potential was estimated formethyl trifluoroacetate. Methyl trifluoroacetatewas estimated to be not irritating to the skin of New Zealand White rabbits. 

The experimental and estimated results are in agreement with each other, indicating the possibility of methyl trifluoroacetate being not irritating to skin.

These results are supported by the experimental study summarized in Food and Cosmetics Toxicology, Volume 14, Supplement, 1976, Pages 745-746; for the functionally similar read across substances, diethyl malonate [CAS: 105-53-3]. Diethyl malonate was tested 4% in petrolatum in 48 hours closed patch test on human volunteers. Diethyl malonate was not irritating to human skin after 48 hours exposure.

These results are also supported by the experimental study summarized in The MAK Collection for Occupational Health and Safety. 1-32; 2012, for thefunctionally similar read across substance, dimethyl adipate [CAS: 627-93-0].The study was performed according to OECD 404 Guidelines. Dimethyl adipate was applied to the skin of 6 rabbits for 4 hours under semi-occlusive conditions. The rabbits were observed for signs of irritation. Dimethyl adipate did not cause any irritation to rabbit skin in a 4 hour exposure.

Hence, dimethyl adipate can be considered not irritating to rabbit skin.

Based on the available data for the target as well as read across substances and applying the weight of evidence approach,methyl trifluoroacetatewas not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

 Eye Irritation:

In different studies,methyl trifluoroacetatehas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical and its functionally similar read across substances, dimethyl adipate [CAS: 627-93-0] and dimethyl succinate [CAS: 106-65-0].  

The ocular irritation potential of methyl trifluoroacetate was assessed(OTS0571344, NTRL report, last updated 1992)in rabbits. The study was performed according to OECD 405 Guidelines. 0.1 ml of the test substance was deposited in the conjunctival sac of 6 male albino New Zealand rabbits with a hundredth graduated sterile polypropylene syringe (Becton Dickinson) of 1ml. Each rabbit was immobilized in a plastic restraining box. The test chemical is introduced into the inferior conjunctival sac of the right eye, left serves as control. The eyelids are held together for 10 seconds to avoid material loss. The animals are restrained for one hour and then replaced in cages. The eyes remained unrinsed throughout the test. The eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours post instillation. The observation period can be extended to 7 and 14 days to study the corrosive potential of test substance. The mean values are respectively calculated for each lesion evaluated on the 6 rabbits examined for conjunctivae, iris and the cornea at 24, 48 and 72 hours after instillation of the test chemical.

When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours. The mean values of Chemosis, edema, iris and corneal opacity were1.55, 1.45, 0.83 and 1.61 respectively. Methyl trifluoroacetate (TFAM) was considered according to Annex VI of Directive 83/467 published in the Official Journal of the European Communities as Not Irritant.

This result is supported by theexperimental study summarized in The MAK Collection for Occupational Health and Safety. 1-32; 2012, for thefunctionally similar read across substance, dimethyl adipate [CAS: 627-93-0]. 0.1 ml dimethyl adipate was instilled into the conjunctival sac of 6 rabbits and observed for signs of irritation till 7 days. Mild to moderate irritant, conjunctival redness & Swelling (6), tear flow (6), corneal opacities (4), iris changes (5)were observed in the treated animals. These effects were reversible in 7 days. Since the observed effects were reversible in 7 days, dimethyl adipate can be considered not irritating to rabbit eyes.

These results are also supported by thestudy summarized in The MAK Collection for Occupational Health and Safety. 1-32; 2012, for thefunctionally similar read across substance, dimethyl succinate [CAS: 106-65-0]. 0.1 ml dimethyl succinate was instilled into the conjunctival sac of 6 rabbits and observed for signs of irritation till 7 days.Mild to moderate irritant, conjunctival redness & Swelling (6), tear flow (6), corneal changes (4) (opacities and ulceration, punctured Cornea (1)), iris changes (4) were observed. These effects were completely reversible in 7 days. Since the observed effects were reversible in 7 days, dimethyl succinate can be considered not irritating to rabbit eyes.

Based on the available data for the target as well as read across substances and applying the weight of evidence approach,methyl trifluoroacetatewas not irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Justification for classification or non-classification

Available data for methyl trifluoroacetate suggests that it is not likely to cause any irritation to eyes and skin.

Methyl trifluoroacetate can be classified under the category “Not Classified” as per CLP regulation.