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Diss Factsheets

Administrative data

Description of key information

Skin irritation study: based on the results of the in vivo study (Gomond, 2005), trifluoromethansulfonic anhydride is considered as corrosive to the skin category 1B.
Eye irritation: based on the corrosivity of trifluoromethanesulfonic anhydride, a waiving was proposed.
Respiratory irritation: no specific study is available, however it can be presumed from the corrosive effects on skin that trifluoromethanesulfonic anhydride may cause respiratory irritation.

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:
key study
Study period:
from 2005-02-07 to 2005-02-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Grimaud supplier (49450 Roussay, France)
- Age at study initiation: no data
- Weight at study initiation: 2.83 kg
- Fasting period before study: no
- Housing: individually housed in stainless steel cage on floor grid (60cm x 45 cm x 32cm)
- Diet (e.g. ad libitum): complete diet from Ergilap Anco
- Water (e.g. ad libitum): no data
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 10 cycles/hour
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: 2005-02-07 to 2005-02-22
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable, the test item is applied undiluted

VEHICLE
not applicable, the test item is applied undiluted
Duration of treatment / exposure:
3 min and 1 hour. Two sites in the same animal were treated with the test item.
The 4 hour treatment was not performed for ethical reasons
Observation period:
1 hour after the end of exposure then daily for 14 days.
Number of animals:
one animal.
two other animal were planned but not used for ethical reasons.
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 6.25 cm² (2.5 x 2.5 cm)
- Type of wrap if used: Micropore tape 5cm x 5 cm.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data.
- Time after start of exposure: 3 min and 1 hour.

SCORING SYSTEM: according to guideline
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Mean individual score after 3 min exposure
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Necrosis on day 11
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Mean individual score after 3 min exposure
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: necrosis on day 11
Irritant / corrosive response data:
After 3 min application : Moderate erythema within 1 hour (score 2). Erythema is becoming more severe in time and reaches a score of 4 at day 7. Eschar formation was observed at day 7 and scar at day 14.

After 1 hour application : Necrosis is observed after 1 hour observation.
Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the test conditions, the test item trifluoromethanesulfonic anhydride is classified as Skin Corr./Irr. 1B (H314; causes severe skin burns and eye damage) when applied topically to rabbits according to the criteria of the Regulation (EC) 1272/2008 (CLP).
Executive summary:

In a GLP dermal irritation study (Gomond 2005) performed according to the OECD No. 404, one New Zeland White rabbit was dermally exposed to 0.5 mL of undiluted trifluoromethanesulfonic anhydride to the dorsal surface of the trunk (skin was shaved before application). Two test sites were covered with a semi-occlusive dressing and tested in the same animal corresponding to 2 different time of exposure: 3 min and 1hr. After the removal of the gauze patch, animals were then observed for 14 days. Skin irritation was assessed and scored at 1, 24, 48, 72 hrs and daily for 14 days after the end of the exposure. The 4 hours exposition time and the treatment of 2 additional rabbits was ot performed for ethical reason and because the results were clear enough to allow conclusion on classification.

The application for 3 minutes of 0.5 ml of the test item to the skin of one rabbit induced a well-defined erythema from D1 to D3, then a moderate to severe erythema from D4 to D13, associated with a moderate to slight edema. The reversibility of the reactions was not complete on D14. On D7 eschar formation was observed and on D14 when the scab was fallen as was noted.

The application of 0.5 ml of the test item for 1 hour induced since the first hour, the formation of a grey necrosis. A severe edema was observed on D2. After desquamation of scab on D13 a scar appeared. On D14, the reversibility was not complete. Presence of a scar, with 3 minutes patch, on D14, indicative of tissue lesions on the whole skin thickness

In conclusion, under the test conditions, the test item trifluoromethanesulfonic anhydride is classified as Skin Corr./Irr. 1B (H314; causes severe skin burns and eye damage) when applied topically to rabbits according to the criteria of the Regulation (EC) 1272/2008 (CLP).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

- In a GLP dermal irritation study (Gomond 2005) performed according to the OECD No. 404, one New Zeland White rabbit was dermally exposed to 0.5 mL of undiluted trifluoromethanesulfonic anhydride to the dorsal surface of the trunk. The application for 3 minutes of 0.5 ml of the test item to the skin of one rabbit induced a well-defined erythema from D1 to D3, then a moderate to severe erythema from D4 to D13, associated with a moderate to slight edema. The reversibility of the reactions was not complete on D14. On D7 eschar formation was observed and on D14 when the scab was fallen as was noted. 

The application of 0.5 ml of the test item for 1 hour induced since the first hour, the formation of a grey necrosis. A severe edema was observed on D2. After desquamation of scab on D13 a scar appeared. On D14, the reversibility was not complete. Presence of a scar, with 3 minutes patch, on D14, indicative of tissue lesions on the whole skin thickness

Under the test conditions, the test item trifluoromethanesulfonic anhydride is classified as corrosive to skin into category 1B (H314; causes severe skin burns and eye damage) when applied topically to rabbits according to the criteria of the Regulation (EC) 1272/2008 (CLP).

Eye irritation:

Trifluoromethanesulfonic anhydride is considered as corrosive (Cat 1B, H314). Therefore, according to the column 2 of the Annex VIII of the Regulation (EC) NO. 1907/2006 (REACh) (section 8.2.1), an in vivo eye irritation study does not need to be conducted if the substance is classified as corrosive to the skin.

Respiratory irritation:

No specific study is available, however it can be presumed from the corrosive effects on skin and the volatility (vapour pressure: 70.93 hPa at 20°C and 93.18 hPa at 25° C) that trifluoromethanesulfonate anhydride should cause respiratory irritation.


Justification for classification or non-classification

Skin irritation:

Based on the above data, trifluoromethanesulfonic anhydride is classified as corrosive into category 1B (H314; causes severe skin burns and eye damage)according to the criteria of the Regulation (EC) 1272/2008 (CLP).

Eye irritation:

No data is available. However, as the substance is classified as corrosive, no further test has to be conducted. As mentioned in the Guidance on the application of Regulation (EC) No 1272/2008, a skin corrosive substance is considered to also cause serious eye damage which is included in the hazard statement for skin corrosion (H314: causes severe skin burns and eye damage).

Respiratory irritation:

No specific study is available, however it can be presumed from the corrosive effects on skin and the volatility (vapour pressure: 70.93 hPa at 20°C and 93.18 hPa at 25° C) that trifluoromethanesulfonic anhydride should cause respiratory irritation and is classified as STOT SE Cat.3, H335 according to the Regulation (EC) No 1272/2008 criteria.