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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trifluoromethanesulphonic anhydride
EC Number:
206-616-8
EC Name:
Trifluoromethanesulphonic anhydride
Cas Number:
358-23-6
Molecular formula:
C2F6O5S2
IUPAC Name:
trifluoromethanesulphonic anhydride
Test material form:
liquid

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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).