Lithium bis(trifluoromethylsulfonyl)imide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May - August 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study according to the OECD 404 guideline but not GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

Test Material: T-4201
Physical Description: White solid chunks
Purity: 99.7%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver PA
- Age at study initiation: young adults
- Weight at study initiation: Three acclimated animals weighing from 2334 to 2670 g were chosen at random for the test.
- Housing: maintained individually in screen-bottom cages in temperature and humidity-controlled quarters.
- Diet: measured amount of High Fiber Rabbit Chow 5326, Purina Mills, Inc., ad libitum
- Water: ad libitum)
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled

IN-LIFE DATES: From: 07/06/1988 To: 21/06/1988

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

The test material was applied to the intact skin of each rabbit in the amount of 0.5 ml.

Duration of treatment / exposure:

4 hours

Observation period:

14 days
Observations: After the exposure period, the bandages were removed and the test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24, 4B, 72 and 96 hours and at 7 and 14 days after patch removal.

Number of animals:

3

Details on study design:

TEST SITE
The treated area was covered with a 2.5 x 2.5cm gauze patch secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape to provide a semi-occlusive dressing.
Collars were applied to restrain the test animals for the 4-hour exposure period.

REMOVAL OF TEST SUBSTANCE
After the exposure period, the bandages were removed and the test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24, 48, 72 and 96 hours and at 7 and 14 days after patch removal.

SCORING SYSTEM: Draize system

Individual body weights were taken just prior to study initiation and at Days 7 and 14.
Pathology: At study termination, all animals were euthanatized and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

on 3 animals

Time point:

other: at 24, 48 and 72 hours

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Necrosis

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

on 3 animals

Time point:

other: at 24, 48 and 72 hours

Score:

2.33

Max. score:

4

Reversibility:

not reversible

Any other information on results incl. tables

Table of results:

		Hours					Days
		4	24	48	72	96	7	14
Erythema	Animal 1	3AB	3N	3N	3N	3N	3N	3N
	Animal 2	3N	3N	3N	3N	3N	3N	4N
	Animal 3	3AB	3N	3N	3N	4N	4N	4N
Edema	Animal 1	4	2	2	2	2	2	2
	Animal 2	4	3	3	3	2	2	3
	Animal 3	4	2	2	2	2	2	2

A - Subcutaneous hemorrhage

B - Blanching

N - Possible necrotic area

Applicant's summary and conclusion

Interpretation of results:

corrosive

Conclusions:

TFSILi is corrosive to skin.

Executive summary:

An skin irritation study was performed with the test item Bis trifluoromethanesulfonimide (TFSILi) in rabbits, in compliance with OECD Guideline n°404, but not under GLP conditions. The test item was applied on clipped skin for 4 hours under semi-occlusive coverage.

After the exposure period, the bandages were removed and the test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24, 48, 72 and 96 hours and at 7 and 14 days after patch removal. For erythema score, the mean on 3 animals at 24, 48 and 72 hours was 3 with necrosis, and the edema score was 2.33. In these conditions, TFSILi is considered corrosive to skin and should be classified H314 according to the CLP 1272/2008 criteria.