Lithium bis(trifluoromethylsulfonyl)imide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - August 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD 402 compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

environmental conditions are outside of those recommended by guideline.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): L-11522
- Name of test material: Lithium (bis)trifluoromethanesulfonimide (TFSILi)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, MI
- Age at study initiation: young adults
- Weight at study initiation: Three acclimated animals weighing from 2032 to 2486 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, 16 to 27°C
- Humidity (%): controlled 31 to 81%

IN-LIFE DATES: From: 01/05/1991 To: 10/07/1991

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
An individual dose of the test material was calculated and weighed out based on each animal's body weight on the day of test material administration. Each dose was thoroughly moistened with 0.9% saline before application.

TEST MATERIAL
The test material was applied to each respective animal's shaved back at dose levels of 200, 350, 500, or 2000 mg/kg of body weight. The area of
application was covered with a 10 cm x 10 cm gauze patch secured with paper tape, and overwrapped with Saran Wrap and Elastoplast tape. Collars were applied to restrain the test animals during the 24-hour exposure period.

REMOVAL OF TEST SUBSTANCE
At the end of the 24-hour exposure period, the bandages were removed and the backs were washed using tap water and disposable paper towels.

Duration of exposure:

Single exposure

Doses:

200, 350, 500 and 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: observation at approximately 1, 2.5, and 4 hours after test material administration. The animals were observed daily thereafter for 14 days for clinical signs and twice daily (morning and afternoon) for mortality.
Body weights were determined before test material administration (Day 0).
Additional body weights were determined at Day 7 and at termination of the experimental phase (Day 14) or at death when survival exceeded 1 day.

- Pathology: At termination of the experimental phase, surviving animals were euthanatized.
All animals, whether dying during the study or euthanatized, were subjected to a gross necropsy examinationand all abnormalities were recorded. After necropsy, the animals were discarded and no tissues were saved.

Statistics:

The LD50 for males, females, and the sexes combined was determined by a computer program utilizing a modified Behrens-Reed-Muench Cumulant Method

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

400 mg/kg bw

Based on:

test mat.

95% CL:

329 - 486

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

371 mg/kg bw

Based on:

test mat.

95% CL:

254 - 542

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

418 mg/kg bw

Based on:

test mat.

95% CL:

329 - 486

Mortality:

200 mg/kg: 0/5 for both sex
350 mg/kg: 2/5 and 0/5 for male and female respectivly
500 and 2000 mg/kg: 5/5 for both sex

Clinical signs:

other: hypoactivity, loss of appetite, staggered gait, subconvulsive jerking, miosis, excessive salivation, aggressive behavior, tremors, prostration, shallow breathing, clonic convulsions, and death.

Other findings:

Dermal irritation consisted of slight to severe erythema and slight edema and desquamation. Subcutaneous hemorrhaging and a possible necrotic were also observed.

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

TFSILI tested is toxic by skin contact.

Executive summary:

The acute dermal toxicity of TFSILi was evaluated in male and female rabbits when administered as a single topical application at levels of 200, 350, 500, and 2000 mg/kg of body weight. Based on the observed mortality, the estimated dermal LD50 was determined to be 371, 418 and 400 mg/kg for males, females, and the sexes combined, respectively.

Clinical signs of toxicity included hypoactivity, loss of appetite, staggered gait, subconvulsive jerking, miosis, excessive salivation, aggressive behavior, tremors, prostration, shallow breathing, clonic convulsions, and death.

All animals surviving to the end of the observation period exhibited no meaningful effect on weight gain. The test material produced slight to severe erythema and slight edema and desquamation dermal reactions. Subcutaneous hemorrhaging and a possible necrotic area were also observed. All mortality occurred within 2 days of test material administration.

Based on the results of this study, the test substance is considered toxic by skin contact according to the CLP 1272/2008 criteria.