lithium bis(fluorosulfonyl)imide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 28 December 2010 and 5 February 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

lithium(1+) bis(fluorosulfonyl)azanide

EC Number:

924-516-9

Cas Number:

171611-11-3

Molecular formula:

(FSO2)2NLi

IUPAC Name:

lithium(1+) bis(fluorosulfonyl)azanide

Specific details on test material used for the study:

Name (abbr. name): LiFSI
Chemical name: Lithium bis(fluorosulfonil)imide
Rational formula: (FS02)2NLi
Molecular formula: F2LiNO4S2
Molecular weight: 187.07
CAS No.: 171611-11-3
Lot No.: 100527475
Purity: 99.5%
Storing conditions : Light shielding at room temperature
Expiration date : May 27, 2011

Test animals

Species:

rabbit

Strain:

other: Japanese White rabbits (Kbs:JW)

Details on test animals or test system and environmental conditions:

Rabbits were chosen according to the OECD Guideline, especially Japanese White rabbits because they were generally used in acute dermal irritation/corrosion studies. Four 10-week old male Japanese White rabbits (Kbs:JW, Healthy) (body weight range: 1.90-1.96kg) produced by Kitayama Labes Co., Ltd. (3052-1 Arai, Ina·shi, Nagano, Japan) were purchased from Oriental Bioservice Kanto, Inc. (3-15·15 Azuma, Tsukuba·shi, Ibaraki, Japan). The animals were quarantined during the 6 days following their arrival. During this period, the animals were weighed with a Sartorius electronic balance (E12000S, Sartorius Co., Ltd.) on the first and last days, observed for clinical signs once every day, and assessed for health conditions on the last day of the period. No abnormal finding was observed throughout the quarantine period, indicating good health conditions. Animals except for the animal used for the first administration were continuously acclimated to housing conditions after the quarantine period, and observed for general conditions.
At approximately 24hr before the first administration, the animals' dorsal hair was removed with an electric hair-clipper (2.0- and 0.5-mm edges, DAITO ELECTRIC MACHINE INDUSTRY CO., LTD.) and pre-treatment skin conditions were examined.
Based on the results, 3 healthy animals with good skin conditions were selected for the study, and the other animal which had island skins was reserved as one of pooled animals. Since the experiment was terminated at first administration, used was only one animal. The animal's age at the time of administration was 10 weeks and the body weight was 2.13kg. Cages were identified with color labels (showing the Study no., name of the test substance, type of the study, sex and temporary animal no. or animal no., etc), and animals with animal no.s. written inside of the auricle (left auricle during the quarantine/acclimation period and right auricle after grouping) with oil ink.

Housing and environmental conditions
Environmental conditions
The animals were individually housed in automatic water-washing aluminum cages for rabbits (350W x 480D x 350H mm) in a conventional system animal room (Room No.8 during the quarantine period, Room No.9 after the quarantine period), where the environmental conditions were maintained to a temperature of 20±3°C (actual values: Room No.S: 18.4-22.4 °C, Room No.9: 19.6-20. 1°C ), humidity of 50±20% (actual values: Room No.8: 22.6-65.1%, Room No.9: 49.5-58.3%), ventilation frequency of 10 times or more per hour (all-fresh-air system), and lighting of 12hr per day (from TOO a.m. to 7:00 p.m., 150-300 lux). Cages and feeders were sterilized with 500-fold aqueous dilution of sodium
hypochlorite prior to use, and changed for new ones at the time of changing the animal room. The animal room was cleaned every day after work and the floor was sterilized by wiping with 200-fold aqueous dilution of benzethonium chloride (Hyamine solution; Daiichi Sankyo Co., Ltd.).

Feed
Pellet diet for experimental animals CR-3 (Lot No. R3070 and, R3080 Clea Japan, Inc., 1-2-7 Higashiyama, Meguro·ku, Tokyo, Japan) was provided ad libitum via feeders. Feed analysis for impurities and contaminants in the lot used in the study was entrusted by the maker to Tokyo Kenbikyo·in foundation (44-1 Nihonbashi Hakozaki-cho, Chuo·ku, Tokyo, Japan). Based on the results (obtained as a copy), the conformity to the standards specified by Nippon Experimental Medical Research Institute Co., Ltd. was confirmed before feeding.

Drinking water
Shibukawa·city tap water was provided ad libitum via an automatic watering system. Water analysis in the samples periodically collected at sites specified by this facility was entrusted to Envfronmental Technical Co., Ltd. (1709· 1 Kaneko·cho, Takasaki·shi, Gunma, Japan) based on the "Ministerial Ordinance Concerning Water Quality Standards (MHLW Ordinance No. 101, 2003)", "Partial Amendment of Ministerial Ordinance Concerning Water Quality Standards (MHLW Ordinance No. 17 4, 2008)", and "Partial Amendment of the Ordinance for Enforcement of the Water Law (MHLW Ordinance No.175, 2008)". Based on the results, the conformity to the above-mentioned water quality standards was confirmed.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5g undiluted test item

Duration of treatment / exposure:

3 minutes or 1 hour

Number of animals:

1 male

Details on study design:

Administration method
Hair-clipped areas (approximately 2.5 x 2.5 cm, approximately 6 cm2 each) of the
dorsal region served as application sites. A 0.5g of the test substance was evenly
spread on a 2.5 x 2.5-cm lint patch (OSATO EISEI ZAIRYO SEIZOSHO, Y.K.) and
applied to each application site to contact to the skin. The lint patch was occluded
with adhesive elastic bandage cut in 3.5 x 3.5cm (Silky Tex, ALCARE CO., LTD.) and
fixed with Silky Tex and surgical tape (NICHIBAN CO., LTD.) wrapped around the
trunk.

First administration
Three application sites (A to C) were prepared on 1 animal. Firstly, a patch of the test substance was applied to Site A (not wrapped with dressing around the trunk). The patch was removed after an exposure period of 3 min and the topical site was observed for corrosion. Because of the absence of corrosion, another patch was applied to Site B. The patch was removed after an exposure period of l hr and the topical site was observed for corrosion. Because of the presence of corrosion in Site B, the experiment was terminated and further process was not performed. At the time of removing each patch, the test substance remaining on the application sites was removed by gently wiping with absorbent
cotton.

Administration for confirmation
Since corrosion was observed at observation in the first administration, further administration for confirmation was not performed.

Rationale for administration route and method
The administration route and method were m accordance with the OECD Guideline.

Observation and measurement
Observation and scoring for dermal irritation/corrosion Since corrosion was observed at observation in the first administration, scoring was not performed.

Clinical observation and body weight measurement
One treated animal was observed for clinical signs, and weighed on the day of administration (Day 0) with a Sartorius electronic balance (E 12000S, Sartorius Co.,Ltd.).

Results and discussion

In vivo

Results

Irritation parameter:

other: corrosion

Basis:

animal #1

Time point:

other: 1 h

Reversibility:

not specified

Remarks on result:

other: corrosive

Remarks:

Scoring not possible as corrosion noted

Irritant / corrosive response data:

Evaluation of dermal irritation/corrosion
In the 3min·treatment site in the first administration, very slight erythema was noted at observation just after removal of the patch; however, no necrosis or corrosive reaction was observed. In the 1hr-treatment site, well defined erythema, and edema raised 1mm or more and extending beyond the area of exposure, as well as corrosion, were noted at observation just after removal of the patch.

Other effects:

Clinical observation
No abnormal finding was observed during the observation period.

Body weight measurement
The body weight at the time of administration was 2.13kg.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the above results, it was concluded that LiFSI was a corrosive substance under the conditions of this study.

Executive summary:

LiFSI was investigated for acute dermal irritation/corrosion m male Japanese White rabbits.

Three application sites were prepared in the clipped dorsal skin of one rabbit. A 0.5g of the test substance was spread on each of 2.5 x 2.5-cm lint patches, and occlusively applied to each application site. First, a patch was removed after application for 3min, and the topical site was observed for the presence or absence of corrosion. Since no corrosion was noted in the application site just after removal of the patch, the animal was subjected to occlusive exposure for 1hr. As a result, corrosion was noted just after removal; therefore, no more observation was performed.

Based on the above results, it was concluded that LiFSI was a corrosive substance under the conditions of this study.