Lithium bis(fluorosulfonyl)imide

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018.01.16~2018.11.18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG422(Combined Repeated dose toxicity study with reproduction/developmental toxicity screening test"

Version / remarks:

29 july 2016

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Lithium bis(fluorosulfonyl)imide

EC Number:

686-526-7

Cas Number:

171611-11-3

Molecular formula:

F2 H N O4 S2 . Li

IUPAC Name:

Lithium bis(fluorosulfonyl)imide

Test material form:

solid: bulk

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Analysis was performed before treatment (1st dosing) based on the analytical method
validation (KTR Study No. TBK-001907-2017), Analytical method validation of the LiFSI
in dosing formulation by using ICP-OES. The results were as follows and were met
the acceptance criteria as follows (precision: less than 10 %, accuracy: 80 – 120 %);
Homogeneity – 1.71 %, 2.10 %, 0.88 %, Concentration – 101.92 %, 104.35 %, 104.35 %)

Duration of treatment / exposure:

7d/week

Frequency of treatment:

once/day

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

45 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

90 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

180 mg/kg bw/day (nominal)

No. of animals per sex per dose:

) 0 mg/kg bw/day "Control animal"
- Male(17), Female(17)

2) 45mg/kg bw/day
- Male (12)/ Female(12)

3) 90mg/kg bw/day
- Male(12)/Female(12)

4) 180mg/kg bw/day
- Male(17) / Female(17)

Control animals:

yes

Statistics:

liver discoloration (median, left lateral lobe –Animal No. 1203) at male 45 mg/kgㆍbw/day group,
small seminal vesicle, right –Animal No. 1402) at male 180 mg/kgㆍbw/day group, liver notch and discoloration
(whole lobe – Animal No. 2102) at female control group, kidney notch (both sides –Animal No. 2304) at female 90 mg/kgㆍbw/day.
Also, gross abnormalities were not observed in recovery group at any dose group

Results and discussion

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

ca. 90 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Observed effects

no effects related to administration of LiFSI were observed on
female and male rats at doses of 0, 45, 90 and 180 mg/kg·bw/day before and
during mating (both sexes) and during gestation and for 13 days of lactation
(females). The administration-related toxicity for reproductive/development was 180
mg/kg·bw/day based on live birth index (PND 0), viability index (PND 4) and number
of live pup at PND 4.
In conclusion, the NOAEL(No Observed Adverse Effect Level) for repeated-dose
toxicity was 180 mg/kgㆍbw/day and the NOAEL for reproductive/developmental
toxicity was 90 mg/kgㆍbw/day. based on no evidence of reproductive toxicity.