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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic and germ cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017.10.24~2018.01.26
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:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
July 29,2016
GLP compliance:
yes
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
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:
mouse
Strain:
other: CrljOri:CD1 (ICR), Mouse
Details on species / strain selection:
CrljOri:CD1 (ICR), Mouse, SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
Temperature : (22 ± 3) celsius
Relative humidity : (50 ± 20) % R.H.
Air exchange : (10 – 20) times/h

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Sterile distilled water(SDW)
Doses / concentrations
Dose / conc.:
400 mg/kg bw/day (nominal)
Remarks:

- Negative control : 0
- Test subs : 100~400mg/mL

- Positive control : 70
No. of animals per sex per dose:
Neg : 5(Dose : 0mg/kg B.W/day)
Subs : 20(5X4 group), (Dose : 100~400mg/kg B.W/day)
Pos : 5(Dose : 70mg/kg B.W/day)
Control animals:
yes
Positive control(s):
Dose : 70mg/kg B.W day
Concentration : 7 mg/mL
Volume : 10mL/kg/times
Times : 1 times
Route : Intraoerutioneal
No. of animals : 5

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects

Applicant's summary and conclusion

Conclusions:
the test substance, LiFSI, was determined not to induce an increased
frequency of micronuclei in the bone marrow cells of male ICR mice under the
present experimental condition.