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EC number: 686-526-7 | CAS number: 171611-11-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018.01.16~2018.11.16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- adapted 29 July 2016
- GLP compliance:
- yes
Test material
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- Crl:CD(SD), Rat, SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Male : 64 / Female : 64
- weight : 9w (M - 300.8g~354.5g) 7W(F-165.8g~199.4g)
- Injection : 58(Male), 58(Female)
- Injection : 10W(M : 337.8~405.2g) , 10W(F : 207.06~276.0g)
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The route of administration is oral. prepared test substance was continuously stirred using a magnetic stirrer before and after the administration,
and was directly administered into the stomach using a sonde-attached syringe. - Vehicle:
- other:
- Remarks:
- Distilled water
- Analytical verification of doses or concentrations:
- yes
- Remarks:
- KTR Study No. TBK-001907-2017
- 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:
- 7 days/week
- Frequency of treatment:
- The substance was administrated once/day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 45 mg/kg bw/day (nominal)
- Dose / conc.:
- 90 mg/kg bw/day (nominal)
- Dose / conc.:
- 180 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 1) 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
- Details on study design:
- Group1) Dose : 0(mg/kg. bw/day) , Volume = 10(mg/kg.bw/day)
Group2) Dose : 45(mg/kg. bw/day) , Volume = 10(mg/kg.bw/day)
Group3) Dose : 90(mg/kg. bw/day) , Volume = 10(mg/kg.bw/day)
Group4) Dose : 180(mg/kg. bw/day) , Volume = 10(mg/kg.bw/day) - Positive control:
- Vehicle control group : Group1) Dose : 0(mg/kg. bw/day) , Volume = 10(mg/kg.bw/day)
Examinations
- Observations and examinations performed and frequency:
- Clinical sign : Signs of clinical mortality and prolonged parturition( once a day)
Detailed clinical observation : Onec a week - 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
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The treatment-related moribund (or dead) animals were not observed during the study
period. - Mortality:
- no mortality observed
- Description (incidence):
- No evidence of death or death due to the administration of the test substance was observed in all test substance-treated groups.
In the case of general symptoms, salivation was observed in the main symptom observed during the administration period in the group treated with cancer 90 and 180 mg / kg · bw / day.
In male, the symptom was temporarily observed (3 days, 17 days; 1 day) in 3 of 90 mg / kg ㆍ bw / day administration group and 13 of 180 mg / kg bw / Were observed intermittently or continuously according to the duration of administration (17-49 days after administration, Animal No. 1406, 1411, 1414, 1416 exclusion animals).
In females, symptom was temporarily observed (from 36 to 49 days) in 4 of 90 mg / kg ' bw / day administration group, and in 9 of 180 mg / kg' bw / Intermittent
Or continuously observed.
In addition, in the 180 mg / kg bw / day administration group, the soiled perineal region; 2 female-Animal No. 2401 (15-17 days of administration), 2406 (15-19 days of administration)], tremor; 6 males - Animal No. 1401, 1407, 1409, 1411, 1415, 1416 (administration 40-47 days), female 3 animals - Animal No. 2413, 2414, 2417 (administration 40-49 days)], aggression [aggression; 1 male, Animal No. 1415 (43 to 49 days of administration)], staining around mouth; 1 female - Animal No. 2417 (41 days of administration)] were observed temporarily or intermittently. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- As a result of body weight measurement, no significant change was observed in males during the administration period and recovery period of the test substance administration group as compared with the control group.
In the case of females, the amount of body weight gain during the fermentation period was significantly decreased (89.6%, p <0.05) in the 180 mg / kg ㆍ bw / day group compared to the control group. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- In food consumption of parents, significantly increase was observed at male on
post-mating period (180 mg/kgㆍbw/day group; 3rd week; 18.3 %, recovery group; 2nd
week; 31.5%), pre-mating period (recovery group, pre-mating 2nd week; 0.5 %) (p <0.05).
In female of 180 mg/kgㆍbw/day group, significantly decreased (PND 0 – 1 day: 37.5 %,
PND 6 – 7 day: 40.6 %, PND 12 – 13 day: 46.6 %, p <0.05). And these observations were
similar to decrease body weight gain of an individual. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in treatment group of both sexes.
In recovery group, HGB was significantly increased in female at 180 mg/kgㆍbw/day. Also,
Lymph was significantly decreased in female at 180 mg/kgㆍbw/day (p <0.05). - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In treatment group, T-BIL was significantly decreased in male at 180 mg/kgㆍbw/day
(p <0.05). Na was significantly decreased in male at 45, 180 mg/kgㆍbw/day and
female at 180 mg/kgㆍbw/day (p <0.05). CK was significantly decreased at female in
treatment group (p <0.05). In recovery group, BUN was significantly increased in female
at 180 mg/kgㆍbw/day (p <0.05). - Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- There were no significant difference compared control group to treatment group.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- In absolute weight, there were significantly increased in Cowper's gland (right side;
male 45 mg/kgㆍbw/day), heart and thymus (female 180 mg/kgㆍbw/day) (p <0.05).
In relative weight, there were significantly increased in liver (male – 45, 180 mg/kgㆍ
bw/day), spleen (male – 180 mg/kgㆍbw/day), heart and thymus (female – 180 mg/kg
ㆍbw/day) (p <0.05). Besides, kidneys (left, both sides) were significantly decreased in
female at 180 mg/kgㆍbw/day. In recovery group, there were significantly decreased
(p <0.05) in testes (absolute – left, right, both sides) and epididymitis (absolute – left,
right, both sides, relative – right, both sides).
In thyroid gland, The thyroid gland was significantly decreased in absolute weight
(male; low dose – right, both sides, high dose – both sides, female; low dose and middle dose
– left, right, both sides, high dose – both sides) and relative weight
(male; low dose – left, right, both sides, middle dose – left, female; low dose - left,
right, both sides, middle and high dose – both sides). In recovery group, there was
significantly increased in female (180 mg/kgㆍbw/day) (p <0.05). - Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In reproductive organ, there were no treatment-related effects in both sexes of
treatment group.
In 180 mg/kgㆍbw/day group, lesions were observed in kidney (tubular basophilia; 1
male – Animal No. 1405, medullary mineralization; 2 females – Animal No. 2403, 2409),
adrenal gland (cortical vacuolation; 3 males – Animal No. 1401, 1403, 1409), heart
(myocardial inflammatory cell infiltration; 1 male – Animal No. 1405), prostate gland
(interstitial inflammatory cell infiltration; 1 male – Animal No. 1407).
In the case of necropsy findings, there was no abnormal lesions in the small seminal
vesicle (right, Animal No. 1402) and liver discoloration (Animal No. 2102). Besides, lesions
were observed as follows; parenchymal necrosis (liver, Animal No. 1203), cyst (kidney,
Animal No. 2304).
Also, there was no treatment-related effect in thyroid of pups (all treatment group).
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 180 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- haematology
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- System:
- female reproductive system
Applicant's summary and conclusion
- Conclusions:
- no repeated-dose toxicity of LiFSI was observed on 0, 45, 90 and 180
mg/kgㆍbw/day until pre-mating, mating, post-natal day 13. However, toxicological
effects of reproductive/developmental toxicity were observed in live birth index (PND
0), viability index (PND 4), number of pup (PND 4) on 180 mg/kgㆍbw/day group (high
dose). 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.
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