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EC number: 251-528-5 | CAS number: 33454-82-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28-July-2016 to 11-October-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- 1. Deviations from the maximum level of daily mean relative humidity occured. 2. No clinical signs were registered for animal no. 1 on Day 8. Considered not to effect study reliability.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- 1. Deviations from the maximum level of daily mean relative humidity occured. 2. No clinical signs were registered for animal no. 1 on Day 8. Considered not to effect study reliability.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000)
- Version / remarks:
- including the most recent revisions
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Lithium trifluoromethanesulphonate
- EC Number:
- 251-528-5
- EC Name:
- Lithium trifluoromethanesulphonate
- Cas Number:
- 33454-82-9
- Molecular formula:
- CHF3O3S.Li
- IUPAC Name:
- lithium trifluoromethanesulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- See confidential details on test material
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL:
- At room temperature container flushed with nitrogen, desiccated
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant
- Age at study initiation: ca. 8-10 weeks old
- Weight at study initiation: body weight variation did not exceed +/- 20% of the sex mean
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test item. Water was available ad libitum.
- Housing: group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm) containing sterilized sawdust as bedding material and paper as cage-enrichment
- Diet: ad libitum
- Water ad libitum
- Acclimatation period: at least 5 days before start of treatment under laboratory conditions
DETAILS OF FOOD AND WATER QUALITY:
- Feed: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water: Free access to tap water
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures.
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single dosage on Day 1 using plastic feeding tubes
- Doses:
- First step: 2000 mg/kg (10 mL/kg) body weight.
Second step: 300 mg/kg (10 mL/kg) body weight. - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality/Viability: Twice daily. The time of death was recorded as precisely as possible.
- Body weights: Days 1 (pre-administration), 8 and 15 and at death (if found dead after Day 1).
- Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The signs were graded according to fixed scales and the time of onset, degree and duration were recorded:
- Maximum grade 4: grading slight (1) to very severe (4)
- Maximum grade 3: grading slight (1) to severe (3)
- Maximum grade 1: presence is scored (1)
- Necropsy of survivors performed: yes
- Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). - Statistics:
- No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 1 000 mg/kg bw
- Remarks on result:
- other: According to the OECD 423 test guideline
- Mortality:
- At 2000 mg/kg, two animals were found dead on Days 3 and 5.
At 300 mg/kg, no mortality occurred. - Clinical signs:
- other: At 2000 mg/kg, hunched posture, piloerection, lean appearance, dehydrated appearance, abnormal gait, shallow respiration and/or diarrhoea were noted for all animals between Days 1 and 4. At 300 mg/kg piloerection and/or restless behaviour were noted for a
- Other findings:
- - Macroscopic findings:
At 2000 mg/kg, abnormalities of the lungs (pale discoloration), uterus (greenish discoloration), spleen (reduced size) and/or stomach (several, dark red, foci, glandular mucosa) were noted for the animals that were found dead.
At 300 mg/kg, macroscopic post mortem examination did not reveal any abnormalities.
- Other observations:
Cannibalism was noted for one of the animals found dead. This was considered not toxicologically relevant.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 value of Lithium Trifluoromethanesulfonate in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.
Based on these results:
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), Lithium Trifluoromethanesulfonate should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.
- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Lithium Trifluoromethanesulfonate should be classified as Category 4 and should be labeled as H302: Harmful if swallowed. - Executive summary:
The assessment of acute oral toxicity of Lithium Trifluoromethanesulfonate in the rat (Acute Toxic Class Method) was carried out, under GLP compliance, based on the guidelines described in: OECD No.423 (2001), EU Method B1 tris, EPA OPPTS 870.1100 (2002) and JMAFF Guidelines (2000), including the most recent revisions.
Initially, Lithium Trifluoromethanesulfonate was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure two additional groups of three females were dosed at 300 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15).
At 2000 mg/kg, two animals were found dead on Days 3 and 5.
At 300 mg/kg, no mortality occurred.
At 2000 mg/kg, hunched posture, piloerection, lean appearance, dehydration, abnormal gait, shallow respiration and/or diarrhoea were noted for all animals between Days 1 and 4.
At 300 mg/kg piloerection and/or restless behaviour were noted for all animals on Day 1.
The mean body weight gain shown by the animals over the study period was considered to be normal.
At 2000 mg/kg, abnormalities of the lungs (pale discoloration), uterus (greenish discoloration), spleen (reduced size) and/or stomach (several, dark red, foci, glandular mucosa) were noted for the animals that were found dead.
At 300 mg/kg, macroscopic post mortem examination did not reveal any abnormalities.
The oral LD50 value of Lithium Trifluoromethanesulfonate in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.
Based on these results:
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), Lithium Trifluoromethanesulfonate should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.
- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Lithium Trifluoromethanesulfonate should be classified as Category 4 and should be labeled as H302: Harmful if swallowed.
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