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Diss Factsheets
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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
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: substance itself [Lithium bis(fluorosulfonyl)imide]
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: The results from the combined repeated dose/reprotox study (OECD 422) are ambiguous. The NOAEL was set to 90 mg/kg bw due to reprotox effects in the higher dose group (180 mg/kg bw).
Thus adverse effects are already known which should be evaluated further.
- Available non-GLP studies: No available non-GLP studies on the substances for the endpoint ‘toxicity to reproduction.
- Historical human/control data: No human data exist on the substance for the endpoint ‘toxicity to reproduction’.
- (Q)SAR: No validated (Q)SAR models exist for the bis(fluorosulfonyl)imide moiety of this molecule regarding ‘toxicity to reproduction.
- In vitro methods:
According to Annex IX of REACH regulation (data requirements for a registration in the tonnage band 100-1000 t/a), section 8.7.3, an Extended One-Generation Reproductive Toxicity Study shall be proposed if available repeated dose toxicity studies (e.g. 28-day or OECD 421/422) indicate adverse effects on reproductive organs or tissues or reveal other concern in relation with reproductive toxicity.
In vitro methods are not an option to waive the in vivo study according to the data requirements defined under REACH.
- Weight of evidence: The date found for this substance are insufficient to apply a weight of evidence approach.
- Grouping and read-across: For the bis(fluorosulfonyl)imide moiety no studies exist for structural similar substances for ‘toxicity to reproduction’. Studies only exist for substances with significantly different structures. For lithium salts reliable studies exist for ‘toxicity to reproduction’. Nevertheless as in the registrant's opinion and according to the guidance documents this is not sufficient to cover the data requirements, no read-across-approach is suggested.
- Substance-tailored exposure driven testing: Not applicable – substance is used in wide-dispersive uses
- Approaches in addition to above: Not applicable
- Other reasons: Not applicable
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and
this endpoint.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The oral route is considered to be the most appropiate route of administration.
Thus a study according to OECD 443 (EOGRTS) is proposed.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- Justification for study design:
- In OECD 422 study no specific adverse effects were observed related to nuerotoxicity or immunotoxicity. Thus a basic study design without extension is suggested.
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
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.