Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 242-449-7 | CAS number: 18621-94-8
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
- Quality of whole database:
- A combined repeat dose and reproductive and developmental screening study (OECD 422) is currently being conducted on dilithium adipate and a 90-day repeat dose toxicity study via oral route is proposed for dilithium sebacate.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The lithium salts of dicarboxylic salts C6 - C10 have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The lithium salts of dicarboxylic salts C6 - C10 have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 298.5 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on monocarboxylate fatty acids C18 (unsaturated) lithium salts via dermal administration. This substance is a structural analogue by virtue of its chemical structure and therefore data have been read across from fatty acids C18 (unsaturated) lithium salts to members of the dilithium salts of dicarboxylic acids C6-10 category.
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 0.23 mg/cm²
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on monocarboxylate fatty acids C18 (unsaturated) lithium salts via dermal administration. This substance is a structural analogue by virtue of its chemical structure and therefore data have been read across from fatty acids C18 (unsaturated) lithium salts to members of the dilithium salts of dicarboxylic acids C6-10 category.
Additional information
The substances in the category are considered to be similar on the basis that they have common structures of a lithium ion varying only by the length of the fatty acid chain. As a result, it is expected that the substances will have similar, predictable properties. Due to the close structural similarity and the narrow range of carbon chain numbers covered in this category, the repeated dose toxicity potential is expected to be similar across the category.
A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on monocarboxylate fatty acids C18 (unsaturated) lithium salts via dermal administration. Although this substance is not in the category, it is a structural analogue by virtue of its chemical structure and therefore read across from data on fatty acids C18 (unsaturated) lithium salts to members of the dilithium salts of dicarboxylic acids C6-10 category is considered to be justified – see read across justification.
The test material was administered at dose levels of 0, 100, 300 and 1000 mg/kg bw/day nominal, equating to 111.25, 345 and 1089.75 mg/kg bw/day by analysis, and were based on local dermal effects from a dose range finding study. There was a 2-week post-dose observation period for satellite high dose level and control groups. No systemic toxicity directly related to the administration of the substance was observed, although dose-related local effects were seen in the skin of treated animals in the 300 and 1000 mg/kg bw/day groups. Since the highest dose of 1089.75 mg/kg bw/day was essentially equivalent to a ‘limit dose’ and was considered to be the systemic NOAEL, this lithium fatty acid salt is not considered to be systemically hazardous. A local NOAEL of 111.25 mg/kg bw/day was determined due to dermal changes seen at higher concentrations.
A number of supporting subacute or subchronic toxicity studies by oral or dermal administration on greases containing ca 8.8% lithium 12 -hydroxystearate and 1.8% dilithium azelate in base oil have been published. These studies gave NOAEL levels of 2100 mg/kg bw/day of the grease. However, it should be noted that these greases also contained other additives and full experimental and analytical details were not presented. Therefore, they can only provide an indication of potential toxicity rather than definitive NOAELs for the category of lithium dicarboxylic acid salts. Nevertheless, the results confirm the low toxicity potential for these substances.
The results from this study also permitted consideration of long-term local effects on the skin. The NOAEL for this effect was 111.25 mg/kg/day, which converts to 0.86 mg/cm2based on the area of rat skin exposed in the subacute study (average weight of the rats in the study was 311g, the body surface area was calculated as being approximately 9.1 x bw(g)0.66, and the approximate surface area exposed was 10%).
Assuming a molecular weight of 288.4 g/mol for fatty acids C18-(unsaturated) lithium salt with a lithium content of 2.4% and a molecular weight of 158 g/mol for dilithium adipate with a lithium content of 8.8%, the values for fatty acid C18-(unsaturated) lithium salts have been recalculated for dilithium adipate, as the smallest substance in the category.
The systemic NOAEL of 1089.75 mg/kg bw/day is equivalent to 26.2 mg Li/kg bw/day and thus 298.5 mg/kg bw/day dilithium adipate. The local NOAEL of 111.25 mg/kg bw/day is equivalent to 2.68 mg Li/kg bw/day and thus 30.5 mg/kg bw/day dilithium adipate. The NOAEL for local long-term effects on the skin of 0.86 mg/cm2 is equivalent to 0.021 mg Li/cm2 and thus 0.23 mg/cm2 dilithium adipate.
On the basis of the lack of systemic toxicity read across from relevant structural analogue (fatty acids C18 (unsaturated) lithium salts - see read across justification document), no classification for specific target organ toxicity is required for dilithium salts of dicarboxylic acids C6 -C10.
Further testing is proposed or currently ongoing to support this conclusion. A combined repeat dose and reproductive and developmental screening study (OECD 422) is currently being conducted on dilithium adipate and a 90-day repeat dose toxicity study via oral route is proposed for dilithium sebacate.
Justification for classification or non-classification
Not classified for STOT systemic. No toxicologically significant adverse effects observed.
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.