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Diss Factsheets
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EC number: 224-772-5 | CAS number: 4485-12-5
- 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
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Carcinogenicity
Administrative data
Description of key information
104 week dermal carcinogenicity study in mice using grease formulated with 7.5% lithium 12-hydroxystearate, at 50 mg/application. No guideline specified. Lithium 12-hydroxystearate is a member of the lithium salts of C14-C22 fatty acids category. The NOAEL of the grease was 408 – 714 mg/kg bw/day, and 31 – 54 mg/kg bw day for the lithium 12-hydroxystearate.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Limited. The study is taken from a regulatory review documents (US EPA 2011, API 2008) citing a proprietary test. No guideline was stated but a standard procedure was used. Only a summary of the study is available, but as the results are taken from a regulatory document, the data are considered reliable and relevant for use for this endpoint.
Justification for classification or non-classification
Not classified for carcinogenicity. No treatment-related increase in tumour incidence.
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 and the presence of unsaturated and/or hydroxyl functional groups. 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 carcinogenicity potential is expected to be similar across the category.
A supporting 104-week dermal carcinogenicity study on a lithium complex grease containing 7.5% lithium 12-hydroxystearate and other additives on mice is reported. 50 mg of the grease was applied to the backs of mice twice weekly. Using an average mouse weight of 20 – 35 g (Derelenko, 2008), the NOAEL of the grease was 2857 – 5000 mg/kg/week or 408 - 714 mg/kg bw/day. Correcting this for the lithium 12-hydroxystearate concentration, this gives a dose of 31 – 54 mg/kg bw/day for the lithium salt. This grease was not found to be a carcinogen under the conditions of the test. On the basis of long history of safe use of fatty acid soaps in greases, the substances in the category are not considered to be carcinogens.
References
Derelenko (2008) The toxicologists' Pocket Handbook. 2nd Edition.
Justification for selection of carcinogenicity via dermal route
endpoint:
Supporting study conducted on grease formulation containing 7.5%
lithium 12-hydroxystearate and other additives.
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.
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