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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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Endpoint summary
Administrative data
Description of key information
In vitro studies on dermal irritation have been conducted on C14, C16, and C18 fatty acid lithium salts. No irritant responses leading to classification were observed.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The irritant/corrosivity properties of free fatty acids are chain length dependent, where the lower carbon chain length < C9 are potentially corrosive, C10 – C12 are potentially irritant and C14 above are expected to be non-irritant (HERA 2002, referencing Briggs et al, 1976 and CIR, 1987). It was expected that similar trends in properties may apply to the lithium salts of fatty acids, so testing was undertaken in a stepwise manner.
Skin irritation studies were undertaken on lithium myristate (C14), which showed negative results. This was supported by results on longer chain length lithium carboxylate salts, a negative outcome in the study on fatty acids C18-(unsaturated) lithium salts. Therefore, as the shortest chain length substance in category was negative, this result was read across the other category members. Further testing on lithium 12-hydroxystearate (C18-OH) and lithium docosanoate (C22) is currently ongoing to confirm this approach.
Key in vitro skin irritation studies on lithium myristate (C14) and Fatty acids C18 (unsaturated) lithium salts gave negative results. Since under REACH, in vitro studies are sufficient for compliance with Annexes VII and VIII, no key in vivo study(ies) has been conducted. A number of in vivo supporting studies in rabbits for skin irritation using greases formulated with lithium 12-hydroxystearate have been conducted. However, since these were performed several decades previously on formulated greases containing other (unknown) performance additives, the results from the in vitro skin irritation tests on isolated C14 and C18 fatty acid lithium salts are considered to be more relevant and indicative of no classification for this endpoint.
References
API (American Petroleum Institute) (2008) Robust Summary of Information on Grease Thickeners (Creation date: October 11, 2003. Printing date: February 20, 2009. Last update: October 20, 2008. Document date: January 11, 2005)
Briggs GB, Doyle RL, Young JA (1976) Safety studies on a series of fatty acids. American Industrial Hygiene Association Journal, vol. 37, pp. 251-252
CIR (Cosmetics Ingredients Review) (1982). Final report of the safety assessment of lithium stearate, aluminum distearate, aluminum stearate, aluminum tristearate, ammonium stearate, calcium stearate, magnesium stearate, potassium stearate, sodium stearate and zinc stearate. Journal of the American college of toxicologists, vol. 1, issue 12, pp. 143-177.
CIR (Cosmetics Ingredients Review) (1987) Final report on the safety assessment of oleic acid, lauric acid, palmitic acid, myristic acid and stearic acid. Journal of American Toxicologists, vol. 6, issue 3, pp. 321-401
HERA (Human Health and Environmental Risk Assessment on ingredients of European household cleaning products) (2002) Fatty Acid Salts (Soap) Environmental and Human Health Risk Assessment
Justification for classification or non-classification
Skin irritation: Not classified. All studies were negative.
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.
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