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Diss Factsheets
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EC number: 209-042-6 | CAS number: 553-54-8
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Review of human data
- Type of information:
- other: Literature review
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Lithium and benzoate salts are used extensively in drug and food applications and there has been a lot of research into human toxicity.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Version / remarks:
- Literature review
- Principles of method if other than guideline:
- A review of literature from a number of national and international reviews relating to use of lithium and benzoates salts in food and pharmaceuticals has been made to assess potential toxicity of lithium benzoate. In view of the wealth of data on these ions, and in view of the necessity to avoid new animal testing, it is considered justified to perform this review
Test material
- Reference substance name:
- Lithium benzoate
- EC Number:
- 209-042-6
- EC Name:
- Lithium benzoate
- Cas Number:
- 553-54-8
- Molecular formula:
- C7H6O2.Li
- IUPAC Name:
- lithium benzoate
Constituent 1
- Specific details on test material used for the study:
- Literature review includes examination of food additive sodium benzoate and the drugs lithium carbonate and lithium citrate.
Test animals
- Species:
- other: Human
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration and frequency of treatment / exposure:
- Chronic / Long-term
Doses / concentrations
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Remarks:
- Examination of human exposure to theraputic dose levels of lithium
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Rapid oral absorption
- Type:
- distribution
- Results:
- Readily distributed as dissociated ions
- Type:
- metabolism
- Results:
- Lithium not metabolised. Benzoate rapidly metabolised
- Type:
- excretion
- Results:
- Lithium rapidly excreted as inorganic salt. Benzoate is metabolised and not excreted.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- For water soluble forms of lithium, absorption is complete within 6 hours of oral administration from conventional tablets and capsules. To maintain blood Li levels, repeated administration is needed with recommendations for dosage 3 times a day.
Benzoate ions rapidly absorb orally.
Dermal penetration of lithium salts and benzoates has not been well evaluated, but in view of the relatively low molecular weight and solubility in water, it is likely that there is some dermal penetration.
Lithium undergoes ion exchange with sodium and potassium and for this reason is thought to adsorb into the skin and not necessarily penetrate. This ion-exchange is two-way and loss through sweat from skin could reverse and local absorption. This has not been well researched, although one human study suggests low absorption into blood from repeated dermal exposure - Details on distribution in tissues:
- Lithium and benzoate are distributed widely throughout the body. In the case of lithium, this has been found to include breast milk, thyroid gland, bone, and brain tissue. In some cases, concentrations exceed serum levels suggesting some accumulation into these areas.
Research has shown steady state serum level of lithium is achieved in 12 hours and therapeutic effect begins in 5 to 10 days and is maximal within 3 weeks. Therapeutic and toxic serum levels and therapeutic effects show good correlation. Therapeutic range is 0.6 to 1.2 mEq/l in blood serum
Transfer into organs
- Key result
- Test no.:
- #1
- Transfer type:
- blood/brain barrier
- Remarks:
- Lithium
- Observation:
- distinct transfer
- Details on excretion:
- Benzoates are not excreted, but are instead metabolised and metabolites will ultimately include carbon dioxide and water. There is evidence of carbon from benzoates being found in other organic substances formed by the body.
Inorganic lithium salts are typically excreted 95% unchanged in urine with about 50% to 80% of a given dose is excreted within 24 hours. The kidney has been found to accumulate lithium during periods of treatment.
Lithium from organic sources, such as benzoate salts, is also considered to be extruded at a similar rate, but in the form of inorganic salts such as chlorides. Lithium citrate is used for therapeutic applications with similar dosing recommendations to the more common carbonate forms.
Metabolite characterisation studies
- Details on metabolites:
- Benzoate ions are readily metabolised and metabolic pathways have been described in public literature
Lithium is not metabolised and is not considered to be an essential element in mammals
Applicant's summary and conclusion
- Conclusions:
- Benzoate ions are readily metabolised and metabolic pathways have been described in public literature
Lithium is not metabolised and is not considered to be an essential element in mammals
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