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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity, carcinogenicity and teratogenicity of lithium compounds
- Author:
- A Leonard, et al
- Year:
- 1 994
- Bibliographic source:
- Mutation Research 339 (1995) 131-137
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- no guideline followed
- Version / remarks:
- In-vivo human chromosome aberration
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Version / remarks:
- Rat, 12 months exposure in drinking water
- Principles of method if other than guideline:
- Chromosome effects in 19 manic-depressive patients receiving lithium treatment were compared to 23 controls
Other human evaluations made on specific patients
Rat study looked at unscheduled DNA synthesis after 3, 6 or 12 months - GLP compliance:
- no
Test material
- Reference substance name:
- Lithium carbonate
- EC Number:
- 209-062-5
- EC Name:
- Lithium carbonate
- Cas Number:
- 554-13-2
- Molecular formula:
- CH2O3.2Li
- IUPAC Name:
- dilithium carbonate
Constituent 1
Test animals
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Rat study was using oral administration in drinking water
- Details on exposure:
- Rat study was using oral administration in drinking water
- Duration of treatment / exposure:
- For rat study, up to 12 months
Length of human treatment not specified, but some patients had been receiving treatment for up to 2 years
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- No adverse treatment related effects were observed in humans or rats in these studies
- Executive summary:
The review document cites many in-vitro and in-vivo (including human) researcvh projects and primary reference sources are provided. However, many of these research projects were conducted before fomalisation of test methods. The authors if this review conclude that in balance Lithium is not considered to be mutagenic, although there is limited evidence of some effects on mutagenic activity under certain conditions.
The only positive resposne was noted when 3 mg/ml lithium carbonate slightly inhibited DNA synthesis in V79 Chinese hamster cells and human fibroblasts. This effect was reduced in the presence of S9 fraction. More single-strand breaks in DNA and a small increase in gene mutations (HGPRT) in V79 Chinese hamster ceils without S9 was also noted. No other studies reported indications of positive effects.
To quote the counclusion in the report:
It is concluded that lithium compounds have no significant clastogenic and, based on studies on microorganisms, only a doubtful mutagenic activity.
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