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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 10 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Assessment of Lithium ions.Lithium Benzoate will dissociate under biological conditions and assessment of toxicity needs to consider both Lithium and Benzoate ions
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of Sub-acute Oral Toxicity of Lithium Carbonate Microemulsion (Nano Size) on Liver and Kidney of Mice
- Author:
- Heibatullah Kalantari et al.
- Year:
- 2 015
- Bibliographic source:
- Jundishapur J Nat Pharm Prod. 2015 Feb; 10(1): e22312
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Mice were dosed orally with lithium carbonate in doses of 50, 100, and 200 mg/kg for ten consecutive days and effects to liver or kidneys examined.
- GLP compliance:
- no
- Limit test:
- 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
- Specific details on test material used for the study:
- Lithium carbonate was administered as either solution or as a micro-emulsion. The reason for examining the different forms of the substance was to assess if the physical form had any affect on bio-availabilty when administered orally for drug use. (Note : the research consluded that the different forms of the substnace had no imppact)
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male Swiss albino mice (age, 6 - 8 weeks old; weight, 25 - 30 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 mice
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Clinical signs dailyBlood samples taken after termination
- Sacrifice and pathology:
- Objective of study to examine liver and kidney functions
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Blood samples were analysed for serum glutamate pyruvate transaminase (SGPT), glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (ALP), blood urea nitrogen (BUN), and creatinine (Cr) Administration in all doses resulted a significant increase in the levels of BUN and Serum activity of SGOT and SGPT in comparison to normal saline group (P < 0.05). Serum activity of ALP, SGOT, and SGPT and levels of BUN and Cr in ME base group were greater than those in normal saline group were. However, this difference was not significant.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver and kidney histopathologic findings confirmed the hepatotoxic and nephrotoxic effects of LC and LCME by demonstrating centrilobular necrosis, fatty changes (steatosis), and scattered lymphocytes infiltrate in hepatic parenchyma as well as glomerulonephritis and urinary protein deposition in kidneyAlthough clearly effects were seen, it is nnot know if these were adaptive or of toxic significance
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Some swelling of cells in liver and kidney that appeared to be treatment relatedAlthough clearly effects were seen, it is nnot know if these were adaptive or of toxic significance
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- haematology
- histopathology: non-neoplastic
- Dose descriptor:
- LOEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 200 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- kidney
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Although the authors found dose related effects on liver and kidney pathology and blood analysis showed statistical changes that appeared to be dose ralted, the effects are possibly adaptive and the highest dose level appeared to be tolerated by mice.The NOAEL is considered to be approximately 200 mg/kg/day for 10 days.
- Executive summary:
Oral administration by gavage of lithium carbonate in two forms (solution and micro-emulsion) lead to effects in liver and kidneys and associated blood changes when dosed at levels of 50 - 200 mg/kg/day.
The significance of the effects was not discussed by the authors and these are considered to be adaptive changes.
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