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EC number: 209-062-5 | CAS number: 554-13-2
- 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

Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-01-18 to 1988-06-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Lithium carbonate
- Molecular formula (if other than submission substance): Li2CO3
- Substance type: white powder
- Analytical purity: 99.4 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Raleigh, North Carolina
- Age at study initiation: male: 49 days; female: 55 days
- Weight at study initiation: male: 321.0 g - 242.9 g; female: 185.0 g - 199.5 g
- Housing: animals were housed individually in an elevated, stainless steel wire mesh cage
- Diet (e.g. ad libitum): ad libitum, Purina Certified Laboratory Chow
- Water (e.g. ad libitum): ad libitum, tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 23.3
- Humidity (%): 43-64
- Air changes (per hr): Exposure-time: 4 hours. The chamber was operated in dynamic mode with a consistent airflow of 35.8 litres per minute (Lpm). The chamber airflow rate was measured using a calibrated Dwyer 0-40 Lpm flowmeter and was recorded every 30 minutes. These conditions gave a calculated air change of 21.5 air changes per hour an a T99 value of 12.87.
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass exposure chamber, which was operated in a dynamic mode
- Exposure chamber volume: 100 L
- Source and rate of air: The chamber was operated in dynamic mode with a consistent airflow of 35.8 litres per minute (Lpm). The chamber airflow rate was measured using a calibrated Dwyer 0-40 Lpm flowmeter and was recorded every 30 minutes. These conditions gave a calculated air change of 21.5 air changes per hour and a T99 value of 12.87.
- System of generating particulates/aerosols: Following 240 minutes of exposure, the generation was discontinued and clean air was passed through the exposure chamber for an additional 30 minutes to clear the test material from the chamber. Afterwards, the chamber was opened and the animals were removed.
- Method of particle size determination: Lithium carbonate dust was determined by sampling a measured volume of test atmosphere through an Andersen Cascade Impactor. The impactor stages each contained a pre-weighed glass-fiber filter designed to retain impacted particles of sequentially dimishing size. The quantity of dust collected on each filter was determined gravimetrically.
- Treatment of exhaust air: The exposure chamber air was exhaust through a HEPA filter.
- Temperature, humidity: 20.6 - 23.3 °C, 43-64 %
TEST ATMOSPHERE
- Particle size distribution: Particle size determinations were performed twice during the exposure.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMAD and GSD of the test material aerosol were estimated from a standard second order polynomial least squares fit of the logarithm for each stage constant versus the cumulative weight distribution of the experimental data.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The concentration of lithium carbonate in the exposure chamber was determined gravimetrically by collection of the dust on preweighed filters. Samples were collected at 5 Lpm for 2 minutes on a preweighted 25-mm Gelman Type A/E glass-fiber.
- Duration of exposure:
- 4 h
- Concentrations:
- Gravimetric concentration: 2.17 mg/L
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Statistics:
- The MMAD and GSD of the test material aerosol were estimated from a standard second order polynomial least squares fit of the logarithm for each stage constant versus the cumulative weight distribution of the experimental data.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2 mg/L air
- Mortality:
- Two male animals died before the scheduled sacrifice. In addition to the typical signs, they exhibited wheezing, rough haircoat, rhinorrhea, and low body temperature (to the touch). Most animals were normal in appearance by Test Day 9 and all were normal by termination. There did not appear to be any substantive differences in the nature, or frequency of occurrence, of the abnormal observations of the surviving male animals and female animals.
- Clinical signs:
- other: During the exposure period, animals were observed with test compound on the fur, increased secretory responses, labored breathing, languid behaviour and squinted eyes. The signs were also exhibited at 30 and 60 minutes post-exposure. Crust on the eyelids
- Body weight:
- Body weight was decreased in all male animals and one female animal at Test Day 8 compared to the pre-exposure body weights. By Test Day 15, all surviving animals had gained relative to their Test Days 1 and 8 body weights.
- Gross pathology:
- All animals surviving to the scheduled sacrifice were normal. The finding of pale kidney in one female animal is considered sporadic in nature. In the male animals found dead, no histopathological evaluation was performed to distinguish spontaneous postmortem changes from potential treatment related lesions. Many of the lesions in these males were considered to probably be spontaneous postmortem changes. The findings of sore and alopecia on the skin of one male animal were considered sporadic in nature. On this basis, the findings at necropsy of the two male animals which died on test were not considered related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Two male rats exposed to an actual concentration of 2.17 mg/L lithium carbonate died prior to termination. Their deaths were considered treatment-related. As no additional exposures were requested, the median lethal concentration (LC50) for this test substance was estimated as greater than 2 mg/L.
- Executive summary:
The acute inhalation toxicity of lithium carbonate in Sprague-Dawley rats was determined according to OECD Guideline 403 and EU method B.2. Five male and five female Sprague-Dawley rats received a single 4 hour whole-body exposure to a gravimetric concentration of 2.17 mg/L lithium carbonate.
The dust was determined to be generally respirable to the rat (73.3 % of particles less than 10 um). Two male rats died as a result of treatment. Signs of treatment included test material on the fur, increased secretory responses, labored breathing, languid behaviour, squinted eyes and crust on the eyelids. The animals that died also exhibited wheezing, rough haircoat, rhinorrhea and low body temperature (to the touch). By Test Day 8 body weights in males were diminished compared to body weights immediately prior to exposure.
Based on the mortality results of this study using combined sexes, the median lethal concentration for a 4 hour exposure to lithium carbonate was estimated to be greater than 2 mg/L. As maximum attainable concentrations were applied without revealing indications for acute toxicity, lithium carbonate has not to be classified with regard to acute toxicity according to Regulation (EC) No 1272/2008 (CLP).
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