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EC number: 208-914-3 | CAS number: 546-89-4
- 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
Endpoint summary
Administrative data
Description of key information
Dermal: The dermal LD50 of the test item is greater than 2000 mg/kg.
Oral: The oral LDLo of the test item was determined as 1500 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Parameters analysed / observed: The minimum lethal dose was investigated. The toxicity of the test substance was determined according to the survival of the animals and their general conditions. The animals were observed for 30 days after the administration of the solution.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 21 - 23 g
- Acclimation period: 10 days - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1 mL
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
- Key result
- Sex:
- not specified
- Dose descriptor:
- LDLo
- Effect level:
- 1 500 mg/kg bw
- Based on:
- test mat.
- Gross pathology:
- Animals that died revealed morphological changes of the lungs, brain and liver that were characterised as sharply expressed polyemia. Selective degeneration mainly affected liver, kidney and the nervous system. Morphological changes increased with the dosage of the test substance.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to Neretin et al. an LDLo of 1500 mg/kg bw was determined for mice.
- Executive summary:
Lithium acetate was tested on 20 white mice per dose group in an acute toxicity study (Neretin, 1958). The LDLo- and LD100-levels in this study were 1500 mg/kg bw and 4000 mg/kg bw, respectively.
Animals that died revealed morphological changes of the lungs, brain and liver that were characterised as sharply expressed polyemia. Selective degeneration mainly affected liver, kidney and the nervous system. Morphological changes increased with the dosage of the test substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- reliable study report, sufficient for assessment
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Reference No.: 434-01A; - FMC-T#: 1562
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage: Room temperature
- Stability: Stable for a minimum of 30 days - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: Adult
- Weight at study initiation: 200-300 g
- Housing: Individually housed in stainless steel, suspended cages containing DACB indirect bedding.
- Diet: Purina Rodent Chow 5001 (pellets), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 20.6 °C
- Humidity: 51 - 56 %
- Photoperiod: 12-hour fluorescent light/dark cycle - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: From the Scapula to the pelvic region.
- % coverage: At least 10 % of the body surface
- Type of wrap if used: Gauze pad was secured with hypoallergenic tape and was covered with an elastic, plastic-lined bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Test sites were rinsed with water
- Time after start of exposure: 24 h
VEHICLE
- Amount(s) applied: 0.50 mL tap water - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for toxicity were conducted 0.5, 1, 2, 3, 4 and 6 hours post-dosing, and daily thereafter. Dermal irritation were recorded on days 1, 3, 7 and 14. Body weights were recorded weekly.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were noted
- Clinical signs:
- All rats remained healthy during the study.
- Body weight:
- Immediately prior to dosing, body weights ranged from 223-266 g. All but one rat gained weight by day 14 of the study; this rat lost weight through day 7, then regained weight to return to its' pre-dosing weight.
- Gross pathology:
- No gross internal lesions were observed in any animal during necropsy.
- Other findings:
- Local irritation: The only irritation noted during the study was erythema in one female on study day 1.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the test material is greater than 2000 mg/kg.
- Executive summary:
The acute dermal toxicity was assessed equivalent or similar to OECD guideline 402. Lithium acetate dihydrate was topically applied to five Sprague-Dawley rats per sex at a dosage level of 2000 mg/kg. The test material was in contact with the skin under an occlusive wrap for 24 hours. Observations for toxicity were conducted 0.5, 1, 2, 3, 4 and 6 hours post-dosing, and daily thereafter for 14 days. Dermal irritation was recorded in day 1, 3, 7 and 14. Body weights were recorded weekly. Gross necropsies were performed on all animals. No death were noted. All rats remained healthy during the study. All but one rat gained weight by day 14 of the study; this rat lost weight through day 7, then regained weight to return to its' pre-dosing weight. The only dermal irritation noted was erythema in one female on day 1. No gross lesions were revealed during necropsy. The dermal LD50 of the test item is greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable study report, sufficient for assessment
Additional information
Acute oral toxicity
Lithium acetate was tested on 20 white mice per dose group in an acute toxicity study (Neretin, 1958). The LDLo- and LD100-levels in this study were 1500 mg/kg bw and 4000 mg/kg bw, respectively.
Animals that died revealed morphological changes of the lungs, brain and liver that were characterised as sharply expressed polyemia. Selective degeneration mainly affected liver, kidney and the nervous system. Morphological changes increased with the dosage of the test substance.
Acute inhalation toxicity
In accordance with column 2 of REACH Annex VIII, an acute inhalation
toxicity study does not need to be conducted as two other routes for
acute toxicity are provided.
Acute dermal toxicity
Lithium acetate dihydrate was topically applied to five
Sprague-Dawley rats per sex at a dosage level of 2000 mg/kg . The test
material was in contact with the skin under an occlusive wrap for 24
hours. Observations for toxicity were conducted 0.5, 1, 2, 3, 4 and 6
hours post-dosing, and daily thereafter for 14 days. Dermal irritation
was recorded in day 1, 3, 7 and 14. Body weights were recorded weekly.
Gross necropsies were performed on all animals. No death were noted. All
rats remained healthy during the study. All but one rat gained weight by
day 14 of the study; this rat lost weight through day 7, then regained
weight to return to its' pre-dosing weight. The only dermal irritation
noted was erythema in one female on day 1. No gross lesions were
revealed during necropsy. The dermal LD50 of the test item is greater
than 2000 mg/kg.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The LDLo-value of 1500 mg/kg bw was used for the determination acute oral toxicity. As a result, the substance is to be classified as Cat. 4 (H302: Harmful if swallowed) but not considered to be classified for acute inhalation and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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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