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EC number: 233-820-4 | CAS number: 10377-48-7
- 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
Under the conditions of the skin irritation study, lithium carbonate is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours. This study that was used for read-across
Lithium sulfate anhydrous and its monohydrate were also tested for corrosive properties in the Corrositex TM Assay which is used for assigning the packaging group according to UN Dangerous Goods Transport Regulations. Both substances were found to be not corrosive.
Under the conditions of the eye irritation study, lithium carbonate is irritating to eyes. The study was used for read-across.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1988-01-21 to 1988-01-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 3.19 kg to 3.33 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum, Purina High Fiber Rabbit Chow 5326
- Water:ad libitum, fresh tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21.7
- Humidity (%): 36 - 48
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The animals were weighed once on the day before dosing. Clinical signs were recorded as noted. Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of Draize.
- Number of animals:
- 3 (2 male, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: The clipped area extended from the scapular to the pelvic region. One test site was located on each side of the spinal column.
- Type of wrap: semi-occlusive cheesecloth bandage
REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water.
SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of Draize. The sites were evaluated daily thereafter for 5 days. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All animals remained healthy throughout the study.
One rabbit had slight erythema on study days 1-4. All irritation had resolved by study day 5 at which time the test was terminated. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this study , the lithium carbonate is not irritating to intact skin of New Zealand White rabbits after 4 hours of exposure.
- Executive summary:
An acute skin irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 404. Three New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of Lithium Carbonate Technical Grade was placed in contact with each test site. The test sites were covered with gauze patches and the trunk of each animal was wrapped with a sheet of cheesecloth. The test material was in contact with the skin for 4 hours, after which the animals were unwrapped and the test material removed. Approximately 30 minutes, 24, 48, 72 hours after the end of the exposure period, the test sites were scored for irritation using the method of Draize. Irritation observed in one of the three animals (scored 1 for erythema) had resolved by the end of the study (day 5). Under the conditions of this study, the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours. The used scores of the test system (US scheme) were adapted to the EU scheme.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2001-08-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable, scientific valid study in order to assess eventual corrosive potential.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Corrositex TM is a quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.
- GLP compliance:
- not specified
- Species:
- other: not applicable
- Details on study design:
- The international Corrositex assay kit is an in vitro method for determining the corrosive potential of chemical substances. The results of this assay were used to determine the United Nations Transport Regulations Packaging Group. For detailed test procedure see Sect. "Any other information on materials and methods incl. tables"
- Irritation / corrosion parameter:
- other: other: corrosivity
- Value:
- > 60
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of breakthrough time of 4 replicates. Time point: > 60 minutes. Remarks: When results of > 60 minutes are obtained, the substance is consequently categorized to be non-corrosive.. (migrated information)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN Dangerous Goods Transport Regulations
- Conclusions:
- Lithium sulfate anhydrous was tested for corrosive properties in the Corrositex TM Assay which is used for assigning the packaging group according to UN Dangerous Goods Transport Regulations. Lithium sulfate anhydrous was found in this test to be not corrosive.
- Executive summary:
Lithium sulfate anhydrous was tested for corrosive properties in the Corrositex TM Assay in a single trial (four replicates) that examines the mean breakthrough time in order to determine the packing group classification. The mean breakthrough time of the 4 replicates was > 60 minutes, therefore, based on the evaluation of the test results lithium sulfate anhydrous was not considered to be corrosive.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2001-04-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable, scientific valid study in order to assess eventual corrosive potential.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Corrositex TM is a quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.
- GLP compliance:
- not specified
- Details on study design:
- The international Corrositex assay kit is an in vitro method for determining the corrosive potential of chemical substances. The results of this assay were used to determine the United Nations Transport Regulations Packaging Group. For detailed test procedure see Sect. "Any other information on materials and methods incl. tables"
- Irritation / corrosion parameter:
- other: other: corrosivity
- Value:
- > 60
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of breakthrough time of 4 replicates. Time point: > 60 minutes. Remarks: When results of > 60 minutes are obtained, the substance is consequently categorized to be non-corrosive. (migrated information)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN Dangerous Goods Transport Regulations
- Conclusions:
- Lithium sulfate monohydrate was tested for corrosive properties in the Corrositex TM Assay which is used for assigning the packaging group according to UN Dangerous Goods Transport Regulations. Lithium sulfate monohydrate was found in this test to be not corrosive.
- Executive summary:
Lithium sulfate monohydrate was tested for corrosive properties in the Corrositex TM Assay in a single trial (four replicates) that examines the mean breakthrough time in order to determine the packing group classification. The mean breakthrough time of the 4 replicates was > 60 minutes, therefore, based on the evaluation of the test results lithium sulfate monohydrate was not considered to be corrosive.
Referenceopen allclose all
One run has been performed with 4 replicates. Each run was longer than > 60 minutes and so is the mean time of the 4 replicates.
Based on the results of the Corrositex TM Assay, the test article, lithium sulfate anhydrous has not to be classified as corrosive according to the UN Dangerous Goods Transport Regulations.
One run has been performed with 4 replicates. Each run was longer than > 60 minutes and so is the mean time of the 4 replicates.
Based on the results of the Corrositex TM Assay, the test article, lithium sulfate monohydrate has not to be classified as corrosive according to the UN Dangerous Goods Transport Regulations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-01-21 to 1988-01-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2.83 kg to 3.15 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum, Purina High Fiber Rabbit Chow 5326
- Water:ad libitum, fresh tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21.7
- Humidity (%): 33 - 48
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per test eye - Duration of treatment / exposure:
- The test material was tapped off a piece of weighing paper into the lower conjunctival sac which was formed when the lower eyelid was pulled away from the test eye. The upper and lower lids were then brought together and held closed for one second and released. The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 ml of tap water approximately 20 - 30 sec after treatment.
- Observation period (in vivo):
- The animals were weighed once on the day before dosing. Clinical signs were recorded as noted.
- Number of animals or in vitro replicates:
- 4 (3 male, 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed with 100 ml of tap water approximately 20 - 30 sec after treatment. The rate of application of the wash water was approximately 100 ml/min.
- Time after start of exposure: 20 - 30 sec
SCORING SYSTEM: The eyes were scored for irritation potential at 1, 24, 48 and 72 hours and on day 4 and 7 using the method of Draize.
TOOL USED TO ASSESS SCORE: After the 24 hour examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- All animals remained healthy throughout the study.
One hour after dosing, unwashed eyes had mild corneal opacities, iritis, moderate conjunctivitis and white and hemorrhagic areas on the conjunctivae. Washed eyes had slight corneal opacities and slight conjunctivitis. At the 24-hour scoring, both washed and unwashed eyes had mild corneal opacities and moderate conjunctivitis. Irritation gradually resolved; washed eyes recovered by day 4, and unwashed eyes recovered by day 7. Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed. - Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test material is irritating to eyes.
- Executive summary:
An acute eye irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 405. Lithium carbonate Technical Grade was instilled into the test eyes of 4 New Zealand White rabbits at a dose of 0.1 g. The eyes of two rabbits remained unwashed while the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 seconds after treatment. Eyes were assessed for irritation using the method of Draize at 1, 24, 48 and 72 hours after installation, as well as on days 4 and 7. Slight to mild corneal opacities, iritis and slight to moderate conjunctivitis were noted in all eyes. Unwashed eyes also had hemorrhages and white areas on the conjunctivae. Washing the eyes with tap water shortly after exposure decreased both the severity and the duration of the irritation observed. Irritation gradually resolved; washed eyes recovered by day 4 and unwashed eyes recovered by day 7. Based on the results obtained with unwashed eyes, lithium carbonate has to be classified as irritating to the eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
An acute eye and skin irritation/corrosion study was not available for lithium sulfate and its monohydrate. Consequently, read-across was applied using study results obtained from lithium carbonate as a characteristically similar compound. The study on skin irritation is supported by two in vitro Corrositex studies performed with lithium sulfate anhydrous and its corresponding monohydrate.
skin irritation/corrosion
An acute skin irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 404. Three New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of Lithium Carbonate Technical Grade was placed in contact with each test site. The test sites were covered with gauze patches and the trunk of each animal was wrapped with a sheet of cheesecloth. The test material was in contact with the skin for 4 hours, after which the animals were unwrapped and the test material removed. Approximately 30 minutes, 24, 48, 72 hours after the end of the exposure period, the test sites were scored for irritation using the method of Draize. Irritation observed in one of the three animals (scored 1 for erythema) had resolved by the end of the study (day 5). Under the conditions of this study, the test material is not irritating to intact skin of New Zealand White rabbits when brought into contact with the skin for four hours. The used scores of the test system (US scheme) were adapted to the EU scheme. (FMC, 1988)
Corrositex Assays with lithium sulfate and the corresponding monohydrate
Lithium sulfate anhydrous and its monohydrate were tested for corrosive properties in the Corrositex TM Assay in a single trial (four replicates) that examines the mean breakthrough time in order to determine the packing group classification. The mean breakthrough time of the 4 replicates was > 60 minutes, therefore, based on the evaluation of the test results both substances were not considered to be corrosive. (FMC, 2001)
eye irritation
An acute eye irritation/corrosion study in New Zealand White rabbits was performed in accordance with OECD Guideline 405. Lithium carbonate Technical Grade was instilled into the test eyes of 4 New Zealand White rabbits at a dose of 0.1 g. The eyes of two rabbits remained unwashed while the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 seconds after treatment. Eyes were assessed for irritation using the method of Draize at 1, 24, 48 and 72 hours after installation, as well as on days 4 and 7. Slight to mild corneal opacities, iritis and slight to moderate conjunctivitis were noted in all eyes. Unwashed eyes also had hemorrhages and white areas on the conjunctivae. Washing the eyes with tap water shortly after exposure decreased both the severity and the duration of the irritation observed. Irritation gradually resolved; washed eyes recovered by day 4 and unwashed eyes recovered by day 7. Based on the results obtained with unwashed eyes, lithium carbonate has to be classified as irritating to the eyes. (FMC, 1988)
Justification for classification or non-classification
In conclusion, lithium sulfate and its monohydrate are not to be classified according to Regulation (EC) No 1272/2008 (CLP) with regard to skin irritation. With respect to eye irritation, both have to be classified into Cat. 2B (H319) according to the Regulation (EC) No 1272/2008 (CLP).
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