GHS Classification Result

Chemical Name：Lithium carbonate
CAS：554-13-2

Result：
ID: 22A4003
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - - Although it contains a metal (Li), its water solubility is 1.3 g/100 ml (ICSC (J) (1999)) and it is considered that the substance doesn't react strongly with water.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - No data available.
15 Organic peroxides Not applicable - - - - Inorganic compound
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		Based on the rat LD50 value of 525 mg/kg bw (PIM 309F (2000)), the substance was classified into Category 4.
1 Acute toxicity （Dermal） Not classified - - - - Based on the rat LD0 value of 2000 mg/kg (GLP-compliant) (IUCLID (2000)), the substance was classified as "Not classified".
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - It is reported that the rat LC50 value was > 2.17 mg/L/4h (GLP-compliant) (IUCLID (2000)). Since this value only did not provide a basis for classification, the substance was classified as "Classification not possible". According to the description, the maximum particle size was 7.95 micrometer (IUCLID (2000)), the substance was considered as dust.
2 Skin corrosion/irritation Not classified - - - - The substance was classified as "Not classified" based on the result of "slightly irritating" from the Draize tests in which erythema was observed in 1 of 3 treated rabbits but disappeared within 5 days (IUCLID (2000)).
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		In the Draize test using rabbits, moderate irritation to unwashed eye was reported based on observation of cornea opacity, iritis, conjunctivitis, conjunctival hemorrhage and white areas on conjunctivae and recuperation within 7 days. Similar effects with less severity were observed in washed eye, and symptoms were reversible within 4 days and reported as mildly irritating (IUCLID (2000)). Based on these documents, the substance was classified as Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In the Buehler test using guinea pigs (OECD 406, GLP-compliant), no sensitization was reported (IUCLID (2000)). However, since it was the datum from the information source in the "List 2" in the GHS classification guidance for the Japanese government, the substance was classified as "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - The positive results in the chromosome aberration test/micronucleus test by intraperitoneal or oral administration of this substance or other lithium compounds are found in various results, but there are some problems concerning the test methods and so on. On the other hand, there is a negative result in the chromosome aberration test, so clastogenicity is not explicitly shown (IUCLID (2000), KemI-Riskline NR 2002: 16). Therefore, the substance was classified as "Not classified" based on the weight of evidence (KemI-Riskline NR 2002: 16). As relevant information, no chromosomal aberrations were observed in the lithium-treated patients (HSDB (2007)). In addition, in the in vitro testing of the lithium compounds, negative in the Ames test and the chromosomal aberration test, and negative and positive in the HGPRT test, were reported (IUCLID (2000), KemI-Riskline NR 2002: 16).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 1A, Additional category: Effects on or via lactation Danger H360: May damage fertility or the unborn child
H362: May cause harm to breast-fed children 		P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P263: Avoid contact during pregnancy/while nursing.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product. 		This substance is a psychotropic drug containing lithium as an ingredient. There were numerous reports about Ebstein's anomalies (congenital cardiovascular malformations) in neonates born from mothers who ingested the drug during pregnancy (PIM 309F (2000), Birth Defects 3rd (2000), HSDB (2007)). In the later follow-up studies, cardiovascular malformations in neonates were not confirmed, and thus there are some reports considering that the risk of neonatal disorders was lower than expected previously (KemI-Riskline NR 2002:16). However, it is well known that lithium can pass through the placenta (KemI-Riskline NR 2002:16). In the precautions of medicines package insert, lithium is contraindicated in the pregnant or possibly pregnant women (Handbook of Japanese pharmaceutical drugs (2010)). Based on the above, the substance was classified as Category 1A. In addition, it is also documented in an insert as a direction for use that lithium is excreted into the mother's milk with a similar concentration in the serum (PIM 309F (2000)) so that suckling should be discontinued when administering to the breast-feeding woman is unavoidably executed (Handbook of Japanese pharmaceutical drugs (2010)). Therefore, "additional category for effects on or via lactation" was added. Besides, in animal studies, in oral exposure studies with rats or mice during the gestational period, decreased litter size, increased resorption rate and increased fetal death were observed (IUCLID (2000)). In oral administration tests using mice during the organogenetic period, the incidence of malformations (cleft palate, fused ribs and exencephaly) in fetuses were documented (IUCLID (2000)).
8 Specific target organ toxicity - Single exposure Category 1 (nervous system), Category 3 (respiratory tract irritation) Danger
Warning 		H370: Causes damage to organs (nervous system)
H335: May cause respiratory irritation (respiratory tract irritation) 		P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell. 		The therapeutic use of this substance as an active ingredient might produce some toxic response depending on the blood lithium concentrations (KemI-Riskline NR 2002:16, Handbook of Japanese pharmaceutical drugs (2010)). According to a medical package insert, it is recommended to monitor the blood lithium concentration as a precaution of usage (Handbook of Japanese pharmaceutical drugs (2010)). Furthermore, it was reported that in patients receiving lithium therapy, severe neurotoxicity might occur which included impaired consciousness, delirium, ataxia, generalized fasciculation and extrapyramidal symptoms when the plasma lithium level would exceed 2.5 mM, and that the toxicity might occur for a few hours to a few hours (KemI-Riskline NR 2002:16). While, in the animal studies, it was reported that the signs consisting of lethargy, slow respiration, convulsion and muscle weakness were observed prior to death in mice administered orally at the dose levels of 250 to 1,000 mg/kg and the pathological changes in the nervous system were noted in these animals (IUCLID (2000)). Based on the above, the classification was determined as Category 1 (nervous system). On the other hand, it was reported that irritation of upper respiratory tract was observed in human by exposure of dust of this substance （KemI-Riskline NR 2002:16). Based on this information, the classification was determined as Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, kidney) Danger H372: Cause damage to organs through prolonged or repeated exposure (nervous system, kidney) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		This substance is a psychotropic drug which included lithium as an ingredient, and side effects such as tremor, lethargy, and confusion were described (KemI-Riskline NR 2002:16, Handbook of Japanese pharmaceutical drugs (2010)). The occurrence of toxicity was related to the blood lithium concentration, and those included neurological toxicity progressed from hand tremor, muscle weakness toward coma (KemI-Riskline NR 2002:16). In a follow up study about side effects for 59 subjects of 101 patients treated with lithium preparation for affective disorders, treatment-related side effects included tremor (23 subjects), subjective memory loss (23 subjects) and loss of creativity (11 subjects) (IUCLID (2000)). Based on the information on human toxicity, the classification was determined as Category 1 (nervous system). Moreover, as side effects other than nervous system, cases with polyuria, polydipsia or nephrogenic diabetes insipidus were reported (KemI-Riskline NR 2002:16, Handbook of Japanese pharmaceutical drugs (2010)). Thus, due to a description of possible occurrence of chronic renal failure (KemI-Riskline NR 2002:16), the classification was also determined as Category 1 (kidney).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 96h-LC50 = 8.1 mg/L for fish (Fundulus heteroclitus) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 2 since its acute toxicity is Category 2 and data on rapid degradation are not available.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information