NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	554-13-2
Chemical Name	Lithium carbonate
Substance ID	m-nite-554-13-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the rat LD50 value of 525 mg/kg bw (PIM 309F (2000)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1A,	Danger	H360 H362	P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, kidney)	Danger	H372	P260 P264 P270 P314 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 2	- -	H401	P273 P501	Classified into Category 2 from its 96h-LC50 = 8.1 mg/L for fish (Fundulus heteroclitus) (AQUIRE, 2011).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Classified into Category 2 since its acute toxicity is Category 2 and data on rapid degradation are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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