NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7447-41-8
Chemical Name	Lithium chloride
Substance ID	m-nite-7447-41-8_v2
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	Not classified	- -	-	-	Not combustible (ICSC (1997))	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	Not classified	- -	-	-	Not combustible (ICSC (1997))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (ICSC (1997))	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 83.2 g/100 g water (20 degC) (Ullmanns) (6th, 2003)) 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	- -	-	-	This substance is an inorganic compound containing halogen atom (Cl), but classification is not possible because no data is 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. In addition, it is reported that the aqueous solution corrodes metals (ICSC (1997)).	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 values of 526 - 840 mg/kg bw (IUCLID (2000)) and 757 mg/kg bw (HSDB (2007)), the substance was classified into Category 4. [For health hazards, refer also to other lithium compounds.]	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	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	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	The substance was classified as Category 2 based on the documented case of "irritating" resulted from rabbit test (Directive 84/449/EEC, B.4, GLP-compliant) in which one of 3 animals showed irreversible crust formation in 14 days (IUCLID (2000)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	The substance was classified as Category 2A based on the documented case of "moderately irritating" resulted from rabbit test (GLP-compliant) in which the irritation was most severe 1 hour after the instillation, and it recovered by day 7 in washed eyes and by day 16 in the unwashed.	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	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The positive data in the chromosome aberration test using bone marrow obtained from mice by oral administration and the negative data in the sister chromatid exchange test were reported (IUCLID (2000)). However, these data contained many improperness, and also details of the test method were not provided there. Therefore, the clear conclusion was not possible based on these data. Thus, the positive results in the chromosome aberration test/micronucleus test in this substance or other lithium compounds (KemI-Riskline NR 2002: 16) were sometimes found, but, these data had problematic issues with the test methods and others. On the other hand, because the negative data in the chromosome aberration test were also reported (KemI-Riskline NR 2002: 16), the induction of chromosome aberration was unclear. Therefore, based on the overall evaluation by weight-of-evidence, the substance was concluded as "Not classified". As relevant information, as for in vitro tests, the bacterial reverse mutation test with negative results (NTP DB (Access on Apr. 2010), KemI-Riskline NR 2002: 16) and the chromosomal aberration test using human peripheral blood culture cells with positive results (IUCLID (2000), KemI-Riskline NR 2002: 16) were reported.	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	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In the acute oral toxicity study in mice, it was reported that the LD50 value was 1,165 mg/kg, and toxic signs included paralytic gait of hindlimbs, stupor with subsequent death, muscle weakness or muscle spasms (IUCLID (2000)). It was also reported in the other studies (dose levels: 1,500 – 3,000 mg/kg) that clinical signs observed were as follows: lethargy, slow respiration, slow response to external stimuli, convulsion prior to death (IUCLID (2000)). Since these clinical signs in mice were seen in dose levels within Category 2 of the guidance values, the classification was determined as Category 2 (nervous system). As the additional information, the therapeutic use of lithium carbonate as an active ingredient may produce unusual 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 also 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 days from a few hours (KemI-Riskline NR 2002:16).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system, kidney)	Warning	H373	P260 P314 P501	In repeated dose study in rats for up to 2 years via drinking water, the rats given the substance at a dose equivalent to 106 mg/kg/day revealed drowsiness and lethargy and subsequent muscle tremor and weakness after 3-5 days of commencement of treatment, and they died within 2 - 3 weeks (IUCLID (2000)). In repeated oral dose toxicity study with dogs for up to 150 days, deaths occurred at 100 mg/kg/day, and the symptoms prior to death included tremors, lethargy, salivation, muscular weakness, extreme weakness, etc. (IUCLID (2000)). Additionally, in the other repeated oral dose toxicity study with dogs for up to 57 weeks (dose levels: 20, 50 and 100 mg/kg/day), renal damage with histopathological lesions in the distal convoluted tubules and collecting ducts were observed (IUCLID (2000)). All these findings were observed in the dose-range equivalent to Category 2 defined as the guidance values, and thus the classification was decided as Category 2 (nervous system, kidney). In humans, it was reported that the signs of lithium intoxication such as drowsiness, tremors, neuromuscular irritability developed by usage of the substance as a substitution for sodium chloride (IUCLID (2000)), and that some of the patients who were fed and maintained with low sodium diet developed chronic renal insufficiency (KemI-Riskline NR 16 (2003)). As additional information on the other lithium compounds, oral ingestion of a psychotropic drug which includes lithium carbonate as an active ingredient induced side effects such as tremor, lethargy, and confusion were described (KemI-Riskline NR 2002:16, Handbook of Japanese pharmaceutical drugs (2010)). The occurrence of clinical signs depended on the blood lithium concentration, and those included neurological toxicity progressing from hand tremor, muscle weakness toward coma (KemI-Riskline NR 2002:16). Moreover, in a follow up study for the patients treated with lithium preparation, treatment-related side effects included tremor, subjective memory loss and loss of creativity (IUCLID (2000)). While, as the 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)), and it was also described that chronic renal failure might occur (KemI-Riskline NR 2002:16).	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)	Not classified	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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