NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7550-35-8
Chemical Name	Lithium bromide
Substance ID	m-nite-7550-35-8_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)	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 (GESTIS (Access on Apr. 2010))	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 (GESTIS (Access on Apr. 2010))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (GESTIS (Access on Apr. 2010))	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 181 g/100 g H2O (Lide (88th, 2008)) 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 (Br), 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.	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 1383 mg/kg (male) and 1600 mg/kg (female) (OECD TG 401, GLP-compliant) ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council (2002)), the substance was classified as 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	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	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	Classification not possible	- -	-	-	Because no in vivo test data available, the classification was not possible. As relevant information, as for in vitro test, the negative data in the Ames test and the chromosomal aberration test using CHL cells were reported ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2002)).	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	Classification not possible	- -	-	-	In the combined repeated oral dose toxicity study with the reproduction/developmental toxicity screening test in rats (OECD TG422, GLP-compliant), reproductive index containing estrous cycle, copulation index, fertility index, gestation index, implantation index, number of newborn and delivery index were not affected, and no morphological defect in offspring due to test substance were reported ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2002)). However, data concerning the influence on the development of fetus containing the teratogenicity were insufficient. As such, the substance was classified as "Classification not possible". As information on other lithium compounds, there are numerous reports about Ebstein's anomalies (congenital cardiovascular malformations) with high frequency in neonates born from mothers who ingested the drug of which principal ingredient is lithium carbonate during pregnancy (PIM 309F (2000), Birth Defects 3rd (2000), HSDB (2007)), in addition, 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)). 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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In the acute oral toxicity study in rats (OECD TG 401, GLP-compliant), as the toxic signs after treatment, decrease of spontaneous activity was observed in most of males in all treatment groups (670 - 2,500 mg/kg) and in all females in groups of 930 mg/kg or more, some of them showed stereotyped behavior immediately after administration, or sedation, incomplete eyelid opening or abnormal gait with time passing after administration. Therefore, it was reported that central nervous system was one of the target organs ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2002)). Because the dose levels that toxic signs appeared belonged to Category 2 defined as 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 the 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 such as impaired consciousness, delirium, ataxia, generalized fasciculation and extrapyramidal symptoms might occur 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 (central nervous system)	Warning	H373	P260 P314 P501	In the combined repeated oral dose toxicity with reproductive/developmental screening study with rats (OECD TG 422, GLP-compliant), almost all of the animals of the highest dose, 80 mg/kg/day (converted dose level as that of 90-day study: approx. 40 mg/kg/day), for both sexes revealed stereotyped behavior ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2002)). In addition, it was noticed that this substance may cause impairment to central nervous system by potential toxicity of bromine in humans ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2002)). Because the dose in which stereotyped behavior was shown in rats corresponded to the dose within Category 2 defined in the guidance values, the classification was determined as Category 2 (central nervous system). Other than the effect on central nervous system, there were several changes in clinical examinations consisting of urinalysis, hematology and blood biochemistry as follows: increases in urine volume and monocyte ratio in the differential leukocyte count, a decrease in plasma chloride concentration as well as an increase in serum triglyceride. Considering that there were no treatment-related abnormalities in histopathological examination in both sexes ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2002)), they were not adopted for the classification. 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 was 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 about the patients treated with lithium preparation for recurrent affective disorders, 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	- -	-	-	Classified as "Not classified" from its 96h-LC50 > 100 mg/L for fish (Oryzias latipes), 48h-EC50 = 110 mg/L for crustacea (Daphnia magna) and 72h-ErC50 = 290 mg/L for algae (Pseudokirchneriella subcapitata) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2001).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since it is not non-water soluble (Initial Risk Assessment Report (NITE, CERI, NEDO), 2010) and its acute toxicity is "Not classified".	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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