GHS Classification Result

Chemical Name：Lithium bromide
CAS：7550-35-8

Result：
ID: 22A4009
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 Not classified - - - - Not combustible (GESTIS (Access on Apr. 2010))
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 Not classified - - - - Not combustible (GESTIS (Access on Apr. 2010))
11 Self-heating substances and mixtures Not classified - - - - Not combustible (GESTIS (Access on Apr. 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.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
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.
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 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.]
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
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 - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
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)).
6 Carcinogenicity Classification not possible - - - - No data available.
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)).
8 Specific target organ toxicity - Single exposure Category 2 (central nervous system) Warning H371: May cause damage to organs (central nervous system) P309+P311: IF exposed or if you feel unwell: 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.
P405: Store locked up.
P501: Dispose of contents/container to ... 		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).
9 Specific target organ toxicity - Repeated exposure Category 2 (central nervous system) Warning H373: May cause damage to organs through prolonged or repeated exposure (central nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		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).
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） 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).
11 Hazardous to the aquatic environment （Long-term） 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".
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）

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