GHS Classification Result

Chemical Name：Lithium chloride
CAS：7447-41-8

Result：
ID: 22A4008
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 (ICSC (1997))
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 (ICSC (1997))
11 Self-heating substances and mixtures Not classified - - - - Not combustible (ICSC (1997))
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.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
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.
15 Organic peroxides Not applicable - - - - Inorganic compound
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)).

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 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.]
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 Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		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)).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious 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.
P280: Wear protective gloves/protective clothing/eye protection/face protection. 		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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
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.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child 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 ... 		In the study using female rats administered orally via drinking water during periods before mating through pregnancy, although no malformations were observed in any offspring, while a decrease in the number of corpora lutea was found in the treated animals compared to that of the control (IUCLID (2000)). In the study of the mice administered via drinking water during the periods before mating through pregnancy and lactation period, parental animals in the high dose died, while in the low doses which no ill effects on growth and development of the parents were shown, increased mortality was noted as a basis of number of offspring as well as the number of the same litter mates (IUCLID (2000)). Furthermore, in the oral administration test using ICR mice during the organogenetic period, malformations were observed in 8.6% of the fetuses (IUCLID (2000)). As mentioned above, although the effects on fertility were observed, there was no description about general toxicity in parental animals, therefore, the substance was classified as Category 2. As information on other lithium compounds, there are numerous reports about Ebstein's anomalies (congenital cardiovascular malformations) 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 (nervous system) Warning H371: May cause damage to organs (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 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).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system, kidney) Warning H373: May cause damage to organs through prolonged or repeated exposure (nervous system, kidney) 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 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).
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 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 3 from its 96h-LC50 = 17 mg/L for fish (Ptychocheilus lucius) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 3 since its acute toxicity is Category 3 and adequate 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