GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 7580-67-8
Chemical Name Lithium hydride
Substance ID H28-B-036, C-047B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
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 Classification not possible
-
-
- -  It is written that it is flammable (ICSC(J) (2014)), but the classification is not possible due to no data.
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
-
-
- -  It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 200 deg C (ICSC(J) (2014)).
11 Self-heating substances and mixtures Classification not possible
-
-
- -  No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Category 1


Danger
H260 P231+P232
P335+P334
P370+P378
P402+P404
P223
P280
P501
 It is written that it reacts vigorously with water (ICSC(J) (2014)). Due to Division 4.3, PGI (UN1414) in UNRTDG, it was classified in Category 1.
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Not classified
-
-
- -  It is written that it is a strong reducing agent and reacts vigorously with oxidants (ICSC(J) (2014)).
15 Organic peroxides Not applicable
-
-
- -  It is an inorganic compound.
16 Corrosive to metals Classification not possible
-
-
- -  Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Classification not possible
-
-
- -  Classification not possible due to lack of data. Additionally, although an LD50 value of 77.5 mg/kg (RTECS) for rats is reported, this information source is listed in List 3, and the original article is unknown. Therefore, it is not possible to classify only with this value.
1 Acute toxicity (Dermal) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
 Two LC50 values (4hours) of 960 mg/m3 (converted value: 0.96 mg/L) (male and female) (ACGIH (7th, 2015)) and 1,800 mg/m3 (converted value: 1.80 mg/L) (male and female) (ACGIH (7th, 2015)) for rats are reported. One of these two corresponds to Category 3, and the other corresponds to Category 4. This substance was classified in Category 3 by adopting the category with higher hazard. Besides, the data (DFGOT Vol.3 (1991)) used for the previous classification was not adopted as the evidence of the classification because it did not specify an LC50 value.
2 Skin corrosion/irritation Category 1


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
 It is reported that it is a severe irritant to the skin (HSDB (Access on June 2016)), and it may be corrosive (ACGIH (7th, 2015)) in humans. Therefore, this substance was classified in Category 1.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
 Because it is reported that it indicates severe eye irritation in humans (DFGOT (1992), HSDB (Access on June 2016)), this substance was classified in Category 1.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
6 Carcinogenicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
7 Reproductive toxicity Category 1A
Additional category for effects on or via lactation


Danger
H360 P308+P313
P201
P202
P280
P405
P501
 There is no information on the reproductive effects of this substance itself. However, this substance is rapidly hydrolyzed to produce lithium hydroxide (CAS RN 1310-66-3 (anhydride: 1310-65-2)), a strong alkali, on contact with water vapor and the mucous membrane (ACGIH (7th, 2015)). Therefore, it is considered that information on lithium salts is available for classification. In humans, an association between lithium dosing in pregnant women and cardiovascular anomalies, such as Ebstein's anomaly, was first reported in 1974. Ebstein's anomaly had since then been thought to occur at a high rate (400 times higher than spontaneous rate), but Cohen et al., reported that based on a reanalysis, the occurrence of Ebstein's anomaly was 2/1,000 live births compared to the spontaneous rate of 1/20,000 live births (Cohen L.S. et al.: JAMA, 271, 146 (1994)). It was indicated that lithium is a "weak" teratogen in humans (Giles J.J and Bannigan J.G.: Curr. Pharm. Des., 12, 1531 (2006)). Thereafter, up to 2016, Cohen et al.'s finding of 2/1,000 cases (0.2%) was cited as the occurrence rate of Ebstein's anomaly due to lithium treatment in pregnant women; and it has been cautioned that special attention, such as observations of high-resolution ultrasound and fetal echo-cardiography, is necessary with regard to pregnant women with bipolar disorder receiving lithium treatment (Khan S.J. et al.: Curr. Psychiatry Rep., 18, 13 (2016)). Also, according to an observational study from Israel in 2014, it was reported that cardiovascular anomalies in neonates occurred more frequently in the lithium-dosed group at 2.4% (5/123 cases) compared with the control group at 0.6% (4/711cases); and the occurrence of cardiovascular anomalies in the combined multicenter data of Australia and Canada was 0.5% (4/842 cases) for the control group and 3.9% (6/152 cases) for the lithium-dosed group (Diav-Cirtrin, O. et al.: Am. J. Psychiatry, 171, 785 (2014)). From the above, it is thought that the cardiovascular anomalies, including Ebstein's anomaly, are clearly considered to be the effect of lithium administration. Furthermore, as for lithium dosing in the first trimester of pregnancy, it is also reported that other signs of neonatal toxicity such as neuropathy, respiratory disturbances, floppy infant, hyperbilirubinemia, disturbance of the heart's rhythm, hypothyroidism, and diabetes insipidus were observed (Khan S.J. et al.: Curr. Psychiatry Rep., 18, 13 (2016)).
 As for experimental animals, when lithium carbonate was administered orally to pregnant rats from day 6-15 of gestation at 100 mg/kg, fetal toxicity (reduction in number of implantation and of the live fetus, increased trend in the number of embryo resorptions) and teratogenicity (wavy ribs, shortening of bones such as the humerus and the femur, malformations in the skull and pelvis, separation in the skull) were recognized (Marathe M.R. and Thomas G.P.: Toxicol. Lett., 34, 115. (1986)). Also, when lithium carbonate was administered intraperitoneally to pregnant female mice at doses ranging from 330 to 340 mg/kg on the ninth gestation day, induction of malformations such as exencephaly, cranioschisis, rachischisis, kinking of the spinal cord, and dilation of the fourth brain ventricle etc. were observed (Jurand A.: Teratology, 38 (2), 101. (1988)). On the other hand, there are several reports in which no developmental effects were observed by lithium administration to pregnant animals, but it is thought that this was due to differences in doses and the animal lineage (Giles, J.J. and Bannigan, J.G.: Curr. Pharm. Des., 12, 1531 (2006)).
 From the above, as for humans, it was reported that cardiovascular anomalies and various developmental effects occur from lithium dosing during pregnancy; as for experimental animals as well, there are reports of teratogenicity. Therefore, this substance was classified in Category 1 for this hazard class. Furthermore, in an examination until 52 weeks after post partum, the lithium levels in the breast milk and the neonatal serum were about half and one fourth of the maternal serum levels, respectively (Khan S.J. et al.: Curr. Psychiatry Rep., 18, 13 (2016)). In Japan, lithium (lithium carbonate) is contraindicated for women anticipating pregnancy, but when administration is inevitable, breast-feeding must be discontinued (Ethical Pharmaceuticals 2017 (2016)). Therefore, "additional category for effects on or via lactation" was added to the classification.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs), Category 2 (nervous system)


Danger
Warning
H370
H371
P308+P311
P260
P264
P270
P321
P405
P501
 This substance is rapidly hydrolyzed to produce lithium hydroxide, a strong alkali, on contact with water vapor and the mucous membranes. It is described that lithium hydroxide causes intensely and immediately caustic damage in the nasal, oral, pharyngeal and respiratory mucosa, and can cause pulmonary edema (ACGIH (7th, 2015)).
 In addition, it is reported that in humans, nausea, muscle twitches, mental confusion, blurring of vision and coma are caused by accidental ingestion of this substance (HSDB (Access on June 2016)). Therefore, this substance was classified in Category 1 (respiratory organs), Category 2 (nervous system).
 Since HSDB is an information source listed in List 2, this substance was classified in Category 2 for the nervous system.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  Classification not possible due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible
-
-
- -  No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- -  No data available.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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