NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	13840-33-0
Chemical Name	Lithium hypochlorite
Substance ID	R02-B-110-MHLW
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2007
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available.
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	Because it is classified in Division 5.1, PG II in UNRTDG (UN1471), and it is considered to be not applicable to pyrophoric substances, hazards of the highest precedence, it was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metal (Li), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 43 weight% (25 deg C) (EPA pesticides RED (1993)).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Category 2	Danger	H272	P370+P378 P210 P220 P280 P501	It was classified in Category 2 because it is classified in Division 5.1, PG II in UNRTDG (UN1471).
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1). Besides, the classification result was changed from the previous classification by using a new information source. [Evidence Data] (1) LD50 for rats: females: 555 mg/kg, males: 748 mg/kg (EPA Pesticides RED (1993))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). Besides, the classification result was changed from the previous classification by using a new information source. [Evidence Data] (1) LD50 for rabbits: 8,100 mg/kg (EPA Pesticides RED (1993))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
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	[Rationale for the Classification] It was classified in Category 1 from (1). The category was changed due to new data obtained. [Evidence Data] (1) In a skin irritation test with rabbits according to EPA OPP 81-5, it was reported to be toxicity Category I (corrosive (tissue destruction into the dermis and/or scarring)) (EPA Pesticides RED (1993)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] It was classified in Category 1 from (1). The category was changed due to new data obtained. [Evidence Data] (1) In an eye irritation test with rabbits according to EPA OPP 81-4, it was reported to be toxicity Category I (corrosive (irreversible destruction of ocular tissue) or corneal effects or irritation persisting for more than 21 days) (EPA Pesticides RED (1993)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] There were data in (1), but because details of test methods could not be confirmed, it was classified as "Classification not possible." [Reference Data, etc.] (1) It was reported to be negative in a skin sensitization test with guinea pigs according to EPA OPP 81-6 (application concentration: 10%) (EPA Pesticides RED (1993)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo data, it was reported to be negative in a chromosomal aberration test in rat bone marrow cells (EPA Pesticides RED (1993)). (2) As for in vitro data, it was reported to be negative in a bacterial reverse mutation test, positive in a chromosomal aberration test with cultured mammalian cells, and negative in a forward mutation test with cultured mammalian cells (EPA Pesticides RED (1993)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" based on IARC's classification result in (1). [Evidence Data] (1) As for classification results by domestic and international organizations, IARC classified hypochlorite salts in Group 3 (IARC 52 (1991)). [Reference Data, etc.] (2) In the past, as soluble lithium compounds, lithium hydroxide monohydrate (CAS RN 1310-66-3) was classified as "Classification not possible" (GHS classification result in FY2014).
7	Reproductive toxicity	Category 1A, Additional category for effects on or via lactation	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified based on the data on this substance (1), hypochlorous acid (CAS RN 7790-92-3) (2) and (3), and soluble lithium (4) to (6), because this substance was considered to dissociate into the hypochlorite ion and lithium ion. Based on (2) and (3), it was considered that hypochlorous acid had no reproductive effects. Meanwhile, based on the data of this substance (1), bifid vertebrae, which were considered to be severe, were observed in fetuses at a dose at which deaths were observed in the dams. In soluble lithium, effects equivalent to Category 1A or Category 2 were observed, and effects on lactation were also observed. Therefore, it was classified in Category 1A, and effects on lactation were added. The source of the rationale for the previous classification was RTECS of List 3, which was not adopted as the rationale for the classification. [Evidence Data] (1) In a developmental toxicity study by an administration of this substance to female rats by gavage on days 6 to 15 of gestation, maternal toxicity (deaths (details were unknown), reduced weight gain, reduced food consumption, inflamed and congested respiratory system) and fetal toxicity (reduced fetal weight, dilated renal pelvis, bifid vertebrae, wavy ribs, unossified foot bones) were observed at 500 mg/kg/day (EPA Pesticides RED (1993)). It was considered that effects were observed in fetuses at a dose at which severe maternal toxicity was observed. (2) In a one-generation reproduction toxicity study by oral administration of hypochlorous acid to rats dosed by gavage, there were no clinical signs of toxicity, hematological changes, body weight depression, alterations in sperm count, sperm motility, or sperm morphology, or histopathological lesions in the reproductive organs, and there were no dose-related effects on fertility, fetal viability, litter size, fetal body weight, day of eye opening, or day of vaginal patency (EURAR (2007), AICIS (previous NICNAS) IMAP (2014)). (3) In a test by oral administration of hypochlorous acid to female rats dosed by drinking water from 2.5 months prior to comception throughout gestation, no maternal toxicity or developmental toxicity was observed (EURAR (2007), AICIS (previous NICNAS) IMAP (2014)). (4) Lithium carbonate (CAS RN 554-13-2) was a psychoneurotic drug, and since there were many reports of Ebstein's malformation (congenital cardiovascular malformation) in children of the women who ingested the drug during pregnancy, and this substance passed through the placenta, it was prohibited to give this drug to pregnant women and women suspected of being pregnant as a precaution for use in the drug package insert. Since lithium was excreted in milk at a rate similar to that in serum, it was described as a precaution for use during lactation that lactation should be discontinued if the drug is given out of necessity, and therefore, it was classified in "Category 1A, additional category: effects on or via lactation" (GHS Classification Results in FY2010). (5) Lithium hydroxide (CAS RN 1310-65-2) was classified in "Category 1A" (GHS Classification Results in FY2009). (6) Lithium chloride (CAS RN 7447-41-8) was classified in "Category 2" (GHS Classification Results in FY2010). [Reference Data, etc.] (7) The GHS Classification Guidance for the Japanese Government (2019 Revised Edition (Ver. 2.0)) stated that lithium was listed as a teratogen in humans, and that substances showing structural similarity to it might correspond to "Category 1A," and therefore, it was necessary to be particularly careful in collecting information on such substances. (8) The AICIS (previous NICNAS) IMAP (2015) stated that no data were available for this substance, but information available for sodium hypochlorite and lithium salts from animal studies and in humans indicated that this chemical was not likely to have specific reproductive or developmental toxicity. It reported that any reproductive and developmental effects were only observed secondary to maternal toxicity.
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system), Category 3 (respiratory tract irritation)	Warning	H371 H335	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1), inflamed lungs due to the corrosive effects of this substance were observed, and therefore, it was classified in Category 3 (respiratory tract irritation). In an excessive exposure, toxicity of lithium might occur, and therefore, based on the information on soluble lithium compounds (2) and (3), it was classified in Category 2 (nervous system). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In an acute oral toxicity test with male rats, due to the corrosive nature of this substance, inflamed gastric mucosa and lungs, distended stomach, congested kidneys, yellow purulent material in chest cavity, labored respiration, etc. were observed (EPA Pesticides RED (1993)). (2) Lithium carbonate (CAS RN 554-13-2) was classified in Category 1 (nervous system) and Category 3 (respiratory tract irritation) (GHS Classification Results in FY2010). (3) Lithium chloride (CAS RN 7447-41-8) was classified in Category 2 (nervous system) (GHS Classification Results in FY2010). [Reference Data, etc.] (4) Lithium metal (CAS RN 7439-93-2) was classified in Category 2 (respiratory organs) (GHS Classification Results in FY2006). (5) Lithium hydroxide (CAS RN 7580-67-8) was classified in Category 1 (respiratory organs) and Category 2 (nervous system) (GHS Classification Results in FY2016).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, cardiovascular system, kidney, gastrointestinal tract)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There was no information on this substance itself, but based on (1), it was examined based on the information on sodium hypochlorite (CAS RN 7681-52-9) and soluble lithium compounds. Based on (3) and (4), repeated dose toxicity of sodium hypochlorite in the oral and dermal routes was considered to be low, but based on the information of lithium carbonate (CAS RN 554-13-2) in (2), it was classified in Category 1 (nervous system, cardiovascular system, kidney, gastrointestinal tract). As a result of examination with the addition of new information, the classification results were changed from the previous classification. [Evidence Data] (1) Lithium hypochlorite dissociated into hypochlorite ions and lithium ions in aqueous solution (AICIS (previous NICNAS) IMAP (2015)). (2) The therapeutic use of lithium carbonate might produce neuromuscular changes (tremor, muscle hyperirritability, and ataxia), central nervous system changes (blackout spells, epileptic seizures, slurred speech, coma, psychosomatic retardation, and increased thirst), cardiovascular changes (cardiac arrhythmia, hypertension, and circulatory collapse), GI changes (anorexia, nausea, and vomiting), and renal damage (albuminuria and glycosuria) (HSDB (Access on October 2020)). (3) In tests by oral administration of sodium hypochlorite to animals dosed by drinking water, only reduced body weight gain, presumably due to low water intake, was observed even when rats and mice were dosed for 90 days and 2 years (EURAR (2007), SIAR (2006)). (4) In a test by dermal application of an aqueous solution of sodium hypochlorite to guinea pigs for 51 weeks (twice a week), no treatment-related effects were observed (AICIS (previous NICNAS) IMAP (2015), EURAR (2007), SIAR (2006)). [Reference Data, etc.] (5) As main adverse effects of ingestion of a psychoneurotic drug containing lithium carbonate as an active ingredient, tremor, thirst, diarrhea, etc. were observed. As severe adverse effects, lithium intoxication (as initial symptoms, digestive symptoms such as anorexia, nausea, vomiting, and diarrhea; central nervous system symptoms such as tremor, drowsiness, and confusion; motor function symptoms or systemic symptoms such as fever and sweating, might be exhibited), malignant syndrome, sick sinus syndrome, high-level bradycardia, nephrogenic diabetes insipidus, acute kidney failure, interstitial nephritis, nephrotic syndrome, hypothyroidism, thyroiditis, hyperparathyroidism, dementia-like symptoms, and consciousness disorders were described (Ethical Pharmaceuticals (2017)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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