NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	7778-54-3
Chemical Name	Calcium hypochlorite
Substance ID	R02-B-107-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	FY2006 FY2009 FY2013
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	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on August 2020)).
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	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on August 2020)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on August 2020)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metal (Ca), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of about 214 g/L (20 deg C) (SIAR (2006)).
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 (UN1748).
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). [Evidence Data] (1) LD50 for rats: males: 790 mg/kg (AICIS (formerly, NICNAS) IMAP (2015), SIAP (2006), SIAR (2006), GESTIS (Access on August 2020), HSDB (Access on August 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (SIAR (2006), HSDB (Access on August 2020))
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)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1). Besides, the classification result was changed from the previous classification by using new information sources. Because an exposure concentration was higher than the saturated vapor pressure concentration (3.9E-010 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (1 hour): 1.202-1.423 mg/L (converted 4-hour equivalent value: 0.301-0.356 mg/L) (SIAR (2006)) (2) Vapor pressure of this substance: 5.03E-011 mmHg (25 deg C) (est) (U.S.EPA: Mpbpwin v1.43) (converted value for the saturated vapor pressure concentration: 3.9E-010 mg/L) [Reference Data, etc.] (3) LC50 for rats (1 hour) on the product (containing 32% of this substance): > 176.4 mg/L (converted 4-hour equivalent value: > 44.1 mg/L (100% converted value: > 14.1 mg/L)) (Agchem Age No. 162 (Japan Crop Protection Association, 1991)) (4) LC50 for rats (3 hours) on the product (containing 32% of this substance): > 158.3 mg/L (converted 4-hour equivalent value: > 118.7 mg/L (100% converted value: > 38.0 mg/L)) (Agchem Age No. 162 (Japan Crop Protection Association, 1991))
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), (2). [Evidence Data] (1) This substance is corrosive to the skin due to the alkalinity of the hypochlorite ion (AICIS (formerly, NICNAS) IMAP (2015)). (2) Direct contact with this substance can be irritating or corrosive (SIAP (2006), GESTIS (Access on August 2020)). [Reference Data, etc.] (3) This substance is often quoted as "corrosive to the skin." The source of this statement was, however, not retrievable, and no additional information was available to substantiate it. Severe effects on the eyes can be expected due to the alkalinity of the calcium cation and non-reacted calcium hydroxide (pH = 12.0 at 1%) (SIAR (2006)). (4) It was classified in Skin Corr. 1B (H314) in EU-CLP classification (EU CLP classification (Access on October 2020)).
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), (2). [Evidence Data] (1) This substance was classified in Category 1 in skin corrosion/irritation. (2) Direct contact with this substance can be irritating or corrosive (SIAP (2006), GESTIS (Access on August 2020)). [Reference Data, etc.] (4) This substance is often quoted as "corrosive to the skin." The source of this statement was, however, not retrievable, and no additional information was available to substantiate it. Severe effects on the eyes can be expected due to the alkalinity of the calcium cation and non-reacted calcium hydroxide (pH = 12.0 at 1%) (SIAR (2006)).
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 was a description of (1), but it was classified as "Classification not possible" due to lack of data. The classification result was changed because new information (1) conflicted with the rationale data for the previous classification. [Reference Data, etc.] (1) Repeated insult patch tests conducted on healthy human volunteers have shown no evidence of potential allergic contact dermatitis (AICIS (formerly, NICNAS) IMAP (2015)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for in vivo, sodium hypochlorite was reported to be negative in micronucleus tests using the bone marrow after intraperitoneal or oral administration to mice and negative in a chromosomal aberration test using the bone marrow after oral administration to mice (SIAR (2006)). (2) As for in vitro, this substance was reported to be negative in a bacterial reverse mutation test and positive in a chromosomal aberration test with cultured mammalian cells (SIAR (2006)). (3) It is described in AICIS that both sodium hypochlorite and calcium hypochlorite (this substance) were considered to have no genotoxic potential (AICIS (formerly, NICNAS) IMAP (2015)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Although no classification results by domestic and international organizations or carcinogenicity reports were obtained for this substance, it was classified as "Not classified" from classification results by other organizations for hypochlorite salts in (1) and carcinogenicity test results in experimental animals for sodium hypochlorite in (2) and (3). [Evidence Data] (1) As for classification results by domestic and international organizations, IARC classified hypochlorite salts, including this substance, in Group 3 (IARC 52 (1991)). (2) In a 104-week drinking water administration test in rats and a 103-week drinking water administration test in mice both using sodium hypochlorite (CAS RN 7681-52-9), no significant increase in tumor incidences was observed (IARC 52 (1991)). (3) In a carcinogenicity test with mice using sodium hypochlorite in the dermal route, no carcinogenicity was seen (IARC 52 (1991)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] There was no information on this substance, however, since this substance dissociated into hypochlorite ions and calcium ions in aqueous solution from (1), the classification was made based on the information on sodium hypochlorite (CAS RN 7790-92-3). Based on (2) to (4), it could be generally considered to have no reproductive effects, but since there were no data on developmental toxicity when administeredonly during the organogenesis period, it was determined that classification was not possible due to lack of data. [Evidence Data] (1) This substance dissociated into hypochlorite ions and calcium ions in aqueous solution (SIAR (2006)). (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 before mating through the gestation period, no maternal toxicity or developmental toxicity was observed (EURAR (2007), AICIS (previous NICNAS) IMAP (2014)). (4) In the EURAR (2007), there were no data on sodium hypochlorite (CAS RN 7681-52-9). However, it was reported that, although the data available were limited, the results of the animal studies using hypochlorous acid and chlorine could draw the conclusion that there was no evidence to suggest that sodium hypochlorite would present adverse effects on development of the next generation or fertility. It was stated that, similarly, no such evidence was obtained from epidemiological studies on populations consuming chlorinated drinking water (EURAR (2007)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 3 (respiratory tract irritation). The data on the central nervous system in (4) were not adopted because specific symptoms were unknown. Based on the review of the information and the use of a new information source, the classification result was changed from the previous classification. [Evidence Data] (1) The ingestion of this substance by a worker in the form of tablets (dose not known) caused vomiting and respiratory complaints (GESTIS (Access on August 2020)). (2) This substance was irritating to the nose and eye (HSDB (Access on August 2020)). (3) The inhalation of a mist of this substance was expected to cause moderate to strong irritation in the nose, throat, and upper airways (GESTIS (Access on August 2020)). [Reference Data, etc.] (4) In an acute oral toxicity test with male rats, moderate depression of the central nervous system one hour after administration, mild to moderate persistent anorexia, and diarrhea were observed at 890-1,260 mg/kg (within the range for Category 2) (AICIS (previous NICNAS) IMAP (2015), SIAR (2006)). (5) This substance dissociated into hypochlorite ions and calcium ions in aqueous solution. Human health effect might be caused by contact with the solid powder, the aqueous solution, or accidentally generated chlorine gas. As for hypochlorite ion toxicity, the exposure scenario for this substance was the same as for sodium hypochlorite solution or chlorine gas, which was utilized as a source of hypochlorite ions (SIAR (2006)). (6) This substance released highly concentrated chlorine gas when it was mixed with strong acids (AICIS (previous NICNAS) IMAP (2015)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] There was no information on this substance itself, but the classification was made based on the information on sodium hypochlorite (CAS RN 7681-52-9) from (1). Based on (2) and (3), it was considered that repeated dose toxicity of sodium hypochlorite in the oral and dermal routes was low, but since effects on the respiratory organs due to inhalation exposure were unknown, it was determined that classification was not possible. [Reference Data, etc.] (1) This substance dissociated into hypochlorite ions and calcium ions in aqueous solution (SIAR (2006)). (2) 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 when rats and mice were dosed for 90 days and 2 years (SIAR (2006)). (3) 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)).
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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