NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	7681-52-9
Chemical Name	Sodium hypochlorite (effective chlorine concentration: 6-15 %)
Substance ID	m-nite-7681-52-9_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on August 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on August 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metal (Na), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 29.3 g/100 g (0 deg C) (HSDB (Access on August 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
13	Oxidizing liquids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen and halogen, but the classification is not possible due to no data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound. It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Besides, it is classified in Class 8, PG II-III in UNRTDG (UN1791).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) LD50 for rats on an aqueous solution (available chlorine concentration 12.5%): males: 5,230 mg/kg (REACH registration dossier (Access on October 2020)) (2) LD50 for rats on an aqueous solution (available chlorine concentration 12.5%): 8,830 mg/kg (AICIS (formerly, NICNAS) IMAP (2014), EURAR (2007)) (3) LD50 for rats on an aqueous solution (available chlorine concentration 5.25%): 13,000 mg/kg (EURAR (2007))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (2) LD50 for rats on an aqueous solution (available chlorine concentration 5.25%): > 2,000 mg/kg (AICIS (formerly, NICNAS) IMAP (2014), EURAR (2007)) (3) LD50 for rabbits on an aqueous solution (available chlorine concentration 12.5%): > 20,000 mg/kg (REACH registration dossier (Access on October 2020))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] The category could not be specified from (1), and it was classified as "Classification not possible." Besides, a reference value in the unit of mg/L was applied as mist from (2). [Evidence Data] (1) LC0 (1 hour) for rats: > 10.5 mg/L (converted 4-hour equivalent value: > 2.63 mg/L) (AICIS (formerly, NICNAS) IMAP (2014), EURAR (2007)) (2) Inhalation exposure to this substance is only possible if aerosols are formed (AICIS (formerly, NICNAS) IMAP (2014), EURAR (2007)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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) - (5). [Evidence Data] (1) In a skin irritation test with rabbits, this substance (undiluted) was corrosive, and the primary irritation index (PII) was 5.08. Besides, an aqueous solution was also corrosive at high concentrations (EURAR (2007)). (2) Solutions of this substance were irritating at 5% to 10% and corrosive at 10% or above (EURAR (2007)). (3) In a skin irritation test by 24-hour application of this substance to rabbits, it was slightly irritating at lower concentrations (available chlorine concentration: up to 5.25%) and moderately to severely irritating at available chlorine concentrations of 12.5-12.7% (AICIS (formerly, NICNAS) IMAP (2014)). (4) In a skin irritation test with rabbits on this substance, solutions at available chlorine concentrations of 0.24-6% showed slight irritant effects at the lowest concentration and corrosive effects at the highest concentration (AICIS (formerly, NICNAS) IMAP (2014)). (5) This substance was irritating and corrosive to the skin and eye (GESTIS (Access on August 2020)). [Reference Data, etc.] (6) It was classified in Skin Corr. 1B (H314) in EU-CLP classification (EU CLP classification (Access on October 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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) - (4). [Evidence Data] (1) This substance was classified in Category 1 in skin corrosion/irritation. (2) In an eye irritation test with rabbits (Draize test), a commercial product (available chlorine concentration 12.5%) and its 1/2 dilution in water were severe irritants, and the maximum irritation score (MAS) was 60 and 49, respectively (EURAR (2007)). (3) At high concentrations, this substance is reported to be corrosive to the eyes (AICIS (formerly, NICNAS) IMAP (2014)). (4) This substance was irritating and corrosive to the skin and eye (GESTIS (Access on August 2020)). [Reference Data, etc.] (5) It was classified in Eye Dam. 1 (H318) in EU-CLP classification (EU CLP classification (Access on October 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) In a skin sensitization test with guinea pigs according to OECD TG 406 on this substance (Buehler test, application concentration 40%), it was reported to be negative (REACH registration dossier (Access on September 2020)). (2) In a skin sensitization test with guinea pigs on a sample containing 8% of this substance, no sensitization responses were seen (EURAR (2007), AICIS (formerly, NICNAS) IMAP (2014)). (3) In skin sensitization tests with guinea pigs on mixtures of this substance and surfactants (Buehler test), no sensitization was observed (EURAR (2007)). [Reference Data, etc.] (4) In a patch test in 225 contact dermatitis patients, only one showed a positive response to this substance (EURAR (2007)). (5) No positive response was observed in a patch test in 69 contact dermatitis patients. Other than this, no clear results were obtained in human patch tests in 20 and 40 persons (EURAR (2007), AICIS (formerly, NICNAS) IMAP (2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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, it was reported to be negative in micronucleus tests using the bone marrow after intraperitoneal or oral administration to mice, negative in a chromosomal aberration test using the bone marrow after oral administration to mice, and negative in a DNA damage test after oral administration to rats (EURAR (2007), NTP TR392 (1992), Patty (6th, 2012)). (2) As for in vitro, it is reported that bacterial reverse mutation tests gave negative and positive results, chromosomal aberration tests with cultured mammalian cells gave negative and positive results (EURAR (2007), NTP TR392 (1992)), and a sister chromatid exchange test with cultured mammalian cells was positive (EURAR (2007)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (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 carcinogenicity tests with male and female rats and mice by drinking water administration of this substance (available chlorine concentration 14%) to rats for 104 week and to mice for 103 weeks, no significant increase in tumor incidences was observed (IARC 52 (1991)). (3) In a carcinogenicity test in which this substance (available chlorine concentration 10%) was dermally applied to female mice, no carcinogenicity was found (IARC 52 (1991)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] There were no data on this substance, however, since this substance was considered to dissociate into hypochlorite ions and sodium ions in aqueous solution, classification was made based on the data of hypochlorous acid (CAS RN 7790-92-3). Based on (1) to (3), it could be considered that there were generally no reproductive effects, however, since there were no data on developmental toxicity when administered only during the organogenesis period, it was determined that classification was not possible due to lack of data. [Evidence Data] (1) 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)). (2) 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)). (3) In the EURAR (2007), there were no data on this substance. 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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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) and (2), it was classified in Category 3 (respiratory tract irritation). Effects on the digestive system were not adopted because they were considered to be due to irritation by this substance. New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In humans exposed to a drug containing this substance, eye and upper respiratory tract irritations were observed (EURAR (2007)). (2) Accidental ingestion of small amounts of chlorine bleach containing this substance could cause esophageal irritation, and at high concentration, it could cause severe damage to the upper respiratory tract and even death (AICIS (previous NICNAS) IMAP (2014)). [Reference Data, etc.] (3) Chlorine gas released from this substance caused burning in the throat and coughing. High levels of exposure could lead to swelling and obstruction of the airway, and in serious cases, noncardiogenic pulmonary edema could occur (IPCS PIM 495 (1998)). (4) A 66-year-old woman who accidentally ingested chlorine bleach containing this substance (unknown quantity) died of cardiac arrest after 4.5 hours, and autopsy revealed esophageal and gastric mucosal erosions, perforations at the gastro-esophageal junction, and extensive necrosis of adjacent soft tissue (AICIS (previous NICNAS) IMAP (2014)). (5) Gastrointestinal irritation with nausea and vomiting occurred with accidental ingestion of this substance, and corrosive injury of the stomach and hypernatremia with hyperchloremic acidosis occurred with ingestion of a large amount of this substance (IPCS PIM 495 (1998)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was considered that repeated dose toxicity of sodium hypochlorite in the oral and dermal routes was low, however, since effects on the respiratory organs due to inhalation exposure were unknown, it was determined that classification was not possible. The information in the information sources were reviewed and the classification result was changed from the previous classification. [Reference Data, etc.] (1) In 90-day and two-year tests by an administration of this substance (a solution of 14% available chlorine) to rats and mice by drinking water, only decreased body weight gain presumably due to low water intake was observed in both cases (EURAR (2007), SIAR (2006)). (2) In a test by dermal application of an aqueous solution of this substance to guinea pigs for 51 weeks (twice a week), no treatment-related effects were observed (AICIS (previous NICNAS) IMAP (2014), EURAR (2007), SIAR (2006)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	From 24-hour LC50 = 5 microg FAC/L for crustacea (Ceriodaphnia dubia) (EU-RAR, 2007), it was classified in Category 1. (FAC = free available chlorine)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 because this substance is a metal compound, and appropriate data on rapid degradability were not obtained, and due to 134-day NOEC = 5 microg TRC/L for fish (EU-RAR, 2007). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because this substance is a metal compound, and appropriate data on rapid degradability were not obtained, and due to 24-hour LC50 = 5 microg FAC/L for crustacea (Ceriodaphnia dubia) (EU-RAR, 2007). From the above results, it was classified in Category 1. (TRC = total residual chlorine, FAC = free available chlorine)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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