GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 7778-66-7
Chemical Name Potassium hypochlorite
Substance ID R02-A-008-MHLW
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised New
Classification result in other fiscal year  
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)
-
-
- - Liquid (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)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Classification not possible
-
-
- - No data available.
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
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
-
-
- - It is estimated that it does not correspond to the hazards of the highest precedence, pyrophoric substances, because it is classified in Class 8, PG II in UNRTDG (UN 1791). Therefore, it was classified as "Not classified."
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Classification not possible
-
-
- - It contains a metalloid (K), but the classification is not possible due to no data.
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. Besides, it is classified in Class 8, PG II in UNRTDG (UN 1791, aqueous solution).
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified."
15 Organic peroxides Not classified (Not applicable)
-
-
- - Inorganic compound. It was classified as "Not classified."
16 Corrosive to metals Classification not possible
-
-
- - No data available. Besides, it is classified in Class 8, PG II-III in UNRTDG (UN 1791).
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) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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), (2).

[Evidence Data]
(1) An aqueous solution of this substance is strongly alkaline (GESTIS (Access on August 2020)).
(2) Solutions of this substance with 5% to 10% work strongly irritant, and those with > 10% strongly corroding (GESTIS (Access on August 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) - (3).

[Evidence Data]
(1) An aqueous solution of this substance is strongly alkaline (GESTIS (Access on August 2020)).
(2) Solutions of this substance with 5% to 10% work strongly irritant, and those with > 10% strongly corroding (GESTIS (Access on August 2020)).
(3) This substance was classified in Category 1 in skin corrosion/irritation.
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]
Classification not possible due to lack of data.
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
There was no information on this substance itself, but since it was considered that this substance dissociated into hypochlorite ions and potassium ions in aqueous solution, and the potassium ions were the ions that existed in large numbers in a living body, this substance was classified based on the information on sodium hypochlorite (CAS RN 7681-52-9). Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo data of sodium hypochlorite, in a micronucleus test using the bone marrow of mice dosed by intraperitoneal injection or oral administration, negative results were reported; in a mammalian bone marrow chromosomal aberration test with mice dosed by oral administration, negative results were reported; and in a DNA damage test with rats dosed by oral administration, negative results were reported (EURAR (2007), NTP TR392 (1992), Patty (6th, 2012)).
(2) As for in vitro data of sodium hypochlorite, in a bacterial reverse mutation test, and an in vitro mammalian cell chromosome aberration test, negative and positive results were reported (EURAR (2007), NTP TR392 (1992)), and in a sister chromatid exchange test, positive results were reported (EURAR (2007)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on the classification result of IARC in (1), it was classified as "Not classified."

[Evidence Data]
(1) As for the classification results by domestic and international organizations, it was classified in Group 3 (IARC 52 (1991)) as hypochlorite by the IARC.
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
There was no data of this substance, but since it was considered that this substance dissociated into hypochlorite ions and potassium ions in an aqueous solution, classification was carried out based on the data of hypochlorous acid (CAS RN 7790-92-3). Based on (1) to (3), it was considered that there were generally no reproductive effects, but since there was no data of developmental toxicity solely due to the administration 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, alterations in body weight, sperm count, sperm motility, or sperm morphology, or histopathological lesions in the reproductive organs, and there were no dose-dependent 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) It was stated as follows in the EURAR (2007). There was no data on sodium hypochlorite (CAS RN 7681-52-9). However, it was reported that although limited data was available, 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. 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]
There was no report on this substance, but it was considered that toxicity occurred by generation of hypochlorite ions in body (in body fluid) in the same way as sodium hypochlorite (CAS RN 7681-52-9). Based on (1) and (2), it was classified in Category 3 (respiratory tract irritation). Effects on the gastrointestinal system were not adopted because they might be due to the irritation nature of this substance.

[Evidence Data]
(1) In humans exposed to drugs containing sodium hypochlorite (CAS RN 7681-52-9), eye and upper respiratory tract irritations were observed (EURAR (2007)).
(2) Accidental ingestion of a small amount of chlorine bleach containing sodium hypochlorite could cause esophageal irritation, and in 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 sodium hypochlorite caused burning in the throat and coughing. Exposure to high concentrations 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 sodium hypochlorite (unknown quantity) died of cardiac arrest in 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 sodium hypochlorite, and corrosive injury of the stomach and hypernatremia with hyperchloremic acidosis occurred with ingestion of a large amount of sodium hypochlorite (IPCS PIM 495 (1998)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
There was no information on this substance itself, but since it was considered that this substance dissociated into hypochlorite ions and potassium ions in aqueous solution, and the potassium ions were the ions that existed in large numbers in a living body, examination was carried out based on the information on sodium hypochlorite (CAS RN 7681-52-9). Based on (1) and (2), 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) In tests by oral administration of sodium hypochlorite to animals dosed by drinking water, only reduced body weight gain, which was considered to be associated with reduced water consumption, was observed when rats and mice were dosed for 90 days and 2 years (EURAR (2007), (SIAR (2006)).
(2) In a test by dermal application of an aqueous solution of sodium hypochlorite to guinea pigs for 8 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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