NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1310-58-3
Chemical Name	Potassium hydroxide
Substance ID	m-nite-1310-58-3_v1
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2010)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2010)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (J) (2010)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains metals (K), but there is the measurement result of water solubility of 110 g/100 mL (25 deg C) (ICSC (J) (2010)). When dissolving, it may generate heat, but does not generate flammable gas.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	There are reports of LD50 values for rats of 273 mg/kg and 365 mg/kg (both SIDS (2004)). One value corresponds to Category 3, and the other value corresponds to Category 4. It was classified in Category 3 by adopting the category with higher hazard.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	There is a description that this substance in the solid state is corrosive (SIDS (2004)). There are cases that a third degree burn occurred by exposure in the human skin, and that tissue corrosion with small perforations was observed from an electrolytic solution in a battery (containing 25% of this substance) (both SIDS (2004)). There is a description that it is corrosive in multiple skin irritation tests with rabbits (SIDS (2004), ECETOC TR66 (1995)). In addition, there is a description that the pH of the aqueous solution of this substance is about 13, so this is strongly alkaline (OEL Documentations (Japan Society For Occupational Health (JSOH), 1978), PATTY (6th, 2012)). Because the exposure time varies depending on the tests, sub-categorization was not performed, and it was classified in Category 1. Besides, this substance was classified as "Skin Corr. 1A, H314" in EU CLP classification (ECHA CL Inventory (Access on August 2017)). This substance is listed as a chemical substance causing skin damage in "Simple chemical substances or compounds designated by the Minister of Health, Labour and Welfare or disease designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It was classified in Category 1 for skin corrosion/irritation. There is a description that this substance is corrosive to the eyes at a concentration of 2.0% or above (SIDS (2004)), and there is a report of strong corrosivity in an eye irritation test with rabbits (SIDS (2004)). In addition, there is a description that the pH of the aqueous solution of this substance is about 13, so it is strongly alkaline (OEL Documentations (Japan Society For Occupational Health (JSOH), 1978), PATTY (6th, 2012)). Therefore, it was classified in Category 1. Besides, this substance is listed as a chemical substance causing anterior ocular damage in "Simple chemical substances or compounds designated by the Minister of Health, Labour and Welfare or disease designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	There is a description of being negative in a skin sensitization test with guinea pigs, and there is a description that because potassium ions (K+) and hydroxide ions (OH-) are naturally present in the body, they are very unlikely to be the cause of skin sensitization (both SIDS (2004)). However, no details of the test are known, and there is no report in humans either. Therefore, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. There are no in vivo data on this substance. As for in vitro, a bacterial reverse mutation test and a mammalian cell chromosome aberration test were negative (SIDS (2004)). In SIDS (2004), the mutagenicity of this substance was evaluated from comprehensive information on this substance, sodium hydroxide (CAS RN 1310-73-2), potassium chloride (CAS RN 7447-40-7), and potassium carbonate (CAS RN 584-08-7). As for in vivo, sodium hydroxide showed negative results in a micronucleus test with mouse bone marrow cells and a chromosomal aberration test with mouse oocytes (SIDS (2004)). As for in vitro, excluding influence of artifacts due to the high pH and osmotic pressure in the medium with the test substance, all of the bacterial reverse mutation tests for sodium hydroxide, potassium chloride, and potassium carbonate, a mouse lymphoma test with cultured mammalian cells for potassium chloride, and a mammalian cell chromosome aberration test for potassium carbonate were negative (SIDS (2004)). From the above, It is stated in SIDS (2004) that these substances are not considered to be genotoxic.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	As a result of application of a 3-6% solution of this substance to the skin of mice for 25-46 weeks, tumors (occurrence: about 15%) were observed at the local application site (SIDS (2004), PATTY (6th, 2012)). However, according to SIDS, it is a report of reliability rank 3. It is thought that this skin tumor is due to indirect cell proliferation resulting from severe skin damage, and is due to a secondary non-genotoxic mechanism caused by repeated irritation and persistent inflammation (SIDS (2004)). In addition, it is concluded that there is no evidence that this substance is carcinogenic under exposure conditions that can be extrapolated to humans (SIDS (2004)). From the above, although it is concluded in SIDS that there is no evidence that this substance is carcinogenic in humans, there is no reliable test data, and there are no classification results by other organizations either. Therefore, it was classified as "Classification not possible" due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	There is no data on this substance itself, but regarding reproductive and developmental effects of potassium ions, there are test reports with potassium chloride and potassium carbonate. In one generation studies in which potassium chloride was orally administered to mice or rats, no effects on parental fertility and offspring were observed at up to 235 mg/kg/day in mice and at up to 310 mg/kg/day in rats (SIDS (2004)). In addition, in a developmental toxicity study in which potassium carbonate was orally administered to pregnant mice or rats during an organogenesis period, no effects on both parental animals and fetuses were observed at up to 290 mg/kg/day in mice and at up to 180 mg/kg/day in rats (SIDS (2004)). It is concluded in SIDS that it is considered that there are no reproductive and developmental effects from this substance at non-irritating doses/concentrations (SIDS (2004)). From the above, in reproductive and developmental toxicity tests with potassium salts, no adverse reproductive/developmental effects were detected from potassium ions, but the parental animals were not dosed at up to the doses where they showed general toxic effects, and it can hardly be said that the doses were sufficient for evaluating the effects. Therefore, it was classified as "Classification not possible" due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It is described that this substance acts as a strong alkali on the skin and mucosa, inhalation exposure to dust or mist may cause irritation of the upper respiratory tract and tissue damage, and damage of the nasal septum and pulmonary edema may be developed (ACGIH (7th, 2001), SIDS (2004), PATTY (6th, 2012), OEL Documentations (Japan Society For Occupational Health (JSOH), 1978)). Therefore, it was classified in Category 1 (respiratory organs).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	As for humans, it is noted that damages caused by inhalation of dusts and mists of this substance are mainly inflammation of the upper respiratory tract, and chronic exposures cause ulcers in the nasal septum. However, there are no reports on investigation and research regarding airborne concentrations and occurrence of damage (OEL Documentations (Japan Society For Occupational Health (JSOH), 1978)). Exposure to dust or mist may cause irritation of the eyes and respiratory tract and lesions of the nasal septum (ACGIH (7th, 2001)). From the above, although there is not enough information, this substance is an alkaline substance, and it clearly causes inflammatory effects on the respiratory organs due to inhalation. Therefore, it was classified in Category 1 (respiratory organs). Besides, since information on the case report and epidemiological research was not obtained in humans, but the descriptions of the above information sources were adopted, the classification result was different from the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	There is a description that in cases of death in which this substance was ingested for unintentional or suicidal purposes, aspiration from the esophagus into the trachea, pneumonitis, etc. were included in the cause of death (ACGIH (7th, 2001)). In addition, there is a description that aspiration of the alkali into the airways causes fatal damages to the larynx, trachea/bronchus, and lungs. Therefore, it was classified in Category 1 for this hazard class (SIDS (2004)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Classification not possible	- -	-	-	Reliable acute toxicity data were not obtained.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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