GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 1310-58-3 |
| Chemical Name | Potassium hydroxide |
| Substance ID | H29-B-117 |
| Classification year (FY) | FY2017 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2006 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2010)). |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2010)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2010)). |
| 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. |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound containing oxygen, but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | 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 |
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." |
| 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." |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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." |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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)). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Classification not possible |
- |
- | - | Reliable acute toxicity data were not obtained. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data available. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |