NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1310-73-2
Chemical Name	Sodium hydroxide
Substance ID	m-nite-1310-73-2_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 molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified	- -	-	-	Not combustible (Hommel (1996))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified	- -	-	-	Not combustible (Hommel (1996))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (Hommel (1996))	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Water solubility is 109 g/100 mL (20 degC) (ICSC (2000)), and the substance is stable against water.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Classification not possible	- -	-	-	Classification is not possible since no data are available though the substance is inorganic compound containing oxygen. However, it is considered that the substance does not have oxidizing properties since sodium ion is a monovalent which is the most stable. (Refer to Guidance for Enterprises)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Classification not possible	- -	-	-	「Classification not possible due to lack of data. As relevant information, a LD50 value is 325 mg/kg for rabbits (SIDS (2002)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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	In a pig test using application of 2N (8%), 4N (16%) and 6N (24%) solutions on the abdominal region, gross blisters developed within 15 minutes of application and the 8 and 16% solutions produced severe necrosis in all epidermal layers. The 24% concentration produced numerous and severe blisters with necrosis extending deeper into the subcutaneous tissue (SIDS (2009)). Additionally, there is a report that severe necrosis occurred after application of a 5% solution to the skin of rabbits for 4-hour (ACGIH (7th, 2001)). Based on these data, the substance was classified into Category 1. As relevant information, the pH is 12 (0.05% w/w) (Merck (14th, 2006)). For humans, 0.5 - 4% solutions were irritating to the skin, and in skin irritation tests with a 0.5% solution, 55% and 61% of the volunteers showed positive skin irritation reactions (SIDS (2009)). In EU classification, the substance is classified into C; R35.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Based on a report that the corrosive concentration for rabbit eyes was 1.2% or higher than 2% (SIDS (2009)) and a pH of 12 (0.05% w/w) (Merck (14th, 2006)), the substance was classified into Category 1. For humans, there are numerous case reports that the accidental exposure to high concentrations of dusts and solutions caused severe eye damage (ACGIH (7th, 2001)) and that accidental contact with the eye leads to blindness (DFGOT vol. 12 (1999)). As relevant information, the substance is corrosive to skin and classified into C; R35 in EU classification.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Not classified	- -	-	-	Male volunteers were exposed on their backs to concentrations of 0.063 - 1.0% of the substance. After 7 days the volunteers were challenged to a concentration of 0.125%. The irritant response correlated well with the concentration, but an increased response was not observed when the previously patch tested sites were rechallenged. Based on these results, sodium hydroxide has no skin sensitization potential. Furthermore sodium hydroxide has been used widely and for a long time, and no human cases of skin sensitization were reported, therefore, sodium hydroxide is not considered to be a skin sensitizer (SIDS (2009)). Based on this conclusion, the substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	In bone marrow micronucleus tests by intraperitoneal administration to mice (in vivo somatic cell mutagenicity test), a significant increase of micronuclei was not observed (SIDS (2009)). In addition, in an oocyte aneuploidy induction test by intraperitoneal administration to mice (in vivo germ cell mutagenicity test), any evidence that suggested a chromosome non-disjunction was not observed (SIDS (2009)). Since there findings indicate negative results for in vivo somatic cell and germ cell mutagenicity tests, the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of a negative Ames test (SIDS (2009)) and a false-positive CHO K1 cell chromosomal aberration test (SIDS (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Classification not possible	- -	-	-	Although there is a report of a negative result in a rat carcinogenicity test by oral administration for 12 weeks (DFGOT vol. 12 (1999)), classification was not possible due to lack of sufficient data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Based on a report that acute exposures involving inhalation of dusts or mists may cause mucous membrane irritation with subsequent cough and dyspnea; and that intense exposure may result in pulmonary edema and shock (PATTY (5th, 2001)), the substance was classified into Category 1 (respiratory system). As relevant information, there is a report that dust formation is unlikely because of the substance's hygroscopic properties and negligible vapour pressure (SIDS (2009)). There is a report of 28 accidental ingestion cases in which approximately 50 - 200 mL of a 25 - 37% solution of the substance was ingested and injury to the upper gastrointestinal tract and esophagus was observed (SIDS (2009)). Additionally, there are numerous case report of serious accidental or suicidal poisoning in which the substances caused severe corrosion of mouth, throat, tongue and oesophagus (DFGOT vol. 12 (1999)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is a report that no animal data are available for repeated dose toxicity tests by oral, dermal, inhalation and other routes of exposure for the substance (SIDS (2009)). There is very little human data available. Classification was not possible due to lack of data. There is a report that following repeated inhalation exposure to aerosols of the substance, rats suffered pulmonary damage (ACGIH (7th, 2001)). This data was not used as the basis of classification since the exposure concentrations are unknown. As relevant information, there is a report that dust formation is unlikely because of the hygroscopic properties and negligible vapour pressure of the substance (SIDS (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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 3	- -	H402	P273 P501	Classified into Category 3 from its 48h-LC50 = 40 mg/L for Crustacea (Cenodaphnia quadrangular) (SIDS, 2004, etc).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified into Not classified since the toxicity is mitigated in environmental water by buffer action though it is considered to be a factor of toxicity that water solution becomes a strong base.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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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