NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1336-21-6
Chemical Name	Ammonia aqueous
Substance ID	m-nite-1336-21-6_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)	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)	- -	-	-	CAS RN (1336-21-6) is given to ammonium hydroxide (ammonia 1: water 1) which corresponds to 48.6% ammonia water. It falls into Dissolved Gas in GHS definition. For Physical Hazards among all, classification was conducted for ammonia water which is commonly distributed. Because products of about 25% is generally sold, they are a liquid (GHS definition) There are no chemical groups associated with explosive properties present in the molecule.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition) Besides, one with more than 10 wt% but not more than 35 wt% ammonia is classified in Class 8, PG III (UN2672), one with more than 35 wt% but not more than 50 wt% ammonia is classified in Division 2.2 (UN2073), and one with more than 50 wt% ammonia is classified in Division 2.3, Subsidiary Risk 8 (UN3318) in UNRTDG.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified	- -	-	-	Not combustible (10-35% solution) (ICSC (1995))	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified	- -	-	-	Not combustible (10-35% solution) (ICSC (1995))	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (10-35% solution) (ICSC (1995))	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Category 1	Warning	H290	P234 P390 P406	A 10-35% solution is classified in Class 8, PG III (UN2672) in UNRTDG and attacks many metals (10-35% solution) (ICSC (1995)). Therefore, it was classified in Category 1.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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 4	Warning	H302	P301+P312 P264 P270 P330 P501	This CAS RN (1336-21-6) means ammonium hydroxide (ammonia 1: water 1), which amounts to a 48.6% ammonia water. Classifications for health hazards were conducted regarding generally distributed ammonia water (a liquid under the GHS definition). Based on an LD50 value of 350 mg/kg for rats (SIDS, 2008), this substance was classified in Category 4.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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	There is a report that in a skin irritation test with rabbits, after application of a 20% aqueous solution of this substance, it was corrosive (SIDS, 2008) and there is a description that it was corrosive to the eyes and skin because of strong alkaline properties (SIDS, 2008). This substance was classified in Category 1 because no data to classify for the sub-category were available. Besides this substance was classified in "C; R34" in EU DSD classification and in "H314 Skin Corr. 1B" in EU CLP classification, respectively.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	There are reports that irritation was observed in a test in which 1 mg of this substance was applied to rabbit eyes (SIDS, 2008), and that in a test in which a 28.5% aqueous solution was applied to rabbit eyes, irreversible corneal injuries such as corneal nebula and opacification and vascularization were observed (HSDB (Access on June 2014)). There are also descriptions that this substance was corrosive to the skin and eyes due to it being a strong alkali (SIDS, 2008) and caused severe irritation of the mucosa (HSDB (Access on June 2014)). Based on the above, this substance was classified in Category 1.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that in an open epicutaneous test with guinea pigs, after application of a 20% ammonia aqueous solution, it was negative (IUCLID, 2000), but the test method was not the one recommended in the classification guidance, therefore, it was judged that the data were not sufficient to use for classification.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. No in vivo data were available and available in vitro data were bacterial reverse mutation tests only with negative results (SIDS, 2008). Besides, as for in vivo, a positive result in a micronucleus test by intraperitoneal administration with mice was reported (ATSDR, 2004). However, details were unknown and not adopted for classification.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	No classification for carcinogenicity by any international organization was available. Besides, as for individual information, although it is reported that it was not carcinogenic in a carcinogenicity test with rats administered by drinking water, this information was not sufficient (SIDS, 2008). From the above, this substance was classified as "Classification not possible" due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In humans, this substance was irritating to the respiratory tract and caused severe irritation and pain in the respiratory tract mucosa. Besides, it was severely corrosive to the mouth, throat and stomach by the oral route (HSDB (Access on June 2014)). Although the neurological effects following inhalation or dermal exposure were known and usually limited to blurred vision due to direct contact, more severe exposures, which resulted in elevation of blood ammonia levels, resulted in seizure, coma, diffuse nonspecific encephalopathy, muscle weakness, decreased deep tendon reflexes and loss of consciousness leading to death (ATSDR, 2004). In an epidemiological death case after ingestion of this substance, autopsy showed hemorrhagic esophagus, stomach and duodenum. In a case of ingestion of household ammonia (ammonium hydroxide), there is a report on lesions and edema in the esophagus and acute respiratory disorder (ATSDR, 2004). In a case of a worker who was exposed to a high concentration (10,000 ppm) of this substance which overflowed from a tank, he immediately developed coughing, vomiting, difficulty in breathing and labored breathing and he died 6 hours after the exposure. On autopsy, there is a report of marked inflammation of the respiratory tract and severe denudation of the tracheal epithelium (HSDB (Access on June 2014)). Although only limited data were available in experimental animals, by oral administration to rats, sedation, staggering, abnormal posture, convulsions, tremors, ataxia, prostration, ptosis, exophthalmus, salivation, labored and irregular breathing and diarrhea were reported (no detailed information available). Although there is no description of the minimum dose affected, provided that these effects, observed at around 350 mg/kg, which is the LD50 value, it corresponds to Category 2 (SIDS, 2008). Based on the above, this substance was classified in Category 1 (central nervous system, respiratory organs).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In humans, no report was available regarding chronic exposure. In experimental animals, in a test in which rats and guinea pigs were continuously exposed by inhalation for 90 days, at a concentration of 455 mg/m3, dyspnea and nasal irritation were observed, and there were dead animals (SIDS, 2008). Although these findings suggest that the respiratory organs were the target organs, information on testing conditions such as exposure time was unknown, therefore, the data could not be adopted for classification. Since there was no other information on chronic exposure to aqueous ammonia, classification was not possible due to lack of data. Besides, the previous classification was made based on the data listed in List 3 or on those not listed in the current classification guidance.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Although there is a description that by oral ingestion of this substance, edema and burning in the upper respiratory tract occurred (HSDB (Access on June 2014)), there were no findings indicative of aspiration hazards, therefore, classification was not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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 3	- -	H402	P273 P501	As for this substance, it was decided that the classification was conducted as total ammonia based on expert judgment. It was classified in Category 3 from 96-hour LC50 = 26.8 mg/L for fish (Oncorhynchus mykiss) (a converted value equivalent to ammonium hydroxide. test substance: NH4Cl, pH: 8.29) (Thurston et al., 1981). The classification result was changed from the previous classification by changing the view on which substance was targeted.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	As for this substance, it was decided that the classification was conducted as total ammonia based on expert judgment. If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (rapidly nitrified in aquatic environment (SIDS, 2007)), and 32-day NOEC =7.1 mg/L for crustacea (Mysidopsis bahia) (a converted value equivalent to ammonium hydroxide. test substance: NH4Cl, pH: 7.92-8.01) (SIDS, 2007). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (algae, fish), then it is classified as "Not classified" due to being rapidly degradable and a low bioaccumulation estimate (log Kow = -2.66 (PhysProp Database)), despite 96-hour LC50 = 26.8 mg/L for fish (Oncorhynchus mykiss) (a converted value equivalent to ammonium hydroxide. test substance: NH4Cl, pH: 8.29) (Thurston et al., 1981). From the above results, it was classified as "Not classified."	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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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