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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7664-41-7
Chemical Name	Ammonia
Substance ID	H26-B-011, -
Classification year (FY)	FY2014
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	FY2009 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)
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 applicable	- -	-	-	Gas (GHS definition)
2	Flammable gases (including chemically unstable gases)	Category 1	Danger	H220	P210 P377 P381 P403	There are both data for Category 1, an explosion limit (15.4-33.6% (GESTIS (Access on July 2014))) and one for Category 2, an explosion limit (16-25% (Matheson (2001))), and it was classified in Category 1 from a safety perspective. Besides, it is classified in Division 2.3 (UN1005) in UNRTDG.
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified	- -	-	-	It was classified in Category 1 for Flammable Gases and is not thought to be Oxidizing Gases.
5	Gases under pressure	Liquefied gas	Warning	H280	P410+P403	From a critical temperature (132.4 deg C (GESTIS (Access on July 2014))) above + 65 deg C, it was classified as liquefied gas (low pressure liquefied gas).
6	Flammable liquids	Not applicable	- -	-	-	Gas (GHS definition)
7	Flammable solids	Not applicable	- -	-	-	Gas (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	Gas (GHS definition)
9	Pyrophoric liquids	Not applicable	- -	-	-	Gas (GHS definition)
10	Pyrophoric solids	Not applicable	- -	-	-	Gas (GHS definition)
11	Self-heating substances and mixtures	Not applicable	- -	-	-	Gas (GHS definition)
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	Gas (GHS definition)
13	Oxidizing liquids	Not applicable	- -	-	-	Gas (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	Gas (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Gas (GHS definition)
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to gas substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not applicable	- -	-	-	Classification of health hazards was conducted based on the information on ammonia (gas). Refer to the health hazard information on ammonia aqueous solution as necessary. Gas (GHS definition)
1	Acute toxicity (Dermal)	Not applicable	- -	-	-	Gas (GHS definition)
1	Acute toxicity (Inhalation: Gases)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on LC50 values (converted 4-hour equivalent value) of 7,679 ppm (EHC 54 (1986)) and 7,729 ppm (DFGOT vol. 6 (1994)) for rats, this substance was classified in Category 4.
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Gas (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Not applicable	- -	-	-	Gas (GHS definition)
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	It is described that contact of the skin with this substance causes severe burns, as a result of dissolution or emulsification of keratin, lipids, cholesterol, and etc. (DFGOT vol. 6 (1994)). In addition, based on the reports of alkali burns and severe irritation in humans exposed to ammonia gas (DFGOT vol. 6 (1994), ATSDR (2004)), it was classified in Category 1. This substance is classified as "C; R34" by EU DSD classification and as "Skin Corr. 1B" in the EU CLP classification.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	There are descriptions that ammonium hydroxide was produced by contact with the mucosa to cause severe necrosis (DFGOT vol. 6, 1994), of eye irritation in humans (EHC 54, 1986) and that exposure to this substance at high concentrations caused severe damage (EHC 54 (1986), ACGIH (7th, 2001)). Besides, conjunctival edema (SIDS (2008), EHC 54 (1986)), symblepharon, pannus and irreversible corneal opacity (EHC 54, 1986) were observed in a test with rabbits. Based on the above, this substance was classified in Category 1.
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	There were multiple reports of asthma or asthma-like symptoms in humans who were exposed to this substance (ATSDR (2004), ACGIH (7th, 2001)). Besides, ATSDR (2004) described that there was a statistically significant correlation between exposure to ammonia gas and symptoms in the respiratory organs including bronchial asthma. In another report, it is described that ammonia caused asthma in an inhalation provocation test. Based on the above, this substance was classified in Category 1.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Although there is a report on increased frequencies of chromosomal abbreviations and sister chromatid exchanges in a survey/analysis of blood samples collected from humans who were exposed or not exposed to ammonia, details were unknown. As for in vitro, there are reports that bacterial reverse mutation tests were negative (SIDS (2008), IUCLID (2000)).
6	Carcinogenicity	Classification not possible	- -	-	-	No classification for carcinogenicity by any international organization was available. It was classified as "Classification not possible" due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As a reproductive test on ammonia gas, it is reported that there were no alternations in sexual maturity, number of live fetuses, fetus-to-corpus luteum ratio and fetal length in an inhalation study with pigs exposed prior to mating and during the gestation period (ATSDR, 2004). However, these data were not adopted for classification because they are not sufficient to investigate reproductive effects due to exposure only at very low concentrations (7 and 35 ppm), no control group employed, and it was exposure to females only (ATSDR, 2004). Besides, the following evidence cited in the previous classification was not adopted because the test was conducted by oral administration, not a test using ammonia gas; "In a developmental toxicity test with rats by the oral route (administered in the diet from gestational day 1 until the end of the lactation period), body weight gain were reduced by 25% and 16% in male and female offspring, respectively, at 120 days old. Body weights of maternal animals and food consumption were not reported (ATSDR, 2004)."
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, by the inhalation route, there are reports on upper respiratory tract irritation, burning sensation of the nose, pharynx and trachea, dyspnea, edema of bronchi and alveolar, lung edema, bronchopneumonia, muscle spasms of hands and feet, and visual disorder. It is reported that neurological effects following inhalation or dermal exposure are usually limited to blurred vision, etc. due to direct contact, but severe exposures, which result in significant elevation of blood ammonia levels (hyperammonemia), can result in diffuse nonspecific encephalopathy, loss of consciousness, muscle weakness, and decreased deep tendon reflexes. (SIDS (2008), ATSDR (2004), EHC 56 (1986), IRIS (1991), OEL Documentations (Japan Society for Occupational Health (JSOH) (1979))). Furthermore, there are reports that inhalation exposure caused hemorrhagic necrosis in the liver at a lethal level and death in 30 minutes at 445–8,900 ppm (SIDS (2008), ATSDR (2004), EHC 56 (1986)). There are also reports on dyspnea, tracheal and pulmonary edema, tracheitis, bronchitis, bronchopneumonia and pulmonary edema by dermal exposure (ATSDR (2004), DFGOT vol. 6 (1994)). In experimental animals, there were reports of dyspnea, cyanosis, nasal discharge, pulmonary edema and pulmonary hemorrhage by inhalation exposure at 256-897 ppm with rats, and there are reports of pulmonary hemorrhage in dead animals and mild to moderate focal pneumonitis in the lungs of surviving animals at 1,190-4,860 ppm and necrosis in the liver at a lethal concentration of 3,440 ppm by inhalation exposure with mice (SIDS (2007), EHC 56 (1986), ATSDR (2004)). These effects in experimental animals were found within the guidance value range of Category 1. Based on the above, this substance was classified in Category 1 (central nervous system, respiratory organs).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There is a description that in a repeated inhalation test with human volunteers exposed to ammonia gas up to 6 weeks, although no disorder was seen up to 25 ppm (2 hours/day), at the 50 ppm level (4 or 6 hours/day), irritation of the eye, nose and throat was observed within 1 week after exposure initiation (ATSDR (2004), DFGOT vol. 13 (1999), IRIS (1991)). And, in experimental animals (rats, rabbits and guinea pigs), irritation of the nasal mucosa was observed within the range of Category 2 (SIDS (2008), DFGOT vol. 6 (1994)), therefore, this substance was classified in Category 1 (respiratory organs).
10	Aspiration hazard	Not applicable	- -	-	-	Gas (GHS definition)

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
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.

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