NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	12125-02-9
Chemical Name	Ammonium chloride
Substance ID	m-nite-12125-02-9_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)	- -	-	-	The substance apparently contains N-Cl bond. However, this bond is not chemical groups associated with explosive properties since this is an ionic bond which is different from chloramines.	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	- -	-	-	Classified into Not classified from the description of "Not combustible" (Weiss (2nd, 1986)).	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	- -	-	-	Classified into Not classified from the description of "Not combustible" (Weiss (2nd, 1986)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Classified into Not classified from the description of "Not combustible" (Weiss (2nd, 1986)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	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	- -	-	-	No data available.	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	LD50 values of 1650 mg/kg (ACGIH (2001)), 1410 mg/kg bw (SIDS (2009)) and 1658 mg/kg bw (IUCLID (2000)) for rats correspond to Category 4.	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	Not classified	- -	-	-	In a Draize test (GLP) using two application sites on each of 6 rabbits (total 12 sites), the score for redness at 24-hour after application was 2 in 7 sites and 3 in 5 sites. The scores of redness, edema and eschar at 48 and 72-hour were zero in all rabbits. The mean score for each animal was 1 or less (SIDS (2009)). Based on these data, the substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on a report of "mild irritating" in a rabbit test (ACGIH (7th, 2001)) and a report that moderate irritation was observed at 10-min, 1- and 24-hour after application and the changes such as redness, swelling and cloudy corneal opacity were reversible within 8-day without leaving any residues, (SIDS (2009)), the substance was classified into Category 2B.	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	- -	-	-	Based on a report of "not sensitizing" (positive rate: 10% (2/20)) in a guinea pig skin sensitizing test (maximization test (GLP)) (SIDS (2001)), the substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on a negative result in a mouse bone marrow micronucleus test by intraperitoneal administration (in vivo somatic cell mutagenicity test) (SIDS (2009)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of negative Ames tests (SIDS (2009), IUCLID (2000)) and a positive cytogenetic assay (SIDS (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Classification not possible	- -	-	-	There is a test in which the substance was tested for promotion effect by exposure in the drinking water (SIDS (2009)). Classification was not possible due to lack of data for carcinogenicity.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Classification not possible	- -	-	-	In an oral two-generation test in mice, no gross external malformations in pups were observed. No viable litters were produced in the high dose group and for the medium dose group, one-half of the litter died (IUCLID (2000)). However, the result was difficult to evaluate and not used as the basis of classification, since a mixture of chemicals (the substance 42.9%) was tested. When the substance was given to rat orally in the drinking water after day 7 of pregnancy, no teratogenic toxicity was found but inhibition of fetal growth was observed. From the effect dose level, it was conclude that the effects on fetal growth were considered to be a consequence of maternal acidosis (SIDS (2009)). There is a report that rats orally administered in the diet (6%) from day 9 to 12 of gestation showed metabolic acidosis, 60 fetuses were held and 20 fetuses were resorbed (IUCLID (2000)). This information was not used as the basis of classification because of a lack of detailed data and the absence of a control group. There is a report that mice administered 600 mg/kg orally 4 times on day 10 of gestation produced 7% ectrodactyly in the fetuses (Teratogenic (12th, 2007)), however, the data was not used as the basis of classification since the detailed data are not available and the daily dose (total 2400 mg/kg/day) is very high (the LD50 value is approx. 1500 mg/kg). Overall, classification was not possible due to lack of sufficient data.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	Following oral administration, signs of toxicity (dyspnea, apathy, abnormal posture and staggering) occurred at dose levels of 1000 mg/kg bw and higher in rats. In mice, diarrhea, cyanosis, and ataxia gait were seen at a dose level of 1200 mg/kg bw (SIDS (2009)). At necropsy, hemorrhage in the brain was observed (SIDS (2009)). Additionally, central nervous system dysfunction is reported to have occurred in animals after ingestion of ammonium chloride (EHC 54 (1986)). Since the effects were observed at dose levels of 1000 - 1200 mg/kg bw which are within the guidance value range for Category 2, the substance was classified into Category 2 (nervous system). As relevant information, there is a report that ingestion of a large dose of the substance may cause nausea, vomiting, headache, and progressive drowsiness, which may and lead to profound acidosis and hypokalemia (SIDS (2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (systemic)	Danger	H372	P260 P264 P270 P314 P501	There are multiple reports of (metabolic) acidosis following ingestion of ammonium chloride for an extended period of time (6 months). In some cases, individuals were taken to the hospital because of exhaustion due to lack of air or hyperventilation and/or confusion. In other cases individuals showed a mild (metabolic) acidosis after taking the substance for a short term (SIDS (2009), ACGIH (2001)). Based on the data, the substance was classified into Category 1 (systemic toxicity). Acidosis was observed at the high dose level in a repeated oral dose test in rabbits, however, no significant adverse effects were observed in repeated oral dose tests in rats. The NOAELs are 684 mg/kg bw/day (90-day equivalence: 532 mg/kg bw/day) in a 70-day feeding test with rats (SIDS (2009)), 493 mg/kg bw/day (90-day equivalence: 307 mg/kg bw/day) in a 56-day feeding test with rats (SIDS (2009)). Additionally, in a 112-day feeding test in cattle, the NOAEL was 206 mg/kg bw/day (SIDS (2009)). These NOAELs with oral exposure exceed the upper limit of the guidance value range.	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	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 = 40.8 mg/L for fish (Oncorhynchus mykiss) (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. It was classified as "Not classified" due to being rapidly degradable (rapidly nitrified in aquatic environment (SIDS, 2007)), and 10-day NOEC= 26.8 mg/L (pH: 8.0) for algae (Navicula pelliculosa), 21-day NOEC= 14.6 mg/L (pH: 8.3-8.6) for crustacea (Daphnia magna), and 28-day NOEC = 8 mg/L (pH: 7.36-7.86) for fish (Menidia beryllina) (all, SIAR, 2004). The classification result was changed from the previous classification by changing the view on which substance was targeted and changing how to classify it in chronic toxicity.	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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