GHS Classification Result (Revision of the past classification result)

Chemical Name:Ammonium chloride
CAS:12125-02-9

Result:
ID: 21B3021
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives 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.
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 - - - - Classified into Not classified from the description of "Not combustible" (Weiss (2nd, 1986)).
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 - - - - Classified into Not classified from the description of "Not combustible" (Weiss (2nd, 1986)).
11 Self-heating substances and mixtures Not classified - - - - Classified into Not classified from the description of "Not combustible" (Weiss (2nd, 1986)).
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - No data available.
15 Organic peroxides Not applicable - - - - Inorganic compound
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
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.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
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".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
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".
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)).
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.
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.
8 Specific target organ toxicity - Single exposure Category 2 (nervous system) Warning H371: May cause damage to organs (nervous system) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
9 Specific target organ toxicity - Repeated exposure Category 1 (systemic toxicity) Danger H372: Cause damage to organs through prolonged or repeated exposure (systemic toxicity) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) - - - - - Due to under review.
11 Hazardous to the aquatic environment (Long-term) - - - - - Due to under review.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


Updated date:
                 2016/12/19

Updated history:
                 2016/12/19 Correction of classifications (Hazardous to the aquatic environment (Acute) and Hazardous to the aquatic environment (Long-term))

NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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