GHS Classification Result (Revision of the past classification result)

Chemical Name:Ammonia
CAS:7664-41-7

Result:
ID: 21B3003
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 - - - - Gas (GHS definition)
2 Flammable gases (including chemically unstable gases) Category 1 Danger H220: Extremely flammable gas P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P377: Leaking gas fire: Do not extinguish, unless leak can be stopped safely.
P381: Eliminate all ignition sources if safe to do so.
P403: Store in a well-ventilated place.
Combustion range (explosive limits) in the air is 15 - 28% (Dangerous Goods Data Book (Tokyo Fire Department (1993))) exceeding 12%.
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not classified - - - - Classified into Not classified since the substance is classified into Division 2.3 in UNRTDG (UN1005), Subsidiary risk 8, but not into Division 5.1 (Oxidizing substances) in UNRTDG.
5 Gases under pressure Low pressure liquefied gas Warning H280: Contains gas under pressure; may explode if heated P410+P403: Protect from sunlight. Store in a well-ventilated place. Critical temperature is 132.4 degC (Merck (13th, 2001)) exceeding 65 degC.
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 gaseous substances are not available. Information is available that the substance attacks aluminum (ICSC (J) (1998)), however, steel and iron have a durability as containers (Hommel (1996)).

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Classification not possible - - - - No data available.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Category 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
Based on LC50 values (4-hour equivalence) of 3669, 5671 and 8300 ppm for rats (EHC 54 (1986)), the substance was classified into 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: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
In a rabbit skin irritation test, necrosis was observed after application of a 20% solution for 5 minutes (IUCLID (2000)). In humans, following contact with gaseous ammonia, the effects including marked irritation and chemical burns (DFGOT vol. 6 (1992)). In the gaseous form, the substance is considered a skin irritant (IUCLID (2000)). The pH of a 1N ammonia solution is 11.6 (Merck (14th, 2006)). Based on these data, the substance was classified into Category 1. As relevant information, in EU classification, the substance is classified into C; R34.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
In a rabbit test, as complications of severe burns, irreversible effects such as symblepharon, corneal ulcerations leading to perforations, permanent corneal opacity, and persistent iritis were observed (EHC 54 (1986)). For humans, direct contact may cause immediate effects and serious ocular damage occurs at high concentrations (EHC 54 (1986), ACGIH (7th, 2001)). The pH of a 1N ammonia solution is 11.6 (Merck (14th, 2006)). Based on these data, the substance was classified into Category 1. As relevant information, in EU classification, the substance is classified into C; R34.
4 Respiratory sensitization Category 1 Danger H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled P304+P341: IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P285: In case of inadequate ventilation wear respiratory protection.
P501: Dispose of contents/container to ...
There are many case reports of asthma and asthma-like symptoms in humans exposed to ammonia (ATSDR (2004), ACGIH (2001)). Ammonia is irritating to the respiratory tract (ACGIH (2001)). Although irritating effect is not excluded, a test showed a significant association between exposure to ammonia gas and respiratory symptoms including bronchial asthma (ATSDR (2004)). In another report, it is concluded that ammonia is responsible for asthma based on a result of an inhalative provocation test. Based on the data, the substance was classified into Category 1.
4 Skin sensitization Classification not possible - - - - Although there is a result of not skin sensitizing in an open epicutaneous test with guinea pigs (IUCLID (2000)), it is not possible to classify the substance as "Not classified", since the test was not conducted using a method recommended in the guidance and the information is reported in a document in List 2. Classification was not possible due to lack of sufficient data.
5 Germ cell mutagenicity Classification not possible - - - - There is a report that analysis of blood samples from humans exposed to ammonia and control humans not exposed to ammonia showed increased frequency of chromosomal aberrations and sister chromatid exchanges (ATSDR 2004). Additionally, a positive result in a micronucleus test by intraperitoneal administration to mice (in vivo mutagenicity test) was reported (ATSDR 2004). However, the details for both reports are unknown, therefore, classification was not possible due to lack of sufficient in vivo data. As relevant information, from in vitro mutagenicity tests, there are reports of both negative and positive bacteria tests (EHC 54 (1986), IUCLID (2000)).
6 Carcinogenicity Classification not possible - - - - Two-year ingestion of ammonia in the drinking-water by mice did not produce any carcinogenic effects (EHC 54 (1986)). Although the role of ammonia on carcinogenesis induced by other substances was investigated in mice (EHC 54 (1986)), there are no results other than a report of "gastric tumor" (details are unclear) (RTECS (2008): Cancer Letters: 65, 15, 1992). Classification was not possible.
7 Reproductive toxicity Classification not possible - - - - There is a report that when rats were treated throughout gestation and lactation, a reduction in body weight gain of pups was observed on postnatal day 120 (ATSDR (2004)). However, classification was not possible since there are no data for effects on sexual function and fertility by exposure before gestation (mating).
8 Specific target organ toxicity - Single exposure Category 1 (respiratory system) Danger H370: Causes damage to organs (respiratory system) P307+P311: IF exposed: 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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
In humans, exposure to the substance was reported to produce dyspnea, pulmonary edema and bronchopneumonia (DFGOT vol. 6 (1992), ATSDR (2004), IRIS (1991), BSDB (2005)). In animal tests, significant toxic effects on the respiratory system including the lung, as evidenced by dyspnoea, cyanosis, pulmonary haemorrhage, oedema, focal pneumonitis was reported (EHC 54 (1986)). Based on the information, the substance was classified into Category 1 (respiratory system). The toxic concentrations estimated from animal data (EHC 54 (1986)) are within the guidance value range for Category 1.
9 Specific target organ toxicity - Repeated exposure Category 2 (lung) Warning H373: May cause damage to organs through prolonged or repeated exposure (lung) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
3 patients significantly exposed to ammonia in occupational settings exhibited chronic dyspnea. Their clinical symptoms were consistent with restrictive lung dysfunction and obstructive lung disease (IUCLID (2000)). In rats exposed to a concentration of 143 ppm (3-month equivalence: 94 ppm) for 2 years, histological changes were observed in the lungs including small areas of interstitial pneumonia with signs of peribronchitis and perivasculitis (EHC 54 (1986)). Since the human case report is on a document of List 2 and the lung lesions in rats were observed at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (lung).
10 Aspiration hazard Not applicable - - - - Gas (GHS definition)

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 1 from its 96h-LC50 = 0.083 mg/L for fish (Pink salmon) (EHC 54, 1986).
11 Hazardous to the aquatic environment (Long-term) Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 1 since its acute toxicity is Category 1and the behavior in water is unknown.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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