GHS Classification Result (Revision of the past classification result)

Chemical Name:Hydrazine monohydrate
CAS:7803-57-8

Result:
ID: 20A2374
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Classification not possible - - - - It contains chemical groups associated with explosive properties. Since no additional information is available, classification is not possible. According to the UNRTDG, it is rated as Division 6.1 and Class 8 (referring to UN No. 2030 (hydrazine aqueous solution with more than 37% hydrazine, by mass)).
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Category 4 - Warning H227: Combustible liquid P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Its flash point is 75degC (open cup) (BUA 205 (1996)), which falls under Category 4. The UNRTDG rated the substance as Division 6.1 and Class 8 with the packing group to which the substance is assigned ranged from I to III (a substance with its assigned packing group being I and flash point being <= 60degC must be attached with a subsidiary risk label for flammable liquids as special requirements) (referring to UN No. 2030 (hydrazine aqueous solution with more than 37% hydrazine, by mass)).
7 Flammable solid Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups associated with explosive properties. Since no additional information is available, classification is not possible. According to the UNRTDG, it is rated as Division 6.1 and Class 8 (referring to UN No. 2030 (hydrazine aqueous solution with more than 37% hydrazine by mass)).
9 Pyrophoric liquids Classification not possible - - - - No data available. According to the UNRTDG, it is rated as Division 6.1 and Class 8 (referring to UN No. 2030 (hydrazine aqueous solution with more than 37% hydrazine by mass)).
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available.
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 - - - - It is an inorganic compound containing oxygen (but not halogen), which is chemically bonded only to water molecule which is added to form a hydrate.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Not an organic compound
16 Corrosive to metals Classification not possible - - - - Regarding its corrosivity to stainless steel (Merck (13th, 2001)), it does not attack V2A, SUS304, or SUS347 stainless steel; however, a stainless steel containing molybdenum such as SUS316 should not be used. Since no further information is available, classification is not possible. According to the UNRTDG, this substance is grouped into corrosive substances. Since this classification includes both skin and metal corrosive substances, we cannot determine if this substance is metal corrosive (referring to UN No. 2030 (hydrazine aqueous solution with more than 37% hydrazine by mass)).

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on LD50 values of 262 mg/kg, 169 mg/kg, and 220 mg/kg reported in oral administration tests using rats (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (2003)), the substance was classified into Category 3.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - It was classified into the "Not applicable" category since it is a liquid (GHS definition), and it is presumably not inhalable as a gas.
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 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 4-hour application test using rabbits, application of solution containing 55% concentration of this substance resulted in localized skin corrosion in 7 of 11 treated rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 73 (2005)). Based on this report, the substance was classified into Category 1.
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.
According to "2. Skin corrosion/irritation," in the health hazards section, the substance is rated as Category 1. Consequently, we classified it into Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
According to Initial Risk Assessment Report (NITE, CERI, NEDO) No. 73 (2005) on health effects of this substance, hydrazine and its salt induce contact allergies. In addition, the substance is rated as Group 2 for skin sensitization by Japan Society for Occupational Health. Based on this information, the substance was classified into Category 1.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
According to reports in Initial Risk Assessment Report (NITE, CERI, NEDO) No. 73 (2005) and EHC 68 (1987), neither heritable mutagenicity tests nor in vivo germ cell mutagenicity tests have been conducted, in vivo mutagenicity tests using somatic cell (mouse spot tests) gave positive results, and no in vivo germ cell genotoxicity tests have been conducted. Given these reports, the substance was classified into Category 2. Regarding health hazards of this substance, see also that of hydrazine (ID 56, CAS: 302-01-2).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In oral administration (through drinking water) tests, increased incidences of malignant uterine neoplasm and liver neoplasm in rats and increased incidences of pulmonary neoplasm in mice were observed at concentrations that show toxic effects (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 73 (2005)). In different oral administration (through drinking water) tests, slight increase in incidences of hepatocyte adenoma in male rats, and increased incidences of hepatocyte adenoma and hepatoma in female rats were noted; no signs of increased tumorigenesis was observed in male mice, but clear increase in incidence of hepatocyte adenoma and slight increase in incidence of hepatoma were noted in female mice (Ministry of Health, Labour and Welfare (Results from Carcinogenicity Studies, 2000). In light of these results, the Ministry of Health, Labour and Welfare has issued Guidelines for Preventing Health Impairment by Hydrazine and its Salt as well as Hydrazine Monohydrate (Ministry of Health, Labour and Welfare Guidelines, 2006). In accordance with the guidelines, the substance was classified into Category 2. It is also rated as Group 2B by Japan Society for Occupational Health (Documentation of Recommendations of Occupational Exposure Limits, 1998).
7 Reproductive toxicity Classification not possible - - - - Classification not possible due to lack of data Regarding health hazards of this substance, see also that of hydrazine (ID 56, CAS: 302-01-2).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, liver, kidney) Danger H370: Causes damage to organs (central nervous system, liver, kidney) 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, acute exposure of this substance is known to affect the central nervous system, liver, and kidney (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment, vol. 1, 2002)). Based on this report, we decided that the central nervous system, liver, and kidney are target organs and we classified this substance into Category 1 for these target organs. In order to make classifications of hydrazine monohydrate, we selected assessment reports clearly stating that tests were conducted on hydrazine monohydrate. However, hydrazine monohydrate is easily formed from hydrazine (ID: 0056, CAS No. 302-01-2) reacting with water. Due to this, when hydrazine is dissolved in water in order to expose animals to hydrazine in animal studies, dissolved hydrazine is thought to be in a state of hydrazine monohydrate. Therefore, see also classifications of hydrazine (ID: 0056, CAS No. 302-01-2) and take them into account for evaluation of hydrazine monohydrate.
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, nervous system, gastrointestinal tract, kidney) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver, nervous system, gastrointestinal tract, kidney) 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 ...
In human cases, liver toxicity, nervous and heart symptoms, jaundice, severe nephritis found in autopsy, necrosis of the renal tubules, glomerulonephrosis, and focal hepatocellular necrosis were noted (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 73 (2005)). In addition, stomatitis, tremor, lethargy incoherent speech, jaundice, a tender and palpable liver due to hypertrophy, elevated blood bilirubin and creatinine levels, protein in urine, and severe renal tubule necrosis found in autopsy were detected (IARC (1987)). Based on the list of these effects, we decided target organs of this substance are the liver, nervous system, gastrointestinal tract, and kidney. The gastrointestinal tract was selected as a target organ because it was affected in dermal exposure studies. From above information, the substance was classified into Category 1 (liver, nervous system, gastrointestinal tract, and kidney). In order to make classifications of hydrazine monohydrate, we selected assessment reports clearly stating that tests were conducted on hydrazine monohydrate. However, hydrazine monohydrate is easily formed from hydrazine (ID: 0056, CAS No. 302-01-2) reacting with water. Due to this, when hydrazine is dissolved in water in order to expose animals to hydrazine in animal studies, dissolved hydrazine is thought to be in a state of hydrazine monohydrate. Therefore, see also classifications of hydrazine (ID: 0056, CAS No. 302-01-2) and take them into account for evaluation of hydrazine monohydrate.
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) - - - - - -
11 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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