NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7803-57-8
Chemical Name	Hydrazine monohydrate
Substance ID	m-nite-7803-57-8_v1
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	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)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	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)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Not an organic compound	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Information on carcinogenicity in humans is limited to (4). In tests conducted according to appropriate test guidelines and GLP standards, (1) and (2), clear evidence of carcinogenicity was observed in two animal species including malignant tumors. Therefore, it was classified in Category 1B. Besides, the same test results as for the previous classification were used for the classification this time. However, the category was revised by putting importance on the fact that the substance was judged to be carcinogenic in animals in Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare), and that guidelines were issued by the ministry from concerns on carcinogenicity after discussions in the small committee of hazard evaluation. Moreover, hydrazine (CAS: 302-01-2) that is anhydrate of this substance was also classified in Category 1B by the Japanese Government. [Evidence Data] (1) In a carcinogenicity test in rats (2-year drinking water administration), a slightly increased incidence of hepatocellular adenoma in males and increased incidences of hepatocellular adenoma and carcinoma in females were observed (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2000)). (2) In a carcinogenicity test in mice (2-year drinking water administration), no evidence indicating an increased incidence of tumors was observed in males, but an increased incidence of hepatocellular adenoma and a slightly increased incidence of hepatocellular carcinoma were observed in females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2000)). (3) As for classification results by domestic and international organizations, IARC classified hydrazine in Group 2A for carcinogenicity (IARC 115 (2018)), ACGIH classified hydrazine in A3 (ACGIH (7th, 2001)), Japan Society for Occupational Health (JSOH) classified hydrazine (anhydrous) and hydrazine hydrate in 2B (Recommendation of Occupational Exposure Limits and so on (2017): proposed in 1998), and hydrazine (this substance, that is a hydrate, is included in a range of EC No. that is targeted) was classified in Carc. 1B in EU CLP respectively. [Reference Data, etc.] (4) In two studies on cohorts of workers who worked at the rocket testing facility in California, excesses of lung cancers were observed, and positive and significant association was observed between exposure to hydrazine and cancer of the lung (IARC 115 (2018)). (5) IARC evaluated hydrazine, that is anhydrate of this substance, together with this substance. By regarding (4) as limited evidence in humans for the carcinogenicity of hydrazine, and because there is sufficient evidence in experimental animals for carcinogenicity, IARC classified hydrazine in Group 2A for carcinogenicity (IARC 115 (2018)). (6) Based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, this substance is subject to guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare (Public announcement on guidelines in order to prevent the impairment of worker's health, No. 23, Oct 10, 2012).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, liver, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, nervous system, gastrointestinal tract, kidney)	Danger	H372	P260 P264 P270 P314 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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 1	Warning	H400	P273 P391 P501	It was classified into Category 1 from 72 hours ErC50=0.19mg/L of the algae (Selenastrum) (MOE Eco-Toxicity Tests of Chemicals, 2001).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Although acute toxicity is Category 1 and bio-accumulation is low (log Kow=-2.07(PHYSPROP Database, 2005)), since there was no rapidly degrading (the decomposition of hydrazine by BOD: 2%(Existing Chemical Safety Inspections Data)), it was classified into Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
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.
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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