NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	302-01-2
Chemical Name	Hydrazine
Substance ID	m-nite-302-01-2_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	- -	-	-	There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule, and there is no data. However, because it is classified in Class 8, Subsidiary Risk 3 and 6.1, PG I (UN 2029) in UNRTDG, and Class 3 is given, it does not correspond to explosives which is hazard class with the highest precedence.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	From a flash point of 40 deg C (closed-cup) (ICSC(J) (2009)), it was classified in Category 3. It is classified in Class 8, Subsidiary Risk 3 and 6.1, PG I (UN 2029) in UNRTDG.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule, and there is no data. However, because it is classified in Class 8, Subsidiary Risk 3 and 6.1, PG I (UN 2029) in UNRTDG, and Class 3 is given, it does not correspond to self-reactive substances and mixtures which is hazard class with the highest precedence.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Inorganic substance containing no oxygen, or halogen atoms	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	There are reports on three LD values for rats: 60 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), ACGIH (7th, 2001), DFGOT Vol.1 (1992), PATTY (6th, 2012), BUA 205 (1996)), 90 mg/kg (BUA 205 (1996)) and 60 - 90 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Based on these, this substance was classified in Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	There are reports of three LD50 values for rabbits: 91 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), DFGOT Vol.1 (1992)), 93 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), ATSDR (1997), EHC 68 (1987)), and 91 - 283 mg/kg (PATTY (6th, 2012)). Two of these correspond to Category 2, and one of them corresponds to Category 2 - 3. Therefore, this substance was classified in Category 2 under which the greatest number of data falls.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on a report of an LC50 value (4 hours) of 570 ppm for rats (Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), ACGIH (7th, 2001), ATSDR (1997), EHC 68 (1987), DFGOT Vol.1 (1992)), this substance was classified in Category 3. Additionally, since the LC50 value was lower than 90% of the saturated vapor pressure concentration (19,005 ppm), a reference value in the unit of ppm was applied as vapour without mist.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	Irritation in application sites was observed in a skin irritation test (4-hour application) using rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), and severe irritation was seen in animal experiments using several animal species (dogs, guinea pigs) including rabbits (ACGIH (2001), PATTY (6th, 2012)). Moreover, skin irritation was reported also in humans (EHC 68 (1987), ACGIH (2001), PATTY (6th, 2012)). Therefore, this substance was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is reported that severe eye damage was observed in eye irritation tests in rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2015)). Moreover, severe eye irritation has also been reported (DFGOT Vol. 1 (1992), PATTY (6th, 2012)). Since eye irritation is also known in humans (EHC 68 (1987), ACGIH (2001), PATTY (6th, 2012)), this substance was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Since this substance was classified in Group 1 of occupational skin sensitizers in the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2015) and allergic contact dermatitis was observed in humans (EHC 68 (1987), DFGOT (1999), ACGIH (2001), PATTY (6th, 2012)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo data, a dominant lethal test was negative, an unscheduled DNA synthesis test in the sperm of mice was negative, micronucleus tests in the bone marrow cells of mice were positive and negative, a sister chromatid exchange test in mouse bone marrow cells was negative, and DNA damage tests in mouse liver or lungs were positive (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ACGIH (7th, 2001), EHC 68 (1987), IARC 71 (1999), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), ATSDR (1997)). As for in vitro data, many positive results have been reported in bacterial reverse mutation tests, and gene mutation tests, mouse lymphoma assays, micronucleus tests, chromosomal aberration tests, and sister chromatid exchange tests using cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), IARC 71 (1999), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), EHC 68 (1987), ACGIH (7th, 2001), ATSDR (1997)). From the above, it was classified in Category 2 according to GHS classification guidance for the Japanese government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	In humans, there are only small cohort epidemiological studies, and no increases in tumor occurrence have been reported. As for experimental animals, it was reported that oral administration (drinking water) to rats or hamsters caused increases in liver tumors, and inhalation exposure caused increases in nasal polypoid adenoma in rats (IARC 71 (1999)). Previously, IARC classified hydrazine in Group 2B, as there was inadequate evidence in humans and sufficient evidence in experimental animals. However, the classification was recently raised to Group 2A (IARC 115 (in prep., Access on June 2016)). Classifications by other organizations include B2 (probable human carcinogen: equivalent to Category 1B) by the EPA (IRIS (1988)), R by NTP (NTP RoC (13th, 2014)), Carc. 1B by the EU (ECHA (2011)), A3 by ACGIH (ACGIH (7th, 2001)), and Group 2B by the Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2015)). Therefore, this substance was classified in Category 1B for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There is no information in humans. As for experimental animals, it has been described that in tests using rats given this substance by oral administration (drinking water) for 6 months or by inhalation for 4 months, embryotoxicity (decreased live embryos and increased resorptions) was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)); that as the result of oral administration of the hydrochloride of this substance to pregnant rats during gestation (8 mg/kg/day), fetal toxicity (reduced fetal weight, pale skin, and edema) was seen at the dose at which decreased body weight gain and mortality were observed in dams (ACGIH (7th, 2001), PATTY (6th, 2012)); and that as the result of oral administration of this substance to pregnant rats (Gestation days 6-15, at 5 or 10 mg/kg/day), developmental delays as fetus toxicity were observed at doses at which maternal toxicity was observed (ACGIH (7th, 2001), PATTY (6th, 2012)). Additionally, it was reported that in tests by intraperitoneal injection to rats or mice, an increased incidence of fetus malformations (fused ribs, hydronephrosis, exencephaly etc.) were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ACGIH (7th, 2001)). However, as described above in the tests by the oral or inhalation route, while embryo/fetal toxicity was observed at doses at which maternal toxicity was largely observed, no increase in malformation formation was observed. Therefore this substance was classified in Category 2 for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, liver), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, accidental oral ingestion of this substance caused vomiting, neurological symptoms (confusion, ataxia etc.) and sharply elevated levels of enzymes (AST, LDH) relating to hepatotoxicity (EHC 68 (1987), DFGOT Vol. 1 (1992), ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Lethargy was also observed (EHC 68 (1987), DFGOT Vol. 1 (1992)). Moreover, accidental inhalation exposure to vapors of this substance caused nausea, vomiting, local irritation of the upper respiratory tract, and substantial increases in hepatotoxicity-related enzymes (DFGOT Vol. 1 (1992), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). From the above, this substance was classified in Category 1 (central nervous system, liver) and Category 3 (respiratory tract irritation, narcotic effects). In addition, it is described that, though detailed dosage descriptions are not provided, in experimental animals, the symptoms of acute toxicity of this substance are not much different between oral administration and non-oral administration; and ataxia, hypoactivity, dyspnea, increased excitability, salivation, vomiting and convulsions were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, respiratory organs, heart, liver, reproductive organs)	Danger	H372	P260 P264 P270 P314 P501	In humans, it was reported that persistent neurobehavioral disorders were observed in a 38-year-old male water treatment technician (exposure concentration was not determined, but it was estimated to be 3-4 mg/m3 from the fact that the odor was detected). In this case, it is thought that both exposure through the respiratory tract and transdermal absorption of anhydrous hydrazine and hydrazine monohydrate occurred (OEL Documentations (Japan Society For Occupational Health (JSOH), 1998)). 　In experimental animals, 12-month toxicity studies by inhalation exposure using rats, hamsters, or dogs have been performed. In rats, effects on the respiratory organs (squamous metaplasia and inflammation in laryngeal and tracheal mucosal epithelium, hyperplasia of lung epithelium etc.) at 0.066 mg/m3 or above, which is in the range of Category 1; effects on the liver (hepatocellular hyperplasia) in females and effects on the heart (myocardial degeneration) in males at 1.33 mg/m3 or above; and effects on the testes (hyperplasia of Leydig cells in the testes), effects on the uterus (endometrial hyperplasia, endometritis), and effects on the ovaries (atrophy of ovaries, salpingitis) at 6.65 mg/m3 were observed. In hamsters, hemosiderosis (liver) and testis atrophy were observed at 0.33 mg/m3 or above, which is in the range of Category 1. In dogs, effects on the liver (increased ALT and vacuolization of hepatocytes) were observed at 1.33 mg/m3, which is in the range of Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). 　Besides, in the previous classification, this substance was classified together with the data on the hydrate of this substance. However, this classification was conducted exclusively for the anhydrate. Therefore, there is a difference in the classification results. 　Accordingly, this substance was classified in Category 1 (central nervous system, respiratory organs, heart, liver, genetic organs).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 72-hour EC50 = 0.006 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 2 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1992)), and 72-hour NOEC = 0.001 mg/L for algae (Pseudokirchneriella subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)). 　If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 2 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1992)), and 48-hour LC50 (static) = 0.04 mg/L for crustacea (Hyalella azteca) (Initial Risk Assessment (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002)). 　It was classified in Category 1 from the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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