GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 302-01-2
Chemical Name Hydrazine
Substance ID H28-B-032, C-043B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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 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.
7 Flammable solids Not applicable
-
-
- -  Liquid (GHS definition)
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.
9 Pyrophoric liquids Classification not possible
-
-
- -  No data available.
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
-
-
- -  Inorganic substance containing no oxygen, or halogen atoms
14 Oxidizing solids Not applicable
-
-
- -  Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- -  It is an inorganic compound.
16 Corrosive to metals Classification not possible
-
-
- -  No data available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Liquid (GHS definition)
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.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
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.
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.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
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.
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.
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.
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.
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)).
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, respiratory organs, heart, liver, genetic 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).
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (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.
11 Hazardous to the aquatic environment (Long-term) 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.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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