NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	10034-93-2
Chemical Name	Hydrazine sulfate
Substance ID	m-nite-10034-93-2_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)	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	Not classified	- -	-	-	Although it is hydrazine salt, it has been classified into Class 8 and PG III in the United Nations Recommendations on the Transport of Dangerous Goods and was classified into Not classified. In addition, this TDG classification is based on the UN No.2923 by Merck KGaA data from March 2009.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	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)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified	- -	-	-	Since it was classified into Class 8 and PG III in the United Nations Recommendations on the Transport of Dangerous Goods and it is not Class 4.1(II), 4.1(III), it was classified into Not classified. In addition, this TDG classification is based on the UN No.2923 by Merck KGaA data from March 2009.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified	- -	-	-	Since it was classified into Class 8 (not 4.1) and PG III in the United Nations Recommendations on the Transport of Dangerous Goods, it was classified into Not classified. In addition, this TDG classification is based on the UN No.2923 by Merck KGaA data from March 2009.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Since it was classified into Class 8 (not 4.2) and PG III in the United Nations Recommendations on the Transport of Dangerous Goods, it was classified into Not classified. In addition, this TDG classification is based on the UN No.2923 by Merck KGaA data from March 2009.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Since it was classified into Class 8 and PG III, not Class 4.2 (II) and 4.2 (III), in the United Nations Recommendations on the Transport of Dangerous Goods, it was classified into Not classified. In addition, this TDG classification is based on the UN No.2923 by Merck KGaA data from March 2009.	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)	- -	-	-	Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified	- -	-	-	Since it was classified into Class 8 and PG III, not Class 5.1 (I), 5.1 (II) and 5.1(III), in the United Nations Recommendations on the Transport of Dangerous Goods, it was classified into Not classified. In addition, this TDG classification was considered to be based on UN No.2923 by Merck KGaA data from March 2009.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	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 4	Warning	H302	P301+P312 P264 P270 P330 P501	From a description of LD50 value of 670 mg/kg (BUA 205 (1996)) and 601 mg/kg (HSDB (2005)) in the oral administration test employing rats, it was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Although there is a description that LD50 value of the dermal administration test employing a rabbit is 91 mg/kg (BUA 205 (1996)) for [ID 56] Hydrazine (CAS 302-01-2), since it is not data of the substance itself, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Although it is written that LC50 value of the 4-hour inhalation exposure test employing rats about [ID56] Hydrazine (CAS 302-01-2) is 0.35-0.76 mg/L (BUA 205 (1996)), classification is not possible since it is not data of this substance itself.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Although it has been described as human data that "no irritation on the skin was shown even if 25% hydrazines sulfate or its concentrated solution was applied for 24 hours in the skin exposure test in volunteers" (CERI/NITE Hazard Assessment Report (2004)), this is a test data with dissolved solution for 24 hours. In addition, although it has also been described that "there was no macroscopically observable symptom" (CERI/NITE Hazard Assessment Report (2004)) in the tests in which the substance-dipped sponges were fixed to the external ears of rabbits for 24 hours, since all of the tests were conducted in 1950s with insufficient data, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Although in HSDB (2005), there is a description of "There was no damage." in the eye irritation test where 0.02 mol concentrations of diluted solution (about 0.26%) was dropped employing rabbits with a corneal being removed, since it is the excessive condition that a corneal is removed and dropped to allow a chemical to penetrate easily and is the test with a diluted solution, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	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	It was classified as Category 1 since it has been described that "allergic contact dermatitis arose to plant employee who employed hydrazine sulfate" (EHC 68 (1987)), or that "it may have sensitizing properties to humans and cause contact dermatitis" (BUA 205 (1996)).	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	Although in vivo genotoxicity test (sister chromosome fission exchange test employing a mouse) is negative (BUA 205 (1996)), in vitro mutagenicity test employing a Salmonella typhimurium is positive (EHC 68 (1987)), and there is a description of methylation (IARC 71 (1999)) of DNA in the body cell in vivo genotoxicity test employing a hamster. Although there is no data of in vivo mutagenicity test as sulfate, as hydrochloride salt (CAS number 2664-70-4), it is positive in body cell in vivo mutagenicity test (mouse spot test) (CERI/NITE Hazard Assessment Report (2004)). Although the water solubility of this substance was 1/10 of Hydrazine hydrochloride, it was considered that the affection comparable to that of Hydrazine hydrochloride reaches on a cell, and it was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	IARC evaluates Hydrazines as group 2B (IARC 71 (1999), EHC 68 (1987)) and NTP evaluates Hydrazine and Hydrazine sulfate as R (NTP RoC (11th, 2005)). Priority was given to the classification of IARC and it was classified into Category 2. In addition, as for tests in which this article was administered to animals, there is a report that hepatocellular carcinoma was developed in the 2-year drinking water medication test which employed hamsters (IARC 71 (1999)), and there are descriptions that lung adenomas was developoed in the repeated oral dose study employing rats and mice and that liver cancer was developed in the 36-week forcible oral administration examination employing mice (EHC 68 (1987)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system, liver), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There is a datum dermal administration test on Hydrazine which calculated the lethal dose employing rabbits, which has a description that "main influences of Hydrazine and Hydrazine sulfate salt are hepatotoxicity and the nephrotoxicity" as consideration (BUA 205 (1996)). Although these influences were seen within the limits of the guidance value of Category 1, it is unknown whether it is a view in the example of survival. About human data, as an accidents cases about [ID 56] Hydrazine (CAS 302-01-2), CERI/NITE Hazard Assessment Report (2004) has an case that "a worker who got the burn in explosion accident went into coma after 14 hours and his brain showed neurological symptoms, such as an activity fall, and the bloody urine and the impaired liver function without a kidney damage were seen three days after the accident", and another case that "the steep rise of the enzyme value relevant to the local irritation of nausea, vomiting, the exposure skin and a conjunctiva, and a top respiratory tract and liver toxicity were seen in workers exposed to steam for 4 to 5 hours. Since it was satisfactory to apply this data to the article, it is classified into Category 1 (a nervous system, liver) and Category 3 (Respiratory tract irritation).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, adrenal gland), Category 2 (kidney, blood system, central nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In several cases where cancer patients were prescribed Hydrazine sulfate, it was reported that "disorders of the central nervous system were seen in some, and when the dosing period was long severe cases of polyneuropathy syndrome were observed" (ATSDR (1997)). However, the report concluded that "The subjects were not healthy individuals so it is possible that the symptoms which presented may be caused by underlying conditions," so it was not used. On the other hand, HSDB (2005), which is the source of information for List 2, contains reports on humans that "a man who received oral administration for 3-4 months presented hepatic encephalopathy, kidney failure and severe coagulopathy," and "a man who received it for 7 weeks suffered severe cerebropathia." For animals, there are reports that "brown discoloration was observed as non-tumorous lesions in the adrenal gland" in a 25-week oral carcinogenicityity study in mice and that "hepatic lesions, reticuloendothelial cell hyperplasia, liver cirrhosis and bile duct hyperplasia were observed" in 15- and 25-week oral gavage administration study in hamsters (EHC 68 (1987)). Since the effects for both mice and hamsters are within the range of guidance values for Category 1, it was classified as Category 1 (liver, adrenal gland) and Category 2 (kidney, blood system, central nervous system).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	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)	Classification not possible	- -	-	-	No data available	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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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