NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	304-20-1
Chemical Name	Hydralazine hydrochloride
Substance ID	m-nite-304-20-1_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	Classification not possible	- -	-	-	The substance contains chemical groups associated with explosive properties (neighboring nitrogen atoms), but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	The substance contains chemical groups associated with explosive properties (neighboring nitrogen atoms), but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	An organic compound does not contain oxygen or fluorine but contains chlorine that is chlorine ion, which is ionically bonded to amine, is conceivable not to contribute to the oxidation of other substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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	Reported LD50 values, 320 mg/kg for male rats and 280 mg/kg for female rats (IARC 24 (1980)), correspond to Category 4 and Category 3 respectively. Because a higher hazard category in these categories was adopted, it was classified in Category 3.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data. Besides, there is the information that a pharmaceutical worker, who developed asthma when exposed to hydralazine that is a free base of this substance, was diagnosed with occupational asthma supported by specific inhalation challenges which produced a delayed asthma reaction and an increase in bronchial response. (HSDB (2005))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Because it is listed as a sensitizing substance in Contact Dermatitis (Frosch) (4th, 2006), it was classified in Category 1. Besides, this substance often shows cross-sensitization reactions with hydralazine that is considered to be a potent sensitizing substance (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data. Besides, a positive is reported in an Ames test on either this substance or a free base of this substance (IARC 24 (1980)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	A significant incidence of lung tumors was reported in a drinking water administration test for life in mice with a remark that data interpretation is difficult due to an unusual protocol and an inappropriate analysis of the results. (IARC 24 (1980)) On the other hand, the classification is not possible due to insufficient human epidemiological data. Besides, hydralazine that is a free base of this substance was classified in Group 3 in an IARC carcinogenicity evaluation, which corresponds to "Classification not possible" in this classification.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	Because an animal test (mice) reported teratogenicity (Ethical pharmaceuticals (2010), corresponding to List 1) and hydralazine that is a free base of this substance showed teratogenicity in mice with a report of a cleft palate and malformation of facial and cranial bones (HSDB (2005)), and general toxicity in both parent animals was unknown, it was classified in Category 2. Besides, there is the information that transfers via placenta may cause thrombopenia and so on in newborns in humans. (Ethical pharmaceuticals (2010)) Furthermore, while there is the information as a caution for breastfeeding women that breastfeeding should be avoided during administration due to a breast milk transfer (Ethical pharmaceuticals (2010)), there is the information that hydralazine, a free base of this substance, produces extremely low levels in breast milk and suggests safety during the breastfeeding period (HSDB (2005)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (cardiovascular system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is information on hydralazine that is a free base of this substance that acute poisoning signs are characterized by hypotension with a marked fall in blood pressure and reflex tachycardia. Observed cardiovascular changes may include palpitations, exacerbation of coronary insufficiency, ischemic changes by electrocardiogram, angina pectoris, myocardial infarction and sudden death may occur. (PIM 264 (1996), corresponding to List 1) Besides, a case mixed with ethanol poisoning in a suicide attempt by a 27-year-old woman reported that mild hypotension, acidemia showed, and ECG was suggestive of myocardial ischemia. (PIM 264 (1996)) From the above knowledge, it was classified in Category 1 (cardiovascular system).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (immune system, blood)	Danger	H372	P260 P264 P270 P314 P501	The onset of a syndrome resembling disseminated lupus erythematosus (rheumatic syndrome) related to the long-term use of hydralazine is well documented. Lupus erythematosus cells have repeatedly been found in hydralazine-treated patients (IARC 24 (1980)). And the drug package insert has a description of syndromes resembling systemic lupus erythematosus (fever, erythema, arthralgia, chest pain and so on) as the serious adverse effects (Ethical pharmaceuticals (2010)). Therefore, it was classified in Category 1 (immune system). Besides, anemia and hemosiderosis in the spleen were observed in tests of 4 weeks oral administration of 60 to 120 mg/kg/day (converted to a 90-day equivalent: 18.5 to 36.9 mg/kg/day) or 13 to 26 weeks oral administration of 60 mg/kg/day in rats (IARC 24 (1980)). And the drug package insert has information that hemolytic anemia and pancytopenia may occur as the serious adverse effects in humans (Ethical pharmaceuticals (2010)). Therefore, it was classified in Category 1 (blood). From the above, the classification is Category 1 (immune system, blood).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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