NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	86-54-4
Chemical Name	Hydralazine
Substance ID	m-nite-86-54-4_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 a chemical group associated with an explosive property (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 a chemical group associated with an explosive property (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 that does not contain oxygen, fluorine, or chlorine.	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)	Classification not possible	- -	-	-	No data.	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	- -	-	-	Lack of data. Besides, there is the information that a pharmaceutical worker exposed to hydralazine, who developed asthma, was diagnosed with occupational asthma which a delayed asthma reaction and an increase in bronchial response produced by specific inhalation challenges supported. (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 contact allergy substance in "Contact Dermatitis (Frosch) (4th, 2006)" (corresponding to List 1), it was classified in Category 1.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data. Besides, as an in vitro test, either this substance or a hydrochloride, which is unknown, was reported to be a positive result in an Ames test. (IARC 24 (1980))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	From Group 3 classification in an IARC carcinogenicity evaluation (IARC 24 (1980)), it was classified as "Classification not possible." A report on increased in incidences of carcinomas in hypertension patients who developed hydralazine toxicity compared to the hydralazine-treated patients without toxicity has a remark that confounders were not fully taken into account. (IARC 24 (1980)) In addition, in a large-scale case-control study conducted in the course of the National Breast-Cancer Screening Project, elevated relative risk estimates for breast cancer in relation to hydralazine use were observed, but a possibility of bias arising from the nature of population for the study was suggested. (IARC 24 (1980))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In an oral administration test in rabbits on day 16 of gestation, finger defect and decrease, missing, or structural anomaly of the phalanx were observed. (Birth Defects (3rd, 2000), corresponding to List 2) Furthermore, teratogenicity was indicated in mice in which skeletal malformations occurred, and teratogenic or fetotoxic to the offspring in rats at the dose where general toxicity was observed in parent animals was reported. (PIM 264 (1996), corresponding to List 1) It was classified in Category 2 because general toxicity in parent animals in rabbits and mice was not described, and effects on the offspring in rats at the dose where parent animals showed general toxicity were observed from the above. Besides, as information on human, it was reported that the incidence of malformation in the children from mothers who took this substance during pregnancy was not statistically significantly different from the expected rate. (IARC 24 (1980)) And there is information that human data demonstrate no increased risk of congenital malformations in children from mothers treated with this substance during a pregnancy period. (PIM 264 (1996))	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	Clinical signs of acute poisoning characterized by hypotension with a remarkable fall in blood pressure and reflex tachycardia, cardiovascular changes, palpitations, exacerbation of coronary insufficiency, ischemic changes by electrocardiogram, angina pectoris, myocardial infarction, and a possibility of sudden death are described. (PIM 264 (1996)) In addition, a case of poisoning in a suicide attempt by a 27-year-old woman mixed with ethanol intoxication reported that mild hypotension and acidemia were observed, 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	Lupus erythematosus cells have repeatedly been found in patients treated with the substance (IARC 24 (1980), PIM 264 (1996)) which is well known for the onset of a syndrome resembling disseminated lupus erythematosus (rheumatic syndrome) related to the long-term use. In addition, syndromes resembling systemic lupus erythematosus (fever, erythema, arthralgia, chest pain and so on), hemolytic anemia, pancytopenia, and so on are described as the serious adverse effects of hydrochloride of this substance (hydralazine hydrochloride) used as a medicine. (Ethical pharmaceuticals (2010), corresponding to List 1) Therefore it was classified in 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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