GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 304-20-1
Chemical name Hydralazine hydrochloride
Substance ID 23A5059
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
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.
2 Flammable gases (including chemically unstable gases) Not applicable - - - "Solids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Solids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Solids" according to GHS definition.
6 Flammable liquids Not applicable - - - "Solids" according to GHS definition.
7 Flammable solids Classification not possible - - - No data.
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.
9 Pyrophoric liquids Not applicable - - - "Solids" according to GHS definition.
10 Pyrophoric solids Classification not possible - - - No data.
11 Self-heating substances and mixtures Classification not possible - - - No data.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - "Solids" according to GHS definition.
14 Oxidizing solids 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.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No established test method suitable for solid substances.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
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.
1 Acute toxicity (Dermal) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Classification not possible - - - No data.
3 Serious eye damage/eye irritation Classification not possible - - - No data.
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))
4 Skin sensitization Category 1

Warning
H317
P302+P352
P333+P313
P261
P272
P280
P321
P363
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).
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)).
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.
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P281
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)).
8 Specific target organ toxicity - Single exposure Category 1 (cardiovascular system)

Danger
H370
P307+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).
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).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - No data.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.



Updated date:
2016/10/13 Addition of Rationale for the classification

List of GHS Classification Results