GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 86-54-4 |
| Chemical name | Hydralazine |
| Substance ID | 23A5072 |
| 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 |
| 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 |
| 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 a chemical group associated with an explosive property (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 a chemical group associated with an explosive property (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 that does not contain oxygen, fluorine, or chlorine. |
| 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. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Classification not possible | - | - | - |
No data. |
| 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 | - | - | - |
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)) |
| 4 | Skin sensitization | Category 1 |
 |
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 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. |
| 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)) |
| 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)) |
| 7 | Reproductive toxicity | Category 2 |
 |
H361 |
P308+P313 P201 P202 P281 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)) |
| 8 | Specific target organ toxicity - Single exposure |
Category 1 (cardiovascular system) |
|
H370 |
P307+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). |
| 9 | Specific target organ toxicity - Repeated exposure |
Category 1 (immune system, blood) |
|
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). |
| 10 | Aspiration hazard | Classification not possible | - | - | - |
No data. |
| 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:
|
* 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. |
Updated date:
|
2017/3/17 Addition of Rationale for the classification |