Item | Information |
---|---|
CAS RN | 52-86-8 |
Chemical Name | Haloperidol |
Substance ID | m-nite-52-86-8_v1 |
Download of Excel format | Excel file |
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) |
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 (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. | FY2012 | 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) |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen, fluorine, and chlorine, all of which are chemically bonded only to carbon or hydrogen. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
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 |
There are three LD50 values for rats [128 mg/kg (Pharmaceutical Interview Forms, Serenace Injection 5 mg (revised twentieth edition, Feb. 2012), corresponding to List 1), 450 mg/kg (Pharmaceutical Interview Forms, Linton Injection (revised fourth edition, May 2008), corresponding to List 1), and 850 mg/kg (PIM 263 (1992), corresponding to List 1)], one corresponded to Category 3, and two corresponded to Category 4. It was classified in Category 4 to which most corresponded. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Skin sensitization | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it was reported to be negative in an Ames test (PIM 263 (1992)). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
6 | Carcinogenicity | Classification not possible |
- |
- | - | Data are lacking. Besides, in a 24-month oral administration test with rats, survival decreased in all dose groups, leading to a decrease in the number of animals for assessment, but a relatively high number of animals survived to the end of the test in the high dose group, and these animals did not have a greater incidence of tumors than the control animals (PIM 263 (1992)). And in an 18-month oral administration test with mice, both mammary gland neoplasia and total tumor incidence and a pituitary gland neoplasia incidence significantly increased in females, but no significant differences in the incidence of total tumors or specific tumor types were noted in males (PIM 263 (1992)). On the other hand, in humans, neither clinical studies nor epidemiological studies have shown to date an association between chronic administration of this substance and mammary tumorigenesis (PIM 263 (1992)). From the above, there is the knowledge in animals and humans, but the available evidence was considered too limited to be conclusive (PIM 263 (1992)). Therefore, it was classified as "Classification not possible." | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
7 | Reproductive toxicity | Category 1B, |
Danger |
H360 H362 |
P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501 |
This substance acts on the central nervous system and has been used as a medicine of a psychoneurotic stabilizer (acting on dopamine). There are cases in which the teratogenicity of this substance was suspected, and in animals tests, there are reports on teratogenicity such as cleft palate and brain malformations and fetotoxicity such as a decrease in the number of implantations, an increase in resorptions, and an increase in the abortion rate, and there is a precaution that it should not be administered to pregnant women or women with the potential to become pregnant (Ethical Pharmaceuticals (2010), corresponding to List 1). Therefore, it was classified in Category 1B. And it was classified in the Additional category: Effects on or via lactation from the description that infants should not be nursed during the treatment of this substance because it is excreted into human milk (PIM 263 (1992)). Besides, as for animal test data, in mice, there are reports on a decrease in the number of implantations, an increase in resorptions, and a decrease in the number of pups born after oral administration, cleft palate after intramuscular administration (Pharmaceutical Interview Forms, Serenace Injection 5 mg (revised twentieth edition, Feb. 2012)), and exencephaly, hydrocephalus, and occasionally ectopia of the neural tubes after intraperitoneal administration (Teratogenics (12th, 2007), corresponding to List 2). On the other hand, in humans, there are reports on malformations in the limbs in children from pregnant women who took this substance with other drugs in the first trimester of gestation (Birth Defects (3rd, 2000), corresponding to List 2). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, heart, endocrine system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
This substance has been used as a medicine of a psychoneurotic stabilizer (acting on dopamine). It is described that chronic poisoning from ingestion may induce neurological syndromes, the most severe of which are parkinsonism, akathisia, and tardive dyskinesia (PIM 263 (1992)), and it is described that the main adverse effects compiled from domestic literature were extrapyramidal symptoms such as tremor, Parkinson-like symptoms, muscle rigidity, and akathisia and neuropsychiatric symptoms such as insomnia and a sense of impatience (Ethical Pharmaceuticals (2010)). Therefore, it was classified in Category 1 (central nervous system). And the Australian Drug Reaction Advisory Committee (ADRAC) reported a case of a 46-year-old woman who had been treated with this substance at 60-100 mg/day for 10 days and developed malignant ventricular tachycardia (PIM 263 (1992)), and it is also described in the package insert of the medicine that ventricular tachycardia and QT prolongation may occur as serious adverse effects (Ethical Pharmaceuticals (2010)). Therefore, it was classified in Category 1 (heart). Furthermore, it was classified in Category 1 (endocrine system) because there is a report on a case of a 54-year-old male patient who showed significant hyponatremia after taking clinical doses of this substance during hospitalization and developed the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) (PIM 263 (1992)), and it is described in the package insert of the medicine that the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with hyponatremia, blood hypoosmosis, increased secretion of urine sodium, etc. may occur as serious adverse effects (Ethical Pharmaceuticals (2010)). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, heart, endocrine system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
It is described that chronic poisoning from the ingestion of this substance may induce neurological syndromes, the most severe of which are parkinsonism, akathisia, and tardive dyskinesia (PIM 263 (1992)), and it is described that the main adverse effects compiled from domestic literature were extrapyramidal symptoms such as tremor, Parkinson-like symptoms, muscle rigidity, and akathisia and neuropsychiatric symptoms such as insomnia and a sense of impatience (Ethical Pharmaceuticals (2010)). Therefore, it was classified in Category 1 (central nervous system). And the Australian Drug Reaction Advisory Committee (ADRAC) reported a case of a 46-year-old woman who had been treated with this substance at 60-100 mg/day for 10 days and developed malignant ventricular tachycardia (PIM 263 (1992)), and it is also described in the package insert of the medicine that ventricular tachycardia and QT prolongation may occur as serious adverse effects (Ethical Pharmaceuticals (2010)). Therefore, it was classified in Category 1 (heart). Furthermore, it was classified in Category 1 (endocrine system) because there is a report on a case of a 54-year-old male patient who showed significant hyponatremia after taking clinical doses of this substance during hospitalization and developed the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) (PIM 263 (1992)), and it is described in the package insert of the medicine that the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with hyponatremia, blood hypoosmosis, increased secretion of urine sodium, etc. may occur as serious adverse effects (Ethical Pharmaceuticals (2010)). | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | No data available. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. | FY2012 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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