NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	52-86-8
Chemical Name	Haloperidol
Substance ID	24A6027
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
UN GHS document (External link)	UN GHS document
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 Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	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).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen, fluorine, and chlorine, all of which are chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
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)).
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."
7	Reproductive toxicity	Category 1B, Additional category: Effects on or via lactation	Danger	H360 H362	P308+P313 P201 P202 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).
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)).
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)).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

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

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.

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