NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	113-92-8
Chemical Name	Chlorpheniramine maleate
Substance ID	m-nite-113-92-8_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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	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	- -	-	-	There is a chemical group present in the molecule associated with a self-reactive property (unsaturated bond), 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 established test method suitable for solid substances with a melting point of 140 degrees C or lower.	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)	- -	-	-	It contains oxygen and chlorine which are not chemically bonded to elements other than carbon or hydrogen.	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 to which most of the three LD50 data for rats (118 mg/kg, 540 mg/kg, 680 mg/kg (above NTP TR317 (1986)) correspond, one of which corresponds to Category 3 and two correspond to Category 4.	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	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	From a negative result in a micronucleus test using bone marrow cells after intraperitoneal administration in mice (in vivo somatic cell mutagenicity test) (NTP DB (1993)), it was classified as "Not classified." Besides, as in vitro tests, results of negatives in an Ames test (NTP DB (1982)) and a mouse lymphoma test (NTP DB (Access on May 2011)) and a positive in a chromosomal aberration test using CHO cells in the presence of metabolic activation (NTP DB (Access on May 2011)) were reported.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Not classified	- -	-	-	In a 103-week oral administration test in rats and mice, it was reported that no evidence of carcinogenicity in either species of either sex was found, though decreased body weights in dosed groups and decreased survival rates in high-dose female rats and high-dose male mice at the end of the test were observed. (NTP TR317 (1986)) Therefore, it was classified as "Not Classified." Besides, reduction of the sensitivity to detect a carcinogenic response due to high mortality in high-dose female rats and high-dose male mice, and proliferative changes by increased incidences of thyroid gland follicular cell cysts and hyperplasia in female mice were reported.	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 using rats, in which males were dosed from 63 days before mating through a mating period, and females were dosed from 21 days before mating until day 14 of gestation or 21 days after parturition, no effects on sexual function and fertility, but an increased percentage of deaths in offspring during a lactation period were observed (NTP TR317 (1986)). Furthermore, mice had 100% of abortion or resorption during a gestation period by oral administration in the highest dose group, and fetuses showed marked decreases in survival rate at the end of gestation or after delivery at doses lower than the highest. (NTP TR317 (1986)) Due to no description of general toxicity in parent animals, it was classified in Category 2 based on the above. Besides, in an oral administration test during an organogenetic period in rats and rabbits, no adverse effects on the development of the offspring including teratogenicity were reported. (NTP TR317 (1986))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is used as an antihistamine medicine (H1 receptor antagonist), and the H1 receptor antagonist is known to cause excitement or depression of central nervous system. (NTP TR317 (1986)) Convulsions and confusions are listed as serious adverse effects, and sedation, nervousness, sleepiness, dizziness, tremor, coordination abnormality and so on are listed as other adverse effects in a neuropsychiatric system in the drug package insert. (Ethical pharmaceuticals (2010), corresponding to List 1) And acute poisoning with H1 receptor antagonists, which show symptoms of hallucinations, excitement, ataxia, incoordination, athetosis, and convulsions, could cause very dangerous situations by their central nervous stimulation. (HSDB (2003)) From the above knowledge in human, it was classified in Category 1 (central nervous system). Besides, also in experimental animals, excitement, muscle tremor, ataxia, and convulsive seizures were reported as symptoms in an acute toxicity test using rats and mice. (NTP TR317 (1986))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, cardiovascular system, hematopoietic system)	Danger	H372	P260 P264 P270 P314 P501	This substance is used as an antihistamine medicine (H1 receptor antagonist), and the H1 receptor antagonist is known to cause excitement or depression of central nervous system. (NTP TR317 (1986)) Convulsions and confusions are listed as serious adverse effects, and sedation, nervousness, sleepiness, dizziness, tremor, coordination abnormality and so on are listed as other adverse effects in a neuropsychiatric system in the drug package insert. (Ethical pharmaceuticals (2010)) Besides, in animal tests, in oral administration in rats and mice for 2, 13, or 104 weeks, hyperactivity, hyperexcitability, and lethargy were observed, and convulsions, tremor, and loss of coordination in addition to deaths were reported at a high dose. (NTP TR317 (1986)) By taking as a target organ from the above results, it was classified in Category 1 (central nervous system). In the second place, in 104-week oral administration in monkeys, decreased heart rates, and prolonged duration of electrical systole at 10 mg/kg/day corresponding to Category 1 in Guidance values or higher, and deaths by cardiac failure in addition to arrhythmias and fainting at 15 mg/kg/day occurred. (NTP TR317 (1986)) Serious adverse effects such as shock, cyanosis, dyspnea, angina pectoris, and hypotension are listed in medical use in humans. (Ethical pharmaceuticals (2010)) Therefore, it was classified in Category 1 (cardiovascular system). There are case reports, moreover, that show association with thrombocytopenic purpura, bone marrow suppression, and aplastic anemia (NTP TR317 (1986)), and aplastic anemia and agranulocytosis are listed as serious adverse effects (Ethical pharmaceuticals (2010)). Therefore it was classified in Category 1 (hematopoietic system). From the above, it is classified in Category 1 (central nervous system, cardiovascular system, hematopoietic system).	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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