NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	147-24-0
Chemical Name	Diphenhydramine hydrochloride
Substance ID	m-nite-147-24-0_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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	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 data.	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)	- -	-	-	An organic compound that contains oxygen which is not chemically bonded to elements other than carbon. Besides, it is conceivable that chlorine, which is a chlorine ion ionically bonded to an amine, does not contribute to the oxidation of other substances.	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	On the basis of three LD50 values for rats (500, 545, 856 mg/kg bw) (NTP TR355 (1989)), it was classified in 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	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as in vitro tests, both negatives as a result of an Ames test and a mouse lymphoma test, a positive in a chromosomal aberration test using CHO cells in the absence of S9mix (NTP DB (Access on May. 2011)), and a negative in a chromosomal aberration test using human leukocytes or fibroblasts in the absence of S9mix (NTP TR355 (1989)) were reported.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	In a 2-year diet administration test using rats and mice, it was reported that no evidence of carcinogenicity in both male and female but only fatty degeneration in the liver in females of a high dose group were observed in mice, and slightly increased incidences of rare brain tumors (astrocytomas, glioma) and alveolar/bronchiolar tumors in males and slightly increased incidences of pituitary gland adenoma in females observed in rats were equivocal evidence of carcinogenicity. (NTP TR355 (1989)). Because a clear conclusion on carcinogenicity was not drawn as a result of the above 2-year administration tests in 2 animal species, it was classified as "Classification not possible."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2,	Warning	H361 H362	P308+P313 P201 P202 P260 P263 P264 P270 P280 P405 P501	In an oral administration test during an organogenetic period or gestational day 11 to 14 in mice, general toxicity such as a decreased weight gain, hyperactivity, and convulsions in maternal animals, together with a dose-dependent tendency to increase an incidence of a cleft palate were observed. (NTP TER 82069 (1983)) Furthermore, it was reported that malformations occurred including a cleft palate, cryptorchid testes, hydronephrosis and so on after intraperitoneal administration to rats on gestational day 10. (NTP TR 355 (1989)) On the other hand, the percentage of mothers whose children had a cleft palate was significantly increased in women who had taken this substance more frequently during the first trimester of pregnancy. (NTP TR 355 (1989)) From the above reports, it was classified in Category 2 as a substance suspected human development toxicity. On the other hand, the package insert states in the "use in pregnant, parturient or breastfeeding women" that "no dosing this substance to breastfeeding women is desirable, and breastfeeding should be avoided if a patient has no choice but to take the substance" and "coma in an infant through breast milk was observed" (Ethical pharmaceuticals (2010), corresponding to List 1). Therefore, "additional category: effects on or via lactation" was adopted.	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	There is the information that syndrome of the acute poisoning from an overdose of this substance in humans includes impaired consciousness, hallucinations, excitement, mydriasis, tachycardia, incoordination, convulsions, and so on, and coma may develop, with the patient dying of cardiopulmonary arrest. (NTP TR 355 (1989)) Besides, it is also reported that a child given 25 mg twice developed an acute extrapyramidal motor system disorder. (HSDB (2003)) It is stated that a central excitatory action is the most threatening in acute poisoning caused by histamine antagonists including this substance. (HSDB (2003)) From the above knowledge, it was classified in Category 1 (central nervous system). Besides, poisoning symptoms in rats or mice observed after oral administration are neuromotor excitements, convulsions, tremor, lethargy, prone positions, and so on. (NTP TR 355 (1989))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system), Category 2 (liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	This substance is used as an antihistamine medicine, and neuropsychiatric adverse effects (dizziness, fatigue, nervousness and so on) are listed in the package insert (Ethical pharmaceuticals (2010), corresponding to List 1). Also, animal tests concluded that administration of 25 to 40 mg/kg/day causes neurogenic reactions from irritability and slight incoordination by oral administration of 40 mg/kg/day in dogs (unknown duration of administration). (NTP TR 355 (1989)) From the above knowleadge, it was classified in Category 1 (nervous system). On the other hand, cytoplasmic vacuolization or fatty degeneration by fat accumulation in liver were reported at 313 to 2500 ppm (15.6 to 125 mg/kg/day) in a 13-week diet administration test in rats and at 313 ppm (46 to 47 mg/kg/day) in a 103-week diet administration test in mice. (NTP TR 355 (1989)) Besides, an increased incidence of granulomas of the liver were also reported in a 103-week diet administration test in rats. (NTP TR 355 (1989)) From these signs in the liver within a range of Category 2 in Guidance values, it was classified in Category 2 (liver).	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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