NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	479-18-5
Chemical Name	Diprophylline
Substance ID	24A6025
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 (but not fluorine or chlorine) which is 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	It was classified in Category 4 based on an LD50 value of 1,954 mg/kg bw for mice (Pharmaceutical Interview Forms, Diprophylline Injection 300 mg "Eisai" (revised fourth edition, May 2011), corresponding to List 1). Besides, as for health hazards, also refer to theophylline (CAS: 58-55-9) because this substance is a 7-hydroxypropyl derivative of theophylline.
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	- -	-	-	No data available.
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	It is described that there was no teratogenicity in rats (Birth Defects (3rd, 2000), corresponding to List 2), but because the test details are unknown, the classification is not possible. Besides, as information on theophylline, which is a related drug, in teratogenicity tests with rats and mice, there is a report on fetotoxicity such as an increase in the percent of resorptions, dead fetuses, and malformed live fetuses and a trend toward an increase in the incidence of external malformations (NTP TER 84111 (1985)). From such information, there is a precaution for the use of this substance in humans: it should be administered to pregnant women or women with the potential to become pregnant only if treatment benefits are determined to exceed the risk (Ethical Pharmaceuticals (2011)).
8	Specific target organ toxicity - Single exposure	Category 1 (cardiovascular system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is a derivative of theophylline and has cardiotonic, diuretic, and bronchodilating actions, and has been used for the treatment of heart failure and asthma in the form of injection and suppository (Pharmaceutical Interview Forms, Diprophylline Injection 300 mg "Eisai" (revised fourth edition, May 2011), Ethical Pharmaceuticals (2011)). As a precaution for use, it is described that it should be carefully administered to patients with acute myocardial infarction or severe myocardial disorder because it may worsen symptoms due to its myocardial stimulating effect, and shock is described as the serious adverse effect of this substance, and there is a description of a precaution and treatment of shock (Ethical Pharmaceuticals (2011)). Therefore, it was classified in Category 1 (cardiovascular system). Besides, it is described that adverse effects such as convulsion, clouding of consciousness, delirium, and coma may occur for theophylline, a related drug, but a safety margin is big for this substance because it has milder pharmacological actions and lower toxicity than theophylline or aminophylline does (Ethical Pharmaceuticals (2011)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (cardiovascular system)	Danger	H372	P260 P264 P270 P314 P501	This substance is a derivative of theophylline and has cardiotonic, diuretic, and bronchodilating actions, and has been used for the treatment of heart failure and asthma in the form of injection and suppository (Pharmaceutical Interview Forms, Diprophylline Injection 300 mg "Eisai" (revised fourth edition, May 2011), Ethical Pharmaceuticals (2011)). As a precaution for use, it is described that it should be carefully administered to patients with acute myocardial infarction or severe myocardial disorder because it may worsen symptoms due to its myocardial stimulating effect, and shock is described as the serious adverse effect of this substance, and there is a description of a precaution and treatment of shock (Ethical Pharmaceuticals (2011)). Therefore, it was classified in Category 1 (cardiovascular system). Besides, it is described that adverse effects such as convulsion, clouding of consciousness, delirium, and coma may occur for theophylline, a related drug, but a safety margin is big for this substance because it has milder pharmacological actions and lower toxicity than theophylline or aminophylline does (Ethical Pharmaceuticals (2011)).
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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