NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	317-34-0
Chemical Name	Aminophylline
Substance ID	m-nite-317-34-0_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)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	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)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	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)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	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)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	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.	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	From an LD50 value of 540 mg/kg for mice (HSDB (2002)), 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)	- -	-	-	It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006))	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	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Because this substance causes contact dermatitis for plant workers, pharmacists, and nurses and it is listed as a contact allergen in Contact Dermatitis (Frosch) (Contact Dermatitis (Frosch) (4th, 2006), corresponds to List 1), it was classified in Category 1.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	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 a human case, a newborn had symptoms such as vomiting and nervousness after dosing a hydrate of this substance to the mother just before the delivery. Therefore, this substance is considered to cross the placenta to the fetus. (Pharmaceutical Interview Forms (2009)). In an animal test, a low/significant number of digital defects, mostly in the left posterior limbs in subcutaneous administration on day 1 to 17 of gestation in rats was reported. (Teratogenic (12th, 2007), corresponding to List 2) From the above, it was classified in Category 2 because adverse effects on the development of the offspring are indicated from adverse effects in the human newborn and teratogenicity in the subcutaneous administration in the animal test. And Ethical Pharmaceuticals state that administration in breastfeeding mothers should be avoided, and that nursing infants might have nervousness by a human breast milk transfer of this substance (Ethical Pharmaceuticals (2010), corresponding to List 1), therefore, it was classified in "the additional category for effects on or via lactation."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (cardiovascular system, nervous system, gastrointestinal system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance used as a medicine for a heart and respiratory disease has potent effects such as cardiac-stimulating, diuretic, and bronchodilation, and other effects such as coronary vasodilating, anapnoic and gastric acid stimulating. (Pharmaceutical Interview Forms (2009)) There is the information that adverse effects depend on a blood concentration of theophylline that is a component of this substance (present as theophylline in the body). A high concentration leads to neuropsychiatric symptoms (a headache, excitement, convulsions, delirium, stupor, coma, and so on) and nervous symptoms, followed by acute encephalopathy. A high concentration also causes digestive symptoms (nausea, vomiting), heart and vascular symptoms (tachycardia, ventricular tachycardia, atrial fibrillation, a drop of blood pressure, and so on), hypokalemia, other electrolyte abnormality, respiratory stimulation. And toxic symptoms such as rhabdomyolysis are liable to occur in a high concentration. (Pharmaceutical Interview Forms (2009), Ethical Pharmaceuticals (2010)) Therefore, it was classified in Category 1 (cardiovascular system, nervous system, digestive system).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (cardiovascular system, nervous system, gastrointestinal system)	Danger	H372	P260 P264 P270 P314 P501	This substance used as a medicine for a heart and respiratory disease has potent effects such as cardiac-stimulating, diuretic, and bronchodilation, and other effects such as coronary vasodilating, anapnoic and gastric acid stimulating. (Pharmaceutical Interview Forms (2009)) As serious adverse effects, bleeding in the digestive tract by the ulcer, and so on (hematemesis, melena, and so on) and possibility of stupors such as convulsions, delirium, and coma are described. (Ethical Pharmaceuticals (2010)) And there is the information that theophylline that is a component of this substance is irritating to the gastrointestinal and central nervous system after administration by any route. And digestive system effects include nausea, vomiting, epigastric pain, abdominal cramps, and hematemesis are described (HSDB (2002)). From the above, it was classified in Category 1 (cardiovascular system, nervous system, digestive 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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