GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 317-34-0 |
| Chemical name | Aminophylline |
| Substance ID | 23A5139 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government （July, 2010）
Environmental Hazards: UN GHS Document （4th revised edition） |
| 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 |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
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 | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 5 | Gases under pressure | Not applicable | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 6 | Flammable liquids | Not applicable | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 7 | Flammable solids | Classification not possible | - | - | - | No data. |
| 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 | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 10 | Pyrophoric solids | Classification not possible | - | - | - | No data. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - | No data. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 14 | Oxidizing solids | Not applicable | - | - | - | An organic compound that contains oxygen which is not chemically bonded to elements other than carbon. |
| 15 | Organic peroxides | Not applicable | - | - | - | An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - | No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | 1 | Acute toxicity （Oral） | Category 4 |  |
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. |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | It is a solid at normal temperatures. (granules or powder (Merck (14th, 2006)) |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | No data. |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - | No data. |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - | No data. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Category 1 | |
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 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. |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - | No data. |
| 6 | Carcinogenicity | Classification not possible | - | - | - | No data. |
| 7 | Reproductive toxicity | Category 2, Additional category: Effects on or via lactation |  |
H361 H362 |
P308+P313 P201 P202 P281 P405 P501 P260 P263 P264 P270 |
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." |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (cardiovascular system, nervous system, digestive system) | |
H370 |
P307+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). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (cardiovascular system, nervous system, digestive system) | |
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). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - | No data. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - | This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* Hazard statement or Precautionary statement will show when hovering the mouse over a code of Hazard statement or Precautionary statement. Hazard statement and Precautionary statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. |
Updated date:
|
2016/11/30 Addition of Rationale for the classification |