GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 15687-27-1 |
| Chemical name | Ibuprofen |
| Substance ID | 23A5140 |
| 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 | - | - | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 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 | - | - | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible | - | - | - | No data. |
| 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. |
| 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 | - | - | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - | An organic compound that contains oxygen which is not chemically bonded to elements other than carbon or hydrogen. |
| 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 636 mg/kg for rats (eChemPortal (Access on Sept. 2011), corresponding to List 1), it was classified in Category 4. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 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 | Classification not possible | - | - | - |
Lack of data. A test report of a maximization test in the guinea pig (OECD TG 406, GLP) before the revision of the OECD Guidelines from List 2 resulted in no sensitizing. (IUCLID (2000)) |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - |
Lack of data. Besides, negatives were reported in a chromosomal aberration test (in vivo somatic cell mutagenicity test) using peripheral blood lymphocytes after administration of this substance in human adults and children (IUCLID (2000)) and a sister chromatid exchange test (SCE) (in vivo genotoxicity test) using lymphocytes of patients with rheumatism who were administered this substance (IUCLID (2000)). But the details are unknown. In addition, an Ames test reported a negative as an in vitro test (IUCLID (2000)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
A 2-year combined carcinogenicity test with a chronic toxicity test by diet administration in rats and mice concluded that this substance was not carcinogenic in three tests including two tests in rats (IUCLID (2000)). But it was classified as "Classification not possible" due to all data from List 2. |
| 7 | Reproductive toxicity | Category 1B, Additional category: Effects on or via lactation |  |
H360 H362 |
P308+P313 P201 P202 P281 P405 P501 P260 P263 P264 P270 |
This substance, which is a medical antipyretic and anti-inflammatory analgesic, states in the package insert that pregnant women or women anticipating pregnancy may be administered only when the benefit exceeds the risk because numbers of implantations and live pups were decreased in high-dose groups in mice (60 mg/kg or higher) in addition to no establishment of safety in administration in pregnancy (Ethical pharmaceuticals (2010), corresponding to List 1). Premature births, a decreased ratio of implantations to corpora lutea, and a decreased live litter number at 60 mg/kg by oral administration to rabbits in gestation were reported as animal test data. (IUCLID (2000)) Because the above precaution for use in administration to pregnant women is based on the animal test data, it was classified in Category 1B. On the basis that milk transfer of this substance is observed and from the information that administration in breastfeeding mothers should be avoided, and breastfeeding should be stopped if a patient has no choice but to receive this substance (Ethical Pharmaceuticals (2010)), it was classified in "the additional category for effects on or via lactation." |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (central nervous system, digestive system) | |
H371 |
P309+P311 P260 P264 P270 P405 P501 |
On the basis that oral administration to rats and mice reported central nervous system depression at 800 mg/kg or higher in rats and at 400 mg/kg or higher in mice (IUCLID (2000)), it was classified in Category 2 (central nervous system). Furthermore, from the information that deaths occurred at 1600 mg/kg or higher in rats and at 400 mg/kg or higher in mice were caused by a perforation in the lower digestive tract in rats and by a gastric ulcer in mice (IUCLID (2000)), it was classified in Category 2 (digestive system). Besides, package insert of this substance, which is a medical antipyretic and anti-inflammatory analgesic, states that digestive ulcer, gastrointestinal hemorrhage, and ulcerative colitis [with unknown frequency for all] might occur (Ethical Pharmaceuticals (2010)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (kidney) | |
H373 |
P260 P314 P501 |
A 2-year diet administration test in rats reported changes in renal papilla as an only dose-related pathological sign at doses of 60 mg/kg/day or higher (IUCLID (2000)). And 52-week oral administration to baboons (capsules) reported increased incidence of damage in kidney cortex at a dose of 100 mg/kg/day (IUCLID (2000)). Because the both doses correspond to a range of Category 2 in Guidance values, it was classified in Category 2 (kidney). Besides, the package insert of this substance as a medical antipyretic and anti-inflammatory analgesic lists acute renal failure, interstitial nephritis, and nephrotic syndrome (with unknown frequency for all) as possible serious adverse effects (Ethical Pharmaceuticals (2010)). |
| 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） | Category 2 | - |
H401 |
P273 P501 |
It was classified in Category 2 from 48-hour EC50 = 9.06 mg/L for crustacea (Daphnia magna) (IUCLID, 2000). |
| 11 | Hazardous to the aquatic environment （Long-term） | Category 2 |  |
H411 |
P273 P391 P501 |
Reliable chronic toxicity data were not obtained. It was classified in Category 2 due to lack of rapid degradability (BIOWIN; IUCLID, 2000), and acute toxicity Category 2. |
| 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 |