GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 13311-84-7 |
| Chemical Name | 2-Methyl-4'-nitro-3'-(trifluoromethyl)propananilide [Flutamide] |
| Substance ID | H29-A-014 |
| Classification year (FY) | FY2017 |
| 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) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | |
| Model SDS by MHLW (External link) | |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, and the calculated oxygen balance of -142 is above the criteria, -200. However, the classification is not possible due to no data on onset temperature and decomposition energy. |
| 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 | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but the classification is not possible due to no data. |
| 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 |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) substances are not 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 | Classification not possible |
- |
- | - | It is an organic compound which does not contain chlorine but contains fluorine and oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
As for humans, it is reported that a major side effect of this substance when it is prescribed as a prostate-cancer treatment drug was gynecomastia (Ethical Pharmaceuticals 2017 (2016)). As for experimental animals, there is a report that in a test (pubertal assay) with male rats dosed by gavage on postnatal days 23-54 after weaning, delayed preputial separation, increased testicular weights, and decreased weights of accessory reproductive organs at or above 25 mg/kg/day, and histopathological lesions in the testis at 50 mg/kg/day were observed (NTP Abstract for RACB20103, RACB20104, RACB20105, RACB20106, and RACB20203 (Access on August 2017)). From the above, the gynecomastia in men is the adverse effect on the endocrine system. This is therefore a finding that is beyond the scope of evaluation of reproductive effects. Meanwhile, in experimental animals, although effects due to the antiandrogenic action of this substance (NTP Abstract for RACB 2010, RACB 2010, RACB 2010, RACB 2010, and RACB 20203 (Access on August 2017)) were observed, these did not include any severe developmental effects. Therefore, it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver, endocrine system, haemal system, genetic organs (men)) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
This substance (synonyms: flutamide) is a nonsteroidal antiandrogen drug, which is used to treat prostate cancer (Ethical Pharmaceuticals 2017 (2016)). In humans, the incidence of side effects and abnormal laboratory values in 6,393 cases was 29.0%, gynecomastia 2.9%, loss of appetite 2.0%, diarrhea 1.7%, nausea and vomiting 1.1%, increased AST 13.2%, increased ALT 13.2%, increased gamma-GT 5.9%, increased LDH 3.8%, increased alkaline phosphatase 3.1%, reduced erythrocyte count 1.8%, reduced hemoglobin 1.5%, reduced hematocrit value 1.5%, etc. were main, and as severe side effects, fatal cases due to severe liver damage such as fulminant hepatitis were reported. It is also described that interstitial pneumonitis (less than 0.1%) and heart failure/myocardial infarction (incidences not specified) may occur (Ethical Pharmaceuticals 2017 (2016)). As for experimental animals, there is a report that decreases in the absolute and relative weights of the epididymis, and lobular atrophy of the mammary glands were observed at or above 1 mg/kg/day (converted guidance value: 0.31 mg/kg/day) which is within the guidance value range for Category 1, and increased blood testosterone and estradiol, decreases in the absolute and relative weights of the seminal vesicles, and an increased number of leptotene-stage spermatocytes during Stages IX-XI of the spermatogenesis cycle were seen at 4 mg/kg/day (converted guidance value: 1.24 mg/kg/day) in a 28-day toxicity test with rats orally dosed (Health Science Research Grants in FY 1998: Study report on a 28-Day Repeated Dose Study etc. (International Joint Validation Project for OECD Test Guideline), http://www.nihs.go.jp/edc/houkoku10/10-9/10-9-shunin.pdf). From the above, it was classified in Category 1 (liver, endocrine system, haemal system, genetic organs (men)). Besides, although loss of appetite, diarrhea, nausea and vomiting in humans are the side effects on the gastrointestinal system, these were insufficient as rationale for GHS classification, and among the severe side effects, the incidence of interstitial pneumonitis, heart failure and myocardial infarction were low. Therefore, it was not adopted as the target organs. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 2 |
- |
H401 |
P273
P501 |
From 96-hour LC50 = 1.38 mg/L for crustacea (Neomysis integer) (EPA AQUIRE: 2017, Verslycke, T. et al. (2004)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
 Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BioWin), and 21-day NOEC (reproduction inhibition) = 0.1 mg/L for crustacea (Daphnia magna) (EPA AQUIRE: 2017, Haeba, M. H. et al. (2008)). Because acute toxicity data were not obtained for a trophic level (algae) for which chronic toxicity data were not obtained, it is classified as "Classification not possible." From the above results, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |