GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 738-70-5 |
| Chemical Name | 2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine [Trimethoprim] |
| Substance ID | H29-A-016 |
| 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 | 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 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) | Category 3 |
 Danger |
H301 |
P301+P310
P264 P270 P321 P330 P405 P501 |
Based on a report of an LD50 value for rats of 200 mg/kg (HSDB (Access on August 2017)), it was classified in Category 3. |
| 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. Besides, there is a report that redness, burning, stinging, or itching occurred after using an ophthalmic solution containing this substance/polymyxin B sulfate (HSDB (Access on August 2017)). |
| 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. There are no in vivo data. As for in vitro, a bacterial reverse mutation test was negative, and both chromosome aberration tests and sister chromatid exchange tests with mammalian cultured cells were positive and negative results (NTP DB (Access on August 2017)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Category 1A, Additional category: Effects on or via lactation |
 Danger |
H360
H362 |
P308+P313
P201 P202 P280 P405 P501 |
As for humans, there is no report on the reproductive effects by using this substance alone, but in this country, a combination drug of this substance and sulfamethoxazole (sulfamethoxazole/trimethoprim: hereinafter referred to as "this medicine") is used clinically as a synthetic antibacterial agent, and this medicine is contraindicated for pregnant women or women who have a possibility of pregnancy (pregnant woman, parturient woman, nursing woman). Reasons for this are as follows: it is reported that congenital anomalies appeared in a child of a patient who took this medicine alone or by combination dosage during her pregnancy; teratogenicity is reported in animal tests; and it is reported that the medicine transfers through mother's milk and may cause hyperbilirubinemia in a low-birth-weight child or a newborn baby (Ethical Pharmaceuticals 2017 (2016)). In addition, there is a report that in an epidemical study that investigates medicines used during pregnancy by mothers of 1,242 infants with neural tube defects as congenital anomaly, the odds ratio of the use of this substance within first two months of early gestation was 4.8 (95% confidence interval: 1.5-16.1) (Catalogue of Teratogenic Agents, 12th ed. (2007), HSDB (Access on August 2017)). On the other hand, as for experimental animals, there is a description that in rats, teratogenicity was shown after the administration of 40 times the usual dose in humans, and in rabbits, an increase in incidence of deaths, resorptions, and malformations in fetuses was observed at 6 times the usual dose in humans (HSDB (Access on August 2017)). From the above, because the combination drug containing this substance is contraindicated for pregnant women, nursing women, etc., epidemiologically the high value in the odds ratio of infants with congenital anomaly (neural tube defects (NTDs)) by the use of this substance in early pregnancy was observed, and teratogenicity of this substance itself was confirmed in experimental animals, it is considered that this substance itself highly likely causes congenital anomalies in humans. Therefore, it was classified in Category 1A for this hazard class, and "additional category for effects on or via lactation" was added to the classification. |
| 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 2 (skin, hematopoietic system) |
Warning |
H373 |
P260
P314 P501 |
This substance is a synthetic antibacterial agent mainly used for the treatment of the urinary tract infection (HSDB (Access on August 2017)). Serious toxicity is rare, but as side effects, it is described that common ones are rash and pruritus, nausea and vomiting, glossitis, epigastric distress, hyperkalemia, hyponatremia, myelosuppression (thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia), and methemoglobinemia while rare ones are exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, cholestatic jaundice and aseptic meningitis (HSDB (Access on August 2017)). As in the above, effects on the skin and hematopoietic system were observed. Other than these, nausea and vomiting, epigastric distress, and also glossitis were observed, but these were judged to be insufficient as evidence for GHS classification. It was classified in Category 2 (skin, hematopoietic system) since it was from the information source in List 2. |
| 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 7-day EC50 of >1 mg/L for aquatic plants (Lemna gibba) (EPA AQUIRE: 2017, Brain, R. A. et al. (2004)), and water solubility of 400 mg/L (25 deg C), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (BioWin), and 7-day NOEC (biomass) = 1 mg/L for aquatic plants (Lemna gibba) (EPA AQUIRE: 2017, Brain, R. A. et al. (2004)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being not rapidly degradable (BioWin), and 96-hour LC50 of >100 mg/L for fish (Oryzias latipes) (EPA AQUIRE: 2017, Kim, Y. et al. (2007)). From the above results, it was classified in Category 2. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* 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. |