GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 65-45-2 |
| Chemical name | Salicylamide |
| Substance ID | 23A5142 |
| 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 does not contain fluorine or chlorine but 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 980 mg/kg for rats (RTECS (2010); original literature: Journal of the American Pharmaceutical Association: 47, 479, 1958) with confirmation of the description in the original literature, 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 | - | - | - |
Lack of data. Besides, because "moderate" irritation reported in a test applied 100 mg to rabbit eyes (Standard Draize test) (RTECS (2010)) was from List 3 data, it was classified as "Classification not possible" due to unknown details. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Classification not possible | - | - | - | No data. |
| 5 | Germ cell mutagenicity | Classification not possible | - | - | - |
The classification is not possible due to no in vivo test data. Besides, an Ames test reported a negative as an in vitro test (NTP DB (1988)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - | No data. |
| 7 | Reproductive toxicity | Category 2 |  |
H361 |
P308+P313 P201 P202 P281 P405 P501 |
An increase in a rate of fetal resorptions in the administration of this substance to pregnant rats and malformed fetuses in administration on day 5 to 11 of gestation were reported. (HSDB (2002)) And a high proportion of fetuses with skeletal defects in ribs, spine, and extremities observed in diet administration at 2% in rats on day 12 to 18 of gestation were reported. (HSDB (2002)) Because all information was from List 2, it was classified in Category 2. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, digestive system) | |
H370 |
P307+P311 P260 P264 P270 P321 P405 P501 |
Pharmacological action of this substance used as an antipyretic and anti-inflammatory medicine is centrally acting analgesic. (Ethical Pharmaceuticals (2010), corresponding to List 1). Dose-related gastrointestinal and central nervous system disturbances are common adverse effects in humans. (HSDB (2002)) Tinnitus, hypacusia, dizziness, anorexia, pyrosis, gastralgia, nausea, and vomiting are listed as adverse effects with a frequency of more than 5% or unknown (Ethical Pharmaceuticals (2010), corresponding to List 1). There is the information that gastrointestinal irritation occurs in about 10% of patients. And there is the information that an overdose especially produces central nervous system depression, hypotension, and eventually respiratory arrest (HSDB (2002)). Therefore, it was classified in Category 1 (central nervous system, digestive system). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (central nervous system, digestive system) | |
H372 |
P260 P264 P270 P314 P501 |
Pharmacological action of this substance used as an antipyretic and anti-inflammatory medicine is centrally acting analgesic. (Ethical Pharmaceuticals (2010)). Dose-related gastrointestinal and central nervous system disturbances are common adverse effects in humans. (HSDB (2002)) Tinnitus, hypacusia, dizziness, anorexia, pyrosis, gastralgia, nausea, and vomiting are listed as adverse effects with a frequency of more than 5% or unknown (Ethical Pharmaceuticals (2010)). There is the information that gastrointestinal irritation occurs in about 10% of patients. And there is the information that an overdose especially produces central nervous system depression, hypotension, and eventually respiratory arrest (HSDB (2002)). Therefore, it was classified in Category 1 (central 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） | Not classified | - | - | - | It was classified as "Not classified" from 96-hour LC50 = 101 mg/L for fish (Pimephales promelas) (AQUIRE, 2012). |
| 11 | Hazardous to the aquatic environment （Long-term） | Not classified | - | - | - |
Reliable chronic toxicity data are not obtained. Because it was classified as "Not classified" in acute toxicity and it is not water‐insoluble (water solubility: 2060 mg/L (PHYSPROP Database, 2009)), it was classified as "Not classified." |
| 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 |