GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 54-85-3 |
| Chemical name | Isoniazid |
| Substance ID | 23A5063 |
| 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 | Classification not possible | - | - | - |
The substance contains a chemical group associated with an explosive property (neighboring nitrogen atoms), but the classification is not possible due to no data. |
| 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 | Classification not possible | - | - | - |
The substance contains a chemical group associated with an explosive property (neighboring nitrogen atoms), but the classification is not possible due to no data. |
| 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 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 | - | - | - |
"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 650 mg/kg bw for rats (PIM 288 (1999), 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 | - | - | - |
No data. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
A negative in a dominant lethal test using mice (in vivo heritable germ cell mutagenicity test) (IARC Suppl. 7 (1987)) and negatives in both of the chromosomal aberration test using human lymphocytes treated with this substance and the chromosomal aberration test using rodents (in vivo mutagenicity test) (IARC Suppl. 7 (1987)) were reported. Therefore, it was classified as "Not classified." Besides, a sister chromatid exchange test and a DNA damage test using rodents (in vivo genotoxicity test) also resulted in negatives. (IARC Suppl. 7 (1987)) But, positives in an Ames test and a chromosomal aberration test using cultured rodent cells were reported as in vitro tests. (IARC Suppl. 7 (1987)) |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
It was classified as "Classification not possible" based on the Group 3 classification in an IARC carcinogenicity evaluation (IARC Suppl. 7 (1987)). Besides, as animal test data on oral administration via diet or drinking water, a dose-dependent increase in the incidence of lung tumors in mice, but no clear increase in the tumor in rats, and no significant effects in hamsters were found. (IARC 4 (1974)) Besides, as a result of a large-scale epidemiological survey in humans, neither a statistically significant increase in deaths from lung tumors and incidence in lung tumors, nor an increase in a frequency of deaths from cancers were observed. (IARC 4 (1974)) |
| 7 | Reproductive toxicity | Category 2 |
 |
H361 |
P308+P313 P201 P202 P281 P405 P501 |
From some reports on adverse effects on the development of the offspring in humans such as an increase in a malformation rate and severe encephalopathies in infants of mothers exposed during the first 3 to 4 months of pregnancy, a stillborn baby with the arthrogryposis multiple congenital syndromes from a mother taken a large dose in a suicide attempt (Birth Defects (3rd, 2000), corresponding to List 2), and births of 10 malformed infants from 85 mothers (Teratogenic (12th, 2007), corresponding to List 2) from List 2 information, it was classified in Category 2. Besides, there is the information that no dosing in pregnant women or women anticipating pregnancy is desirable (development disorders of fetuses were found in mice) (Ethical pharmaceuticals (2010), corresponding to List 1). Furthermore, though this substance is excreted in breast milk, effects on or via lactation were not used as a basis for classification due to its low concentration in milk (HSDB (2005)). |
| 8 | Specific target organ toxicity - Single exposure |
Category 1 (nervous system) |
|
H370 |
P307+P311 P260 P264 P270 P321 P405 P501 |
From a description of acute effects of exposure such as seizures found at doses of 30 to 40 mg/kg, even at a low dose of 14 mg/kg in adults with prior seizure disorders (PIM 288 (1999)), and a description of initial symptoms such as vision disorders, dizziness, and slurred speech in addition to nausea and vomiting followed by severe grand mal seizures, respiratory distress, and coma and so on in the second stage (PIM 288 (1999)), it was classified in Category 1 (nervous system). |
| 9 | Specific target organ toxicity - Repeated exposure |
Category 1 (nervous system, liver, blood) |
|
H372 |
P260 P264 P270 P314 P501 |
In chronic use of this substance which is used as a tuberculosis chemotherapeutic medicine, peripheral neuropathy and hepatotoxicity are described as the most common adverse effects. (PIM 288 (1999)) (Ethical pharmaceuticals (2010), corresponding to List 1) From the information that peripheral neuropathy, whose predisposing factors are alcohol, malnutrition, pregnancy and so on, manifests dose-dependently and is uncommon at 5 mg/kg/day and frequent at 300 mg/kg/day (PIM 288 (1999)), it was classified in Category 1 (nervous system). On the other hand, from a description of an asymptomatic elevation of serum GOT shown in 10 to 20% of patients and a possibility of hepatitis with jaundice (0.5%) which occurs within the 3 months following the onset of the treatment (PIM 288 (1999)), it was classified in Category 1 (liver). Furthermore, it was classified in Category 1 (blood) because disseminated intravascular coagulation syndrome, granulocytosis, anemia, thrombocytopenia, and so on are listed as other main adverse effects (PIM 288 (1999)). From the above, the classification resulted in Category 1 (nervous system, liver, blood). |
| 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 3 | No pictogram |
H402 |
P273 P501 |
It was classified in Category 3 from 24-hour EC50 = 84.6 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012). |
| 11 | Hazardous to the aquatic environment （Long-term） | Category 3 | No pictogram |
H412 |
P273 P501 |
Reliable chronic toxicity data were not obtained. Due to lack of rapid degradability (BIOWIN), and acute toxicity Category 3, it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - |
This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* 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. |
Updated date:
|
2017/3/17 Addition of Rationale for the classification |