GHS Classification Result
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
Reference：
Chemical Name：Azathioprine
CAS：446-86-6
Result：
| ID: | 21A3726 |
| Classifier: | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| Year Classified: | FY2009 |
| Reference Manual: | GHS Classification Guidance by the Japanese Government （March, 2009） |
PHYSICAL HAZARDS
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Explosives | Classification not possible | - | - | - | - | Classification is not possible since no data are available though the substance contains chemical groups (N-O) associated with explosive properties present in the molecules and oxygen balance is -112.53. |
| 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 | - | - | - | - | Classification is not possible since no data are available though there are chemical groups (N-O) associated with explosive properties present in the molecules. |
| 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 | Classification not possible | - | - | - | - | Classification is not possible since no data are available though the substance is an organic compound containing oxygen which is chemically bonded to nitrogen. |
| 15 | Organic peroxides | Not applicable | - | - | - | - | Organic compounds containing no bivalent -O-O- structure |
| 16 | Corrosive to metals | Classification not possible | - | - | - | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 4 |
|
Warning | H302: Harmful if swallowed |
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P330: Rinse mouth. P501: Dispose of contents/container to ... |
Based on a LD50 value of 400 mg/kg bw for rats (IARC vol. 26 (1981)), the substance was classified into Category 4. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | - | No data available. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | - | Solid (GHS definition) |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | - | No data available. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | - | No data available. |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - | - | No data available. |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - | - | No data available. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | - | No data available. |
| 4 | Skin sensitization | Category 1 |
|
Warning | H317: May cause an allergic skin reaction |
P302+P352: IF ON SKIN: Wash with plenty of soap and water. P333+P313: If skin irritation or rash occurs: Get medical advice/attention. P261: Avoid breathing dust/fume/gas/mist/vapours/spray. P272: Contaminated work clothing should not be allowed out of the workplace. P280: Wear protective gloves/protective clothing/eye protection/face protection. P321: Specific treatment （see ... on this label）. P363: Wash contaminated clothing before reuse. P501: Dispose of contents/container to ... |
Since the substance is on the Frosch contact allergen list (FROSCH, TEXTBOOK OF CONTACT DERMATITIS), the substance was classified into Category 1. |
| 5 | Germ cell mutagenicity | Category 1B |
|
Danger | H340: May cause genetic defects |
P308+P313: IF exposed or concerned: Get medical advice/attention. P201: Obtain special instructions before use. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P405: Store locked up. P501: Dispose of contents/container to ... |
Based on a positive result in a mouse dominant lethal test (in vivo heritable germ cell mutagenicity test) (IARC suppl. 7 (1987) and IARC vol. 26 (1981)), the substance was classified into Category 1B. In addition, there are reports of positive chromosomal aberration tests using rabbit peripheral lymphocytes and Chinese hamster bone marrow (in vivo somatic cell mutagenicity test) (IARC suppl. 7 (1987)) and positive micronucleus tests in mice, rats and hamsters (in vivo somatic cell mutagenicity tests) (IARC suppl. 7 (1987) and IARC vol. 26 (1981)). For humans, there are reports of chromosomal abnormalities in the lymphocytes and bone marrow of patients receiving azathioprine (IARC suppl. 7 (1987)) as well as chromosomal abnormalities and increases in sister chromatid exchanges in the peripheral lymphocytes of non-cancer patients (IARC vol. 26 (1981)). As relevant information, from in vitro mutagenicity tests, there are reports of positive Ames tests and a human lymphocytes chromosomal aberration test (IARC vol. 26 (1981) and NTP DB (access on Oct. 2009)). |
| 6 | Carcinogenicity | Category 1A |
|
Danger | H350: May cause cancer |
P308+P313: IF exposed or concerned: Get medical advice/attention. P201: Obtain special instructions before use. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P405: Store locked up. P501: Dispose of contents/container to ... |
Based on the classification of "Group 1" in IARC (IARC suppl. 7 (1987), 100A (2008)) and "Known to be Human Carcinogens" in NTP (NTP ROC, 11th (2004)), the substance was classified into Category 1A. From tests in experimental animals, it was reported that high incidences of squamous-cell carcinoma of the ear duct was observed in rats orally exposed, and high incidences of lymphoma was observed in mice exposed by intraperitoneal, subcutaneous, or intramuscular injection (IARC vol. 26 (1981), NTP ROC, 11th (2004)). Additionally, it was reported that non-Hodgkin's lymphoma, squamous-cell carcinoma of the skin, hepatobiliary carcinoma, mesenchymal tumors, pulmonary cancer, colon cancer and breast cancer were observed in patients who are treated with azathioprine (IARC vol. 26 (1981), NTP ROC. 11th (2004)). |
| 7 | Reproductive toxicity | Category 1A |
|
Danger | H360: May damage fertility or the unborn child |
P308+P313: IF exposed or concerned: Get medical advice/attention. P201: Obtain special instructions before use. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P405: Store locked up. P501: Dispose of contents/container to ... |
There are human case reports that women treated with the substance during pregnancy had infants with low birth weights (less than 2500 g) or aborted fetuses (IARC vol. 26 (1981)). Infants exposed during pregnancy showed immune abnormality or other abnormalities (PIM 053 (1996)). The substance is classified as developmental toxicity in California Proposition 65 (Birth Defects (3rd, 2000)). Based on all information, the substance was classified into Category 1A. From animal tests, there are reports that intragastric doses to rabbits during gestation induced a large variety of skeletal malformations and that various abnormalities (encephalocele, cleft palate, vertebral anomalies, oligodactyly, micrognathia) were induced in mice administered orally, intraperitoneally or subcutaneously (IARC vol. 26 (1981)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (bone marrow) |
|
Danger | H370: Causes damage to organs (bone marrow) |
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician. P260: Do not breathe dust/fume/gas/mist/vapours/spray. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P321: Specific treatment （see ... on this label）. P405: Store locked up. P501: Dispose of contents/container to ... |
Based on a report that the substance is an immunosuppressive agent and can cause bone marrow depression resulting in hematologic disorder as a major side effect (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (bone marrow). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (bone marrow) |
|
Danger | H372: Cause damage to organs through prolonged or repeated exposure (bone marrow) |
P260: Do not breathe dust/fume/gas/mist/vapours/spray. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P314: Get medical advice/attention if you feel unwell. P501: Dispose of contents/container to ... |
Based on a report that bone-marrow depression was observed in a rat test (dosage 45 mg/kg/day, the exposure route and period are unknown) (IARC vol. 26 (1981)) and a report that treatment of patients caused bone-marrow depression leading to leucopenia, anaemia, thrombocytopenia and bleeding (EHC 180 (1996) and IARC vol. 26 (1981)), the substance was classified into Category 1 (bone marrow). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | - | No data available. |
| Hazard class | Classification | Symbol | Signal word | Hazard statement | Precautionary statement | Rationale for the classification | |
|---|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Classification not possible | - | - | - | - | No data available. |
| 11 | Hazardous to the aquatic environment （Long-term） | Classification not possible | - | - | - | - | No data available. |
NOTE:
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* 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. |
Reference：
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Reference Manual |
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Definitions / Abbreviations |
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Model Label by MHLW |
MHLW Website （in Japanese Only） |
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Model SDS by MHLW |
MHLW Website （in Japanese Only） |