GHS Classification Result

Chemical Name：6-Mercaptopurine
CAS：50-44-2

Result：
ID: 22A4116
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement 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 - - - - 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 - - - - Organic compounds containing no oxygen, fluorine or chlorine.
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.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the rat LD50 value of 277 mg/kg (RTECS (2010), original literature: Gekkan Yakuji. Pharmaceuticals Monthly. 15, 1037 (1973)), confirming the description of the original literature, the substance was classified as Category 3.
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 Classification not possible - - - - No data available.
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 ... 		The classification was concluded as Category 1B based on the positive results in the mouse dominant lethal test (in vivo inheritable mutagenicity test in germ cells) (IARC 26 (1981)). In other in vivo studies, positive results in the micronucleus test using mouse bone marrow, and chromosome aberration test using rats, Chinese hamsters, and mice (in vivo mutagenicity test in somatic cells) were reported (IARC 26 (1981)). As relevant information, as for in vitro studies, positive results in the Ames test, chromosome aberration test using human peripheral blood lymphocytes and chromosome aberration test using CHO cells were reported (IARC 26 (1981), NTP DB (Access on Oct. 2010)).
6 Carcinogenicity Classification not possible - - - - The classification was concluded as "Classification not possible" based on the criterion of "Group 3" in the carcinogenicity assessment by the IARC (IARC Supplement 7 (1987)). As relevant information, there are tests by dermal, subcutaneous, intraperitoneal, or intravenous administration using mice and rats, however, these tests were conducted under limited conditions. Therefore, it was reported that a possibility of carcinogenicity of this substance could not be evaluated (IARC Supplement 7 (1987)).
7 Reproductive toxicity Category 1B 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 ... 		In the developmental toxicity study in which rats were orally administered with the test substance on days 7 - 8 of pregnancy, treatment of 5 or 10 mg/kg induced high incidence of fetal death and resorption. In addition, as for teratogenesis, malformations of limbs, palate and mandible were observed in hamsters given 5 - 9 mg/animal of this substance by intraperitoneal injection on day 9 of pregnancy. Malformations (anophthalmia, microphthalmia) were observed in the fetuses of rats treated with the test substance from day 5 to 9 of pregnancy (IARC 26 (1981)). In addition, by administration to rats on days 6 - 12 of pregnancy, 100% of embryonic lethality was shown at 1 mg/kg, and anomalies of the central nervous system or of the eyes in 12 - 14% of surviving fetuses were observed at 0.5 - 0.75 mg/kg (IARC 26 (1981)). Effects on development of embryo shown above were the evidence at very low dose levels compared with the rat oral LD50 value (270 mg/kg), and it was judged that relation to the general toxicity was low. Therefore, the substance was classified as Category 1B.
8 Specific target organ toxicity - Single exposure Category 1 (bone marrow, liver, small intestine) Danger H370: Causes damage to organs (bone marrow, liver, small intestine) 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 ... 		It was reported that the predominant toxicity in rats and mice was damage to the bone marrow and intestinal epithelium and hepatic necrosis, and that major toxic symptoms in dogs were marked damage to the small intestinal mucosa and depletion of bone marrow (IARC 26 (1981)). It was also reported that biochemical evidence of liver damage was present and jaundice was apparent in treated animals (IARC 26 (1981)). Based on these findings and in consideration of LD50 value (rat, oral) of 270 mg/kg (RTECS (2010), originated from Gekkan Yakuji, Pharmaceuticals Monthly, 15, 1037 (1973)), the substance was classified as Category 1 (bone marrow, liver, small intestine).
9 Specific target organ toxicity - Repeated exposure Category 1 (hematopoietic system, liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (hematopoietic system, liver) 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 ... 		It was reported that the major toxic effect on the human was on the hematopoietic system which was chiefly characterized as decreased leukocyte count. And it was also reported that the higher doses frequently caused reversible jaundice due to hepatocellular toxicity: symptom was noted in 16/38 patients in a series of studies (IARC 26 (1981)). While the substance is a drug used to alleviate the symptoms of leukemia, it was described in the package insert that as serious side effects it might cause inhibition of bone-marrow such as pancytopenia, agranulocytosis, leukopenia, thrombocytopenia or anemia, etc. As the other side effects, abnormalities in the values of liver function test containing hepatopathy, jaundice, and elevations of AST (GOT) or ALT (GPT) were also described (Handbook of Japanese Pharmaceutical Drugs (2010)). Based on the information described above, the substance was classified as Category 1 (hematopoietic system, liver).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 3 from its 48h-EC50 = 54.5 mg/L for crustacea (Daphnia pulex) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BIOWIN).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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