NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	50-44-2
Chemical Name	6-Mercaptopurine
Substance ID	m-nite-50-44-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (bone marrow, liver, small intestine)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (hematopoietic system, liver)	Danger	H372	P260 P264 P270 P314 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	Classified into Category 3 from its 48h-EC50 = 54.5 mg/L for crustacea (Daphnia pulex) (AQUIRE, 2011).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BIOWIN).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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