NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	446-86-6
Chemical Name	Azathioprine
Substance ID	m-nite-446-86-6_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on a LD50 value of 400 mg/kg bw for rats (IARC vol. 26 (1981)), the substance was classified into Category 4.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Since the substance is on the Frosch contact allergen list (FROSCH, TEXTBOOK OF CONTACT DERMATITIS), the substance was classified into Category 1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 1B	Danger	H340	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1A	Danger	H360	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (bone marrow)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (bone marrow)	Danger	H372	P260 P264 P270 P314 P501	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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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