NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	320-67-2
Chemical Name	5-Azacytidine
Substance ID	m-nite-320-67-2_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)	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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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	Since its rat LD50 is 572 mg/kg (RTECS, accessed in September 2007), the substance was classified into Category 4.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since the substance is a solid (GHS definition), it was classified into the "Not applicable" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	With regard to heritable mutagenicity tests, dominant lethal tests using male mice were conducted and gave negative results (IARC 50, 1990). Regarding in vivo mutagenicity tests using somatic cell, intraperitoneal administration tests using mice were conducted in which micronuclei were induced in bone marrow cells and peripheral blood erythrocytes (NTP DB, accessed in September 2007). Since test results in in-vivo genotoxicity tests using germ cells have not been acquired, the substance was classified into Category 2.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It is rated as "Group 2A" by IARC S7 (1987) and "R" by the U.S. NTP (2005). Based on these ratings, the substance was classified into Category 1B.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	According to IARC 26 (1981), intraperitoneal administration of 5-azacytidine at 1.5 mg/kg for 3 consecutive days to pregnant mice from day 7 or day 14 of pregnancy resulted in 100% and 20% embryonic mortality, respectively. In offspring that were born from mothers administered from day 14 of pregnancy, nervous or hepatic tissues had been destroyed. 5-azacytidine particularly affected cell division and proliferation in the liver and brain at doses that were not toxic to maternal animals. IARC 50 (1981) reported that single intraperitoneal doses of 1-2 mg/kg to mice during the period of embryogenesis can cause a high resorption rate and malformations in the majority of surviving fetuses, including major central nervous system defects, facial clefts and limb defects. In conclusion, since signs of reproductive toxicity appeared at doses that did not induce general toxicity to parental animals, the substance was classified into Category 1B.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, liver)	Danger	H372	P260 P264 P270 P314 P501	According to IARC 50 (1990), medicinal administration of this substance caused leukopenia in humans, and fatal hepatic damage was reported in four patients with previous hepatic dysfunction, who had been treated with azacytidine. Based on these reports on the effects on the blood system and liver, the substance was classified into Category 1 (blood system and liver).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）

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.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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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