GHS Classification Result

Chemical Name：5-Azacytidine
CAS：320-67-2

Result：
ID: 34
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2007
Reference Manual: GHS Classification Manual （10 Feb, 2006）
Technical Guidance Document on the GHS Classification （6 Dec, 2005）

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 molecules.
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 - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
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 ... 		Since its rat LD50 is 572 mg/kg (RTECS, accessed in September 2007), the substance was classified into Category 4.
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Since the substance is a solid (GHS definition), it was classified into the "Not applicable" category.
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 2 Warning H341: Suspected of causing 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 ... 		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.
6 Carcinogenicity Category 1B 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 ... 		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.
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 ... 		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.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system, liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (blood 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 ... 		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).
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） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.


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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