Chemical Name：4-Amino-1-[(2R,5S)-5-(hydroxymethyl)oxolan-2-yl］pyrimidine-2-one, (alias Zalcitabine)
CAS：7481-89-2

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
1	Acute toxicity （Oral）	Classification not possible	-	-	-	-	Classification not possible due to lack of data. As relevant information, a lethal dose is 2 g/kg and more for rats (RTECS (2004)).
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 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 ...	Based on a positive result from an in vivo mouse somatic cell (bone marrow and peripheral blood) micronucleus test (NTP DB (access on Oct. 2009), IARC 76 (2000)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of weakly positive (NTP DB (access on Oct. 2009)) and negative (IARC 76 (2000)) Salmonella typhimurium mutation tests, negative gene mutation tests using Chinese hamster lung cells and mouse lymphoma cells (IARC 76 (2000)), positive chromosomal aberration tests using Chinese hamster ovary cells and human lymphocytes (NTP DB (access on Oct. 2009), IARC 76 (2000)).
6	Carcinogenicity	Category 2		Warning	H351: Suspected of causing 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 ...	Based on the classification of "Group 2B" in IARC (IARC vol. 76 (2000)), the substance was classified into Category 2. In 6-month oral administration tests in B6C3F1 mice and NIH Swiss mice, a treatment-associated mortality was seen in NIH Swiss male and female mice and B6C3F1 female mice, but not in B6C3F1 male mice. The incidences of thymic lymphoma were higher in both strains of male and female mice of the treated groups but 0% in each control group. The deaths were due to thymic lymphomas in the females, whereas the male mice died from toxic effects such as anaemia (IARC 76 (2000)). Additionally, some cases of non-Hodgkin lymphoma were seen in HIV-infected patients treated with the substance (IARC 76 (2000)).
7	Reproductive toxicity	Category 2, Additional category: Effects on or via lactation		Warning	H361: Suspected of damaging fertility or the unborn child H362: May cause harm to breast-fed children	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 ... P260: Do not breathe dust/fume/gas/mist/vapours/spray. P263: Avoid contact during pregnancy/while nursing. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product.	In a developmental toxicity test in C57BL/6N mice administered by gavage during organogenesis period, the mean litter size was decreased and the percentage of resorptions per litter was increased at a high dose level (2000 mg/kg/day) at which maternal weight gain were decreased (IARC 76 (2000)). Additionally, the number of fetuses with any malformation, the number of litters with one or more malformed fetuses and the percentage of malformed fetuses per litter were increased at 1000 mg/kg and higher (IARC 76 (2000)). Based on this result, the substance was classified into Category 2. The malformations included open eyelids, micrognathia, kinked tail, clubbed paws, and cleft palate. Based on a report that mothers must be instructed not to breast feed when taking this drug (the excretion into breast milk was reported in animals (rats)) (JAPIC prescription drug book (2010)), the substance was classified as "Effects on or via lactation".
8	Specific target organ toxicity - Single exposure	Classification not possible	-	-	-	-	No data available.
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, pancreas, liver, heart, blood, systemic toxicity)		Danger	H372: Cause damage to organs through prolonged or repeated exposure (nervous system, pancreas, liver, heart, blood, systemic toxicity)	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 ...	The substance is an antiviral drug. In it's package insert, there are the following reports as significant adverse reactions; peripheral neuropathy, suicide attempt, epileptic seizure, convulsion, paralysis, acute psychiatric disorder can occur, pancreatitis (hemorrhagic) can occur, severe hepatic steatosis, serious hepatic dysfunction can occur, cardiomyopathy, and cardiac failure can occur (JAPIC prescription drug book (2010)). Based on these reports, the substance was classified into Category 1 (nervous system, pancreas, liver, heart). In addition, of 285 AIDS patients with CD4 counts of <=300 cells/microL, who received the substance for 17 months, 14% had anaemia or neutropenia, (IARC 76 (2000). Anemia was reported in 3.1-8.4% of patients who received the substance alone or in conjunction with zidovudine and leukopenia, neutropenia and thrombocytopenia occurred (HSDB (2004)). Based on the data, the substance was classified into Category 1 (blood system). In addition, there are the following reports as significant adverse reactions; lactic acidosis, esophageal and intraoral ulcer, anaphylactic reaction, and subarachnoid hemorrhage (JAPIC prescription drug book (2010)). Since these symptoms cannot identify the affected organ, the substance was classified into Category 1 (systemic toxicity). Based on all information, the substance was classified into Category 1 (nervous system, pancreas, liver, heart, blood system, systemic toxicity).
10	Aspiration hazard	Classification not possible	-	-	-	-	No data available.