Chemical Name：1-Methyl-1-nitroso-3-［(2S,3R,4R,5S,6R)‐2,4,5‐trihydroxy‐6‐(hydroxymethyl)oxsan-3-yl］urea, (alias Streptozocin)
CAS：18883-66-4

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
1	Acute toxicity （Oral）	Category 3		Danger	H301: Toxic if swallowed	P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P264: Wash ... thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P321: Specific treatment （see ... on this label）. P330: Rinse mouth. P405: Store locked up. P501: Dispose of contents/container to ...	Based on a LD50 value of 260 mg/kg bw for mice (IARC (1978)), the substance was classified into Category 3.
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 in an intraperitoneal mouse bone marrow micronucleus test (in vivo somatic cell mutagenicity test) (Mutagenesis vol. 7, No. 6, 1992), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there is a report of a positive Ames test (IARC 17 (1978)).
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 suppl. 7 (1987)), the substance was classified into Category 2. In animal tests where rats and mice received i.p. injections of the substance for 6 months and were observed for an additional 12 months, the incidences of lung and kidney tumours in male and female mice, uterine tumours in female mice, kidney and pancreatic tumours in male and female rats, liver tumours in female rats and peritoneal sarcomas in male rats were significantly increased (IARC 17 (1978)).
7	Reproductive toxicity	Category 2		Warning	H361: Suspected of damaging 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 ...	Although there are reports that the substance caused growth retardation and malformations of fetuses in an intraperitoneal injection test in rats (Birth Defects (2000)) and that the substance showed impairment of fertility and teratogenic effects in rats and showed an abortifacient effect in rabbits (HSDB (2003)), the effects in parental animals are unclear. Therefore, the substance was classified into Category 2. As relevant information, it is unknown whether the substance is excreted in human milk (Package Insert ZANOSAR (2007)).
8	Specific target organ toxicity - Single exposure	Category 1 (pancreas)		Danger	H370: Causes damage to organs (pancreas)	P307+P311: IF exposed: Call a POISON CENTER or doctor/physician. 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. P321: Specific treatment （see ... on this label）. P405: Store locked up. P501: Dispose of contents/container to ...	Based on information that the substance has a specific toxic action on pancreatic beta-cells, inducing hyperglycaemia (IARC 17 (1978)) and results that a single intraperitoneal injection of 100 mg/kg resulted in a transient diabetic state in Chinese hamsters (IARC 17 (1978)), the substance was classified into Category 1 (pancrea).
9	Specific target organ toxicity - Repeated exposure	Category 1 (pancreas, kidney, liver)		Danger	H372: Cause damage to organs through prolonged or repeated exposure (pancreas, kidney, 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 ...	The substance is a therapeutic drug for metastatic pancreatic islet cell carcinoma (Package Insert ZANOSAR (2007)). Based on information that the substance has a specific toxic action on pancreatic beta-cells, inducing hyperglycaemia (IARC 17 (1978)), the substance was classified into Category 1 (pancreas). Many patients treated with the substance have experienced renal toxicity, as evidenced by azotemia, anuria, glycosuria and renal tubular acidosis and two cases of nephrogenic diabetes insipidus were reported (Package Insert ZANOSAR (2007)). In addition, most patients treated with the substance have experienced severe nausea and vomiting, occasionally requiring discontinuation of drug therapy and a number of patients have experienced hepatic toxicity, as characterized by elevated liver enzyme levels and hypoalbuminemia (Package Insert ZANOSAR (2007)). Based on this information, the substance was classified into Category 1 (liver, kidney). Based on all information, the substance was classified into Category 1 (pancreas, kidney, liver). Although it was reported that anaemia, leucopenia or thrombocytopenia was observed in patients (IARC 17 (1978)), the information was not used as the basis of classification based on a report that hematological toxicity was rare, most often involving mild decreases in hematocrit values (Package Insert ZANOSAR (2007)).
10	Aspiration hazard	Classification not possible	-	-	-	-	No data available.