Topotecan HCl

Sagent Pharmaceuticals, Inc.

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

69-65-8

Name of the chemical

D-mannitol C6H14O6

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Product name

Topotecan HCl

Chemical name

(S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H- pyrano[3’,4’:6,7] indolizino [1,2-b]quinoline-3,14- (4H,12H)-dione monohydrochloride

1.2.1 Relevant identified uses

Anti-tumor

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Company Information

company name

Sagent Pharmaceuticals, Inc.

GHS Information

Signal word

-

Hazard Codes

Hazard statements (CLP)

H303

Hazard statements

Code

Statements

H303

May be harmful if swallowed

Section 2

SECTION 2: Hazards identification

NFPA Rating Classification

Health hazards

Flammability Instability Other Not Available HMIS Rating (Chronic Hazard) Flammability Hazard WARNING! THIS PRODUCT CONTAINS A CYTOTOXIC AGENT EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED In the workplace, this product may cause irritation by all routes of exposure. May be harmful if swallowed. In therapeutic use this product can cause bone marrow suppression which can lead to serious infection or death. The most common non-hematologic adverse reactions were nausea, alopecia, vomiting, sepsis or pyrexia/infection with neutropenia, diarrhea, constipation, fatigue, and fever. Can cause fetal harm. Hypersensitivity reactions have been reported from therapeutic use. Suspected of carcinogenic and mutagenic effects, based on animal and microorganism test data. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability Hazards: This solution is not flammable or combustible. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds, including carbon and nitrogen oxides and hydrogen chloride. Reactivity Hazards: This product is not reactive.

Physical hazards

Signal Word, Hazard Description of Hazards statement(s), Symbol(s), and/or Precautionary

Signal word

- DANGER

Hazard statements

- May damage the unborn child - May cause genetic defects EMERGENCY OVERVIEW

Product definition

This product is a clear, light yellow to greenish solution, odorless solution

Environmental hazards

Large quantities released to the aquatic and terrestrial environment may have an adverse effect. No data are available. Emergency Considerations: Emergency responders should wear appropriate protection for the situation to which they respond. (d) Unknown Acute Toxicity: N/A

2.1 Classification of the substance or mixture

US OSHA: May damage the unborn child. May cause genetic defects. NFPA Rating Health Hazard 2 Flammability 0 Instability 0 Other Not Available HMIS Rating Health Hazard 2 (Chronic Hazard) Flammability Hazard 0 Physical Hazard 0 (b) Signal Word, Hazard (c) Description of Hazards

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