I-Dox , GedawellTM

SECTION 2: Hazards identification

OSHA Component CAS# Formula Percent Doxorubicin Hydrochloride 25316-40-9 C27 H29 NO11- HCI 0.2% Liposomal carrier* Not applicable 99.8%

Contains

N- ( carbamoyl-methoxypolyethelenc glycol 2000)- 1, 2- distearoyl-sn- glycero-3-phosphoethanolamine sodium salt( MPEG-DSPE), fully hydrogenated soy phophtidylcholine(HSPC), cholesterol, ammonium sulfate, histidine, sucrose and hydrochloric acid and/or sodium hydroxide for pH control.

Health hazards

WARNING STATEMENT CAUTION: Contains Doxorubicin Hydrochloride an antineoplastic agent used in chemotherapy. Doxorubicin Hydrochloride is a known carcinogen in animals and a probable carcinogen in humans. This drug is intended for human pharmaceutical use by intravenous infusion as prescribed by a physician.

Precautionary statements

Irritant Irritating to eyes, skin and mucosa Potential routes to exposure Skin, eyes, ingestion, inhalation, accidental injection Systemic Acute: Due to the nature of the use (intravenous infusion) of this drug no oral or inhalation toxicity data exists. Chronic: Due to the nature of the use (intravenous infusion) of this drug no oral or inhalation toxicity data exists. Reproductive and Developmental Toxicity Doxorubicin HCl Liposome Injection is embryotoxic at doses of 1mg/kg/day (about 1/3 of the recommended human dose on mg/m2 basis) in rats. Doxorubicin HCl Liposome Injection is embryotoxic and abortifacient at 0.5mg/kg/day (about ¼ the recommended human dose on mg/m2 basis) in rabbits. No data exists, for tests in humans, to confirm or deny the results of the animal models. Carcinogencity and Mutagenicity Although no studies have been conducted with Doxorubicin HCl Liposome Injection has been shown to have mutagenic and carcinogenic properties when tested in animal models. No data exists, for tests in humans, to confirm or deny the results of the animal models. Permissible Exposure Limit No OSHA or ACGIH exposure limits have been set.