General Information
Revision date
2013-05-09
Product name
BLEOMYCIN SULFATE API
Chemical name
N’-[3-(dimethylsul-phonio)propyl]bleomycin-amide (bleomycin A2) and N’-[4-(guaniodobutyl)]bleomycin- amide (bleomycin B2)
CAS No.
9041-93-4
1.2.2. Uses advised against
Other than Relevant Use
Manufacturer Name
TEVA
Emergency telephone
1-800/424-9300, 01-703-527-3887
Icons in SDS
Company Information
company name
TEVA
e-mail address of the competent person responsible for the Safety Data Sheet
TevaSDSRequest@tevapharm.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H303
Hazard statements
Code
Statements
H303
May be harmful if swallowed
Section 2
SECTION 2: Hazards identification
67/548/EEC GLOBAL HARMONIZATION LABELING AND CLASSIFICATION: Classified in accordance with the Global Harmonization Standard. The following classification is self-classification for the pure material when not in a formulated human pharmaceutical product. Carcinogenic Cat. 2, Germ Cell Mutagen Cat. 1B, Reproductive Toxicity Cat. 1B
Signal word
Danger
Hazard statements
H351, H340, H360D
Precautionary statements
Codes P201, P202, P280, P308 + P313, P405, P501
Hazard pictograms
GHS08 EU 67/548/EEC LABELING AND CLASSIFICATION: Classified in accordance with the European Community Council Directive 67/548/EEC or subsequent Directives. The material is not in finished pharmaceutical state. This is a self-classification. Carcinogenic Cat. 3, Germ Cell Mutagen Cat. 2, Reproductive Toxicity Cat. 2 Risk Phrase Codes: R45, R46, R63 Safety Phrase Codes: S22, S36/37/39, S45, S53, S60 T EMERGENCY OVERVIEW Material Description This material is a white, crystalline, odorless solid. Health Hazards THIS MATERIAL IS A CYTOTOXIC AGENT. EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED. In the workplace, exposure via inhalation or skin contact may cause irritation. Eye contact can cause mechanical irritation. May be harmful if swallowed or inhaled. When formulated in therapeutic use, this material may induce blood disorders and/or aggravate pre-existing blood disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders or cause anaphylactoid reaction. Chronic exposure may cause adverse effects on liver, lungs, skin and blood. May cause harm to the fetus, based on animal information. Has been shown to be mutagenic both in vitro and in vivo studies. Suspect carcinogen. These effects may be possible as a result of workplace exposure. See Section 11 (Toxicological Information) for information on other potential health hazards known from therapeutic use. Flammability Hazards: If heated to high temperatures for a prolonged period, the material may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds, including carbon, sulfur and nitrogen oxides. Reactivity This material is not reactive.
Environmental hazards
Large quantities released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for the situation to which they respond.