BLEOMYCIN SULFATE API

TEVA

Revision date : 2013-05-09

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GHS08
Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

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

GHS08

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.

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