General Information
Revision date
2010-11-04
Product name
BENDAMUSTINE HYDROCHLORIDE
Product Synonyms
5-[bis(2-Chloroethyl)amino]-1-methyl-1H-Benzimidazole-2-Butannic Acid Monohydrochloride; 4(5-[bis(2-chloroethyl)amino)-1-methyl-1H-benzimidazol- 2yl]butanoic Acid Hydrochloride; Bendamustin Hydrochloride; Cytostasan; Ribomustin
CAS No.
3543-75-7
1.2.1 Relevant identified uses
Pharmaceutical Active Ingredient
Manufacturer Name
CEPHALON, INC
Emergency telephone
1-800/424-9300, 01-703-527-3887
Icons in SDS
Company Information
company name
CEPHALON, INC
e-mail address of the competent person responsible for the Safety Data Sheet
bpogozel@cephalon.com
GHS Information
Signal word
Danger, Warning
Section 2
SECTION 2: Hazards identification
Signal word
Danger, Warning
Hazard statements
H301, H317, H318, H334, H340, H351, H372, H360fd EU LABELING/CLASSIFICATION: This product meets the definition of hazardous, as defined by the European Community Council Directive 67/548/EEC or subsequent Directives. This is a self-classification. (See Section 15 for full details on classification). R 25, R 40, R 41, R 42/43, R 46, R 48/23/24, R 60, R 61 EMERGENCY OVERVIEW This product is an odorless white crystalline powder.
2.1 Classification of the substance or mixture
Carcinogenic Category 3; Toxic [T]; Harmful [Xn], Irritant [Xi]
Health hazards
THIS MATERIAL IS A POWERFUL CYTOTOXIC AGENT. EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED. The main health hazards in a workplace setting is expected to be moderate to severe irritation of respiratory system from inhaled dusts, severe eye irritation, and adverse effects from skin absorption. In therapeutic use, this material has caused adverse effects on the blood system, kidneys, lymphatic system, bone marrow, digestive system and reproductive system. Ingestion, skin contact and inhalation may cause sensitization and allergic reaction in susceptible individuals. Severe anaphylactic and anaphylactoid reactions have occurred rarely, mainly in the second and subsequent cycles of therapy. Contact with the eyes may cause serious irritation or damage, especially if contact is prolonged. This material is has been shown to be a reproductive toxin in animal tests, causing mutagenic and teratogenic effects. This material is a suspect carcinogen, based on animal tests. Flammability Hazards: This material is assumed to be combustible. The accumulation of dusts of this product can create a serious hazard of explosion. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides). Reactivity Hazards: This product is not reactive. Environmental Hazards Negligible. Emergency Recommendations Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.
