300 Northfield Road
Bedford, OH 44146 MATERIAL SAFETY DATA SHEET
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Dihydroergotamine Mesylate Injection (DHE) ?1mg/mL; ml/vial
Chemical Names: Dihydroergotamine Mesylate
Synonyms: DHE Mesylate, Ergotamine, 9, 10-dihydro- Mesylate
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: 1(800)424-9300
Telephone Number for Info.: (440)232-3320 -or- (800)562-4797
Medical Emergency: Professional Services 1(800)521-5169
Date Prepared: September 9, 2003
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
Dihydroergotamine 0.1 6190-39-2 NONE NONE NONE KNOWN
Mesylate, USP
Ethyl Alcohol 4.9 64-17-5 1000 PPM 1000 PPM 1000 PPM
Glycerin 15.4 56-81-4 NONE NONE NONE KNOWN
Water for Injection 79.6 7732-18-5 NONE NONE NONE KNOWN
Methanesulfonic Acid(CAS# 75-75-2) and Sodium Hydroxide (CAS# 1310-73-2) used for pH adjustment
Dihydroergotamine Mesylate is a sterile injectable liquid drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Exposure can occur upon contact with skin/eyes; inhalation of aerosols or accidentally
ingested. Under normal use with supervision of a physician, Dihydroergotamine Mesylate presents
little hazard.
Health Hazard (Acute & Chronic): Dihydroergotamine Mesylate is a drug generally used for the
treatment of migraine. Adverse acute effects are irritation to mucous membranes and respiratory
tract, nausea, vomiting, headache, diarrhea, thirst, coldness of skin, weak pulse numbness and
tingling or extremities, confusion. Possible allergic reaction to material if inhaled, ingested or in
contact with skin. Chronic reaction may cause allergic reaction.
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Medical Conditions Generally Aggravated by Exposure: Hypersensitivity to material, coronary artery
disease, renal impairment..
Carcinogenicity: NTP? NO IARC Monographs? NONE OSHA Regulated? NO
Signs & Symptoms of Exposure: Possible irritation to skin, eyes, and respiratory tract.
BVL Internal Hazard Category: 3
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 or more minutes. Get medical attention if
irritation or signs of exposure are noted.
Skin Exposure: Remove contaminated clothing, wash skin with water and soap for 15 minutes. Get
medical attention if irritation or signs of exposure are noted.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
Never give anything by mouth to an unconscious person.
Injection: In cases of accidental injection, wash and disinfect area, get medical attention.
Inhalation: If difficulty with breathing, remove from exposure, administer oxygen. Seek attention
of a physician immediately. When appropriate and trained in CPR, provide artificial
respiration.
Section V - FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): Not Applicable LEL: Not Applicable UEL: Not Applicable
Flammable Limits: Not Applicable
Extinguishing Media: Use water or an ABC multi-purpose extinguisher.
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters
should wear self-contained breathing apparatus to avoid inhalation of smoke. Product is aqueous-
based and is not expected to present a fire hazard concern.
Unusual Fire/Explosion Hazards: Heat of the fire could cause vials to burst.
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Dihydroergotamine Mesylate with absorbent materials and dispose according
to local, state, and federal guidelines.
Release to Air: If aerosolized, reduce exposures by ventilating area; clean up spill immediately to
prevent evaporation
Release to Water: Refer to local water authority. Drain disposal is not recommended; however,
refer to local, state, and federal disposal guidelines.
Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE
Steps to be taken in case material is released or spilled: See Section VI above.
Wear latex or nitrile gloves and safety glasses when cleaning spills. A dust/mist respirator (N95)
may be necessary if excessive aerosols are generated.
Waste Disposal Method: Incineration in an approved incinerator is recommended. Refer to local, state,
and federal rules.
Precautions to be taken in handling and storing: Store between 15-25癈. Follow instructions
provided in packaging.
Other Precautions: None Known
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Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Under normal use, respirators are not required. If aerosols are generated, a
disposable dust/mist respirator (N95) may be used. Personnel wearing respirators should be fit
tested and approved for respirator use under the OSHA Respiratory Protection Standard 29 CFR
1910.134.
Ventilation: Handle product in a well-ventilated area.
Protective Gloves: Latex or nitrile
Eye Protection: Safety glasses
Other Protective Clothing or Equipment: Lab Coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking while
handling this product.
Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS
Physical State: Liquid Specific Gravity: Approx. to water
Appearance and Odor: Clear to Yellowish Melting Point: Approx. 0癈
or reddish solution
Boiling Point: Approx. 100癈 Evaporation Rate: Approx. to water
Vapor Pressure: Not available Solubility in Water: Soluble
Vapor Density: Not available pH: Not Available
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): water-reactive materials.
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts such as oxides of carbon, nitrogen and sulfur.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Storage near water reactive materials
Section XI - TOXICOLOGICAL INFORMATION
For Dihydroergotamine Mesylate (active ingredient) RTECS Number IT3675000
LD50 rat, intravenous = 110 mg/kg LD50 mouse, oral = > 8gm/kg
LD50 mouse, intravenous = 118 mg/kg LD50 rabbit, oral = >8 gm/kg
LD50 mouse, subcutaneous = 80 mg/kg LD50 rabbit, intravenous = 25 mg/kg
LD50 cat, subcutaneous = 68 mg/kg
Additional reproductive health data is available from the National Institute for Occupational Safety and
Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS).
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Dihydroergotamine Mesylate.
Handle in a manner to prevent spills or releases to the environment.
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Section XIII - DISPOSAL INFORMATION
Dispose of by incineration at an approved/permitted incinerator.
Review local, state, and federal regulations for your regulatory area.
Section XIV - TRANSPORTATION INFORMATION
Dihydroergotamine Mesylate is not a DOT hazardous material.
Dihydroergotamine Mesylate is not a DOT Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
TSCA listed?: YES
State List: California Proposition 65 Code D
Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address therapeutic use of this material.
2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and
other sharps used in the administration. All needle sticks must be reported to your company
management.
REFERENCES:
1. Registry of Toxic Effects of Chemical Substances, 8/2003
2.
The information provided is believed to be complete and accurate. It is the user's responsibility to use the information according to their
application. Bedford Laboratories and Ben Venue Labs, Inc. assumes no additional liability or responsibility resulting from the use of or
reliance on this information.
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