Dobutamine Hydrochloride for Injection Page 1 of 8
Dobutamine Hydrochloride for
Injection
Eli Lilly and Company Effective Date: 11-Mar-2000
Material Safety Data Sheet
Section 1 - Chemical Product and Company
Manufacturer's Emergency Phone:
Manufacturer:
1-317-276-2000
Eli Lilly and Company
CHEMTREC:
Lilly Corporate Center
1-800-424-9300 (North America)
Indianapolis, IN 46285
1-703-527-3887 (International)
Common Name: Dobutamine Hydrochloride for Injection
Chemical Name: 1,2-Benzenediol, 4-[2-[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-,
hydrochloride
Chemical Name 2: 1,2-Benzenediol, 4-[2-[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-,
hydrochloride, (+/-)-
Synonym(s): 081929 Hydrochloride Formulation; Dobutamine Hydrochloride; Dobutamine HCl;
Dobutamine; 046236 Formulation
Trademarks(s): Docutrix; Inorex; Inotrex; Dobutrex
Lilly Item Code(s): AM7050; AM7051; AM7056; AM7175; CA1517; CA1518; VL7050; VL7051;
VL7054; VL7226
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Dobutamine Hydrochloride 49745-95-1 52 - 73
Mannitol 69-65-8 27 - 48
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or
greater) not listed above.
Exposure Guidelines: Dobutamine hydrochloride - LEG 2.2 mg/m3 TWA for 12 hours.
Mannitol - Exposure Guideline 10 mg/m3 TWA for 8 or 12 hours.
Section 3 - Hazards Identification
Appearance: White to off-white plug
Physical State: Solid
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Odor: Odorless
Emergency Overview
Emergency Overview Effective Date: 11-Mar-2000
Lilly Laboratory Labeling Codes:
Health 3 Fire 1 Reactivity 0
Primary Physical and Health Hazards: Corrosive (eyes). Heart Effects.
Caution Statement: Dobutamine Hydrochloride for Injection may cause burns or permanent tissue
damage to the eyes. Effects of exposure may include increased blood pressure and change in heart
rate.
Routes of Entry: Inhalation and skin contact.
Effects of Overexposure: Eye irritation has been reported from occupational exposure to dobutamine
hydrochloride. Based on animal data, dobutamine hydrochloride may cause burns or permanent tissue
damage to the eyes.
Medical Conditions Aggravated by Exposure: None known.
Carcinogenicity:
Remaining ingredients - Not listed by IARC, NTP, ACGIH, or OSHA.
Mannitol - Not listed by IARC, NTP, ACGIH, or OSHA. Two-year dietary studies demonstrated no
evidence of carcinogenicity in mice and rats.
Section 4 - First Aid Measures
Eyes: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. See an
ophthalmologist (eye doctor) or other physician immediately.
Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with
plenty of soap and water. Get medical attention if irritation develops.
Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not
breathing, provide artificial respiration assistance (mouth-to-mouth) and call a physician immediately.
Ingestion: Do not induce vomiting. Call a physician or poison control center. If available, administer
activated charcoal (6-8 heaping teaspoons) with two to three glasses of water. Do not give anything by
mouth to an unconscious person. Immediately transport to a medical care facility and see a physician.
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Section 5 - Fire Fighting Measures
Flash Point: No applicable information found
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.
Unusual Fire and Explosion Hazards: As a finely divided material, may form dust mixtures in air
which could explode if subjected to an ignition source.
Hazardous Combustion Products: May emit toxic chloride fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: Vacuum material with appropriate dust collection filter in place. Be aware of potential for dust
explosion when using electrical equipment. If vacuum is not available, lightly mist material and remove
by sweeping or wet wiping. Wear protective equipment, including eye protection, to avoid exposure
(see Section 8 for specific handling precautions).
Section 7 - Handling and Storage
Storage Conditions: Store in a cool, dry, well-ventilated area.
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Under normal use and handling conditions, no protective equipment is required. The following is
recommended for a production setting:
Respiratory Protection: Use an approved respirator.
Eye Protection: Chemical goggles and/or face shield.
Ventilation: Laboratory fume hood or local exhaust ventilation.
Other Protective Equipment: Chemical-resistant gloves and body covering to minimize skin
contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face
shield may not be required. Safety glasses are always required.
Additional Exposure Precautions: In production settings, airline-supplied, hood-type respirators are
preferred. Shower and change clothing if skin contact occurs.
Section 9 - Physical and Chemical Properties
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Appearance: White to off-white plug
Odor: Odorless
Boiling Point: Not applicable
Melting Point: Not applicable
Specific Gravity: Not applicable
pH: 2.5-5.0
Evaporation Rate: No applicable information found
Water Solubility: Soluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found
Section 10 - Stability and Reactivity
Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid,
etc.).
Hazardous Decomposition: May emit toxic chloride fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
Data for the active ingredient, dobutamine hydrochloride, are reported.
Oral: Dobutamine hydrochloride - Rat, 500 mg/kg, no deaths, reduced activity.
Skin: Dobutamine hydrochloride - Rabbit, 500 mg/kg, no deaths or toxicity.
Inhalation: Dobutamine hydrochloride - Rat, 83 mg/m3 for 1 hour, no deaths or toxicity.
Dog, 546 mg/m3 for 4 hours, no deaths, increased heart rate.
Intravenous: Dobutamine hydrochloride - Rat, median lethal dose 92 mg/kg, convulsions, coma,
diarrhea.
Dog, 72-hour infusion, median lethal dose estimated greater than 80 mcg/kg/minute, mortality, reddened
eyes, relaxed nictitating membrane, peripheral vasodilation across skin and gums, reduced activity,
vomiting, body weight loss, increased alkaline phosphatase, premature ventricular contractions, sinus
and ventricular tachycardia.
Skin Contact: Dobutamine hydrochloride - Rabbit, nonirritant
Eye Contact: Dobutamine hydrochloride - Rabbit, corrosive
Chronic Exposure
Data for the active ingredient, dobutamine hydrocloride, are reported.
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Target Organ Effects: Dobutamine hydrochloride - Heart effects (increased strength at contraction,
increased heart rate, tissue changes, increased blood pressure), circulatory effects (vasodilation).
Reproduction: Dobutamine hydrochloride - No effects identified in animal studies.
Sensitization: Dobutamine hydrochloride - Guinea pig, not a contact sensitizer.
Mutagenicity: Dobutamine hydrochloride - Not mutagenic in bacterial cells.
Section 12 - Ecological Information
No data are available for mixture. Environmental data for mannitol are reported.
Environmental Fate:
Mannitol
Log Kow: -3.10
Log Koc: 0.7
Henry's Law constant (atm*m3/mole): 7.3 x 10(-13)
Bioconcentration factor: 1
Biological oxygen demand (5-day): 1.15
Theoretical oxygen demand (5-day): 59%
Chemical oxygen demand (5-day) : 87%
Environmental Summary:
Mannitol - Material is not expected to be toxic to aquatic organisms. Material is expected to exist in the
particulate phase if released into the air. Material is expected to have very high mobility in soil and is
not expected to volatilize from aquatic environments. Material is not expected to bioconcentrate in
aquatic organisms. Material is a simple sugar alcohol and should be readily biodegraded.
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws
and regulations.
Section 14 - Transport Information
Regulatory Organizations:
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
Section 15 - Regulatory Information
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Below is selected regulatory information chosen primarily for possible Eli Lilly and Company
usage. This section is not a complete analysis or reference to all applicable regulatory
information. Please consider all applicable laws and regulations for your country/state.
U.S. Regulations
Dobutamine hydrochloride
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
Remaining Ingredients
TSCA - Yes
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
EU Regulations
EC Classification
Contains dobutamine hydrochloride (C = 52-73%)
Xi (Irritant)
Risk Phrases
R 41 - Risk of serious damage to eyes.
Safety Phrases
S 26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S 36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S 45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label where
possible).
Section 16 - Other Information
MSDS Sections Revised: Sections 1, 2, 3, 7, 8, and 12.
Emergency Overview Sections Revised: Caution statement.
As of the date of issuance, we are providing available information relevant to the handling of this
material in the workplace. All information contained herein is offered with the good faith belief that it
is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE
ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this
material, this safety data sheet is not intended to be a substitute for consultation with appropriately
trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which
may accompany the finished product.
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For additional information contact:
Eli Lilly and Company
Hazard Communication
317-277-6029
For additional copies contact:
Eli Lilly and Company
1-800-LILLY-Rx (1-800-545-5979)
GLOSSARY:
ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHAN = Chemical Hazard Alert Notice
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
Kow = Octanol/Water Partition Coefficient
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
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TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
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