300 Northfield Road
Bedford, OH 44146 MATERIAL SAFETY DATA SHEET
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Propofol Injectable Emulsion, 10 mg/ml in 20, 50 and 100 ml vials
Chemical Names: Phenol, 2, 6-diisopropyl
Synonyms: Diprivan? 2, 6-Bis(1-methylethyl)phenol; ICI 35868; 2, 6-Diisopropylphenol, Phenol; 2, 6-bis(1-
methylethyl)-; Propofol
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: January 14, 2003
Date Revised: March 12, 2003
Date Revised: April 22, 2005
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
0.5 mg/m3
Propofol 1 2078-54-8 NONE NONE
(BVL OEL)
Soybean Oil 10 8001-22-7 NONE NONE NONE
Egg Lecithin 1.2 8002-43-5 NONE NONE NONE
Glycerin 2.25 56-81-4 NONE NONE NONE
Benzyl Alcohol 0.1 100-51-6 NONE NONE NONE
Water for Injection 85.45 7732-18-5 NONE NONE NONE
Sodium Hydroxide is used to adjust pH of 7-8.5
Propofol Emulsion is a sterile injectable liquid drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Exposure may occur via contact with skin/eyes, inhalation of aerosols and accidental ingestion.
Propofol Emulsion should be used under the supervision of a physician (trained in its use) to monitor the
anesthetic's side effects. It is not readily absorbed into the skin.
Health Hazard (Acute & Chronic): Propofol Emulsion is a fast acting, short duration general anesthetic.
Acute effects are moderate to severe irritation to skin, eyes and respiratory tract. Ingestion of large
amounts and injection may induce central nervous system depression and possible unconsciousness.
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Medical Conditions Generally Aggravated by Exposure : May cause allergic reaction in sensitized
persons and a risk of seizure to persons with epilepsy.
Carcinogenicity: NTP? NO IARC Monographs? NONE OSHA Regulated? NO
Signs & Symptoms of Exposure : Exposure may cause irritation to skin, eyes, and respiratory tract,
depression of the central nervous system leading to shallow breathing, headache, nausea, lethargy
and unconsciousness.
BVL Hazard Category: 2
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 if central nervous system
depression occurs. 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): 234癋 LEL: Not Determined UEL: Not Determined
Flammable Limits: Not Determined
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.
Unusual Fire/Explosion Hazards: Heat of the fire could cause vials to burst.
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Propofol Emulsion 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 4-22癈 (40-72癋). Do not freeze.
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Other Precautions: None Known
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: 0.955
Appearance and Odor: White to faintly yellow, Melting Point: Approx. 0癈
Slight phenolic odor
Boiling Point: 242癈 (468?F) Evaporation Rate: Approx. to water
Vapor Pressure: 0.142 mmHg @ 20?C Solubility in Water: Soluble
Vapor Density: Not available pH: 7-8.5
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): water-reactive materials and oxidizers.
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include potentially
hazardous byproducts such as oxides of carbon.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Storage near water reactive materials, emits toxic fumes under fire/heat.
Section XI - TOXICOLOGICAL INFORMATION
For Propofol Emulsion (active ingredient) RTECS Number SLO810000
LDLo human, intravenous = 386 mg/kg
LD50 rat, oral = 500 mg/kg
LD50 rat, Intravenous = 42 mg/kg
LD50 mouse, oral = 1100 mg/kg
LD50 mouse, intravenous = 50 mg/kg
LD50 mouse, intraperitoneal = 170 mg/kg
LD50 dog, intravenous = 30 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).
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Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Propofol. Handle in a manner to prevent
spills or releases to the environment.
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
Propofol Emulsion is not a DOT hazardous material.
Propofol Emulsion is not a DOT Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
TSCA listed?: YES, Section 8(b)
Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address the 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.
3. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories):
1 = Low Toxicity
2.= Moderate Toxicity
3 = Potent or Toxic
4 = Highly Potent or Toxic
5 = Extremely Potent or Toxic
This document is generated to distribute health, safety and environmental data. It is not a specification sheet and
none of the displayed data should be construed as a specification. Information on this MSDS sheet was obtained
from sources which we believe are reliable, and we believe that the information is complete and accurate. However,
the information is provided without any warranty, express or implied, regarding its correctness. Some of the
information presented and conclusions drawn are from sources other than direct test data of the substance. The
conditions or methods of handling, storage, use and disposal of the product are beyond our control and may also be
beyond our knowledge. It is the user's responsibility to determine the suitability of any material for a specific
purpose and to adopt such safety precautions as may be necessary. If the product is used as a component in another
product, this MSDS information may not be applicable. For these reasons, we do not assume any responsibility and
expressly disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling,
storage, use or disposal of this product.
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