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MATERIAL SAFETY DATA SHEET PAGE 1
ENFLURANE, USP ISSUED 10/03/97
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1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
-----------------------------------------------
MATERIAL NAME: ENFLURANE, USP
LIST NUMBER: 9406
MANUFACTURER: HOSPITAL PRODUCTS DIVISION
ABBOTT LABORATORIES
ABBOTT PARK, ILLINOIS 60064
EMERGENCY TELEPHONE NUMBER: 1-847-937-7970
CHEMTREC TELEPHONE NUMBER: 1-800-424-9300
2. COMPOSITION/INFORMATION ON INGREDIENTS
------------------------------------------
INGREDIENT NAME: ENFLURANE *
CAS/RTECS NUMBERS: 13838-16-9/KN6800000
OSHA-PEL 8HR TWA: N/L
STEL: N/L
CEILING: N/L
ACGIH-TLV 8HR TWA: 75 PPM (566 MG/M3)
STEL: N/L
CEILING: N/L
OTHER 8HR TWA: 75 PPM (566 MG/M3) [ABBOTT LABORATORIES]
LIMITS STEL: N/A
CEILING: N/A
* HAZARDOUS PER OSHA CRITERIA
3. HAZARDS INFORMATION
-----------------------
EMERGENCY OVERVIEW: THIS MATERIAL IS USED TO PRODUCE ANESTHESIA. IT IS
AN EYE IRRITANT AND CAN CAUSE LIVER INJURY UNDER EXAGGERATED
EXPOSURE CONDITIONS. TARGET ORGANS INCLUDE THE CARDIOVASCULAR
SYSTEM, CENTRAL NERVOUS SYSTEM, AND RESPIRATORY SYSTEM.
ROUTE(S) OF ENTRY: SKIN: N/D
INHALATION: YES
INGESTION: NO
INGESTION RATING: NONE
SKIN ABSORPTION RATING: N/D
INHALATION RATING: NONE
CORROSIVENESS RATING: N/D
SKIN CONTACT RATING: N/D
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ENFLURANE, USP ISSUED 10/03/97
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3. HAZARDS INFORMATION, CONTINUED
-----------------------
SKIN SENSITIZATION RATING: N/D
EYE CONTACT RATING: IRRITANT
TARGET ORGANS: CENTRAL NERVOUS SYSTEM, EYES, LIVER, CARDIOVASCULAR
SYSTEM, RESPIRATORY SYSTEM, AND POSSIBLY REPRODUCTIVE SYSTEM.
CARCINOGENICITY RATING: NTP: N/L IARC: N/L OSHA: N/L
ACGIH: N/L
NONE
SIGNS AND SYMPTOMS: N/D. IN CLINICAL USE, ENFLURANE PRODUCES
ANESTHESIA THAT CAN BE ACCOMPANIED BY HYPERTHERMIA, MUSCLE
TWITCHING, RESPIRATION DEPRESSION, HYPOTENSION, ARRYTHMIAS,
SHIVERING, NAUSEA, VOMITING, ELEVATED WHITE BLOOD CELL COUNT AND
LIVER INJURY. SUBCLINICAL CONCENTRATIONS HAVE PRODUCED IMPAIRMENT
IN LEARNING, TRANSIENT AMNESIA, AND PSYCHOLOGICAL IMPAIRMENT.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: N/D. PATIENTS SENSITIVE TO
CORTICAL STIMULATION; HYPERTHERMIA; CARDIOVASCULAR, RESPIRATORY OR
LIVER AILMENTS; OR HYPERSENSITIVITY TO ENFLURANE OR OTHER
HALOGENATED ANESTHETICS.
4. FIRST AID MEASURES
----------------------
EYES: REMOVE FROM SOURCE OF EXPOSURE. FLUSH WITH COPIOUS AMOUNTS OF
WATER. IF IRRITATION PERSISTS OR SIGNS OF TOXICITY OCCUR, SEEK
MEDICAL ATTENTION. NO KNOWN ANTIDOTE. PROVIDE SYMPTOMATIC/SUPPORTIVE
CARE, MAINTAINING VENTILATION WITH PURE OXYGEN, AS NECESSARY.
SKIN: REMOVE FROM SOURCE OF EXPOSURE. FLUSH WITH COPIOUS AMOUNTS OF
WATER. IF IRRITATION PERSISTS OR SIGNS OF TOXICITY OCCUR, SEEK
MEDICAL ATTENTION. NO KNOWN ANTIDOTE. PROVIDE SYMPTOMATIC/SUPPORTIVE
CARE, MAINTAINING VENTILATION WITH PURE OXYGEN, AS NECESSARY.
INGESTION: REMOVE FROM SOURCE OF EXPOSURE. IF SIGNS OF TOXICITY OCCUR,
SEEK MEDICAL ATTENTION. NO KNOWN ANTIDOTE. PROVIDE
SYMPTOMATIC/SUPPORTIVE CARE, MAINTAINING VENTILATION WITH PURE
OXYGEN, AS NECESSARY.
INHALATION: REMOVE FROM SOURCE OF EXPOSURE. IF SIGNS OF TOXICITY OCCUR,
SEEK MEDICAL ATTENTION. NO KNOWN ANTIDOTE. PROVIDE
SYMPTOMATIC/SUPPORTIVE CARE, MAINTAINING VENTILATION WITH PURE
OXYGEN, AS NECESSARY.
$PAGE
MATERIAL SAFETY DATA SHEET PAGE 3
ENFLURANE, USP ISSUED 10/03/97
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5. FIRE FIGHTING PROCEDURES
----------------------------
FLASH POINT: NON-FLAMMABLE
FLASH POINT METHOD: N/A
LOWER EXPLOSIVE LIMIT(%): N/D
UPPER EXPLOSIVE LIMIT(%): N/D
AUTOIGNITION TEMPERATURE: N/D
FIRE & EXPLOSION HAZARDS: ENFLURANE DOES NOT BURN.
EXTINGUISHING MEDIA: USE MEDIA APPROPRIATE FOR PRIMARY CAUSE OF FIRE.
FIRE FIGHTING INSTRUCTIONS: WEAR PROTECTIVE CLOTHING AND SELF-CONTAINED
BREATHING APPARATUS.
6. ACCIDENTAL RELEASE MEASURES
-------------------------------
SPILL OR RELEASE PROCEDURES: SPILLS IN POORLY VENTILATED AREAS PRESENT
AN INHALATION HAZARD. ALL SPILLS, REGARDLESS OF ROOM VENTILATION
CONDITIONS, REQUIRE CAREFUL HANDLING. RESTRICT SPILL AREA ACCESS TO
ONLY THOSE EQUIPPED WITH PERSONAL PROTECTION SPECIFIED IN SECTION 8.
ABSORB REMAINING LIQUID WITH SUITABLE MATERIAL AND CONTAINERIZE FOR
DISPOSAL IN ACCORDANCE WITH SECTION 13.
7. HANDLING AND STORAGE
------------------------
HANDLING: NO SPECIAL HANDLING REQUIRED.
STORAGE: RECOMMENDED STORAGE TEMPERATURE OF 25 DEGREES C.
SPECIAL PRECAUTIONS: PROTECT FROM FREEZING. AVOID EXCESIVE HEAT.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
-----------------------------------------
ENGINEERING CONTROLS: ANESTHETIC GAS SCAVENGING SYSTEMS SHOULD BE USED
TO CONTROL WASTE ANESTHETIC. IN THE LABORATORY ENVIRONMENT, THIS
PRODUCT SHOULD BE HANDLED IN A HOOD.
RESPIRATORY PROTECTION: IF ENGINEERING CONTROLS ARE IN PLACE,
RESPIRATORS ARE GENERALLY NOT REQUIRED DURING NORMAL CONDITIONS OF
USE. ENTRY INTO AREAS OF UNKNOWN AIRBORNE CONCENTRATION OF THIS
PRODUCT SHOULD ONLY BE MADE WITH A SELF-CONTAINED BREATHING
APPARATUS.
SKIN PROTECTION: UNDER NORMAL USE CONDITONS, NO SKIN PROTECTION IS
ANTICIPATED. IF DIRECT SKIN CONTACT IS EXPECTED, IMPERVIOUS GLOVES
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8. EXPOSURE CONTROLS/PERSONAL PROTECTION, CONTINUED
-----------------------------------------
ARE RECOMMENDED.
EYE PROTECTION: UNDER NORMAL USE CONDITIONS, NO EYE PROTECTION IS
ANTICIPATED. EYE PROTECTION SHOULD BE WORN IF EYE CONTACT IS LIKELY.
OTHER PROTECTION: N/A.
9. PHYSICAL AND CHEMICAL PROPERTIES
------------------------------------
APPEARANCE/PHYSICAL STATE: CLEAR, COLORLESS, NON-FLAMMABLE LIQUID.
ODOR: CHARACTERISTIC ODOR
BOILING POINT: 56.5 C
MELTING/FREEZING POINT: N/L
VAPOR PRESSURE (MM HG): 174.5 MMHG AT 20 C
VAPOR DENSITY (AIR=1): N/L
EVAPORATION RATE: N/A
BULK DENSITY: N/D
SPECIFIC GRAVITY: 1.516 - 1.519 AT 25 DEGREES C.
SOLUBILITY: ORGANIC LIQUIDS, INCLUDING FATS AND OILS.
PH: N/L
VISCOSITY: N/L
10. STABILITY AND REACTIVITY
----------------------------
CHEMICAL STABILITY: PROTECT FROM FREEZING AND EXCESIVE HEAT.
INCOMPATIBILITIES: N/D
HAZARDOUS DECOMPOSITION PRODUCTS: WHEN HEATED TO DECOMPOSITION IT EMITS
VERY TOXIC FUMES OF F- AND CL-.
HAZARDOUS POLYMERIZATION: N/D
11. TOXICOLOGICAL INFORMATION
-----------------------------
ORAL TOXICITY: LD50 = 5000-5450 MG/KG IN RATS AND MICE.
DERMAL TOXICITY: N/D
INHALATION TOXICITY: LC50 = 8100-31,500 PPM/3-4 HOURS IN ANIMALS.
CORROSIVENESS: N/D
DERMAL IRRITATION: N/D
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MATERIAL SAFETY DATA SHEET PAGE 5
ENFLURANE, USP ISSUED 10/03/97
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11. TOXICOLOGICAL INFORMATION, CONTINUED
-----------------------------
OCULAR IRRITATION: ENFLURANE WAS MODERATELY IRRITATING TO THE EYES IN
RABBITS.
DERMAL SENSITIZATION: N/D
SPECIAL TARGET ORGAN EFFECTS: N/D. CLINICALLY, ENFLURANE PRODUCES
ANESTHESIA WITH A MINIMUM ALVEOLAR CONCENTRATION TO PRODUCE A
SURGICAL PLAIN OF ANESTHESIA OF 16,800 PPM. A VERY SMALL AMOUNT OF
AN INSPIRED DOSE (ABOUT 2.4%) IS METABOLIZED TO FLUORIDE CONTAINING
METABOLITES. UNDER EXAGGERATED CONDITIONS, LARGE CONCENTRATIONS OF
ENFLURANE HAVE PRODUCED INJURY TO THE LIVER, HEART AND SPLEEN AND
PRODUCED MINOR SKELETAL VARIATIONS, ABNORMAL SPERMATOZOA, MATERNAL
TOXICITY AND FETOTOXICITY IN ANIMALS STUDIES.
CARCINOGENICITY INFORMATION: N/D
12. ECOLOGICAL INFORMATION
--------------------------
ECOLOGICAL INFORMATION: N/D
13. DISPOSAL CONSIDERATIONS
---------------------------
WASTE DISPOSAL METHODS: DISPOSE OF IN ACCORDANCE WITH LOCAL, STATE AND
FEDERAL REGULATIONS.
14. TRANSPORTATION INFORMATION
------------------------------
DOT STATUS: NOT REGULATED
PROPER SHIPPING NAME: N/A
HAZARD CLASS: N/A
UN NUMBER: N/A
PACKING GROUP: N/A
REPORTABLE QUANTITY: N/A
IATA/ICA0 STATUS: REGULATED
PROPER SHIPPING NAME: OTHER REGULATED SUBSTANCES (ENFLURANE).
HAZARD CLASS: 9
UN NUMBER: ID 8027
PACKING GROUP: III
REPORTABLE QUANTITY: N/A
$PAGE
MATERIAL SAFETY DATA SHEET PAGE 6
ENFLURANE, USP ISSUED 10/03/97
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14. TRANSPORTATION INFORMATION, CONTINUED
------------------------------
IMO STATUS: NOT REGULATED
PROPER SHIPPING NAME: N/A
HAZARD CLASS: N/A
UN NUMBER: N/A
PACKING GROUP: N/A
REPORTABLE QUANTITY: N/A
FLASH POINT: NON-FLAMMABLE
15. REGULATORY INFORMATION
--------------------------
TSCA STATUS: N/A
CERCLA STATUS: N/L
SARA STATUS: N/L
RCRA STATUS: N/L
PROP 65 (CA): N/L
16. OTHER INFORMATION
---------------------
LEGEND: N/A = NOT APPLICABLE
N/D = NOT DETERMINED
N/L = NOT LISTED
L = LISTED
C = CEILING
S = SHORT-TERM
(R) = REGISTERED TRADEMARK OF ABBOTT LABORATORIES
(TM) = REGISTERED TRADEMARK OF ABBOTT LABORATORIES
THE INFORMATION AND RECOMMENDATIONS CONTAINED HEREIN ARE BASED UPON
INFORMATION BELIEVED TO BE RELIABLE. HOWEVER, ABBOTT LABORATORIES DOES
NOT GUARANTEE THEIR ACCURACY OR COMPLETENESS NOR SHALL ANY OF THIS
INFORMATION CONSTITUTE A WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO
THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE
FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE. ADJUSTMENT TO CONFORM
WITH ACTUAL CONDITIONS OF USAGE MAY BE REQUIRED. ABBOTT LABORATORIES
ASSUMES NO RESPONSIBILITY FOR RESULTS OBTAINED OR FOR INCIDENTAL OR
CONSEQUENTIAL DAMAGES ARISING FROM THE USE OF THESE DATA. NO FREEDOM
FROM INFRINGEMENT OF ANY PATENT, COPYRIGHT OR TRADEMARK IS TO BE
INFERRED.
$ENDDTR:
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