HOWMEDICA DIV OF PFIZER HOSPI -- 6191-0-000 SURGICAL SIMPLEX P RADIOPAQUE BONE
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Material Safety Data Sheet
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MSDS Num: CJCYV
MSDS NAME: 6191-0-000 SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT CE MARK
Responsible Party
Name: HOWMEDICA DIV OF PFIZER HOSPITAL PROD GROUP INC
Address: 359 VETERANS BLVD
City: RUTHERFORD NJ 07070
Emergency Phone Number: 201-507-7516
Review Ind: Y
Published: Y
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Contractor Summary
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Name: AFIERA/RSH AIR FORCE SAFETY & HEALTH ANNA WILLIS
Address: 2513 KENNEDY CIR BLDG 180 RM 134
City: BROOKS AIR FORCE BASE TX 78235-5123
Phone: 210-536-6159, DSN 240-6159
Name: HOWMEDICA DIV OF PFIZER HOSPITAL PROD GROUP INC
Address: 359 VETERANS BLVD
City: RUTHERFORD NJ 07070
Phone: 201-507-7796/201-507-7300
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Ingredients
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Cas: 80-62-6
RTECS #: OZ5075000
Name: METHYL METHACRYLATE
Percent by Wt: 97.5
OSHA PEL: 410 MG/M3;100 PPM
ACGIH TLV: 410 MG/M3;100 PPM
ACGIH STEL: NOT ESTABLISHED
EPA Rpt Qty: 1000 LBS
DOT Rpt Qty: 1000 LBS
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Cas: 99-97-8
RTECS #: XU5803000
Name: N,N-DIMETHYL-P-TOLUIDINE
Percent by Wt: 2.5
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Cas: 123-31-9
RTECS #: MX3500000
Name: HYDROQUINONE
OSHA PEL: 2 MG/M3
ACGIH TLV: 2 MG/M3
ACGIH STEL: NOT ESTABLISHED
EPA Rpt Qty: 1 LB
DOT Rpt Qty: 1 LB
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Health Hazards Data
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Route Of Entry Inds - Inhalation: YES
Ingestion: YES
Effects of Exposure: INHALATION: RESPIRATORY IRRITANT. SKIN: SLIGHT IRRITATION.
MAY CAUSE ALLERGIC SENSITIZATION TO SOME PEOPLE. REPEATED EXPOSURE MAY CAUSE
DERMATITIS. EYES: MODERATE IRRITANT. INGESTION: IRRITATION OF TH E
GASTROINTESTINAL TRACT.
Signs And Symptions Of Overexposure: IRRITATION, DIZZINESS, DROWSINESS,
CONFUSION, UNCONSCIOUSNESS
First Aid: INHALATION: REMOVE TO FRESH AIR. KEEP WARM & AT REST. LOOSEN
CLOTHING. GIVE OXYGEN/CPR IF NECESSARY. SKIN: WASH W/SOAP & WATER FOR
SEVERAL MINS. EYES: WASH IMMEDIATELY W/COPIOUS AMOUNTS OF CLEAN WATER /SALINE
EYEWASH SOLUTION FOR 15 MINS. INGESTION: DON'T INDUCE VOMITING. ENSURE A
CLEAR AIRWAY. IF CONSCIOUS, WASH OUT MOUTH W/WATER & GIVE 200-300 ML OF
WATER TO DRINK.OBTAIN MEDICAL ATTENTION IN ALL CASES. MEDICAL ADVICE:
SYMPTOMATIC TREATMENT AS INDICATED. FOLLOWING INGESTION, ABSORBENTS SUCH AS
ACTIVATED CHARCOAL MAY BE OF VALUE. GASTRIC LAVAGE MAY BE EFFECTIVE WHEN
PERFORMED W/IN 4 HOURS OF IN GESTION.
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Handling and Disposal
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Spill Release Procedures: ELIMINATE IGNITION SOURCES. ENSURE PERSONAL
PROTECTION. WEAR APPROPRIATE RESPIRATORY PROTECTIVE EQUIPMENT. PREVENT ENTRY
INTO DRAINS. ABSORB ONTO SAWDUST/OTHER COMBUSTIBLE MATERIALS. TRANSFER TO A
SUI TABLE NON-FLAMMABLE CONTAINER FOR DISPOSAL/RECOVERY
Waste Disposal Methods: DISPOSE OF IN ACCORDANCE W/LOCAL, STATE & FEDERAL
REGULATIONS.
Handling And Storage Precautions: BOTH POWDER & LIQUID COMPONENTS MUST BE
STORED IN ITS ORIGINAL PACKAGING IN DARK, DRY CONDITIONS BELOW 77F. AS THE
PRODUCT IS MANUFACTURED STERILE, IT MUST ONLY BE OPENED BY TRAINED OPERATING
THEATRE STAFF.
Other Precautions: AVOID EXPOSURE TO DUST & VAPORS. PROVIDE ADEQUATE
VENTILATION IN THE WORK AREA. WEAR SURGICAL GLOVES. DON'T ALLOW THE LIQUID TO
COME INTO CONTACT WITH/BE ABSORBED BY THE BODY. WEAR EYE & HAND PROTECTI
ON WHEN OPENING THE AMPOULE.
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Fire and Explosion Hazard Information
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Flash Point: =11.5C, 52.7F
Flash Point Text: ABEL CLOSED CUP
Autoignition Temp: =421.C, 789.8F
Lower Limits: 2.1
Upper Limits: 12.5
Extinguishing Media: CO2, FOAM, DRY POWDER/BCF (BROMOCHLOROFLUOROCARBON) MEDIA
Fire Fighting Procedures: LIQUID IMMISCIBLE W/WATER. LIQUID FLOATS ON WATER.
Unusual Fire/Explosion Hazard: LIQUID MAY POLYMERIZE ON HEATING. SEALED
CONTAINERS MAY RUPTURE EXPLOSIVELY IF HOT.
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Control Measures
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Respiratory Protection: REQUIRED
Ventilation: ADEQUATE VENTILATION
Protective Gloves: REQUIRED
Eye Protection: REQUIRED
Work Hygienic Practices: REMOVE/LAUNDER CONTAMINATED CLOTHING & SHOES BEFORE
REUSE. WASH W/SOAP & WATER FOR SEVERAL MINS.
Supplemental Safety and Health: DON'T WEAR SOFT CONTACT LENSES IN THE WORKING
AREA AS THEY MAY BE DAMAGED BY METHYL METHACRYLATE VAPOR.
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Physical/Chemical Properties
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Boiling Point: =100.5C, 212.9F
Solubility in Water: SLIGHTLY-1.6%
Appearance and Odor: CLEAR COLORLESS FLAMMABLE LIQUID W/PUNGENT CHARACTERISTIC
SLIGHTLY SWEET ODOR
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Reactivity Data
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Stability Indicator: YES
Stability Condition To Avoid: HEATING, SUNLIGHT
Materials To Avoid: CATALYSTS, STRONG ACIDS, ALKALIS/OXIDIZING AGENTS
Hazardous Polymerization Indicator: YES
Conditions To Avoid Polymerization: SUSCEPTIBLE TO POLYMERIZATION INITIATED BY
PROLONGED HEATING, THE PRESENCE OF A CATALYST/EXPOSURE TO SUNLIGHT.
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Toxicological Information
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Toxicological Information: EXPOSURE TO METHYL METHACRYLATE MONOMER MAY CAUSE
IRRITATION, CNS EFFECTS & ALLERGIC SKIN REACTIONS (SENSITIZATION); IT MAY
ALSO CAUSE LIVER & KIDNEY TOXICITY, LUNG CONGESTION & HEART FAILURE.
N,N-DIM ETHYL-PARA-TOLUIDINE MAY CAUSE IRRITATION. IT IS RAPIDLY ABSORBED
THROUGH THE SKIN & MAY CAUSE A SYSTEMIC BLUISH DISCOLORATION OF THE SKIN,
ESPECIALLY EVIDENT UNDER THE FINGER & TOE NAILS (CYANOSIS).
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Ecological Information
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Ecological: NO DATA ARE AVAILABLE ON THE ADVERSE EFFECTS OF SURGICAL SIMPLEX
BONE CEMENT PRODUCTS ON THE ENVIRONMENT.
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MSDS Transport Information
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Transport Information: THE LIQUID COMPONENT OF SURGICAL SIMPLEX BONE CEMENTS
ARE CLASSIFIED AS HAZARDOUS MATERIALS FOR SHIPPING UNDER THE INTERNATIONAL
AIR TRANSPORT ASSOCIATION DANGEROUS GOODS REGULATIONS. SHIPPING NAME: M ETHYL
METHACRYLATE MONOMER, INHIBITED. HAZARD CLASS: FLAMABLE LIQUID. ID NUMBER:
UN1247. TRANSPORTATION BY LAND/SEA IS NOT RESTRICTED, PROVIDED THAT THE
PRESENCE OF THE MONOMER IS NOTIFIED TO THE CARR IER AT THE TIME OF SHIPMENT.
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Regulatory Information
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State Regulatory Information: SURIGICAL SIMPLEX P RADIOPAQUE BONE CEMENT IS
MANUFACTURED UNDER THE CONTROLS FOR MEDICINAL PRODUCTS. IT IS CLASSIFIED AS A
PHARMACY MEDICINE. UPON ADOPTION OF THE EU MEDICAL DEVICES DIRECTIVE SURGICA
L SIMPLEX P RADIOPAQUE BONE CEMENT WILL BE A CLASS IIB MEDICAL DEVICE.
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Other Information
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Other Information: THIS INFORMATION IS FURNISHED W/O WARRANTY,
EXPRESSED/IMPLIED EXCEPT THAT IT IS ACCURATE TO THE BEST KNOWLEDGE OF
HOWMEDICA INTERNATIONAL INC. THE DATA ON THIS SHEET RELATE ONLY TO THE
SPECIFIC MATERI ALS DESIGNATED HEREIN. HOWMEDICA INTERNATIONAL INC. ASSUMES
NO LEGAL RESPONSIBILITY FOR THE USE/RELIANCE UPON THESE DATA.
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HAZCOM Label
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MSDS NAME: 6191-0-000 SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT CE MARK
Company: HOWMEDICA DIV OF PFIZER HOSPITAL PROD GROUP INC
Street: 359 VETERANS BLVD
City: RUTHERFORD NJ
Zipcode: 07070
Health Emergency Phone: 201-507-7516
Label Required IND: Y
Date Of Label Review: 02/04/1999
Status Code: A
Origination Code: G
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Disclaimer (provided with this information by the compiling agencies): This
information is formulated for use by elements of the Department of Defense.
The United States of America in no manner whatsoever expressly or implied
warrants, states, or intends said information to have any application, use or
viability by or to any person or persons outside the Department of Defense
nor any person or persons contracting with any instrumentality of the United
States of America and disclaims all liability for such use. Any person
utilizing this instruction who is not a military or civilian employee of the
United States of America should seek competent professional advice to verify
and assume responsibility for the suitability of this information to their
particular situation regardless of similarity to a corresponding Department
of Defense or other government situation.
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