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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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1. PRODUCT AND COMPANY IDENTIFICATION
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DePuy International Ltd
t/a DePuy CMW
Cornford Road
Blackpool, England, FY4 4QQ
EMERGENCY TELEPHONE NUMBERS
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Health, Safety & Environmental Officer +44 (0) 1253 765167
PRODUCT NAME: Smartset GHV (medicated bone cement)
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2. COMPOSITION/INFORMATION ON INGREDIENTS
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OEL: 150mcg/m3 8hourTWA (in-house)
Active Ingredient: GENTAMICIN SULPHATE
Powder: Liquid:
Methyl acrylate /polymethyl Methyl methacrylate: >50.0%
N,N-Dimethyl-p-toluidine: 2.5%
Methacrylate co-polymer: >50.0%
Gentamicin Sulphate: 1-5%
Ziconium dioxide: 10-20%
Benzoyl Peroxide: 1-2%
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3. HAZARDS IDENTIFICATION
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***************************** EMERGENCY OVERVIEW *****************************
* This products (powder and liquid) may cause eye, skin and respiratory *
* Irritation and skin sensitisation. *
* Avoid heat, sparks or open flame with liquid components. *
* *
* R36/37/38 *
* R20/21/22 *
* R10 *
******************************************************************************
POTENTIAL HEALTH EFFECTS
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PRIMARY ROUTE(S) OF ENTRY
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Eye, skin and respiratory tract.
EYES
----
Powder and liquid components may be irritating to the eyes.
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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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SKIN
----
May cause skin irritation and sensitisation. The degree of reaction may vary
significantly between individuals and on the amount and duration of exposure.
INGESTION
---------
Liquid components may be toxic if swallowed.
INHALATION
----------
Powder may be irritating to the respiratory system. Liquid vapour may cause
irritation of the respiratory tract, dizziness, headache and anaesthetic
effects based on exposure.
CHRONIC (CANCER INFORMATION)
----------------------------
Repeated exposure of high concentration levels of the liquid components may
cause adverse effects on lungs, heart , kidney and liver.
REPRODUCTIVE EFFECTS
--------------------
Unknown.
MUTAGENICITY (GENETIC EFFECTS)
------------------------------
Unknown.
ADDITIONAL INFORMATION
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These Medicated cements contain the pharmaceutical active gentamicin. The
following side effects or adverse reactions have been known to occur: confusion,
depression, dizziness, muscle twitching, numbness, tremors and vertigo.
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4. FIRST AID MEASURES
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EYES
----
In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice;S26 (Powder and Liquid).
SKIN
----
After contact with skin, wash immediately with plenty of water and get
medical attention if irritation develops or persists;S28 (Powder and Liquid).
INGESTION
---------
If swallowed, seek medical advice. Do not induce vomiting with liquid.
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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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INHALATION
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If exposure occurs, remove individual to fresh air and obtain medical
attention (Liquid).
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5. FIRE FIGHTING MEASURES
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FLAMMABLE PROPERTIES
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FLASH POINT: 10.5 C DIN 51755
AUTOIGNITION: 421 C
LOWER EXPLOSIVE LIMIT (%): 2.1 by volume
UPPER EXPLOSIVE LIMIT (%): 12.5 by volume
FIRE AND EXPLOSION HAZARDS
--------------------------
Combustible powder, St class 2 explosive dust, will dissolve in some solvents.
Sensitive to static discharge.
EXTINGUISHING MEDIA
-------------------
Use any media which is suitable for the surrounding fire.
FIRE FIGHTING INSTRUCTIONS
--------------------------
Wear self-contained breathing apparatus and full protective gear.
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6. ACCIDENTAL RELEASE MEASURES
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Spilled or released material may polymerise and release heat/gases.
Extinguish all ignition sources and ventilate area. Wear protective equipment
during clean-up. Soak up small spill with inert solids and sweep/shovel into
vented disposal container. Wash spill area with detergent and water solution
and rinse with water. Do not allow spilled liquid to enter drains.
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7. HANDLING AND STORAGE
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HANDLING AND STORAGE PRECAUTIONS
--------------------------------
Store in tightly closed containers away from heat, sparks, open flame. Keep
in a cool well ventilated area.
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8. EXPOSURE CONTROLS/PERSONAL PROTECTION
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ENGINEERING CONTROLS
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Local exhaust ventilation.
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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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EYE/FACE PROTECTION
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Wear eye/face protection;S39. Concentrated vapours of the liquid component may
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8. EXPOSURE CONTROLS/PERSONAL PROTECTION
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have an adverse reaction with soft contact lenses.
SKIN PROTECTION
---------------
Wear suitable gloves;S37. Nitrile is recommended.
RESPIRATORY PROTECTION
----------------------
Respiratory protection dependent on airborne exposures. Refer to organic
solvents and particulates involved in exposure.
OTHER/GENERAL PROTECTION
------------------------
Wear suitable protective clothing;S36.
Exercise proper industrial hygiene procedures to prevent exposure by washing
hands and arms thoroughly with soap and hot water after working with
material. Gloves should be washed with soap and water before removal.
Contaminated clothing should be promptly removed and washed before reuse.
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9. PHYSICAL AND CHEMICAL PROPERTIES
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APPEARANCE
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Powder component-A white odourless free flowing powder.
Liquid component-Colou8rless mobile liquid with characteristic pungent odour.
BASIC PHYSICAL PROPERTIES
-------------------------
Powder component:
Relative density=1.14 (polymer)
Melting point=200C (polymer)
Liquid Component:
BOILING POINT: 100.5 C
VAPOUR PRESSURE: 28mmHg(20C)
VAPOR DENSITY (AIR=1): 0.94
SOLUBILITY (H2O): 1.59%
EVAPORATION RATE: 4(butyl acetate=1)
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10. STABILITY AND REACTIVITY
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CONDITIONS TO AVOID (STABILITY)
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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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Liquid component is a volatile flammable liquid, which slowly attacks rubber.
The liquid will polymerise very readily and all contamination must be
Avoided, particularly organic peroxides, catalysts, free radicals generators
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10. STABILITY AND REACTIVITY - Continued
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and multivalent metal oxides, especially when wet. Heat and strong light,
particularly fluorescent or U.V. could cause polymerisation.
INCOMPATIBLE MATERIALS
----------------------
Avoid high temperatures, oxidizing and reducing agents.
HAZARDOUS POLYMERIZATION: May occur
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11. TOXICOLOGICAL INFORMATION
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ACUTE STUDIES
-------------
Unknown for product.
Benzoyl Peroxide (CAS No.94-36-0):
LD50 Oral-Rat=7710mg/kg
Methyl Methacrylate (CAS No. 80-62-6):
LC50 Inhalation-Rat=3750ppm
Gentamicin Suphate (Cas No. 1405-41-0):
LD50 Ivn-Rat=108mg/kg
Zirconium Oxide (CAS No. 1314-23-4):
Not known.
EYE EFFECTS
-----------
Powder and liquid components may be irritating to the eyes.
SKIN EFFECTS
------------
Powder and liquid components may cause irritation and sensitisation.
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12. ECOLOGICAL INFORMATION
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ECOTOXICOLOGICAL INFORMATION
----------------------------
Unknown. Follow all regulatory regulations. The liquid components are not
readily biodegradable and could be harmful to fish and invertebrates.
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13. DISPOSAL CONSIDERATIONS
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In all instances this product must be disposed of in accordance with all
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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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applicable regulations.
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Material Safety Data Sheet
Rev. Date
Smartset GHV (medicated bone cement)
31 May 2006
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14. TRANSPORT INFORMATION
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PROPER SHIPPING NAME: Consumer Commodity
UN 1247
HAZARD CLASS: Flammable
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15. REGULATORY INFORMATION
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TSCA status: All components of this product are listed, or excluded from
listing, on the EPA/TSCA inventory.
This product is not subject to the regulatory requirements under California
Proposition 65.
International Inventory status:
Australia (AICS)-Included
Canada (DSL)-Included
European Economic Community (EINECS)-Not applicable
Japan (MITI)-Included
Korea (MOE)-Included
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16. OTHER INFORMATION
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REFERENCE DOCUMENTATION
-----------------------
Refer to package insert.
DISCLAIMER OF EXPRESSED AND IMPLIED WARRANTIES
----------------------------------------------
Although reasonable care has been taken in the preparation of this document,
we extend no warranties and make no representations as to the accuracy or
completeness of the information contained therein, and assume no
responsibility regarding the suitability of this information for the user's
intended purposes or for the consequences of its use. Each individual should
make a determination as to the suitability of the information for their
particular purpose(s).
DePuy International Ltd
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