CACTIS
Center for Advanced Computed Tomography Imaging Services
Melissa Myers, BS, RT(R), RDMS
Clinical Research Coordinator
Radiology Research, Cardiovascular Imaging
Hospital of the Univ. of Penn.
3400 Spruce Street
Silverstein 1,
c/o Harold Litt, MD, PhD
Philadelphia, PA 19104
Phone: 215-349-5891
Pager: 215-281-4353
Fax: 215-662-4627
melissa.myers@uphs.upenn.edu
This document describes the policies and procedures that govern the use of all of Computed Tomography facilities in the Center for Advanced Computed Tomography Imaging Studies (CACTIS) in the Department of Radiology.
These guidelines must be followed by all groups who will have access to the CT Scanners for research purposes. It is the policy of CACTIS to maintain a safe environment and to promote a conscientious approach to research projects and developments.
Please select:
APPENDIX 1 - OMNIPAQUE
MATERIAL SAFETY DATA SHEET # 1022
Date: April 2003
Product Name: Omnipaque
Synonyms: Omnipaque 140 mg I/ml, 180 mg I/ml, 210
mg I/ml, 240 mg I/ml, 300mgI/ml and 350 mg I/ml Injection
Applications: Radiodiagnostic
Emergency Number: In an emergency, call 1-800-654-0118
Manufacturer:
Amersham Health
101 Carnegie Center
Princeton, NJ 08540-9998
609-514-6000 or 1-800-654-0118
Ingredient Name CAS No. Percent by Weight
Iohexol* 66108-95-0 > 25.0
Water 7732-18-5 > 25.0
* - Sterling Health Protection Guide:
5mg/m3 8-hr TWA, 10mg/m3 STEL
***** EMERGENCY OVERVIEW*****
An aqueous solution. Presents little or no hazard if spilled or in
fire.
WARNING: This is a pharmaceutical material available only with a prescription - use only as directed. Persons allergic to shellfish or iodine may be allergic to iohexol.
FIRST AID MEASURESEyes: In case of eye contact, flush eyes with plenty
of water for at least 15 minutes. Seek medical attention if irritation
develops.
Skin: Wash thoroughly with soap and water.
Ingestion: In case of overdosage, seek immediate
medical attention or contact the Poison Control Center for further
instructions.
Inhalation: Not an expected route of entry.
Flammable Properties: Nonflammable. This is an aqueous-based
formulation.
Extinguishing Media: Use any extinguishing agent
which is suitable for the surrounding fire.
Fire Fighting Procedures: Use normal fire fighting
gear. Ventilate area - free flame may rupture container and decompose
product to form toxic and irritating iodine vapors. Unusual Fire and
Explosion Hazards: None known
Spills: Contain the spill by placing paper towels or a suitable absorbent material around the edges of the spill and work inward. Carefully scoop up into a properly labeled waste container for disposal. Wash area of spill to remove from surfaces.
HANDLING AND STORAGEHandling and Storage Precautions: Store away from
heat and light - these conditions may produce iodine vapors. Keep
this and all drugs out of the reach of children.
Work/Hygienic Practices: Use good personal hygiene
- wash hands and exposed skin thoroughly with soap and water after
use.
Engineering controls: Normal ventilation
Eye/Face Protection: None normally required. Avoid
eye contact.
Skin Protection: None normally required. Gloves should
be worn to clean up spills.
Respiratory Protection: None normally required.
Appearance: Clear liquid
Color: Colorless to pale yellow
Solubility in Water: Soluble
Specific Gravity: Not applicable
Stability: Stable
Conditions to Avoid: Exposure to flame or temperatures
above 300 EF.
Materials to Avoid: None known
Hazardous Decomposition Products: Iodine vapors
Hazardous Polymerization: Will not occur
Subchronic (Target Organ Effects): The following adverse reactions have been reported:
Central Nervous System: Vertigo
(including dizziness and lightheadedness), pain, vision abnormalities
(including blurred vision and photomas), headache, and taste perversion.
Other including anxiety, fever, motor and speech dysfunction, convulsion,
paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering,
transient ischemic attack, cerebral infarction, and nystagmus were
reported.
Gastrointestinal System: Nausea and vomiting. Others
including diarrhea, dyspepsia, cramp, and dry mouth were reported.
Cardiovascular System: Arrhythmias including PVCs
and PACs, angina/chest, pain and hypotension. Others including cardiac
failure, asystole, bradycardia, tachycardia, and vasovagal reaction
were reported. In controlled clinical trials, involving 1485 patients,
one fatality occurred. A cause and effect relationship between this
death and iohexol has not been established.
Respiratory System: Dyspnea, rhinitis, coughing,
and laryngitis. Skin and Appendages: Urticaria, purpura, abscess,
and pruritus.
Carcinogenicity: NTP: No, IARC: No, OSHA: No.
No data available
DISPOSAL CONSIDERATIONSDisposal Methods: As of the MSDS revision date, this product does not meet the United States EPA definition of a hazardous waste. Dispose in accordance with local, state and federal regulations.
TRANSPORT INFORMATIONProper Shipping Name: Non-regulated
REGULATORY INFORMATIONU. S. Federal Regulations: This product does not contain any ingredients which are regulated on the U.S. EPA List of Toxic Chemicals (40 CFR 372) above the deminimus threshold, and is therefore not subject to release reporting under Section 313 of EPCRA.
OTHER INFORMATIONRevision Date: April 2003 (company name and emergency number) Reference Documentation: Primary references used in the preparation of this document:
1. Omnipaque Package Insert
2. Omnipaque MSDS (Sterling Winthrop)
3. ACGIH Guide to Occupational Exposure Values - 1991
4. Sterling Winthrop Corporate Quality Pharmaceutical File - 2/10/89
Disclaimer: This information is furnished
without warranty, representation, or license of any kind, except that
it is accurate to the best of Amersham Health knowledge or obtained from
sources believed to be accurate. Amersham Health does not assume any legal
responsibility for use or reliance upon same. Customers are encouraged
to conduct their own tests. Before using any product, read its label.
SOURCE: AMERSHAM HEALTH WEBSITE: www.amershamhealth-us.com
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APPENDIX 2 -
BARIUM SULFATE SUSPENSION PRODUCTS
Date REVISED: MARCH 1, 2004
SECTION I.
Product Identification
-
Product Name: Barium Sulfate Suspension Products
Manufacturer: E-Z-EM Canada Inc. 11100 Colbert, Anjou,
Quebec, H1J2M9, Canada; *Product Code 575 is Manufactured for E-Z-EM.
Emergency/Information Contact: Judy Hauser/Adrianne Setton
Emergency/Information Telephone:(516) 333-8230 Extension 2377/2400
Product Codes: 575*, 720, 721, 723, 724, 726, 728, 729, 738, 770, 7150, 7250, 7350, 7450, 8100, 8140, 9450, L147, L150, L164, L168, L172, L178, L186, L196, P410, P650pps, P850pps
SECTION II.
Components
| Components | CAS No. | %(Optional) |
| Barium Sulfate (can contain silica - quartz ) |
7727-43-7 (14808-60-7) | Proprietary (0.1 - 1% of barium sulfate) |
| Suspending and Dispersing Agents | Proprietary | |
| Flavors | Proprietary | |
| May contain Sorbitol | 50-70-4 | Proprietary |
| May contain Poligeenan | 53973-98-1 | ›0.1% |
| May contain Sodium Saccharin | 128-44-9 | ‹0.1% |
SECTION III.
Physical Data
-
Boiling Point: Not tested
Specific Gravity (H2O = 1): Range : Not tested
Vapor Pressure (mm Hg): Not tested
Melting Point: Not tested
Vapor Density (Air = 1): Not tested
Evaporation Rate (Butyl Acetate = 1): Not tested
Solubility in Water: Insoluble
Appearance & Odor: White to off-white or tan suspension with no odor or slightly fruity or vanillin odor.
SECTION IV.
Fire and Explosion Hazard Data
-
Flash Point (method): Not tested
Flammable Limits: UEL - N/A LEL - N/A
Fire Extinguishing Media: Use extinguishing media that is suitable for surrounding fire.
Special Fire Fighting Procedures: Firefighters should wear full protective equipment and self- contained breathing apparatus with full face piece.
Unusual Fire & Explosion Hazards: None known
Toxic Gases Emitted: Sulfur dioxide
SECTION V.
Reactivity Data
-
Stability: Stable
Conditions to avoid: None documented
Incompatible materials: Phosphorus, Aluminum
Decomposition products: Not tested
Hazardous Polymerization: Will not occur
SECTION VI.
Health Hazard Data
-
Permissible Exposure Limit (PEL) for barium sulfate: Total
Dust - 15 mg/m3 Time Weighted Average (TWA), Respirable dust - 5 mg/m3
TWA. Dust is not a concern since these products are liquids.
Threshold Limit Value (TLV) for barium sulfate: Total Dust: 10 mg/m3 TWA Silica - quartz, respirable dust - 0.1 mg/m3. Dust is not a concern since these products are liquids.
Short-Term Exposure Limit (STEL): Not established
Routes of Exposure: Inhalation (dust exposure is not a concern since these products are liquids), Ingestion
Health Hazards (acute and chronic): Through normal routes of entry, not expected to be a hazard. In some cases where skin and eye contact occurs, product may cause irritation. No adverse health effects expected from chronic exposure.
Carcinogenicity: Some products contain poligeenan. IARC lists poligeenan as a Class 2B meaning it is Apossibly carcinogenic to humans. NTP: No IARC: Yes OSHA: No
Effects of exposure: May cause constipation. Some formulations contain sorbitol, which may cause diarrhea in some individuals. Consult label for more information.
Medical conditions generally aggravated by exposure: No information found relating to normal routes of exposure.
- Eye contact - Flush with water for at least 15 minutes.
- Skin contact - Wash area thoroughly with soap and water.
- If ingested and person is conscious - Give several glasses of water to dilute. If irritation persists or large quantities are ingested, get medical attention.
SECTION VII.
Spill and Disposal Information
-
Steps to be taken in case material is released or spilled: Wear
appropriate protective equipment. Absorb material with an absorbent and
inert material, such as sand or vermiculite. Place materials in a container
and label properly.
Waste Disposal Procedures: Products are not listed hazardous wastes under RCRA. Products are not likely to qualify as characteristic hazardous wastes, but any final determination depends on the specific circumstances of product usage and handling. Disposal should take place in compliance with federal, state and local laws and regulations.
SECTION VIII.
Handling and Storage Precautions
-
Store indoors in a tightly closed container, protected from extreme temperatures
and potential sources of damage. Can be stored in any general chemical
storage area.
Do not smoke, eat or drink while handling any chemical. Practice good industrial and personal hygiene to avoid unnecessary exposure.
SECTION IX.
Protective Equipment
-
Respiratory Protection: Barium sulfate liquid suspensions
are not expected to require any personal respirator usage.
Ventilation: Use adequate local exhaust ventilation to keep fume levels as low as possible.
Protective Gloves: Appropriate gloves
Eye Protection: Safety goggles or glasses
Emergency Equipment: Always ensure there is an emergency eye wash in the area.
Disclaimer: The information contained
in this Material Safety Data Sheet is believed to be correct, but does
not purport to be all inclusive, and should only be used as a guide. E-Z-EM
Inc. or subsidiaries of shall not be held liable for any damage resulting
from the handling or contact with these products.
SOURCE: E-Z-EM, Inc website: www.ezem.com
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APPENDIX 3 - GASTROVIEW
MATERIAL SAFETY DATA SHEET
-
Revision Date: January 1, 2003
Information Telephone Number: (888) 744-1414
Emergency Telephone Number: (314) 654-1600
CHEMTREC: 1-800-424-9300
CANUTEC: 613-996-6666
66%
10%
24%
Inhalation: Not expected to be a health hazard via inhalation.
Ingestion: Excessive oral doses may cause gastrointestinal upset.
Skin Contact: May cause irritation.
CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: MD-Gastroview
Synonyms: Diatrizoate meglumine and diatrizoate sodium
Manufacturer:
Mallinckrodt Inc.
P. O. Box 5840
St. Louis, MO 63134
COMPOSITION, INFORMATION ON INGREDIENTS
Diatrizoate meglumine Diatrizoate
sodium Proprietary Components Component CAS # Wt %
HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW
Read Package Insert Prior to Use Ensure prompt removal from skin,
eyes and clothing. As part of good laboratory and personnal hygiene
and safety procedure, avoid all unnecessary exposure to the chemical
substance.
POTENTIAL HEALTH EFFECTS
Eye Contact: May cause irritation with redness and
pain.
Chronic Exposure: No information found.
Aggravation of Pre-existing Conditions: No information
found.
Inhalation: Not expected to require first aid measures.
Eye Exposure: In case of contact, immediately flush
eyes with plenty of water for at least 15 minutes. Call a physician.
Flammability: Not a flammable material.
Fire/Explosion Hazards: Not considered to be a fire
or explosion hazard.
Fire Extinguishing Media: Use any means suitable
for extinguishing surrounding fire.
Special Instructions: In the event of a fire, wear
full protective clothing and NIOSH-approved self-contained breathing
apparatus with full face piece operated in the pressure demand or
other positive pressure mode.
Ventilate area of leak or spill. Clean-up personnel may require protective
clothing. Absorb liquid spills with a dry absorbent. Containerize
unusable material for disposal in an approved waste facility.
Ensure compliance with local, state and federal regulations.
Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage.
EXPOSURE CONTROLS, PERSONAL PROTECTIONAirborne Exposure Limits: None established.
Engineering Controls: Not expected to require any
special ventilation.
Respiratory Protection: (NIOSH Approved) Not expected
to require personal respirator usage.
Skin Protection: Wear protective gloves and clean
body-covering clothing.
Eye/Face Protection: Use chemical safety goggles.
Maintain eye wash fountain and quick-drench facilities in work area.
Ingestion: If large amounts were swallowed, give
water to drink and get medical advice.
Skin Exposure: Remove any contaminated clothing.
Wash skin with soap or mild detergent and water for at least 15 minutes.
Give medical attention if irritation develops or persists.
Appearance: Yellow to light brown solution.
Odor: Odorless.
Solubility: Soluble in water.
Boiling Point: Approx. 100°C (212°F).
Melting Point: Approx. 0°C (32°F).
Density: No information found.
Vapor Density (Air=1): No information found.
Vapor Pressure (mm Hg): No information found.
Evaporation Rate: No information found.
Stability: Stable under ordinary conditions of use
and storage.
Hazardous Decomposition Products: May emit carbon
oxides, nitrogen oxides, and iodine vapors when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: No information found.
Intravenous rat LD50: 14565 mg/kg (Diatrizoate Meglumine);
Intravenous mouse LD50: 14000 mg/kg (Diatrizoate
Sodium); investigated as a mutagen (Diatrizoat Sodium).
For detailed toxicological information on specific components,
write to the address listed in Section 1 - Attn: Corporate Product
Monitoring Department.
Because this product is intended for use by hospital or clinic patients, it is expected to be treated by standard wastewater treatment facilities with no adverse environmental impacts.
DISPOSAL CONSIDERATIONSIf medical waste is involved, such as blood, blood products, or sharps, the waste must be handled as a biohazard and disposed of accordingly. If not a biohazard, waste MD-GastroviewÆÊ is considered non-hazardous. Consult local, state and federal regulations for proper disposal.
TRANSPORT INFORMATIONNot regulated as a Hazardous Material by the Department of Transportation.
REGULATORY INFORMATIONOSHA Hazard Communication
This product is not considered hazardous under the OSHA Hazard Communication
Standard (29 CFR 1910.1200).
CERCLA Reportable Quantities: Not applicable.
SARA Title III
302 Extremely Hazardous Substances: None
313 Toxic substances subject to annual release reporting requirements:
None
RCRA Hazardous Waste Status: Non-hazardous (See Section
13 for additional details.)
California Proposition 65 Warning: Not Applicable
Australian Hazchem Code: None allocated.
Australian Poison Schedule: None allocated.
WHMIS: This MSDS has been prepared according to the
hazard criteria of the Controlled Products Regulations (CPR) and the
MSDS contains all of the information required by the CPR.
MSDS Status: Revised in accordance with
ANSI Guideline Z400.1-1998.
NFPA Ratings: Health: 0 Fire: 0 Reactivity: 0
Product Use: Diagnostic imaging agent
Revision Information: Sections 1, 11 and 15 updated.
Source: Mallinckrodt, Inc: www.imaging.mallinckrodt.com
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