MATERIAL SAFETY DATA SHEET
OPTIRAY餂? Ioversol Injection
SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: Optiray餂? Ioversol Injection Manufacturer: Mallinckrodt Inc.
Synonyms: Optiray餂? 160 Ioversol Injection 34%; P.O. Box 5840
St. Louis, MO 63134
Optiray餂? 240 Ioversol Injection 51%;
Optiray餂? 300 Ioversol Injection 64%; Revision Date: January 1, 2003
Optiray餂? 320 Ioversol Injection 68%; Information Telephone Number: (888) 744-1414
Optiray餂? 350 Ioversol Injection 74%; Emergency Telephone Number: (314) 654-1600
CHEMTREC: 1-800-424-9300
N,N'-bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl
CANUTEC: 613-996-6666
-glycolamido]-2,4,6-triiodoisophthalamide
SECTION 2. COMPOSITION, INFORMATION ON INGREDIENTS
Component CAS # Wt %
Ioversol 87771-40-2 34-74%
Edetate calcium disodium 63-33-9 < 1%
Tris (hydroxymethyl) aminomethane 77-86-1 < 1%
Proprietary Components 鈥? 26-66%
SECTION 3. 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
Inhalation: Not expected to be a health hazard Eye Contact: No adverse effects expected, but
via inhalation. splashes may cause mechanical irritation.
Ingestion: Chronic Exposure:
Excessive oral doses may produce No adverse effects expected from chronic
gastrointestinal disturbances. exposure.
Skin Contact: Aggravation of Pre-existing Conditions:
No adverse health effects expected. May provoke an allergic reaction in people
allergic to iodine or iodinated substances.
OPTIRAY餂? IOVERSOL INJECTION
OPTIRAY餂? IOVERSOL INJECTION
SECTION 4. FIRST AID MEASURES
Inhalation: Skin Exposure:
Not expected to require first aid measures. Wash exposed area with soap and water. Get
medical advice if irritation develops.
Ingestion:
If large amounts were swallowed, give water to
Eye Exposure:
drink and get medical advice.
In case of contact, immediately flush eyes with
plenty of water for at least 15 minutes. Call a
physician if irritation develops.
SECTION 5. FIRE FIGHTING MEASURES
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 facepiece operated in the pressure demand or other positive
pressure mode.
SECTION 6. ACCIDENTAL RELEASE MEASURES
Small spills may be mopped up or flushed to sewer. Large spills may be collected for disposal or
absorbed with an inert material and containerized for disposal. Flush any residue with copious amounts of
water.
Ensure compliance with local, state and federal regulations.
SECTION 7. HANDLING AND STORAGE
Store at 25掳C (77掳F); excursions permitted to 15-30掳C (59-86掳F) and protect from light.
SECTION 8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Airborne Exposure Limits: Skin Protection:
None established. Wear protective gloves and clean
body-covering clothing.
Engineering Controls:
Not expected to require any special ventilation. Eye/Face Protection:
Safety glasses. Maintain eye wash fountain and
Respiratory Protection: (NIOSH Approved)
quick-drench facilities in work area.
Not expected to require personal respirator
usage.
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OPTIRAY餂? IOVERSOL INJECTION
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: Clear, colorless to pale yellow Specific Gravity: 1.188-1.405
solution.
Odor: Odorless.
Solubility: Very soluble in water.
Boiling Point: ca. 100掳C (212掳F).
Melting Point: ca. 0掳C (32掳F).
SECTION 10. STABILITY AND REACTIVITY
Stability: Stable under ordinary conditions of use and storage. Light sensitive.
Hazardous Decomposition Products: May emit toxic fumes of nitrous oxides and iodine when heated
to decomposition.
Hazardous Polymerization: This substance does not polymerize.
Incompatibilities: No information found.
SECTION 11. TOXICOLOGICAL INFORMATION
Intravenous rat LD50: 15 gm/kg (68% injection); No teratogenic or mutagenic activity.
For detailed toxicological information on specific components, write to the address listed in Section 1 -
Attn: Corporate Product Monitoring Department.
SECTION 12. ECOLOGICAL INFORMATION
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.
SECTION 13. DISPOSAL CONSIDERATIONS
Collected spills may be flushed to sewer with large amounts of water. Containerized material may be
disposed in an approved waste facility.
If 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 Optiray餂? Ioversol Injection is considered non-hazardous. Consult local, state
and federal regulations for proper disposal.
SECTION 14. TRANSPORT INFORMATION
Not regulated as a Hazardous Material by the Department of Transportation.
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OPTIRAY餂? IOVERSOL INJECTION
SECTION 15. REGULATORY INFORMATION
OSHA 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.
SECTION 16. OTHER INFORMATION
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: The following sections have been revised: 1,7, 9, 11, 15.
Mallinckrodt provides the information contained herein EXPRESS OR IMPLIED, INCLUDING WITHOUT
in good faith but makes no representation as to its LIMITATION ANY WARRANTIES OF MERCHANT-
comprehensiveness or accuracy. This document is ABILITY, FITNESS FOR A PARTICULAR PURPOSE
intended only as a guide to the appropriate WITH RESPECT TO THE INFORMATION SET
precautionary handling of the material by a properly FORTH HEREIN OR THE PRODUCT TO WHICH
trained person using this product. Individuals receiving THE INFORMATION REFERS. ACCORDINGLY,
the information must exercise their independent MALLINCKRODT WILL NOT BE RESPONSIBLE
judgment in determining its appropriateness for a FOR DAMAGES RESULTING FROM USE OF OR
particular purpose. MALLINCKRODT MAKES NO RELIANCE UPON THIS INFORMATION.
REPRESENTATIONS OR WARRANTIES, EITHER
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