MATERIAL SAFETY DATA SHEET
OCTREOSCAN餂?
SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: OctreoScan餂? Revision Date: January 1, 2003
Information Telephone Number: (888) 744-1414
Synonyms: Indium In-111 labeled Pentetreotide
Emergency Telephone Number: (314) 654-7860
Manufacturer: Mallinckrodt Inc.
2703 Wagner Place CHEMTREC: 1-800-424-9300
Maryland Heights, MO 63043 CANUTEC: 613-996-6666
SECTION 2. COMPOSITION, INFORMATION ON INGREDIENTS
Chemical Ingredients:
Component CAS # Wt %
Lyophilized Material:
Pentetreotide 138661-02-6 0.06%
Inositol 87-89-8 57.8%
Trisodium Citrate Dihydrate 6132-04-3 28.4%
Gentisic Acid 490-79-9 11.6%
Citric Acid Monohydrate 5949-29-1 2.1%
Indium Chloride In-111 Sterile Solution-0.2M:
Indium Chloride In-111 50800-85-6 <1%
Hydrogen Chloride 7647-01-0 <1%
Ferric Chloride 7705-08-0 <1%
Water 7732-18-5 >99%
SECTION 3. HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW
CAUTION! RADIOACTIVE MATERIAL. Read Package Insert prior to use. Promptly remove any
contamination from the skin, eyes, or clothing. Radioactive drugs must be handled by qualified personnel
in conformity with regulations appropriate to the government agency authorized to license the use of this
radionuclide. The vial containing the drug should be kept within its container or within heavier shielding.
Avoid contact with the radioactive contents which would cause unnecessary exposure to radiation.
POTENTIAL HEALTH EFFECTS
Eye Contact:
The hazardous ingredients found in OctreoScan
are skin and eye irritants, but due to the form of No adverse effect expected, but may cause
the material (Iyophilized pellet) no adverse mechanical irritation.
health effects are expected to occur from
exposure. The following information applies to
Chronic Exposure:
the radioactive Indium (In-111) in the kit:
The health risks associated with chronic
Inhalation: radiation exposure (cancer, leukemia, genetic
Indium Chloride does not easily become and teratogenic effects) are believed to involve
airborne. Not expected to be a health hazard via levels of radiation exposure which are much
inhalation. higher than those permitted occupationally.
Ingestion: Aggravation of Pre-existing Conditions:
May cause asymptomatic physiological uptake No information found.
by specific target organs or tissues.
OCTREOSCAN餂?
OCTREOSCAN餂?
SECTION 4. FIRST AID MEASURES
Minimal first aid is expected to be required as a The amount of material ingested should be
result of exposure to the Iyophilized material. Wash assessed and documented.
exposed skin with soap and water and wash
Skin Exposure:
exposed eyes thoroughly with running water. In
If skin contact occurs, wash the affected area
both instances, seek medical attention if irritation
thoroughly with soap and water until no more
develops.
radioactivity can be removed. Always blot dry.
The following information applies to the radioactive
Do not abrade skin. Notify radiation safety
Indium (In-111) in the kit.
personnel.
Inhalation:
Notify radiation safety personnel immediately. Eye Exposure:
The amount of material inhaled should be If a splash occurs, wash eyes with water for at
assessed and documented. least 15 minutes or until no more radioactivity
can be removed. Notify radiation safety
Ingestion:
personnel.
Notify radiation safety personnel immediately.
SECTION 5. FIRE FIGHTING MEASURES
Fire: Not considered to be a fire hazard.
Explosion: Not considered to be an 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
If product is received in a leaking condition or any loss or release of the radioactive contents occurs, notify
your Radiation Safety Department and Mallinckrodt at (314) 654-7860. All cleanup operations should be
performed according to the Standard Operating Procedures (SOPs) established for your facility and by
the NRC or other applicable local, state or federal regulations.
SECTION 7. HANDLING AND STORAGE
Protect from light. The drug should be stored at 2掳C to 8掳C both prior to and following reconstitution with
Indium Chloride In-111 and discarded after six (6) hours from the time of preparation. After reconstitution,
handling time should be kept to a minimum, and appropriate shielding should be used. Handling devices
such as syringe shields and tongs should be used. Storage and disposal of product should be controlled
in a manner that is in compliance with the appropriate regulations of the government agency authorized to
license the use of this radionuclide.
SECTION 8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Airborne Exposure Limits: Skin Protection:
鈥揘RC Occupational concentration limit is Disposable plastic, latex, or rubber gloves;
3 x 10-6 碌Ci/mL of air. labcoat.
Engineering Controls: Eye/Face Protection:
Properly sealed containers are not expected to Safety glasses.
require any special ventilation.
Precautions:
Respiratory Protection: No smoking, eating, or drinking should be
Not expected to require personal respirator allowed in any area where radioactive materials
usage. are handled or stored.
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OCTREOSCAN餂?
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: Lyophilized white pellet in a 10 mL vial. Radioactivity: 3.3 mCi at the time of calibration
Clear, colorless liquid in a 10 mL vial (Indium 111). (Indium 111)
Odor: Odorless. Concentration: 3.0 mCi/mL minimum on the
calibration date and time (Indium 111)
Solubility: Somewhat soluble in water.
Half Life: 67.32 hours.
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.
Hazardous Decomposition Products: When heated to decomposition, Iyophilized material may emit
carbon dioxide and carbon monoxide; solution may emit radioactive fumes containing In-111.
Hazardous Polymerization: Will not occur.
Incompatibilities: Protect from light, strong oxidizers and reducing agents.
SECTION 11. TOXICOLOGICAL INFORMATION
It is widely accepted by the scientific community that exposure to sufficient quantities of ionizing
radiation can potentially cause harmful biological effects which include cancer, leukemia, and genetic
and teratogenic effects. For detailed toxicological information on specific components, write to the
address listed in Section 1 - Attn: Regulatory Compliance 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
Octreoscan餂? reconstituted with Indium Chloride In-111 is Radioactive Waste until the activity has
decayed to nondetectable levels. Radioactive waste must be handled in accordance with procedures
established by your Radiation Safety Officer, NRC and other applicable regulations.
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 radioactive or a biohazard, waste Octreoscan is considered non-hazardous. Consult local, state
and federal regulations for proper disposal.
SECTION 14. TRANSPORT INFORMATION
DOT (Department of Transportation):
Proper Shipping Name: Radioactive Material, n.o.s.
Hazard Class: 7
Identification Number: UN2982
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OCTREOSCAN餂?
SECTION 15. REGULATORY INFORMATION
CERCLA Reportable Quantities:
In-111 = 100 Ci (3.7 E 12 Bq)
Releases to air, land or water of these hazardous substances which exceed the Reportable Quantity
(RQ) must be reported to the National Response Center at 800-424-8802.
SARA Title III
302 Extremely Hazardous Substances: None
311/312 Hazard Categories: Chronic
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
This product contains a substance known to the State of California to cause cancer.
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: 1 Flammability: 0 Reactivity: 0
Product Use: Diagnostic imaging agent
Revision Information: Section 8 updated.
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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