MATERIAL SAFETY DATA SHEET
GastroMARK餂?
(ferumoxsil oral suspension)
SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: GastroMARK餂? Revision Date: January 1, 2003
Synonyms: ferumoxsil oral suspension; Information Telephone Number: (888) 744-1414
Poly[N-(2-aminotethyl)-3-aminopropyl] siloxane-coated Emergency Telephone Number: (314) 654-1600
non-stoichiometric magnetite CHEMTREC: 1-800-424-9300
Manufacturer: Mallinckrodt Inc. CANUTEC: 613-996-6666
P.O. Box 5840
St. Louis, MO 63134
SECTION 2. COMPOSITION, INFORMATION ON INGREDIENTS
Chemical Formula: FeOx(C5H13N2SiO2)y
Chemical Ingredients:
Component CAS # Wt %
Superparamagnetic Iron Oxide 1345-25-1 91%
Silicone 63148-62-9 9%
The formulation contains CML, parabens, orange color, orange flavor,
saccharin, sorbitol, NaCl, NaOH, and water.
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 personal hygiene
and safety procedure avoid all unnecessary expose to the chemical substance.
POTENTIAL HEALTH EFFECTS
Skin Contact:
Inhalation:
No adverse effects expected.
Not expected to be a health hazard via
inhalation.
Chronic Exposure:
No adverse health effects expected from
Ingestion:
chronic exposure.
Excessive oral doses may produce
gastrointestinal disturbances.
Aggravation of Pre-existing Conditions:
May provoke an allergic reaction in people with
Eye Contact:
hypersensitivity to iron oxides.
No adverse effects expected, but spashes may
cause mechanical irritation.
GastroMARK餂?
GastroMARK餂?
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:
May cause diarrhea and flatulence.
Eye Exposure:
In case of eye 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. Ensure compliance with local, state and
federal regulations.
SECTION 7. HANDLING AND STORAGE
Store at 2掳C to 25掳C (36掳F-77掳F). Do not freeze.
SECTION 8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Airborne Exposure Limits: Respiratory Protection:
None established. Not expected to require personal respirator
usage.
Engineering Controls:
Not expected to require any special ventilation. Skin Protection:
Wear protective gloves.
Eye/Face Protection:
Safety glasses. Maintain eye wash fountain and
quick-drench facilities in work area.
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GastroMARK餂?
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: Dark brown to orange brown Specific Gravity: 1.01.
suspension.
pH: 5.5-9.0 adjusted with sodium hydroxide.
Odor: Odorless.
Osmolality: 250 mOsm/kg.
Solubility: Insoluble in water, alkali and
Melting Point: Not applicable.
organic solvents. Decomposed in strong acids.
Boiling Point: ca. 100掳C (212掳F).
SECTION 10. STABILITY AND REACTIVITY
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: None known.
Hazardous Polymerization: Will not occur.
Incompatibilities: No information found.
SECTION 11. TOXICOLOGICAL INFORMATION
Maximum dose level studies in rats and dogs exceeded the anticipated human clinical dose of
approximately 2-3 mg Fe/kg by up to 1000 times as the drug substance and 20 times as the drug
product.
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.
餂?
If not a biohazard, waste GastroMARK is considered non-hazardous. Consult local, state and federal
regulations for proper disposal.
SECTION 14. TRANSPORT INFORMATION
DOT (Department of Transportation): Not regulated as a hazardous material.
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GastroMARK餂?
SECTION 15. REGULATORY INFORMATION
OSHA Hazard Communication:
This product is not considered hazardous under the OSHA Communication Standard (29 CFR
1910.1200) guidelines.
CERCLA Reportable Quantities:
Not applicable.
SARA Title III:
302 Extremely Hazardous Substances: None
311/312 Hazard Categories: 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: Sections 1 and 15 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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