Material Safety Data Sheet
Biogen, Inc. 24-Hour Emergency Phone:
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Cambridge, MA 02142 Biogen Environmental Health & Safety:
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Section 1. Identification
Product Name: LFA-3 Immunoglobulin Fusion Protein
Chemical Name: LFA-3 Immunoglobulin Fusion Protein
CAS Number: None
Substance: LFA-3 Immunoglobulin Fusion Protein (LFA3TIP) is a fusion
protein that is obtained from cultured recombinant Chinese Hamster Ovary cells.
Other Names or Code Numbers: LFA3TIP, BG9273, BG9712, LFA-3/IgG1 Fusion Protein
Section 2. Composition / Information on Ingredients
Components % Optional OSHA PEL ACGIH TLV OTHER STANDARDS
LFA3TIP
(bulk intermediate) 65 - 90% n/a n/a none known
(final product) 65 - 90% n/a n/a none known
LFA3TIP is obtained from cultured recombinant Chinese Hamster Ovary (CHO)
cells in a nutrient medium of proteins, amino acids, vitamins, glucose,
and salts in purified water. The bulk intermediate is contained in a
frozen aqueous solution. This solution does not contain any hazardous
components, as defined by the OSHA Hazard Communication Standard (29 CFR
1910.1200), at concentrations above 1%.
Section 3. Hazards Identification
General Statement: CAUTION: THE CHEMICAL, PHYSICAL, AND TOXICOLOGICAL
PROPERTIES OF LFA3TIP HAVE NOT BEEN THOROUGHLY INVESTIGATED. EXERCISE CARE
TO PREVENT CONTACT OR EXPOSURE.
Carcinogen Status: OSHA: No NTP: No IARC: No
Carcinogen Statement:
Mutagenic Effects: None observed in animal studies. LFA3TIP is
non-mutagenic and non-clastogenic. It was negative in the Salmonella
typhimurium and Escherichia coli plate incorporation mutation assays, and
in an in vitro human peripheral blood lymphocyte chromosome aberration
assay.
Teratogenic Effects: None observed in animal studies.
Reproductive Effects: None observed in animal studies. See Section 11.
Neurotoxic Effects: None observed in animal studies.
Section 4. First Aid Measures
If Inhaled: Remove to fresh air. Get medical attention. If breathing has
stopped, give artificial respiration. Treat symptomatically and
supportively
If Swallowed: Wash out with water.
In Case of Skin or Eye Contact: No data available. Flush at least 15
minutes with water. Wash exposed skin with soap and water. Contact
physician if irritation persists.
Skin Absorption: No data available.
If Injected: No data available.
Medical Conditions Aggravated by Exposure: No data available.
Section 5. Fire Fighting Measures
Flash Point: No data available oC
Flammable Limits: n/a
Extinguishing Media: Use water spray, CO2, ABC Dry Chemical, or Foam
Special Fire Fighting Materials: No special procedures.
Unusual Fire and Explosion Hazards: No data available.
Section 6. Accidental Release Measures
Spill/Leak Procedures:
Wear gloves, safety glasses or goggles, and lab coat or coveralls to
prevent contact. Wipe working surfaces to dryness, then wash with soap
and water.
Confine and contain small spills using inert material (e.g. paper towels,
spill control pillows, absorbants). In the event of a large spill, dike
the area to prevent runoff. Clean the spill area with soap and water.
Discard spill clean up materials in accordance with local regulations. In
addition, comply with local regulations concerning spill reporting.
Section 7. Handling and Storage
Handle all pharmaceutical products in a way that will avoid contact with
and inhalation of dust, fumes, mists, and/or vapors associated with the
product. No special safety procedures are required for storing this
product.
Section 8. Exposure Control / Personal Protection
Keep container tightly closed.
Wear gloves to prevent skin contact. Replace gloves which become torn or
punctured. Wash hands with soap and water whenever gloves are removed.
Either safety glasses with side shields, or goggles, should be worn when ha
ndling this material to prevent eye contact.
Lab coat, apron, or other impermeable clothing may be worn when handling
LFA3TIP.
Section 9. Physical and Chemical Properties
Molecular Formula:glycoprotein
Molecular Weight: 119 kilodaltons
Appearance/Odor: Odorless solution and/or frozen solid
Solubilities: Up to 50mg/mL in water; No data available for other solvents
Boiling Point: < 100 °C (decomposes)
Melting Point: Approximately 0 °C
Vapor Pressure (mm HG): No data available
Vapor Density (Air = 1): No data available
Specific Gravity (H20 = 1): No data available
pH: 7.5 +/- 0.3
Section 10. Stability and Reactivity
LFA-3 Immunoglobulin Fusion Protein is Stable
Hazardous Polymerization: No data available
Incompatible Materials: No data available
Conditions to Avoid: No data available
Hazard Decomposition Products: No data available
Section 11. Toxicology Information
CAUTION: THE CHEMICAL, PHYSICAL, AND TOXICOLOGICAL PROPERTIES OF LFA3TIP
HAVE NOT BEEN THOROUGHLY INVESTIGATED. THERE ARE NO DATA ON EFFECTS
FOLLOWING ACUTE INHALATION, INGESTION, SKIN OR EYE EXPOSURE. ANY
TOXICOLOGICAL DATA ON THE CHRONIC EFFECTS OF THIS PRODUCT ARE PROVIDED
BELOW.
WORKERS SHOULD EXERCISE CAUTION AND USE WORK PRACTICES WHICH MINIMIZE ANY
CONTACT OR EXPOSURE WHEN HANDLING THIS MATERIAL.
Target Organ Effects Data (Subchronic/chronic):
Single and repeat dose studies were conducted in baboons to determine the
potential toxicity of LFA3TIP following intravenous administration of
doses up to 20 mg/ kg. Baboons were clinically normal (unremarkable
clinical observations) during the treatment and post-treatment periods.
The pharmacological effects of LFA3TIP included a decrease in the absolute
number of peripheral blood and lymphoid organ T-lymphocytes. Single
intravenous doses ( greater than or equal to 1.0 mg/kg) administered
approximately every 3 days for one month or three months caused reductions
in peripheral blood and lymphoid organ T -cells. No other data are
available on the effects of exposure to LFA3TIP.
Carcinogenic effects data: No data available.
Mutagenic Effects data: None observed in animal studies. LFA3TIP was
negative in the bacterial mutagenicity assay, and non-clastogenic in in
vitro human PBL cytogenetics assay.
Reproductive/Teratogenic Effects data: No effects on reproductive
tissues from male and female baboons were observed following repeat dose
administration of LFA3TIP up to 20 mg/kg for 3 months.
Section 12. Ecological Information
No data available.
Section 13. Disposal Considerations
LFA3TIP is not a regulated hazardous material. It is water soluble and
may be disposed of as aqueous waste in accordance with state and local
regulatory requirements.
Section 14. Transport Information
DOT Proper Shipping Name: n/a
Hazard Class: n/a
ID #: n/a
Section 15. Regulatory Information
No data available.
Section 16. Other Information
MSDS Created: 1-Mar-95
Revised: 4-Mar-97
Prepared By: Susan B. Lee, CIH
Manager, Environmental Health and Safety
DISCLAIMER: The above mentioned data are based on Biogen's best present
knowledge of this product. Biogen cannot guarantee completeness or
accuracy of the information contained herein, and disclaims all liability
for incompleteness or inaccuracy of the information and for any claims of
damages arising from handling or use of this product.