Material Safety Data Sheet

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Cambridge, MA 02142                            Biogen Environmental Health & Safety:
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Section 1. Identification

Product Name: Recombinant Human Plasma Gelsolin Chemical Name: Recombinant Gelsolin CAS Number: None Substance: Gelsolin is a protein (molecular weight approximately 83,000 daltons) that normally occurs at a concentration of 100-300 ug/mL in human plasma. Recombinant Human Plasma Gelsolin (rhu-pGelsolin) is made by a fermentation process using genetically modified E.coli. Other Names or Code Numbers: BG9385, Brevin, I18222, rhu-pGelsolin

Section 2. Composition / Information on Ingredients

Components % Optional OSHA PEL ACGIH TLV OTHER STANDARDS rhu-pGelsolin (Bulk Intermediate) < 20 mg/mL n/a n/a n/a (Final Formulation) 5 mg/mL n/a n/a n/a The mixtures do 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: Gelsolin is a protein normally present in human plasma. rhu-pGelsolin is made by a fermentation process in genetically modified E.coli. It also may be cultured in Chinese Hamster Ovary (CHO) cells. The chemical, physical and toxicological properties of this protein have not been thoroughly investigated. Exercise care to prevent contact or exposure. Carcinogen Status:OSHA: No NTP: No IARC: No Carcinogen Statement: Mutagenic Effects: No data available Teratogenic Effects: No data available Reproductive Effects: No data available Neurotoxic Effects: No data available

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 mouth out with water and seek medical attention. 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 Notes to Physician: The principal activities of Gelsolin relate to its ability to bind actin. Gelsolin can cap or sever actin filaments; it plays a critical role in regulating the actin monomer-polymer equilibrium. Based upon the observations made in primary dermal irritation studies and primary eye irritation studies, rhu-pGelsolin is not irritating.

Section 5. Fire Fighting Measures

Flash Point: No data available Flammable Limits: No data available 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

No data available. rhu-pGelsolin is not a hazardous material as defined by US EPA.

Section 7. Handling and Storage

No special safety procedures are required. For product safety and efficacy store bulk intermediate at -70°C; store final product at -70°C.

Section 8. Exposure Control / Personal Protection

Keep container tightly closed. Wear gloves, safety glasses and lab coat when handling.

Section 9. Physical and Chemical Properties

Molecular Formula: Molecular Weight: ~ 83,000 daltons Appearance/Odor: clear to very slightly opalescent solution with no odor. Solubilities: water, 40 mg/ml in Phosphate buffered saline (PBS) Boiling Point: ~ 100 °C Melting Point: ~ 0 °C Vapor Pressure (mm HG): n/a Vapor Density (Air = 1): n/a Specific Gravity (H20 = 1): ~ 1 pH: Bulk intermediate: 6.5 - 8.0 Solution l 18222: 6.8 - 7.5 @ 2-8 °C Final Formulation: 6.4 - 7.8

Section 10. Stability and Reactivity

rhu-pGelsolin 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 this product have not been thoroughly investigated. Clinical trials are under way. Exercise care to prevent contact or exposure. In limited pilot studies, single and repeat intravenous administrations of early development material to rats and to cynomolgus monkeys were well tolerated at dose levels of 50 mg/kg and 20 mg/kg, respectively, and produced no evidence of toxicity, anaphylactic response or sensitization. As a result of primary eye and dermal irritation studies, rhu-pGelsolin was classified as non-irritating.

Section 12. Ecological Information

No data available. rhu-pGelsolin is not a regulated hazardous material.

Section 13. Disposal Considerations

rhu-pGelsolin 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: 27-Apr-96 Revised: 31-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.