Material Safety Data Sheet
Biogen, Inc. Emergency Phone Number:
14 Cambridge Center 1(800) 262-4363
Cambridge, MA 02142 Biogen Environmental Health and Safety:
(617) 679-2000 1 (617) 679-2236
Section 1. Identification
Product Name: BG9713
Chemical Name: Osteogenic Protein-1 (OP-1)
CAS Number: None
Substance: Recombinant Human Osteogenic Protein-1 produced in
culture by Chinese Hamster Ovary (CHO) cells
Other Names or Code Numbers: Osteogenic Protein-1, OP-1; Bone
Morphogenetic Protein-7, BMP-7
Section 2. Composition / Information on Ingredients
Components % OSHA PEL ACGIH TLV OTHER STANDARDS
Optional
OP-1 none none none known
The bulk intermediate product is a lyophilized powder. The finished
product is a frozen aqueous solution in 20 millimolar Sodium acetate
buffer. No other hazardous components are present in concentrations
greater than 1%.
Section 3. Hazards Identification
General Statement: BG9713 (OP-1) is a member of the tissue growth
factor (TGF-ß) family that is involved in bone
formation and in development of the kidney.
Carcinogen Status:OSHA: No NTP: No IARC: No
Carcinogen Statement: No data available.
Mutagenic Effects: No data available
Teratogenic Effects: No data available
Reproductive Effects: In vitro, OP-1 reduced production of pregnancy
maintaining hormones secreted by cultured human
trophoblasts.
Neurotoxic Effects: In a rat model, OP-1 protected nerve cells from
the effects of reduced oxygen and blood flow to
the brain.
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 biological activity of OP-1
relates to developing tissues. It has been shown to
regulate growth and differentiation of a variety of
cell types, including bone cells, cartilage, neural,
and epithelial cells.
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 or materials.
Unusual Fire and Explosion Hazards: No data available.
Section 6. Accidental Release Measures
No data available. OP-1 is not a hazardous material as defined by US EPA
or OSHA.
Section 7. Handling and Storage
Lyophilized product can be stored at 2-8°C. No special safety precautions
required.
Section 8. Exposure Control / Personal Protection
CAUTION: The chemical, physical, and toxicological properties of OP-1
have not been thoroughly investigated. Its biological activity relates to
regulation of growth and differentiation of a variety of cell types
including bone cells, cartilage, neural, and epithelial cells. Exercise
care to minimize contact or exposure.
Perform work in a chemical fume hood, Type IIB biological safety cabinet,
or other well ventilated area wherever possible.
For work performed without mechanical ventilation, follow procedures which
minimize the potential for direct skin or mucous membrane contact, or the
potential for exposure by inhalation or ingestion.
Use personal protective equipment such as lab coat, gloves, safety glasses
or goggles. Wash hands immediately upon removing gloves. Respiratory
protection should not be needed, however, if it is worn, be sure the
device is NIOSH approved, and individually fit tested.
Section 9. Physical and Chemical Properties
Molecular Formula: OP-1 is a 431 amino acid glycoprotein.
Molecular Weight: 49313 (predicted)
Appearance/Odor:
Bulk intermediate product:white, lyophilized powder/odorless
Finished product: frozen aqueous solution
Solubilities: 20 millimolar Sodium acetate buffer
Boiling Point: Decomposes at temperatures > 40 °C
Melting Point: No data available.
Vapor Pressure: n/a
Vapor Density: n/a
Specific Gravity: n/a
pH: 4.5 (0.5 mg/mL in sodium acetate buffer)
Section 10. Stability and Reactivity
OP-1 is Stable
Hazardous Polymerization: Will not occur
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 OP-1 have
not been thoroughly investigated. Exercise care to prevent exposure or
contact.
A single dose acute toxicity study was conducted in rats. Doses up to 2.5
mg/kg were administered once on Day 1 and animals were observed for a
total of 14 days. No acute toxicity or injection site histopathology was
observed.
A 28 day repeat dose intravenous toxicity study in rats was conducted.
Doses were administered once daily for 28 consecutive days at dose levels
up to 2.5 mg/kg. No systemic toxicity was observed; slight changes in
body weight, food consumption, red blood cell parameters, platelet and
neutrophil counts and serum globulin were observed at 2.5 mg/kg.
Localized injection site (tail vein) gross pathology revealed a
dose-dependent formation of cartilaginous and ossified tissue in white
concentric rings at the 2.5 mg/kg dose level.
Section 12. Ecological Information
No data available. OP-1 is not a regulated hazardous material.
Section 13. Disposal Considerations
OP-1 is not a regulated hazardous material. Dispose in accordance with
state and local regulatory requirements.
Section 14. Transport Information
DOT Proper Shipping Name: n/a
ID #: n/a
Section 15. Regulatory Information
No data available.
Section 16. Other Information
MSDS Created: 1-Jul-97
Revised:
Prepared By: Susan 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.