property (dry) | procedure | BioSpan® |
|---|---|---|
Initial Modulus (psi) |
D-1708 |
1833 |
Tensile Strength (psi) |
D-1708 |
6162 |
Ultimate Elongation (%) |
D-1708 |
875 |
Hardness |
D-2240 |
70A |
Glass Transition Temperature (°C) |
D-3418 |
-65 |
Water Absorption (%) |
D-570 |
1.5 |
Mw (Daltons) |
D-3593 |
180,000 |
Appearance |
NA |
Translucent |
Solution Concentration by Weight (%) |
NA |
24 |
Representative Biological Test Results
biological test | results |
|---|---|
Primary Skin Primary Mucosal |
Non-irritant Non-irritant |
Kligman's Maximuzation-CSO extract Kligman's Maximization-NaCl extract |
Weak allergic potential Weak allergic potential |
USP Cytotoxicity (MEM Elution) |
Non-cytotoxic |
USP Acute Systemic Intracutaneous Injection |
Non-toxic Non-toxic |
Hemolysis Lee White Clotting |
Non-hemolytic No effect on the clotting time of whole blood |
USP Pyrogen |
Non-pyrogenic |
USP Muscle Implantation (14 days/rats) |
Macroscopic-not significant tissue contact irritation Microscopic-Non-irritant |
Ames Mutagenicity Assay Chromosome Aberation Balb/c-3T3 Cell Transformation |
Non-mutagenic Non-clastogenic Does not induce morphological cell transformation in activated or non-activated test systems |
Repeat Dose IV Study |
Non-toxic |
USP Muscle Implantation (120 days/rats) |
Macroscopic-not significant tissue contact irritation Microscopic-slight irritant |
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