Evaluation of Two Epoxy Ether Compounds for Biocompatible Potential

Abstract

Bovine arterial tissue exposed to two epoxy ether compounds (Denacol EX-313 and Denacol EX-810) was evaluated for its biocompatible potential by in vitro and in vivo test procedures. The battery of test procedures included percent Inhibition of Cell Growth, Medium Eluate Method (MEM), Agar Overlay (AO), Blood Compatibility, Acute Mouse Systemic Injection, Rabbit Intracutaneous Irritation, Rabbit Subcutaneous Implantation, Guinea Pig Maximization, and Ames Tests. The epoxy exposed tissue was found to be noncytotoxic, nonmutagenic, and biocompatible by the test methods employed. In addition, the maximum concentrations of the unreacted Denacol EX-313 and EX-810 solutions found to demonstrate noncytotoxic reactions by the MEM and AO procedures were identified as 55 and 60 ppm for the MEM and 150 and 200 ppm for the AO procedure, respectively. These studies suggest that Denacol EX-313 and EX-810 are acceptable solutions for the processing of implantable tissue provided the epoxy residuals remain below those levels found to be cytotoxic.