In vitro evaluation of hemolytic and cell culture toxicity potential of residual ethylene oxide in selected medical materials.

The hemolytic potential of pure ethylene oxide in solution was evaluated as a function of initial ethylene oxide concentration in three test systems, diluted whole blood in isotonic saline, erythrocytes washed and resuspended in isotonic saline, and erythrocytes washed and resuspended in isotonic phosphate buffer. Concentrations of 2 mg/ml (2000 ppm) were necessary before cell lysis was observed in either of the isotonic saline systems. This value increased to 10 mg/ml 10,000 ppm) in the isotonic buffer system. Efforts have been made to correlate the hemolysis and cell culture toxicity of residual ethylene oxide in five medical materials to the toxicity of pure ethylene oxide. Only materials exhibiting a low order of inherent toxicity showed any correlation. In poly(vinyl chloride) tubing containing 1.8 and 2.1 mg ethylene oxide per gram of material, a small amount of toxicity was seen in the cell culture system but toxicity was absent in the hemolysis test.