Lohre J M, Baclig L, Wickham E, Guida S, Farley J, Thyagarajan K, Tu R, Quijano R C
Baxter Healthcare Corporation, Edwards CVS Division, Irvine, California 92714.
ASAIO J. 1993 Apr-Jun;39(2):106-13.
Two epoxy ether compounds [glycerol polyglycidyl ether (Denacol EX-313) and ethylene glycol diglycidyl ether (Denacol EX-810)] are under consideration as alternatives to glutaraldehyde for use in the processing of an arterial graft. The two are utilized as cross-linking and sterilant agents, respectively. Epoxy resins are multifunctional alkylating agents, and bifunctional alkylating epoxide solutions are known to be mutagenic. The correlation between mutagenic potential and carcinogenicity, in addition to evidence that diepoxides are carcinogenic in mice and rats, prompted the evaluation of the mutagenic potential of the epoxy treated, clinically rinsed graft. Ames and sister chromatid exchange (SCE) test procedures were used to assess mutagenic potential. Normal saline and distilled water were selected as the most physiologically representative and procedurally acceptable extraction mediums for the Ames and SCE tests, respectively. The results of the Ames and SCE tests in both the activated and non activated systems indicated that there were no statistically significant differences detected between various test article concentrates and the spontaneous mutation controls for both the activated and non activated systems. The epoxy treated graft was determined to be non mutagenic and demonstrated no dose related responses by these methods.
两种环氧醚化合物[甘油聚缩水甘油醚（Denacol EX - 313）和乙二醇二缩水甘油醚（Denacol EX - 810）]正在被考虑作为戊二醛的替代品，用于动脉移植物的处理。这两种化合物分别用作交联剂和消毒剂。环氧树脂是多功能烷基化剂，已知双功能烷基化环氧化合物溶液具有致突变性。致突变潜力与致癌性之间的相关性，以及二环氧物在小鼠和大鼠中具有致癌性的证据，促使人们对经环氧处理并经临床冲洗的移植物的致突变潜力进行评估。采用艾姆斯试验和姐妹染色单体交换（SCE）试验程序来评估致突变潜力。生理盐水和蒸馏水分别被选为艾姆斯试验和SCE试验中最具生理代表性且在操作上可接受的提取介质。在活化和非活化系统中进行的艾姆斯试验和SCE试验结果表明，各种受试物浓缩物与活化和非活化系统的自发突变对照之间均未检测到统计学上的显著差异。经环氧处理的移植物被确定为无致突变性，并且通过这些方法未显示出剂量相关反应。
