Bantle J A, Burton D T, Dawson D A, Dumont J N, Finch R A, Fort D J, Linder G, Rayburn J R, Buchwalter D, Maurice M A
Department of Zoology, Oklahoma State University, Stillwater 74078.
J Appl Toxicol. 1994 May-Jun;14(3):213-23. doi: 10.1002/jat.2550140312.
An interlaboratory validation study was undertaken to evaluate the repeatability and reliability of the Frog Embryo Teratogenesis Assay-Xenopus (FETAX), which is a whole embryo developmental toxicity screening assay. A three-phase experimental program with seven participants was carried out. Phase I was a training and protocol evaluation phase where the identity of the three test materials was known. Hydroxyurea, isoniazid and 6-aminonicotinamide were tested in Phase I. Because the chemicals has been tested previously in FETAX, the same concentrations needed to establish the 96-h median lethal concentration (LC50) and the concentration inducing malformations in 50% of the surviving embryos (EC50) were used by all laboratories. The results of Phase I are presented in this report, and FETAX has proved to be as repeatable and reliable as many other bioassays. Some excess variation was observed in individual laboratories. Some of this variation may have been due to training difficulties. One change in protocol design necessitated by this study was the use of 6-aminonicotinamide as a reference toxicant. While 6-aminonicotinamide provided excellent concentration-response data in most laboratories, the protocol was written too strictly based on historical FETAX data. Phases II and III are currently in progress.
开展了一项实验室间验证研究，以评估非洲爪蟾胚胎致畸试验（FETAX）的重复性和可靠性，该试验是一种全胚胎发育毒性筛选试验。进行了一个有七个参与者的三阶段实验项目。第一阶段是培训和方案评估阶段，已知三种测试材料的身份。在第一阶段测试了羟基脲、异烟肼和6-氨基烟酰胺。由于这些化学品此前已在FETAX中进行过测试，所有实验室都使用了用于确定96小时半数致死浓度（LC50）和导致50%存活胚胎出现畸形的浓度（EC50）的相同浓度。本报告展示了第一阶段的结果，并且FETAX已被证明与许多其他生物测定法一样具有重复性和可靠性。在个别实验室中观察到了一些过度变异。其中一些变异可能是由于培训困难所致。这项研究导致方案设计的一个变化是使用6-氨基烟酰胺作为参考毒物。虽然6-氨基烟酰胺在大多数实验室中提供了出色的浓度-反应数据，但该方案基于FETAX的历史数据编写得过于严格。第二阶段和第三阶段目前正在进行中。
