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首页> 美国卫生研究院文献>Environmental Health Perspectives >The OECD program to validate the rat uterotrophic bioassay. Phase 2: coded single-dose studies.
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The OECD program to validate the rat uterotrophic bioassay. Phase 2: coded single-dose studies.

机译：经合发组织的计划以验证大鼠子宫营养生物测定。阶段2：编码的单剂量研究。

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The Organisation for Economic Co-operation and Development has completed phase 2 of an international validation program for the rodent uterotrophic bioassay. This portion of phase 2 assessed the reproducibility of the assay with a battery of positive and negative test substances. Positive agonists of the estrogen receptor included the potent reference estrogen 17-ethinyl estradiol (EE), and the weak estrogen agonists bisphenol A, genistein, methoxychlor, nonylphenol, and o,p -DDT. The negative test substance or nonagonist was n-dibutylphthalate. The test substances were coded, and prescribed doses of each test substance were administered in 16 laboratories. Two versions of the uterotrophic assay, the intact immature and the adult ovariectomized female rat, were tested and compared using four standardized protocols covering both sc and po administration. Assay reproducibility was compared using a) EE doses identical to those used in phase 1 and in parallel dose-response studies, b) single doses of the weak agonists identical to one of five doses from the dose-response studies, and c) a single dose of the negative test substance. The results were reproducible and in agreement both within individual laboratories and across the participating laboratories for the same test substance and protocol. The few exceptions are examined in detail. The reproducibility was achieved despite a variety of different experimental conditions (e.g., variations in animal strain, diet, housing protocol, bedding, vehicle, animal age). In conclusion, both versions of the uterotrophic bioassay and all protocols appear robust, reproducible, and transferable across laboratories and able to detect weak estrogen agonists. These results will be submitted along with other data for independent peer review to provide support for the validation of the uterotrophic bioassay.
机译：经济合作与发展组织已经完成了啮齿动物子宫营养生物测定国际验证计划的第二阶段。第2阶段的这一部分评估了一系列阳性和阴性测试物质的测定的可重复性。雌激素受体的阳性激动剂包括有效的参考雌激素17-乙炔基雌二醇（EE），弱雌激素激动剂双酚A，染料木黄酮，甲氧基氯，壬基酚和o，p -DDT。阴性测试物质或非激动剂是邻苯二甲酸二丁酯。对测试物质进行编码，并在16个实验室中按规定剂量服用每种测试物质。使用涵盖皮下注射和口服给药的四种标准化方案，测试并比较了两种形式的子宫营养测定法，即完整未成熟和成年卵巢切除的雌性大鼠。使用以下方法比较测定的可重复性：a）EE剂量与阶段1和平行剂量反应研究中使用的剂量相同，b）单剂弱激动剂与剂量反应研究中的五剂之一相同，并且c）单剂阴性测试物质的剂量。结果是可重复的，并且在单个实验室内以及在参与研究的实验室中，对于相同的测试物质和实验方案，结果都是一致的。我们将详细检查一些例外情况。尽管有各种不同的实验条件（例如，动物品系，饮食，住房规程，被褥，媒介物，动物年龄的变化），仍可实现可重复性。总之，两种形式的子宫营养生物测定法和所有方案在实验室之间均表现出强大，可重复和可移植的特性，并且能够检测到弱的雌激素激动剂。这些结果将与其他数据一起提交以供独立同行评审，以支持子宫营养生物测定的验证。

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