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J Environ Pathol Toxicol. 1977 Nov-Dec;1(2):161-82.
For the foreseeable future toxicologists will continue to rely on animal bioassays as the main predictive tools for safety evaluation. While their predictive value is good, there are serious limitations which must be recognized in applying the test results to assess human risk. These limitations are of especially great concern for chronic toxicity tests. During the past decade numerous protocols and guidelines for chronic toxicity and carcinogenesis tests have been developed by national and international organizations. These have been reviewed with two aspects in mind: the potential for standardization and the assessment of issues of greatest concern. Of the major design aspects, animal models, route of exposure, dose selection, pathology, and reporting requirements are the most controversial. While a degree of standardization of protocols has many advantages, complete standardization is not considered desirable as test objectives may differ, and overly rigid protocols would likely stifle development of improved methodology. One of the greatest dilemmas facing government health agencies is the extent of pathology to require in routine bioassays. A thorough microscopic examination is obviously desirable; however, the increased requirements for testing chemicals using the extensive pathology protocols now in existence has created a demand exceeding available scientific manpower.
在可预见的未来，毒理学家将继续依赖动物生物测定作为安全评估的主要预测工具。虽然其预测价值良好，但在将测试结果应用于评估人类风险时，存在一些必须认识到的严重局限性。这些局限性在慢性毒性测试中尤为令人关注。在过去十年中，国家和国际组织制定了许多慢性毒性和致癌性测试的方案和指南。对这些方案和指南进行审查时考虑了两个方面：标准化的可能性以及对最受关注问题的评估。在主要设计方面，动物模型、暴露途径、剂量选择、病理学和报告要求是最具争议性的。虽然方案的一定程度标准化有许多优点，但完全标准化并不被认为是可取的，因为测试目标可能不同，而且过于严格的方案可能会扼杀改进方法的发展。政府卫生机构面临的最大困境之一是在常规生物测定中需要进行病理学检查的程度。显然需要进行全面的显微镜检查；然而，使用现有的广泛病理学方案对化学品进行测试的要求增加，导致需求超过了现有的科学人力。
