MacFarland H N
J Assoc Off Anal Chem. 1975 Jul;58(4):689-91.
Two kinds of problems associated with developing standardized procedures for the safety evaluation of new compounds are identified. The first of these is the question of the desirability of using such standard methods. It is concluded that a basic set of procedures is to be recommended, but this should be supplemented with special tests as may be indicated. The second problem is connected with the technical difficulties of any given type of assay and is normally dealt with in terms of the state of the art at the time. Assays by the inhalation route tend to be custom designed and do not follow standard protocols. One of the causes of this situation is the propensity of individual investigators to design de novo the equipment used to effect exposure of animals to airborne substances. Second, some confusion exists because investigators do not always appreciate that the concentration-time product is not the same as the true dose received by the exposed subjects and this may lead to anomalies when dose-response relationships are being characterized. It is suggested that interlaboratory studies be undertaken to ascertain the variability that might be expected in independent assays of inhalation toxicity.
确定了与开发新化合物安全性评估标准化程序相关的两类问题。其中第一个问题是使用此类标准方法是否可取。得出的结论是，应推荐一套基本程序，但应根据具体情况辅以特殊测试。第二个问题与任何给定类型分析的技术困难有关，通常根据当时的技术水平来处理。吸入途径的分析往往是定制设计的，并不遵循标准方案。造成这种情况的一个原因是个别研究人员倾向于从头设计用于使动物接触空气传播物质的设备。其次，存在一些混淆，因为研究人员并不总是认识到浓度-时间乘积与暴露受试者实际接受的剂量不同，这可能会在表征剂量-反应关系时导致异常。建议开展实验室间研究，以确定吸入毒性独立分析中可能预期的变异性。
