Schlatter C, Reinhardt C A
Food Chem Toxicol. 1985 Feb;23(2):145-8. doi: 10.1016/0278-6915(85)90006-7.
The two most important elements in assessing the risk of topical injury from a chemical are its biological properties, in the context of skin and mucous membrane damage, and the likelihood and likely nature of topical contact with the chemical. Appropriate biological tests in model systems should be based on the probable circumstances of exposure. Topical contact takes place under two distinct sets of circumstances--intentional and accidental. Chemicals that are intended to come into contact with skin and mucous membranes include cosmetics and dermatological preparations. For such compounds the frequency and extent of skin contact is predictable and any irritant effects are unacceptable. The absence of irritant effects is established by testing in human volunteers or experimental animals. Since animal skin and mucous membranes are more susceptible to irritants than those of man, the amounts or concentrations tested need not be greater than those intended for human use. It is hoped that validated alternatives to animal models will soon be available. For household or industrial chemicals where skin and/or mucous-membrane contact occurs accidentally, topical contact should generally be avoided. In such cases the objective of irritancy testing should be to establish which compounds are particularly irritant and therefore need extra care in handling. We are convinced that this latter objective can be achieved by simpler and less cruel tests than the Draize eye-irritation test.
评估化学品造成局部损伤风险的两个最重要因素，一是在皮肤和黏膜损伤方面的生物学特性，二是与该化学品发生局部接触的可能性及可能的接触方式。模型系统中的适当生物学测试应基于可能的暴露情况。局部接触发生在两种不同情况下——有意接触和意外接触。旨在与皮肤和黏膜接触的化学品包括化妆品和皮肤科制剂。对于这类化合物，皮肤接触的频率和程度是可预测的，任何刺激作用都是不可接受的。通过在人类志愿者或实验动物身上进行测试来确定是否不存在刺激作用。由于动物的皮肤和黏膜比人类的更容易受到刺激物影响，测试所用的量或浓度不必高于拟用于人类的量或浓度。希望很快能有经过验证的动物模型替代方法。对于家庭或工业化学品，若意外发生皮肤和/或黏膜接触，通常应避免局部接触。在这种情况下，刺激性测试的目的应是确定哪些化合物具有特别强的刺激性，因此在处理时需要格外小心。我们相信，通过比德莱兹眼刺激试验更简单、更人道的测试就能实现后一个目标。
