Santella R M
Occup Med. 1987 Jan-Mar;2(1):39-46.
A large number of in vitro assays for chemical carcinogenicity and mutagenicity have been developed. They have been validated to various extents with the use of known carcinogens and noncarcinogens. When applied to chemicals of unknown carcinogenicity, they must be used in a battery or a tiered testing protocol. This is necessary since false negatives may occur with any one assay. The size of the battery should depend upon the potential risk to humans. A chemical with high human exposure (e.g., food additives) should be tested with a larger number of assays than one with more limited human exposure. The tests should complement one another and detect different events. Thus bacterial or mammalian mutation, cell transformation, DNA repair and chromosome assays should all be included in a test battery. Results form in vitro assay can be utilized to determine whether the chemical should also be tested in an animal bioassay. While negative results in all tests may indicate low risk, a chemical with widespread human exposure may still be worth evaluating in a long-term animal bioassay. It is impossible to prove a chemical safe and without risk. Short-term assays do, however, provide a means for quickly obtaining reasonable information about the genotoxic potential of large numbers of chemicals.
已经开发出大量用于化学致癌性和致突变性的体外试验。它们已使用已知致癌物和非致癌物在不同程度上得到验证。当应用于致癌性未知的化学物质时，必须将它们用于一组试验或分级测试方案中。这是必要的，因为任何一种试验都可能出现假阴性。试验组的规模应取决于对人类的潜在风险。与人类接触有限的化学物质相比，与人类有高接触性的化学物质（如食品添加剂）应该用更多的试验进行测试。这些试验应该相互补充并检测不同的事件。因此，一组试验中应该包括细菌或哺乳动物突变、细胞转化、DNA修复和染色体试验。体外试验的结果可用于确定该化学物质是否也应在动物生物测定中进行测试。虽然所有试验的阴性结果可能表明风险较低，但与人类有广泛接触的化学物质仍可能值得在长期动物生物测定中进行评估。不可能证明一种化学物质是安全且无风险的。然而，短期试验确实提供了一种快速获取大量化学物质遗传毒性潜力合理信息的方法。
