Nixon G A, Bannan E A, Gaynor T W, Johnston D H, Griffith J F
Procter & Gamble Company, Miami Valley Laboratories, Cincinnati, Ohio 45239-8707.
Regul Toxicol Pharmacol. 1990 Oct;12(2):127-36. doi: 10.1016/s0273-2300(05)80054-6.
The premarket testing of household cleaning products for dermal irritancy is best achieved via human testing. Animal dermal irritation testing is generally limited to screening for possible dermal hazard of totally new or unique products or ingredients prior to human testing or to meeting regulatory requirements of government bodies. Alternatives to animal tests are being sought; however, until such time that these alternatives are identified, validated, and accepted by government bodies, the judicious use of animal testing remains a necessity. Modifications to standard animal skin irritation test procedures have been evaluated against human skin irritation results with the objective of defining one method that could be used in place of current standard procedures that differ slightly from one another, and thereby avoid excessive and redundant use of animals. Hill Top Chambers (19 mm) and standard gauze patches (U.S. Department of Transportation procedure) were used to obtain comparative irritation responses for 24 cleaning products, common caustics, and acids in rabbits and humans. Exposure times were 1 or 4 hr, and responses were graded over a 72-hr period. Results indicate that use of the Chamber offers the potential to (1) reduce the number of animals used for skin irritation screening (smaller group size and up to eight test substances/concentrations per animal); (2) eliminate the need for conducting multiple tests to satisfy different governmental requirements; and (3) reduce animal stress by reducing exposure times without compromising the value of the irritancy patch test as a screening tool. When animal data are required, it is suggested that the use of a Chamber and other modifications of traditional test procedures offers advantages that could result in using fewer animals and/or have less potential for producing unnecessarily severe responses in animals.
家用清洁产品的皮肤刺激性上市前测试最好通过人体测试来完成。动物皮肤刺激测试一般仅限于在人体测试之前筛选全新或独特产品或成分可能存在的皮肤危害，或满足政府机构的监管要求。目前正在寻找动物试验的替代方法；然而，在这些替代方法被政府机构识别、验证并接受之前，明智地使用动物试验仍然是必要的。针对人体皮肤刺激结果，对标准动物皮肤刺激试验程序的修改进行了评估，目的是确定一种可用于替代目前略有不同的标准程序的方法，从而避免过度和重复使用动物。使用Hill Top Chambers（19毫米）和标准纱布贴片（美国运输部程序），对24种清洁产品、常见苛性碱和酸在兔子和人类身上获得比较刺激反应。暴露时间为1或4小时，并在72小时内对反应进行分级。结果表明，使用Chambers有可能：（1）减少用于皮肤刺激筛选的动物数量（每组动物数量更少，每只动物最多可测试八种物质/浓度）；（2）无需进行多次测试以满足不同政府要求；（3）通过缩短暴露时间减轻动物应激，同时不影响刺激性贴片试验作为筛选工具的价值。当需要动物数据时，建议使用Chambers和对传统测试程序的其他修改具有优势，可能会减少动物使用数量和/或降低在动物身上产生不必要严重反应的可能性。
