Basics (Guidelines) on Cell Culture Testing for Topical/Dermatological Drugs/Products and Cosmetics With Regard to Efficacy and Safety of the Preparations

Topical skin formulations that are designed either for personal care or for therapeutic treatment all have a certain potential of causing adverse skin reactions. Companies manufacturing skin preparations are required by law to investigate any possible hazard to human health in order to assure safe usage by the consumer. The ingredients of these preparations and the finished products must be screened extensively, a procedure which usually still involves animal testing (Boucher et al. 1990). The use of laboratory animals in safety testing of cosmetics and drugs has increasingly been questioned by both the public and scientists (Nixon et al. 1975;Balls et al. 1995). In recent years, this common concern has resulted in a substantial reduction and refinement in animal tests, which has been paralleled by a growing exploration of non-animal methods for toxicity testing. The alternative tests should not only reduce or replace the use of living animals but should also predict the responses of human skin to a higher degree than those obtained when animal skin is used. Although human skin in vitro can be considered the preferred alternative to animal skin, its use for screening purposes is often complicated by practical obstacles. The main problems are related to an irregular and minimal supply by surgical departments and to the often stringent requirements of fresh skin. Since studies on human beings are often considered ethically unacceptable, very time-consuming when performed on a large-scale basis, and difficult to interpret due to large donor-to-donor variability,the development of cultured human skin substitutes will be an attractive alternative.