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KMID : 0984920130150010059
Journal of Skin Barrier Research
2013 Volume.15 No. 1 p.59 ~ p.64
Animal Test Ban in Cosmetics and Alternative to Animal Test Methods
Lim Kyung-Min

Abstract
With a completion of animal test ban in the development of cosmetics in EU, enormous efforts and resources are being directed to develop validated animal alternative tests (AAT) that could replace conventional animal safety tests. As planned, EU Cosmetic Directives 76/768/EEC enforced an exclusive ban on animal tests that include systemic toxicity tests such as carcinogenicity, reproductive toxicity, repeat dose toxicity and toxicokinetic studies on March 11, 2013. The animal test ban is being expanding to efficacy tests and basic researches regarding cosmetics. Although many experts believe that many efficacy/toxicity tests are not expected to obtain the validated and substitutable AATs within foreseeable future, a huge progress has been made in the categories of skin toxicity tests such as skin primary irritation, eye irritation, skin hypersensitivity and phototoxicity tests that are essential in ensuring the minimum level of safety for the participants in clinical trial and final consumers of cosmetic products. In the course of developing new AATs to local toxicity tests, advanced biotechnological tools and instruments, tissue engineering technique, gene modification and cell culture technology have been employed. More importantly, advanced and combined knowledge of dermatology, mechanism based toxicology, immunotoxicology and biostatistics is being widely incorporated to all the stages of AAT development including study design, endpoint selection, interpretation of study results and establishment of scientific justification. Newly developed and validated AATs like 3D human tissue models and Keratinosense¢ç not only replace conventional toxicity test methods but also may provide solutions to species difference, low through-put and unclear mechanism that are unanswered by conventional test methods. In this presentation, a brief overview on the background for development, recent trends and current status of AATs will be given with a prospect to enlighten the audience of the importance of AATs and ultimately to encourage the active participation of fellow scientists in the exploration of new and better AATs that can cover up wider ranges of conventional animal test methods.
KEYWORD
Animal Alternatives, Skin Toxicity, 3D skin model, Cosmetics
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