ECVAM Feasibility Study: Can the Pre-validated EpiDerm In Vitro Phototoxicity Test be Upgraded to Quantify Phototoxic Potency of Topical Phototoxins?
2009
Kandarova,H. | Kejlova,K. | Jirova,D. | Bendova,H. | Tharmann,J. | Traue,D. | Spielmann,H. | Liebsch,M.
German. The determination of phototoxicity of a chemical in the 3T3 NRU-PT according to OECD TestGuideline 432 is often the first step in the sequential phototoxicity testing strategy. If thechemical provides a negative result in the 3T3NRU-PT, in most instances no further testing isrequired. However, if the result is positive, the chemical may be still applied topically at safeconcentrations, depending on the absorption and accumulation of the chemical in the skin.Thus, in addition to the information on inherent phototoxicity potential assessed by the3T3NRU-PT, additional testing may be required to obtain combined information on the phototoxicity and bioavailability of the chemical in the skin.Ideally, confirmatory tests should be performed in vivo on human volunteers, but for ethicalreasons, this is not acceptable if the 3T3NRU-PT has provided a positive result. Thus, toavoid confirmatory testing in vivo in animals, reconstituted human 3-D skin models areoffering an attractive in vitro alternative for testing, since such models are characterized byboth skin barrier function and viable primary skin cells.In the current study, several substances (mostly cosmetic ingredients) which are known to be safely usedin humans, and which provided positive results in the 3T3 NRU PT were evaluated on thereconstructed human skin model EpiDerm and if the result was negative, tested in a limitedgroup of human volunteers. First results we obtained show that the human skin modelphototoxicity test represents a useful step in the sequential strategy for phototoxicity testing.
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