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The international EU/COLIPA in vitro phototoxicity validation study: results of phase II (blind trial). part 1: the 3T3 NRU phototoxicity test.


Spielmann, H., Balls, M., Dupuis, J., Pape, W.J., Pechovitch, G., de Silva, O., Holzhütter, H-G., Clothier, R., Desolle, P., Gerberick, F., Liebsch, M., Lovell, W.W., Maurer, T., Pfannenbecker, U., Potthasl, J.M., Csato, M., Sladowski, D., Steiling, W. and Brantom, P.

Toxicology in Vitro, 12(3), 305-327 (1998).

To date, no standardized international guideline for the testing of chemicals for phototoxic potential has been accepted for regulatory purposes. In 1991, the European Commission (EC), represented initially by the Directorate General XI and later by ECVAM (the European Centre for the Validation of Alternative Methods) and COLIPA (the European Cosmetic, Toiletry and Perfumery Association), agreed to establish a joint EU/COLIPA programme on the development and validation of in vitro phototoxicity tests. The first phase (phase I, 1992–93) was designed as a prevalidation study, to identify in vitro test procedures and test protocols for a formal validation trial under blind conditions. In the second phase (phase II, 1994–95), the formal validation study, the most promising in vitro phototoxicity tests were validated with 30 carefully selected test chemicals in 11 laboratories in a blind trial. The 3T3 mouse fibroblast neutral red uptake phototoxicity test %