UV-induced effects.

摘要: Regulatory requirements: According to the current Notes for Guidance of Scientific Committee on Cosmetic Products and Non-Food (SCCNFP), cosmetic ingredients mixtures absorbing UV light (in particular filter chemicals used, example, ensure stability cosmetics or used in sun protection products) should be tested acute phototoxic photogenotoxic potential. Testing photosensitisation (immunological photoallergy) potential is not specifically required, but it nevertheless often performed. Acute phototoxicity: Due a thorough multi-stage multi-centre validation trial (1992-1998) In Vitro 3T3 Neutral Red Uptake Phototoxicity Test (3T3-NRU-PT) had already gained acceptance by SCCNFP 1998, recommended EMEA/CPMP as basic preclinical test phototoxicity. It was accepted Method No. 41 Annex V Directive 67/548/EEC year 2000, new Guideline 432 OECD 2002. The 3T3-NRU-PT regarded screen identifying Two additional vitro tests, formally evaluated controlled blind trials, RBC (RBC-PT) Human 3-D Skin Model (H3D-PT), are useful important adjunct tests overcome some limitations 3T3-NRU-PT, namely fairly low UVB tolerance fibroblasts inability model bioavailability materials topically applied skin. addition, RBC-PT permits an evaluation mechanisms involved. conclusion, identification hazards now being sufficiently covered so that animal testing endpoint can 100% replaced. Photogenotoxicity: area photogenotoxicity, almost whole battery genetic toxicity have been (or currently being) converted into protocols photogenotoxicity tests. Tests exclusively predictive gene mutation, Photo-Ames (P-Ames) Photo-Thymidine Kinase (P-TKT), become less than clastogenic effects (for Photo-Chromosome Aberration [P-CAT] Photo-Micronucleus [P-MNT]). number promising indicator such Photo-Comet Assay (P-Comet) developed. Although routinely date none validated. Therefore, P-MNT P-Comet formal interlaboratory study. expected these methods may available validated within next five years. Photoallergy (Photosensitisation): photoallergy (photosensitisation), development delayed contact sensitisation (allergenicity) without involvement light, due lack ability complex underlying allergy, no predict photo-sensitisation sight (see section skin sensitisation). One screening method, which models covalent binding activated chemical human serum albumin, relevant. However, while excited proteins prerequisite photoallergy, this sufficient predictor its own. only alternatives under vivo refinements, like Photo Local Lymph Node (PLLNA). Once reliable strategy assessment "dark" developed accepted, their adaptation similar will possible.