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Skin phototoxicity of cosmetic formulations containing photounstable and photostable UV-filters and vitamin A palmitate

Lorena R. Gaspar, Julian Tharmann, Patricia M.B.G. Maia Campos, Manfred Liebsch
Abstract

The aim of this study was to evaluate the in vitro skin phototoxicity of cosmetic formulations containing photounstable and photostable UV-filters and vitamin A palmitate, assessed by two in vitro techniques: 3T3 Neutral Red Uptake Phototoxicity Test and Human 3-D Skin Model In Vitro Phototoxicity Test. For this, four different formulations containing vitamin A palmitate and different UV-filters combinations, two of them considered photostable and two of them considered photounstable, were prepared. Solutions of each UV-filter and vitamin under study and solutions of four different combinations under study were also prepared. The phototoxicity was assessed in vitro by the 3T3 NRU phototoxicity test (3T3-NRU- PT) and subsequently in a phototoxicity test on reconstructed human skin model (H3D-PT). Avobenzone presented a pronounced phototoxicity and vitamin A presented a tendency to a weak phototoxic poten- tial. A synergistic effect of vitamin A palmitate on the phototoxicity of combinations containing avobenz- one was observed. H3D-PT results did not confirm the positive 3T3-NRU-PT results. However, despite the four formulations studied did not present any acute phototoxicity potential, the combination 2 contain- ing octyl methoxycinnamate (OMC), avobenzone (AVB) and 4-methylbenzilidene camphor (MBC) pre- sented an indication of phototoxicity that should be better investigated in terms of the frequency of photoallergic or chronic phototoxicity in humans, once these tests are scientifically validated only to detect phototoxic potential with the aim of preventing phototoxic reactions in the general population, and positive results cannot predict the exact incidence of phototoxic reactions in humans.

Keywords

EpiDerm (EPI-200), phototoxicity, cosmetic formulations, photounstable, photostable, UV-filters, 3-D Skin Model In Vitro Phototoxicity Test (H3D-PT), OECD 498, 3T3 NRU phototoxicity test, Sunscreen, UVA, benzophenone-3, butyl methoxydibenzoylmethane (avobenzone), ethylhexyl methoxycinnamate, Octocrylene, methylbenzylidene camphor, ethylhexyl salicylate, Vitamin A palmitate (retinylpalmitate), Chlorpromazinehydrochloride, Bergamot oil, hydroxyethyl cellulose, glycerin, BHT, phosphate-based self emulsifying wax, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, 6% of C12–C15 alkyl benzoate, propyleneglycol, polyglyceryl-10 myristate, diphenylmethicone, trietilexanoine, cyclopentasiloxane, phenoxyethanol, parabens

Materials Tested

benzophenone-3, butyl methoxydibenzoylmethane (avobenzone), ethylhexyl methoxycinnamate, Octocrylene, methylbenzylidene camphor, ethylhexyl salicylate, Vitamin A palmitate (retinylpalmitate), Chlorpromazinehydrochloride, Bergamot oil, hydroxyethyl cellulose, glycerin, BHT, phosphate-based self emulsifying wax, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, 6% of C12–C15 alkyl benzoate, propyleneglycol, polyglyceryl-10 myristate, diphenylmethicone, trietilexanoine, cyclopentasiloxane, phenoxyethanol, parabens

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