Evaluation of phototoxic and photogenotoxic risk associated with the use of photosensitizers in suntan preparations: application to tanning preparations containing bergamot oil.
Bases for the elaboration of a standardized protocol are proposed for studying phototoxic effects of skin tanning preparations containing photosensitizing agents. The experimental procedure includes in vivo phototoxicity tests, evaluation of the photogenotoxic risk and determination of the photosensitizer concentration in plasma after topical application. This procedure was carried out with tanning preparations containing a well-known photosensitizer, 5-methoxypsoralen, as a component of bergamot oil. The whole study has been performed using topical application of the commercial suntan product, i.e. containing the sunscreens and all other components. Whereas the exposure to solar simulated radiation never triggered any phototoxic response, a photosensitizing effect was observed for skin type I volunteers exposed to high doses of ultraviolet A. The transepidermal penetration resulted in a 5-methoxypsoralen concentration of 1-4 ng/ml in the suction blister fluid. The photogenotoxicity of this suction blister fluid containing 5-methoxypsoralen and also other ingredients of the tanning preparation was assayed on yeast cells and was found to be rather low. 5-Methoxypsoralen was also detected in plasma after repeated applications but at low concentrations (about 1 ng/ml) which do not present a potential risk for systemic ocular effects.
Moysan
A
A
Laboratoire de Dermatologie, INSERM U-312, Hôpital Henri-Mondor, Créteil, France.
Morlière
P
P
Averbeck
D
D
Dubertret
L
L
D000078223:5-Methoxypsoralen; D001768:Blister; D017484:Dermatitis, Phototoxic / Q000453:epidemiology / Q000209:etiology*; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D008730:Methoxsalen / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000032:analysis; D017319:Photosensitizing Agents / Q000009:adverse effects*; D010938:Plant Oils / Q000009:adverse effects*; D012307:Risk Factors; D012441:Saccharomyces cerevisiae / Q000187:drug effects; D012869:Skin Absorption; D013473:Sunscreening Agents / Q000009:adverse effects* / Q000737:chemistry; D014466:Ultraviolet Rays / Q000009:adverse effects
D017319:Photosensitizing Agents; D010938:Plant Oils; D013473:Sunscreening Agents; C068336:bergamot oil; D000078223:5-Methoxypsoralen; D008730:Methoxsalen