Preliminary Data on the Safety of Phytoene- and Phytofluene-Rich Products for Human Use including Topical Application

Abstract

The colorless carotenoids phytoene and phytofluene are comparatively understudied compounds found in common foods (e.g., tomatoes) and in human plasma, internal tissues, and skin. Being naturally present in common foods, their intake at dietary levels is not expected to present a safety concern. However, since the interest in these compounds in the context of many applications is expanding, it is important to conduct studies aimed at assessing their safety. We present here results of in vitro cytotoxicity and genotoxicity studies, revealing no significant cytotoxic or genotoxic potential and of short- and long-term human in vivo skin compatibility studies with phytoene- and phytofluene-rich tomato and Dunaliella salina alga extracts, showing a lack of irritancy or sensitization reactions. These results support the safe use of phytoene- and phytofluene-rich products in human topical applications.

Toxicity assessment of the green Dunaliella salina microalgae

“…Dunaliella salina because of β-carotene abundance, is seen as a potent antioxidant and vitamin A precursor so, it utilized as a health food supplement, food coloring agent, cosmetics additive [1]. There is a large body of evidence documented that Dunaliella salina may promote health-modulating effects and participate in diminishing the risk of developing different metabolic diseases [2].…”

Avaliação de carotenoides e atividade antioxidante da polpa madura do abacate (persea americana mill)

“…O fitoflueno juntamente com o fitoeno são carotenoides incolores que podem ser encontrados em frutos que são comuns na dieta humana como: banana, tomates, frutas cítricas, cenouras, abacate entre outros. Além de serem encontrados no plasma humano, no leite, nos tecidos internos e na pele (Havas et al, 2018). Ainda de acordo com esses autores o fitoflueno e o fitoeno podem agir como compostos antixidantes e antiinflamatórios, prevenindo dessa forma o câncer de pele.…”

Skin Carotenoids in Public Health and Nutricosmetics: The Emerging Roles and Applications of the UV Radiation-Absorbing Colourless Carotenoids Phytoene and Phytofluene

“…Concerning the barrier function of the skin, the stratum corneum has a prominent role as a water-proof, relatively impermeable barrier that is key in preventing the entry of diverse xenobiotics [2] However, many compounds can absorb through the stratum corneum, from which derives the existence of a wide variety of pharmaceutical and cosmetic products intended for topical application [27,28,29,30].…”

“…The safe use of phytoene and phytofluene in topical applications is backed by various evidence, namely in vitro cytotoxicity and genotoxicity studies or human in vivo 48-h patch tests and a longer-term Human Repeat Insult Patch Test [29]. The safety of oral formulations can be presumed.…”

“…However, the safety of its use raises controversies as it may cause irritation and has been associated to the possible development of malignancies [10]. In this context, the use of phytoene and phytofluene-containing products for skin whitening offers obvious advantages, including their safety, which may be assumed from their constant consumption in the human diet worldwide [29]. The use of these carotenoids for this purpose may also result in additional cosmetic and health benefits, due to their distinctive strong UV radiation absorbing properties and various attributed effects (antioxidant, antiinflammatory, anticarcinogenic [22,23,24].…”