Frangula Alnus Bark Extract

While FRANGULA ALNUS BARK EXTRACT has shown antioxidant and antimicrobial efficacy at concentrations up to 2.5 mg/mL (2500 µg/ml), safety data reveals concerning adverse effects at significantly lower concentrations. Cytotoxicity has been observed at 500 µg/ml of the bark extract, and increased reactive oxygen species at 250 µg/ml. This substantial gap between observed efficacy and safety thresholds indicates that achieving benefits topically without incurring significant risks is highly improbable, making responsible formulation extremely difficult.

Fresh Frangula alnus bark is toxic and necessitates at least one year of drying or heat processing before use. Both the extract and its component emodin have demonstrated activation of the skin sensitization pathway in a KeratinoSens assay, indicating a strong potential for inducing allergic reactions in humans. High concentrations of the bark extract (500 µg/ml) and emodin (150-200 µg/ml) exhibited cytotoxicity and genotoxicity in human peripheral blood lymphocytes. Furthermore, increased reactive oxygen species were noted at 250 µg/ml for the extract and 25 µg/ml for emodin. It is crucial to note that the European Medicines Agency (EMEA) and the Committee on Herbal Medicinal Products (HMPC) have only approved Frangula bark for short-term oral use to treat constipation, not for topical application. PrecisionFDA also lists this substance as 'non-approved'.