Final Report on the Safety Assessment of Hypericum Perforatum Extract and Hypericum Perforatum Oil

The document from 2001 assessed the safety of Hypericum Perforatum Extract and Hypericum Perforatum Oil, derived from St. John's Wort, used in cosmetic formulations. Various extraction methods were described, and the extract was found in over 50 cosmetic products, while the oil was in just over 10. Acute toxicity studies in animals suggested low toxicity, but significant signs of toxicity were observed in animals exposed to the flowers, including erythema, edema, alopecia, and blood chemistry changes. Hypericum Perforatum is a primary photosensitizer due to hypericin. Clinical tests showed hypericin in the blood after oral administration, with a steady-state reached after 14 days. The extract and oil were not irritants or sensitizers in animals, and caused minimal or no ocular irritation in rabbits. Mutagenic activity was observed in some tests but not others. No data on carcinogenicity or reproductive toxicity were available. Adverse reactions in clinical treatment of depression included skin issues and neurological symptoms. The report concluded that the available data were insufficient to support the safety of these ingredients in cosmetics, and additional data were needed on various safety aspects, including photosensitization, toxicity, and human irritation.