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Planta Med
DOI: 10.1055/a-2727-1619
Original Papers

Genotoxicity Assessment of Hypericum perforatum Dry Extracts in the Ames Test Based on the “Bracketing and Matrixing” Concept

Authors

  • Jens Flade 

    1   Rudolf-Boehm-Institut für Pharmakologie und Toxikologie, Postgraduate Study of Toxicology and Environmental Protection, Leipzig University, Leipzig, Germany

  • Olaf Kelber 

    2   Phyto & Biotics Technology Platform, Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany
    3   Kooperation Phytopharmaka GbR, Bonn, Germany

  • Karen Nieber

    3   Kooperation Phytopharmaka GbR, Bonn, Germany
    4   Institute for Pharmacy, Leipzig University, Leipzig, Germany

  • Björn Feistel   †

    3   Kooperation Phytopharmaka GbR, Bonn, Germany
    5   Finzelberg GmbH & Co. KG, Andernach, Germany

The authors gratefully acknowledge the support of the Kooperation Phytopharmaka GbR, Bonn, Germany, including financial support for the laboratory work.
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Abstract

HMPs derived from Hypericum perforatum, herba (St. Johnʼs wort) play an important role in treating mild to moderate depressive episodes and mental exhaustion, for example. The genotoxic safety of these HMPs has already been assessed and reviewed in recent years. However, further data on the genotoxic potential of Hypericum perforatum, herba preparations would allow the evaluation of the therapeutic safety of the herbal drug and preparations thereof in accordance with the genotoxicity guideline of the HMPC of the EMA. Accordingly, their genotoxic potential was tested using the “bracketing and matrixing” concept, whereby extracts are tested at and between the extremes of their extraction solvents (ranging in strength from polar to non-polar) to cover the entire spectrum of the drugʼs constituents. In the present study, five dry extracts of Hypericum perforatum, herba, representing the full range of potential extraction solvent polarities (water, ethanol 50% (v/v), methanol 80% (v/v), ethanol 80% (v/v), and n-heptane) were tested using the Ames test, according to the OECD and HMPC guidelines. No mutagenic effects were observed for any of the five test strains in two independent experiments (plate incorporation test and pre-incubation test) each carried out with and without metabolic activation, even at the highest concentrations (5000 µg/plate), in accordance with the OECD guideline No. 471.

Keywords

Hypericum perforatum - Hypericaceae - plant extracts - herbal medicines - mutagenesis - genotoxicity tests

† This work is dedicated to the memory of Björn Feistel, who became deceased on 29 August 2025.


Supporting Information

    The mean revertant rates for the hydro-alcoholic extracts and the n-heptane extract of Hypericum perforatum, herba (Tables 1S a – h) and the corresponding fold responses (Tables 2S a – j) are available as Supporting Information. Information on the test strains is given in Table 3S.

    Results from Hypericum perforatum, herba pressed juice, examined outside the scope of the “bracketing and matrixing” concept, are available under Tables 4S to 6S.

    References Okpanyi et al. (1990), Peron et al. (2013), and Schimmer et al. (1994) [34], [35], [36] are summarised in Table 7S.

  • Supporting Information (PDF)


Publication History

Received: 25 June 2025

Accepted after revision: 11 November 2025

Accepted Manuscript online:
11 November 2025

Article published online:
19 December 2025

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