Planar umuC assay: a novel effect-directed analysis kit for screening of genotoxic potential of plant extracts

Botanical raw materials for phytopharmaceutical applications must comply with the current regulations for medicines in the EU or guidelines for herbal medicinal products in terms of quality, safety and effectiveness when placed on the market in Europe. In the EU, the legal requirements for active ingredients (API) and medicines (Herbal Medicinal Products for human use) as well as the guidelines and monographs of the Herbal Medicinal Product Committee (HMPC) as an expert committee for medicinal plant products within the EMA apply here. If extracts are used in the food sector, the safety regulations of the European Food Safety Agency (EFSA) must be considered. In both cases, genotoxicity testing is an important aspect of the safety assessment of plant extracts and their preparations.

So far, the Ames test has been mandatory. In recent years it has been shown that this established test has some disadvantages. In the field of ecotoxicology, which also deals with multi-component mixtures, the suitability of the more sensitive umuC test in addition to or even instead of the Ames test is already being discussed.

This poster demonstrates the application of the umuC test coupled to HPTLC (planar umuC) for assessing plant extracts and their leachables from their containers. The results of a validation study as well as S9 activation of metabolites prior to chromatography show the applicability of the novel effect directed analysis method for routine safety screening in R&D, quality control and regulatory compliance of plant derived natural health products.

Publication History

Article published online:
16 November 2023