Lead impurities in traditional herbal medicinal products with L., folium (Ribwort Plantain leaves) available in Polish pharmacies - toxicological risk assessment for adults.

Traditional herbal medicinal products (THMP) with L., folium (Ribwort Plantain Leaves) are well-known and very popular among the European population. The aim of our study was the toxicological risk assessment for adults of Pb impurities in THMP with L. obtained from pharmacies in Poland. The estimations of Pb impurities in the single dose (22.1 - 50.7 ng/single dose) and in the daily dose (ng/day) were based on the worst-case scenario (WCS), i.e. based on the posology recommended by manufacturers. The estimated daily exposure (ng/day) meets the standards of the ICH Q3D (R1) guideline on elemental impurities (5.0 µg/day) according to the Pb levels (all results were below 250 ng/day). It can be concluded that all investigated THMPs with L., folium available in pharmacies from Poland should not represent any health risk to the adults.