The Health Risk Assessment of Essential Elemental Impurities (Cu, Mn and Zn) Through the Dermal Exposure of Herbal Ointment Extracted from Marjoram Herb (Majoranae herbae extractum)

Abstract

Essential elements like Cu, Mn and Zn are extremely important for herbs’ growth and physiological functions; however, from a toxicological point of view, the exposure of these elements (as essential elemental impurities) can exhibit potential harmful effects for patients. In Europe, very popular are ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products for adjunctively in rhinitis (runny nose). Based on posology of ointments with Marjoram herb extract, the exposure to these elemental impurities may be high during long-term use. Hence, the aim of this article is the health risk assessment of essential elemental impurities (Cu, Mn and Zn) through the dermal exposure of ointments with Marjoram herb extract (Majoranae herbae extractum) as herbal medicinal products applied adjunctively in rhinitis available in Polish pharmacies. The investigated essential elements were determined by well-validated methodology (R > 0.997, recoveries, LOD and LOQ values were acceptable) based on flame atomic absorption spectrometry (FAAS). Our results indicated that all analysed herbal medicinal products with Marjoram herb extract available in Polish pharmacies contain relatively low levels of essential element impurities, i.e. Cu (0.14–0.49 mg/kg), Mn (0.31–2.57 mg/kg) and Zn (0.73–3.19 mg/kg). The estimated exposure of the investigated elemental impurities confirms the safety of all products. To the best of our knowledge, the study about Cu, Mn and Zn contents in HMPs with Majoranae herbae extractum is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view due to ICH Q3D elemental impurity guideline for pharmaceuticals.

Comparative Study on the Distribution of Essential, Non-Essential Toxic, and Other Elements across Trophic Levels in Various Edible Aquatic Organisms in Sri Lanka and Dietary Human Risk Assessment

“…Some of the elements are essential but toxic in excess quantities (EBTEs) of such elements to humans and fish (e.g., tin (Sn), ferrous (Fe), copper (Cu), chromium (Cr), zinc (Zn), and selenium (Se)). Some of these toxic and essential elements have been reported in herbal medicinal products [ 5 ], in snacks [ 6 ], and aquatic organisms including fish [ 7 , 8 ]. A certain level of some elements that exceed the maximum allowable limit (MAL) in the intake are non-essential and toxic (NETs) to humans (e.g., arsenic (As), antimony (Sb), cadmium (Cd), mercury (Hg), and lead (Pb)) [ 9 , 10 ]; however, there are several other elements, including some metals (Others), which their specific biological functions are not well known.…”