The Content and Toxicological Risk Assessment of Trace Elemental Impurities (Pb and Cr) in Snacks from Ogun State, Southwestern Nigeria

2021 ◽  
Author(s):  
Adewale Matthew Taiwo ◽  
Stephen Olukayode ◽  
Oluwaseyi Zacchaeus Ojekunle ◽  
John Adebayo Oyedepo ◽  
Julius Awonusi Awomeso ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Southwestern Nigeria ◽  
Elemental Impurities ◽  
Ogun State ◽  
Trace Elemental ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment

scholarly journals The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Nickel and Chromium due to Application of Ointments with Marjoram Herb Extract (Majoranae Herbae Extractum) Available in Polish Pharmacies

2021 ◽  
Author(s):  
Kamil Jurowski ◽  
Maria Fołta ◽  
Barbara Tatar ◽  
Mehmet Berkoz ◽  
Mirosław Krośniak
Keyword(s):  
Risk Assessment ◽  
Dermal Exposure ◽  
Pharmaceutical Products ◽  
Dermal Absorption ◽  
Potential Health ◽  
Daily Exposure ◽  
Elemental Impurities ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment ◽  
Herb Extract

AbstractFor elemental impurities that have been studied for transcutaneous absorption, the available data are rarely suitable for proper toxicological risk assessment — there are multiple factors that can influence this dermal absorption. Hence, in our studies, we applied generic and conservative approach — cutaneous permitted daily exposure (CPDE) described in International Conference on Harmonisation’s Q3D Guideline on Elemental Impurities (ICH Q3D). The aim of this article is toxicological risk assessment (TRA) of dermal exposure of patients exposed to nickel and chromium due to application of ointments with Marjoram herb extract (Majoranae herbae extractum) available in Polish pharmacies (n = 5, because only five manufacturers produce this kind of pharmaceutical products in Poland). To make the appropriate TRA approach, we considered (1) raw results (metal per kg of ointment), (2) one-time administration of applied ointments, and (3) daily exposure versus CPDE. Due to the fact the concentrations of Ni generally present in cutaneous products as impurities are not considered sufficient to induce sensitization, the cutaneous and transcutaneous concentration limits (CTCLs) approach was applied for this element assessment. The toxicological analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomization atomic absorption spectrometry. Our results show that the ointments with Marjoram herb extract from pharmacies in Poland represent a potential health hazard to patients; however, there may be a requirement for the monitoring of impurities of nickel in future. To the best of our knowledge, this paper is the first study about nickel and chromium content in ointments with Marjoram herb extract (Majoranae herbae extractum).

scholarly journals The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

2021 ◽  
Author(s):  
Kamil Jurowski ◽  
Maria Fołta ◽  
Barbara Tatar ◽  
Mirosław Krośniak
Keyword(s):  
Risk Assessment ◽  
Single Dose ◽  
Plantago Lanceolata ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Elemental Impurities ◽  
Herbal Medicinal ◽  
Toxicological Risk ◽  
Traditional Herbal Medicinal Products ◽  
Toxicological Risk Assessment

AbstractPlantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 – 20.6 μg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the ‘worst-case scenario’ (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.

scholarly journals The Toxicological Risk Assessment of Cu, Mn, and Zn as Essential Elemental Impurities in Herbal Medicinal Products with Valerian Root (Valeriana officinalis L., radix) Available in Polish Pharmacies

2021 ◽  
Author(s):  
Kamil Jurowski ◽  
Maria Fołta ◽  
Barbara Tatar ◽  
Mehmet Berkoz ◽  
Mirosław Krośniak
Keyword(s):  
Risk Assessment ◽  
Daily Intake ◽  
Valeriana Officinalis ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Elemental Impurities ◽  
Flame Atomic Absorption ◽  
Herbal Medicinal ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment

AbstractThe toxicological risk assessment (TRA) of elemental impurities (EI) in especially herbal medicinal products (HMP) is a significant challenge for pharmaceutical industry. In Europe, very popular are traditional HMP with valerian root (Valeriana officinalis L., radix) for relief of mild symptoms of mental stress and to aid sleep. The aim of our unique article is the comprehensive TRA of Cu, Mn, and Zn as EI in HMP with V. officinalis L., radix available in Polish pharmacies. This article is a continuation of our previously conducted studies about TRA of heavy metals (Pb and Cd) in these same samples. Investigated elements were determined by flame atomic absorption spectrometry (F AAS). The values of the correlation coefficients (R > 0.998) confirm the linearity of the applied instrument for precision and accuracy of results. The recoveries, LOD and LOQ values were acceptable. Our results show that all investigated HMP with valerian root available in Polish pharmacies contain Cu (0.16–0.23 mg/L), Mn (0.11–0.76 mg/L), and Zn (0.22–0.48 mg/L) at a very low level. Based on our estimation of EI including single dose (µg/20 mL) and estimated daily intake (µg/day), our results confirm the safety of all pharmaceuticals. To the best of our knowledge, the Cu, Mn, and Zn impurity profile in HMP with V. officinalis L., radix is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view (ICH Q3D elemental impurities guideline for pharmaceuticals).

Toxicological risk assessment of Aristolochia species

Planta Medica ◽  
2011 ◽  
Vol 77 (12) ◽  
Author(s):  
J Michl ◽  
M Simmonds ◽  
M Ingrouille ◽  
M Heinrich
Keyword(s):  
Risk Assessment ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment ◽  
Aristolochia Species

Aristolochia species: Toxicological risk assessment using a metabolomic approach

Planta Medica ◽  
2013 ◽  
Vol 79 (13) ◽  
Author(s):  
J Michl ◽  
G Kite ◽  
M Simmonds ◽  
M Ingrouille ◽  
M Heinrich
Keyword(s):  
Risk Assessment ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment ◽  
Aristolochia Species ◽  
Metabolomic Approach

scholarly journals Toxicological risk assessment of Acetylsalicylic acid (ASA) in pigeons (columba levia)

2019 ◽  
Vol 6 (5) ◽  
pp. 139-145
Author(s):  
Waqar Khan ◽  
Fayaz Ali ◽  
Murad Ali ◽  
Hanif Khan ◽  
Ayaz Ali Khan ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Acetylsalicylic Acid ◽  
Toxicological Risk ◽  
Toxicological Risk Assessment
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