The Toxicological Risk Assessment of Dermal Exposure of Patients

Overview

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Key numbers

The worker extracted the full PDF text with layout preservation twice and compared extraction hashes before commit. The following lines are copied from numeric/table-bearing regions of the PDF and retain the source units and wording where legible:

• into account application of the parenteral PDE (100% of
• study is described shortly in Table 1.
• digested with 5.0 mL of concentrated nitric acid (63%). The
• Table 1 Short description of analyzed samples
• ple A: 178.84 ± 6.85 μg/kg for Ni and 254.13 ± 12.59 μg/ tigated metallic elements in this kind of pharmaceuticals
• D (56.51 ± 3.22 μg/kg), and the lowest content of Cr was this situation is actual level in the one-time administration
• in sample C (21.16 ± 3.75 μg/kg). The nickel levels were (single dose) of the product (approximately 0.20 g). The
• (21.157–254.13 μg/kg). It can be assumed that in general, exposure of investigated elements (the maximum daily
• Ni levels were approximately similar (mean = 92.11 μg/ dose of applied pharmaceuticals).
• kg) to Cr levels (mean = 118.97 μg/kg).
• Medicines Agency (EMA) as 35 μg/kg (1). Analysis of the ointments were calculated considering the maximum use
• obtained results shows that CTCL value was exceeded in during the day — Table 3. We use five applications as rec-
• uct poses a potential allergic risk due to Ni content. For from Table 3.
• Cr assessment, additional approaches due to sensitization Results from Table 3 show that the estimated exposure of
• Table 2 The levels of nickel and chromium in analyzed samples Table 3 The estimated daily exposure of investigated metals in ana-
• Table 4 The calculations of cutaneous permitted daily exposure Conclusions and Recommendations
• the CTCL (> 35 μg/kg). This indicates a potential allergy
• parenteral PDE, which assumed 100% bioavailability, to gle dose of applied ointment, again, is also at a very low
• skin 10; 100%/10% = 10) — Eq. 1. dermal route. The toxicological risk assessment approach
• shown in Table 4. patients. It should be emphasized that there is a potential

Methods (brief)

• 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
• Abbreviations ET AAS Electrothermal atomization atomic absorption
• OTC Samples and Preparation
• The samples were traditional herbal medicinal products used for
• methodological standards, all samples were coded (as A, B,
• wave digestion. After this step, all samples were digested
• using microwave digestion system. Five replications were
• Table 1 Short description of analyzed samples
• B kept and done for all samples. The detailed information
• about digestion procedure and all instrumental parameters
• ized water. The cooled samples were stored in plastic bottles
• as stock sample solutions until analysis.
• was based on our studies published earlier (7, 10). Five data of five independent replicates (five replicate samples
• replications were performed for each sample. The qual- from one tube of each preparation) were expressed as the
• medical products samples (A,
• kg for chromium. The lowest content of Ni was in sample should include more information. Required information in
• in sample C (21.16 ± 3.75 μg/kg). The nickel levels were (single dose) of the product (approximately 0.20 g). The

Implications

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Wiki pages this source may touch

• Infant Formula Powder
• Fish — marine, non-predatory (sardines, anchovies, salmon, cod)
• teething-and-snacks
• Cadmium
• Nickel
• Aluminum
• Chromium

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Update history

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