The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)

Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kamil Jurowski [verfasserIn] Mirosław Krośniak [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2023

Schlagwörter:	heavy metals toxicological risk assessment marjoram herb ICH Q3D (R2)

Übergeordnetes Werk:	In: International Journal of Environmental Research and Public Health - MDPI AG, 2005, 20(2023), 2701, p 2701
Übergeordnetes Werk:	volume:20 ; year:2023 ; number:2701, p 2701

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc Journal toc

DOI / URN:	10.3390/ijerph20032701

Katalog-ID:	DOAJ080643574

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allfields	10.3390/ijerph20032701 doi (DE-627)DOAJ080643574 (DE-599)DOAJ1c97e0b6eb584efabbe1071d06f4678f DE-627 ger DE-627 rakwb eng Kamil Jurowski verfasserin aut The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature. heavy metals toxicological risk assessment marjoram herb ICH Q3D (R2) Medicine R Mirosław Krośniak verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 20(2023), 2701, p 2701 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:20 year:2023 number:2701, p 2701 https://doi.org/10.3390/ijerph20032701 kostenfrei https://doaj.org/article/1c97e0b6eb584efabbe1071d06f4678f kostenfrei https://www.mdpi.com/1660-4601/20/3/2701 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2023 2701, p 2701
spelling	10.3390/ijerph20032701 doi (DE-627)DOAJ080643574 (DE-599)DOAJ1c97e0b6eb584efabbe1071d06f4678f DE-627 ger DE-627 rakwb eng Kamil Jurowski verfasserin aut The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature. heavy metals toxicological risk assessment marjoram herb ICH Q3D (R2) Medicine R Mirosław Krośniak verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 20(2023), 2701, p 2701 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:20 year:2023 number:2701, p 2701 https://doi.org/10.3390/ijerph20032701 kostenfrei https://doaj.org/article/1c97e0b6eb584efabbe1071d06f4678f kostenfrei https://www.mdpi.com/1660-4601/20/3/2701 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2023 2701, p 2701
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allfieldsSound	10.3390/ijerph20032701 doi (DE-627)DOAJ080643574 (DE-599)DOAJ1c97e0b6eb584efabbe1071d06f4678f DE-627 ger DE-627 rakwb eng Kamil Jurowski verfasserin aut The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature. heavy metals toxicological risk assessment marjoram herb ICH Q3D (R2) Medicine R Mirosław Krośniak verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 20(2023), 2701, p 2701 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:20 year:2023 number:2701, p 2701 https://doi.org/10.3390/ijerph20032701 kostenfrei https://doaj.org/article/1c97e0b6eb584efabbe1071d06f4678f kostenfrei https://www.mdpi.com/1660-4601/20/3/2701 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2023 2701, p 2701
language	English
source	In International Journal of Environmental Research and Public Health 20(2023), 2701, p 2701 volume:20 year:2023 number:2701, p 2701
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author	Kamil Jurowski
spellingShingle	Kamil Jurowski misc heavy metals misc toxicological risk assessment misc marjoram herb misc ICH Q3D (R2) misc Medicine misc R The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)
authorStr	Kamil Jurowski
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topic_title	The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<) heavy metals toxicological risk assessment marjoram herb ICH Q3D (R2)
topic	misc heavy metals misc toxicological risk assessment misc marjoram herb misc ICH Q3D (R2) misc Medicine misc R
topic_unstemmed	misc heavy metals misc toxicological risk assessment misc marjoram herb misc ICH Q3D (R2) misc Medicine misc R
topic_browse	misc heavy metals misc toxicological risk assessment misc marjoram herb misc ICH Q3D (R2) misc Medicine misc R
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title	The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)
ctrlnum	(DE-627)DOAJ080643574 (DE-599)DOAJ1c97e0b6eb584efabbe1071d06f4678f
title_full	The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)
author_sort	Kamil Jurowski
journal	International Journal of Environmental Research and Public Health
journalStr	International Journal of Environmental Research and Public Health
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author_browse	Kamil Jurowski Mirosław Krośniak
container_volume	20
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author-letter	Kamil Jurowski
doi_str_mv	10.3390/ijerph20032701
author2-role	verfasserin
title_sort	toxicological risk assessment of dermal exposure of patients exposed to lead and cadmium due to application of ointments with marjoram herb extract (<i<majoranae herbae extractum</i<)
title_auth	The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)
abstract	Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature.
abstractGer	Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature.
abstract_unstemmed	Potential heavy metal impurities (HMI) in pharmaceuticals/pharmaceutical products/drugs based on plant raw materials (e.g., herbs) are an important problem in the pharmaceutical industry; however, there is a lack of scientific articles on the comprehensive toxicological risk assessment of HMI in ointment applied dermally. To make the appropriate toxicological risk assessment, we consider: (1) the raw results of the levels of lead and cadmium in the ointments (metal per kg of mass), (2) one-time administration of the applied ointment, (3) daily exposure of Pb and Cd in the applied ointments according to the maximum daily dose of applied pharmaceuticals, including transcutaneous penetration, (4) human health risk assessment based on the USEPA model, and 5) the margin of exposure (MoE). The raw results indicated that lead (7.05–101.78 µg/kg) and cadmium (0.32–0.81 µg/kg) were present in all samples. The levels of analyzed HMI (independently of the producer and declared composition) were similar. Pb and Cd contamination associated with daily doses met the standards of the ICH Q3D (R2) guide on elemental impurities in pharmaceuticals, including the cutaneous route of administration. Taking into account the daily amount of lead and cadmium (ointment, ug/day) the results were satisfactory, confirming the safety of marjoram herb extract ointments available in Polish pharmacies according to the ICH guideline Q3D (R2) on elemental impurities. The HQ values obtained for Pb and Cd in all samples were less than 1; therefore, exposure to these HMI would not cause a health risk based on the USEPA model strategy. Furthermore, the obtained values of MoE for Pb and Cd in ointments were above 100, so exposure to these elements would not cause a health risk based on the MoE-based strategy. The original contribution of this work is that this is the first study on the triple approach strategy to evaluate the safety of heavy metal impurities in traditional herbal medicinal products applied dermally in solid form (ointments with marjoram herb extract). The research is novel and has not been previously published; The proposed procedure includes transcutaneous penetration of heavy metal (Pb and Cd) impurities described for the first time in the literature.
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title_short	The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)
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The Toxicological Risk Assessment of Dermal Exposure of Patients Exposed to Lead and Cadmium Due to Application of Ointments with Marjoram Herb Extract (<i<Majoranae herbae extractum</i<)

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