PMID- 35559879 OWN - NLM STAT- MEDLINE DCOM- 20220519 LR - 20220706 IS - 2452-0748 (Electronic) IS - 2452-0748 (Linking) VI - 25 DP - 2022 Jan TI - Occupational risk of nano-biomaterials: Assessment of nano-enabled magnetite contrast agent using the BIORIMA Decision Support System. PG - 100373 LID - S2452-0748(21)00082-3 [pii] LID - 10.1016/j.impact.2021.100373 [doi] AB - The assessment of the safety of nano-biomedical products for patients is an essential prerequisite for their market authorization. However, it is also required to ensure the safety of the workers who may be unintentionally exposed to the nano-biomaterials (NBMs) in these medical applications during their synthesis, formulation into products and end-of-life processing and also of the medical professionals (e.g., nurses, doctors, dentists) using the products for treating patients. There is only a handful of workplace risk assessments focussing on NBMs used in medical applications. Our goal is to contribute to increasing the knowledge in this area by assessing the occupational risks of magnetite (Fe(3)O(4)) nanoparticles coated with PLGA-b-PEG-COOH used as contrast agent in magnetic resonance imaging (MRI) by applying the software-based Decision Support System (DSS) which was developed in the EU H2020 project BIORIMA. The occupational risk assessment was performed according to regulatory requirements and using state-of-the-art models for hazard and exposure assessment, which are part of the DSS. Exposure scenarios for each life cycle stage were developed using data from literature, inputs from partnering industries and results of a questionnaire distributed to healthcare professionals, i.e., physicians, nurses, technicians working with contrast agents for MRI. Exposure concentrations were obtained either from predictive exposure models or monitoring campaigns designed specifically for this study. Derived No-Effect Levels (DNELs) were calculated by means of the APROBA tool starting from in vivo hazard data from literature. The exposure estimates/measurements and the DNELs were used to perform probabilistic risk characterisation for the formulated exposure scenarios, including uncertainty analysis. The obtained results revealed negligible risks for workers along the life cycle of magnetite NBMs used as contrast agent for the diagnosis of tumour cells in all exposure scenarios except in one when risk is considered acceptable after the adoption of specific risk management measures. The study also demonstrated the added value of using the BIORIMA DSS for quantification and communication of occupational risks of nano-biomedical applications and the associated uncertainties. CI - Copyright (c) 2022 The Authors. Published by Elsevier B.V. All rights reserved. FAU - Cazzagon, V AU - Cazzagon V AD - Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, via Torino 155, 30170 Venice Mestre, Italy. FAU - Giubilato, E AU - Giubilato E AD - Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, via Torino 155, 30170 Venice Mestre, Italy; GreenDecision S.r.l., 30170 Venice Mestre, Italy. Electronic address: giubilato@unive.it. FAU - Pizzol, L AU - Pizzol L AD - GreenDecision S.r.l., 30170 Venice Mestre, Italy. FAU - Ravagli, C AU - Ravagli C AD - COLOROBBIA CONSULTING S.r.l., Ce.Ri.Col. Centro Ricerche Colorobbia, Via Pietramarina, 123, 50053 Sovigliana, Vinci (FI), Italy. FAU - Doumett, S AU - Doumett S AD - COLOROBBIA CONSULTING S.r.l., Ce.Ri.Col. Centro Ricerche Colorobbia, Via Pietramarina, 123, 50053 Sovigliana, Vinci (FI), Italy. FAU - Baldi, G AU - Baldi G AD - COLOROBBIA CONSULTING S.r.l., Ce.Ri.Col. Centro Ricerche Colorobbia, Via Pietramarina, 123, 50053 Sovigliana, Vinci (FI), Italy. FAU - Blosi, M AU - Blosi M AD - Institute of Science and Technology for Ceramics (CNR-ISTEC), National Research Council of Italy, Via Granarolo 64, 48018 Faenza, RA, Italy. FAU - Brunelli, A AU - Brunelli A AD - Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, via Torino 155, 30170 Venice Mestre, Italy. FAU - Fito, C AU - Fito C AD - ITENE, C/ Albert Einstein, 1, 46980 Paterna, Valencia, Spain. FAU - Huertas, F AU - Huertas F AD - ITENE, C/ Albert Einstein, 1, 46980 Paterna, Valencia, Spain. FAU - Marcomini, A AU - Marcomini A AD - Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, via Torino 155, 30170 Venice Mestre, Italy. FAU - Semenzin, E AU - Semenzin E AD - Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, via Torino 155, 30170 Venice Mestre, Italy. FAU - Zabeo, A AU - Zabeo A AD - GreenDecision S.r.l., 30170 Venice Mestre, Italy. FAU - Zanoni, I AU - Zanoni I AD - Institute of Science and Technology for Ceramics (CNR-ISTEC), National Research Council of Italy, Via Granarolo 64, 48018 Faenza, RA, Italy. FAU - Hristozov, D AU - Hristozov D AD - Department of Environmental Sciences, Informatics and Statistics, University Ca' Foscari of Venice, via Torino 155, 30170 Venice Mestre, Italy. Electronic address: danail.hristozov@unive.it. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20211210 PL - Netherlands TA - NanoImpact JT - NanoImpact JID - 101676795 RN - 0 (Contrast Media) RN - XM0M87F357 (Ferrosoferric Oxide) SB - IM MH - *Contrast Media/adverse effects MH - *Ferrosoferric Oxide MH - Humans MH - Occupational Exposure MH - Risk Assessment/methods MH - Risk Management MH - Workplace OTO - NOTNLM OT - Decision Support System OT - Magnetite nanoparticles OT - Nano-biomaterials OT - Occupational risk assessment EDAT- 2022/05/14 06:00 MHDA- 2022/05/20 06:00 CRDT- 2022/05/13 18:42 PHST- 2021/09/03 00:00 [received] PHST- 2021/11/24 00:00 [revised] PHST- 2021/12/02 00:00 [accepted] PHST- 2022/05/13 18:42 [entrez] PHST- 2022/05/14 06:00 [pubmed] PHST- 2022/05/20 06:00 [medline] AID - S2452-0748(21)00082-3 [pii] AID - 10.1016/j.impact.2021.100373 [doi] PST - ppublish SO - NanoImpact. 2022 Jan;25:100373. doi: 10.1016/j.impact.2021.100373. Epub 2021 Dec 10.