Occupational risk of nano-biomaterials: Assessment of nano-enabled magnetite contrast agent using the BIORIMA Decision Support System

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 (Fe3O4) 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

Valutazione preliminare della specie Paulownia tomentosa per la fitorimediazione di terreni contaminati da metalli pesanti

Il presente lavoro riporta i risultati di una valutazione preliminare (riferita alla prima stagione vegetativa dalla piantumazione) dell’idoneità della specie arborea Paulownia Tomentosa alla fitoestrazione di Cd, Cu, Pb e Zn da un terreno contaminato da metalli pesanti ed idrocarburi. La sperimentazione, condotta su 20 mesocosmi e 100 vasi, è volta a studiare lo sviluppo e le potenzialità estrattive di tale pianta in funzione delle caratteristiche agronomiche e dell’idrologia del terreno anche con somministrazione di ammendanti naturali e sintetici a differenti concentrazioni. I primi risultati evidenziano la promettente idoneità dell’essenza investigata all’uso in processi di fitoestrazione dei suddetti metalli da suoli contaminati in virtù delle buone capacità traslocanti, del grande potenziale traspirativo, della resistenza alla fitotossicità degli ammendanti e della notevole produttività in termini di biomassa