Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping
- Author(s)
- Luisana Di Cristo, Johannes G. Keller, Luca Leoncino, Valentina Marassi, Frederic Loosli, Didem Ag Seleci, Georgia Tsiliki, Agnes G. Oomen, Vicki Stone, Wendel Wohlleben, Stefania Sabella
- Abstract
The dissolution of a nanomaterial (NM) in an in vitro simulant of the oro-gastrointestinal (OGI) tract is an important predictor of its biodurability in vivo. The cascade addition of simulated digestive juices (saliva, stomach and intestine), including inorganic/organic biomacromolecules and digestive enzymes (complete composition, referred to as “Type 1 formulation”), strives for realistic representation of chemical composition of the OGI tract. However, the data robustness requires consideration of analytical feasibility, such as the use of simplified media. Here we present a systematic analysis of the effects exerted by different digestive juice formulations on the dissolution% (or half-life values) of benchmark NMs (e.g., zinc oxide, titanium dioxide, barium sulfate, and silicon dioxide). The digestive juices were progressively simplified by removal of components such as organic molecules, enzymes, and inorganic molecules (Type 2, 3 and 4). The results indicate that the “Type 1 formulation” augments the dissolution via sequestration of ions by measurable factors compared to formulations without enzymes (i.e., Type 3 and 4). Type 1 formulation is thus regarded as a preferable option for predicting NM biodurability for hazard assessment. However, for grouping purposes, the relative similarity among diverse nanoforms (NFs) of a NM is decisive. Two similarity algorithms were applied, and additional case studies comprising NFs and non NFs of the same substance were included. The results support the grouping decision by simplified formulation (Type 3) as a robust method for screening and grouping purposes.
- Organisation(s)
- External organisation(s)
- Italian Institute of Technology, BASF SE, University of Bologna, ILSP/Athena RC, National Institute of Public Health and the Environment, University of Amsterdam (UvA), Heriot-Watt University
- Journal
- Nanoscale Advances
- Volume
- 6
- No. of pages
- 19
- ISSN
- 2516-0230
- DOI
- https://doi.org/10.1039/d3na00588g
- Publication date
- 12-2023
- Peer reviewed
- Yes
- Austrian Fields of Science 2012
- 104023 Environmental chemistry, 210004 Nanomaterials, 211914 Risk research
- ASJC Scopus subject areas
- Bioengineering, Atomic and Molecular Physics, and Optics, General Chemistry, General Materials Science, General Engineering
- Portal url
- https://ucrisportal.univie.ac.at/en/publications/344f5fc7-24de-43b5-9493-d6405e59b026