Updated Aspects of Safety Regulations for Biomedical Applications of Aerogel Compounds—Compendia-Like Evaluation
Monica Neagu,
Fabia Grisi,
Alfio Pulvirenti,
Rosana Simón-Vázquez,
Carlos A. García-González,
Antonella Caterina Boccia
Affiliations
Monica Neagu
Immunology Department, Victor Babes National Institute of Pathology, 99-101 Spl Independentei, 050096 Bucharest, Romania
Fabia Grisi
Chemical and Biological Department “A. Zambelli”, and INSTM Research Unit, Università di Salerno, Via Giovanni Paolo II 132, 84084 Fisciano, Italy
Alfio Pulvirenti
CNR National Research Council, Istituto di Scienze e Tecnologie Chimiche-SCITEC “G. Natta”, Via A. Corti, 12, 20133 Milan, Italy
Rosana Simón-Vázquez
CINBIO, Universidade de Vigo, Inmunology Group, 36310 Vigo, Spain
Carlos A. García-González
AerogelsLab, I+D Farma Group (GI 1645), Departament of Pharmacology, Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, iMATUS and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15782 Santiago de Compostela, Spain
Antonella Caterina Boccia
CNR National Research Council, Istituto di Scienze e Tecnologie Chimiche-SCITEC “G. Natta”, Via A. Corti, 12, 20133 Milan, Italy
Aerogels have recently started to be considered as “advanced materials”; therefore, as a general consideration, aerogels’ toxicity testing should focus on their functionality which resides in their nanoscale open internal porosity. To assess the hazards of organic aerogels, testing at three levels may characterize their biophysical, in vitro and in vivo toxicity, defining distinct categories of aerogels. At the first level of testing, their abiotic characteristics are investigated, and the best aerogel(s) is forwarded to be tested at level 2, wherein in vitro methodologies may mainly evaluate the aerogels’ cellular behavior. Within level 2 of testing, the main characteristics of toxicity are investigated and the selected aerogels are introduced to in vivo animal models at level 3. In the animal model testing, target organs are investigated along with systemic parameters of toxicity. Some study cases are presented for organic or anorganic aerogels. Within this tiered workflow, aerogels-based materials can be tested in terms of human health hazard.
