Background: Nanomaterials (NMs) exist in a varying physicochemical characteristics such as size, morphology and surface characteristics. Due to financial, time and ethical consideration, safety testing of every unique NM for their potential adverse effects is virtually impossible. For these reasons, more efficient ways to obtain safety information are needed.
Goal: In order to streamline the risk assessment process, the main goal of GRACIOUS is to generate a highly innovative science-based Framework to enable practical application of grouping, leading to read-across of NMs.
Approach: The GRACIOUS Framework is underpinned by scientific hypotheses identifying endpoints relevant to grouping and read-across. We have generated a template and protocol for hypothesis generation that encompasses information relevant to "Lifecycle environmental release and human exposure", "What they are: physicochemical identity", "Where they go: Environmental fate, uptake and toxicokinetics", and iv) "What they do: human and environmental toxicity". Each hypothesis will trigger specific tailored Integrated Approaches to Testing and Assessment (IATAs) that guide testing, modelling and assessment in a tiered manner. The IATAs will reduce, refine and replace (where possible) the need for animal testing by promoting the use of modelling (e.g. in silico, fate, exposure), in vitro and cell-free tests. We are working with stakeholders in an iterative cycle of design, testing and refinement to ensure that the Framework effectively meets the needs of both regulators and industry.
Vicki Stone is Director of the Institute of Biological Chemistry, Biophysics and Bioengineering at Heriot-Watt University, Edinburgh, UK. Vicki is also an Honorary Principal Scientist at the Institute of Occupational Medicine. Vicki is a fellow of the Royal Society of Chemistry, the Royal Society of Biology and the Royal Society of Edinburgh. She was the holder of the Royal Society of Chemistries Toxicology Award (2015-16) and the Editor-in-chief of the journal Nanotoxicology (http://informahealthcare.com) for 6 years (2006-2011). Vicki has also published over 165 publications pertaining to particle toxicology over the last 25 years and is recognised by Clarivate Analytics (formerly Thomson Reuters) as one of the top 1% of all researchers in the world for the most cited publications in the field of Pharmacology and Toxicology. Vicki is currently involved in three new large EU funded projects GRACIOUS, PATROLS and BIORIMA. GRACIOUS (for which Vicki is coordinator) will generate a framework for streamlining the risk assessment by facilitating grouping and read-across of nanomaterials. PATROLS will generate advanced alternative models for assessing the hazards of nanomaterials to humans and other species. BIORIMA will generate a risk assessment framework for nanomedicines. Other current funding includes UK Research Councils (BBSRC and NC3Rs) and industry (Byk/Altana).