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The

Nano-Safety Research Group

Specialists in the assessment of nanomaterial toxicity to human health and the environment

GRACIOUS

 

GRACIOUS - Framework for grouping and read-across of nanomaterials/nanoforms for regulatory risk assessment and safe-by-design

Funding: EU H2020 Jan 2018 - Jun 2021 - Euro's 6.9 million total (0.8 million to HWU)

Background: Manufacturing and functionalising materials at the nanoscale can lead to a whole array of nanoforms (NFs) of a substance varying in e.g. size, morphology and surface characteristics. Due to financial, time and ethical consideration, safety testing for the risk assessment of every unique NF is virtually impossible. Grouping and read-across are currently used in a regulatory context to predict hazard and exposure information for data poor substances based on structural and chemical similarity with data rich substance.   

Goal: The main goal of GRACIOUS is to generate a highly innovative science-based Framework to enable practical application of grouping, leading to read-across and between NFs. In achieving this goal, GRACIOUS will streamline the risk assessment process for both regulatory and safe-by-design processes.

The GRACIOUS Framework is based on scientifically sound hypotheses that allow NFs, materials and substances to be grouped logically, subsequently facilitating read-across. The GRACIOUS Framework has 3 levels that facilitate initiation, development and justification of the hypothesis 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 “What they do: human and environmental toxicity”.  Based on the available data and information, each hypothesis may trigger specific tailored Integrated Approaches to Testing and Assessment (IATAs) that guide testing, modelling and assessment in a tiered manner, with the aim of generating the scientific evidence justifying the grouping and read-across. The IATAs will reduce, refine and replace (where possible) the need for animal testing by promoting the use of predictive modelling, in vitro and cell-free tests.  Stakeholders play an active role in the iterative cycle of design, testing and refinement to ensure that the Framework effectively meets the needs of both regulators and industry.