GRACIOUS

GRACIOUS: Grouping, Read-Across and ClassIficatiOn framework for regUlatory risk assessment of manufactured nanomaterials and Safer design of nano-enabled products

Background: Manufacturing and functionalising materials at the nanoscale leads to a whole array of nanomaterials (NMs) varying in e.g. 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 and classification of NMs/NFs. 

Methodology:  The project will work continuously 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.

The GRACIOUS Framework will be underpinned by scientific hypotheses identifying endpoints relevant to grouping and read-across. To generate the knowledge and data needed to identify and test the hypotheses we will develop Intelligent Testing Strategies (ITSs) covering all domains of relevance for risk assessment: (i) “Lifecycle environmental release and human exposure” (WP2), (ii) “What they are: physicochemical identity” (WP3), (iii) “Where they go: Environmental fate, uptake and toxicokinetics” (WP4), and iv) “What they do: human and environmental toxicity” (WP5). The ITSs 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.

To enable the Framework to inform SbD options that retain product functionality, we will apply Stage-Gate thinking which incorporates a risk/cost-benefit analysis to inform decisions on project termination, the need for stage reiteration to improve the safety, and/or progression to the next stage.

Impact:  Application of the Framework will allow movement away from the case-by-case risk assessment paradigm, thereby impoving the efficiency of risk analysis and decision making for safer design of quality NEPs.

To ensure impact the Framework (and the ITSs) will be delivered both as a Guidance Document and a software module designed for practical application to i) help industries and regulators assess environmental and human health risks of existing NMs/NFs cost-effectively; ii) facilitate business decisions concerned with developing new NEPs, and iii) inform SbD practices.

Start date: January 2018

Project duration: 42 months

Coordinator: Hariot-Watt University

Contact: Vicki Stone (v.stone@hw.ac.uk)

Partners

  • Hariot-Watt University (UK)
  • BASF SE (Germany)
  • GreenDecision SRL (Italy)
  • Institute of Occupational Medicine (UK)
  • European Research Services GmbH (Germany)
  • Yordas Limited (UK)
  • Det Nationale Forskningscenter for Arbejdsmiljo (Denmark)
  • Bundesinstitut fuer Risikobewertung (Germany)
  • Natural Enfiornmental Research Council (UK)
  • Universitaet Wien (Austria)
  • Fondazione Istituto Italiano di Tecnologia (Italy)
  • Rijksinstituut voor Volksgezondheid en Milieu (Netherlands)
  • Eidengenoessische Technische Hochschule Zuerich (Switzerland)
  • Acondicionamento Tarrasense Association (Spain)
  • Akzo Nobel Pulp and Performance Chemicals AB (Sweden)
  • IdeaConsult Ltd (Bulgaria)
  • JRC Joint Reserch Centre – EC (Belgium)
  • Unilever UK Central Resources Ltd (UK)
  • Thinkworks BV (Netherlands)
  • Arizona Board of Regents (US)
  • Duke University (US)
  • Athena RC (Greece)
  • Eidgenoessische Materialpruefungs- und Forschungsanstalt (Switzerland)