Nanomaterial Safety Assessment Platform

ABSTRACT: Nanomaterials promise to bring critical advancements to technologies and products affecting multiple DoD mission areas. A major obstacle to realizing the strategic benefits of nanomaterials is the absence of computational risk assessment tools that allow nanomaterial developers to integrate and translate dose-response data and hazard rankings across in vitro and in vivo systems, between species and dose-routes, to assure the safety of nanomaterials in the work place and in their application. The overarching goal of this SBIR is to overcome these key barriers by developing the Nanomaterial Safety Assessment Platform (NSAP), an integrated quantitative pharmacokinetic and dose-response platform for determining the human exposure levels equivalent to those showing no toxicity in in vitro or in vivo assays, enabling rapid assessment of potential hazards posed by selected nanomaterials. The utility of the software will be demonstrated by predicting hazard rankings and human no effect levels for gold and silica nanomaterials using existing experimental data. In Phase II, capabilities for sensitivity analysis/variability analysis, conducting quantitative property-toxicity relationship analysis and derivation of dose-response models for transcriptional regulatory pathways will be developed, added, and extended to other nanomaterials. BENEFIT: AEgis Technologies expects this SBIR program to produce the first computational framework for rapidly deriving human safe exposure levels to nanomaterials through a novel integration of dose-response models, in vitro and in vivo data, and exiting in vivo/in vitro pharmacokinetic models. By enabling more rapid, more accurate nanomaterial safety assessments, the software will permit safer, more cost effective development and deployment of nanomaterial based materials supporting DoD missions.