IATAs
Integrated Approaches to Testing and Assessment
A Complete Solution
IATA are approaches for ENM hazard characterisation that rely on an integrated analysis of existing information coupled with the generation of new information using testing strategies. We have developed workflows that combine and integrate external exposure models with biokinetic models for extracting the maximal amount of information among disparate models and improve the source to exposure to dose estimate.
Defining Nanomaterials for Regulatory and Industry Applications
A pivotal aspect of the NanoSolveIT project involves the precise definition of nanomaterials for regulatory purposes, ensuring the tools and methodologies developed are relevant and effective for both industry and regulatory stakeholders. Nanomaterials are characterized as natural, incidental, or manufactured materials consisting of solid particles. These particles may exist in isolation or as identifiable components within aggregates or agglomerates. To qualify as a nanomaterial, at least 50% of these particles, based on a number size distribution, must fulfill one of the following conditions:
- Size Specification: The particle has one or more external dimensions in the size range of 1 nm to 100 nm.
- Elongated Shape: The particle adopts an elongated shape, such as a rod, fibre, or tube, where two external dimensions are smaller than 1 nm and the other is larger than 100 nm.
- Plate-like Formation: The particle exhibits a plate-like shape, with one external dimension smaller than 1 nm and the other dimensions greater than 100 nm.
This definition is integrally incorporated into the NanoSolveIT IATA (Integrated Approach to Testing and Assessment) and its decision tree. The aim is to maximize the applicability and relevance of these tools for industry and regulatory stakeholders, aligning with the evolving needs and standards of nanotechnology regulation and application. By adopting this approach, the NanoSolveIT project not only adheres to current regulatory guidelines but also facilitates informed decision-making and innovation in the field of nanotechnology, benefitting a broad spectrum of industrial and regulatory entities.
Available Services
NanoSolveIT IATA: PBPK models and integration with the occupational exposure model
This web application enables the use of PBPK models for simulating the biodistribution of nanoparticles in humans as a result of exposure via the inhalation route. External exposure scenarios can be defined directly by the user or simulated through integration with the NanoSolveIT occupational exposure model.