Suchergebnisse

Abstract
Throughout their whole life cycle from production to waste disposal, nanomaterials (NMs) and nano-enabled products (NEPs) are in contact with humans by different exposure routes and may induce adverse health effects. After oral exposure they may give rise to local or even systemic toxic effects associated to their dissolution behaviour, intestinal absorption or by being trapped into the gastrointestinal barrier Safe and sustainable-by-design (SSbD) interventions to reduce or mitigate NM/NEP risks along their life cycle have been suggested in the last years. However, no clear physico-chemical (PC) properties modulating the hazard by the oral route have been identified. Based on published practical examples of successful SSbD strategies, key PC properties determining the technical function of the NM in the NEP as well as those modified by the SSbD intervention are identified. In addition, oral IATAs from the GRACIOUS project are used to identify which PC properties could be relevant to determine the fate of NMs/NEPs after oral exposure. A further literature search on the specific NM/NEP may help to unravel the relationships among key PC properties and associated mechanisms of hazards.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 862419.

According to some legislation grouping can streamline data gap filling for the hazard assessment of substances. The GRACIOUS Framework aims to facilitate the application of grouping of nanomaterials or nanoforms (NFs), in a regulatory context and to support innovation. This includes using grouping to enable read-across from (a) source(s), for which data and information exist, to a similar target NF where information is lacking. The Framework provides an initial set of hypotheses for the grouping of NFs which take into account the identity and use(s) of the NFs, as well as the purpose of grouping. Initial collection of basic information allows selection of an appropriate pre-defined grouping hypothesis and a tailored Integrated Approach to Testing and Assessment (IATA), designed to generate new evidence to support acceptance or rejection of the hypothesis. Users needing to develop their own user-defined hypothesis (and IATA) are also supported by the Framework. In addition, the IATA guides acquisition of the information needed to support read-across. This approach gathers information to render risk assessment more efficient, affordable, as well as reducing the use of test animals.