Basic definitions are provided and compared, with a view to identifying inconsistencies in the way terminology is used. A mapping exercise identified guidance documents that are systematically described in a supporting file. IATA are pragmatic, science-based approaches for chemical hazard characterisation that rely on an integrated analysis of existing information coupled with the generation of new information using testing strategies. IATA follow an iterative approach to answer a defined question in a specific regulatory context, taking into account the acceptable level of uncertainty associated with the decision context.
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Alternatives to Animal Testing pp Cite as. New streamlined approaches that use fewer resources and animals are needed for the safety assessment of chemicals. Data gathering should be streamlined to fit regulatory need and the specific properties of the chemicals being assessed. An IATA is designed to address a specific question, and may include exposure or regulatory considerations, depending on the context. IATA can be informed by mechanistic information about the chemical and related biology. An AOP is the collected chemical and biological information about a particular biological pathway. The AOP-KB also accepts information about the perturbations of these pathways caused by chemical exposure — information can be used to design prediction models.
According to the case study, the purpose of the read-across exercise was to determine the genotoxic hazard potential of two nano-TiO2 target substances based on the in vitro comet assay results from other TiO2 nanoforms. Overall, the case study shows the practical application of the ECHA guidance for grouping and read-across of nanomaterials, which was slightly adapted for the case study. Furthermore, the case study states, it demonstrates the usefulness of cheminformatics techniques to support the grouping hypothesis by identifying the differences between nanoforms and by supporting the weight of evidence. According to the case study, some nanospecific issues were identified for further specification of the RAAF for nanomaterials, in particular the concept of similarity, which cannot be based only on structural similarity for nanomaterials.
The Organisation for Economic Co-operation and Development OECD works with member countries and other stakeholders to improve and harmonize chemical assessment methods. The guidance document on the reporting of defined approaches to be used within IATA, also published in , provides a set of principles for reporting defined approaches to testing and assessment to facilitate their evaluation. In the guidance documents, the AOP concept plays an important role for building IATA approaches in a science-based and transparent way. In , the IATA Case Studies Project was launched to increase experience with the use of IATA and novel hazard methodologies by developing case studies, which constitute examples of predictions that are fit-for-regulatory use.