Minimising environmental and human health risks from chemicals is a critical regulatory issue. The assessment of environmental and human health risk requires the identification, compilation and integration of information on the chemical hazards, exposure, and the relationships between exposure, dose and adverse effects.
Advances in testing methods, biotechnology and computational models are paving the way for major improvements in how scientists evaluate the risks posed by potentially toxic chemicals. These advances enable toxicity testing that is faster, less expensive, and more relevant to human responses than traditional toxicity testing methods. These new methods also rely on in silico, in chemico and in vitro approaches that reduce the need for animal testing.
Integrated Approaches to Testing and Assessment (IATA) combine multiple sources of information to conclude on the toxicity of chemicals. IATAs may include existing information from the scientific literature or other resources, along with newly generated data resulting from new or traditional toxicity testing methods to fill data gaps. These approaches are developed to address a specific regulatory scenario or decision context.
The OECD IATA Case Studies Project allows countries to share and explore the use of novel methodologies in IATA for evaluating the safety of chemicals within a regulatory context. In the interactive reports below, you will find:
IATAs can include a combination of methods [(Q)SAR, read-across, in chemico, in vitro, ex vivo, in vivo] or omic technologies (e.g. toxicogenomics), the results of which are integrated.
As a first step in building the IATA, existing data are collected. Additional testing is only conducted if the available information is not adequate to answer the question. In many cases, additional information can be obtained from in vitro testing or computational models, and animal testing may not be necessary.
IATAs are frameworks for integrating information. The term “new approach methods” can include in vitro (e.g. omics, cell-based, tissue-based, etc.) assays, in silico (e.g. [Q]SARs, expert systems, etc.) models, and other biotechnological and computational approaches. IATAs often include data from NAMs.
When integrating data generated from different methods and informing different levels of biology (e.g. molecule, cell, organ, organ system, organism), may be difficult to combine the data. Adverse Outcome Pathways (AOPs) provide a framework for organising data collected from different methods and relevant to different levels of biology to evaluate relationships between key events and adverse effects.
Though an AOP can help develop an IATA, interpret results, and identify information gaps, an AOP is not required to develop an IATA.
In addition to potentially reducing animal testing, IATAs can leverage existing data and use high-throughput methods to rapidly assess a large number of chemicals. In addition, grouping and read-across approaches allow information on existing chemicals to be used to evaluate the safety of new chemicals, and/or chemicals for which hazard/exposure information is limited (e.g. “data-poor chemicals”).
IATAs are intended to be flexible, however, some aspects can be standardised or reported in a consistent manner to aid the review.
Reporting templates can be found for: