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Integrated Approaches to Testing and Assessment (IATA)

Integrated Approaches to Testing and Assessment (IATA)

Integrated Approaches to Testing and Assessment (IATA)

Developing Integrated Approaches for Testing and Assessment (IATAs) in order to support chemical safety

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 silicoin 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.

Join our webinar on IATA concepts and OECD Case Studies

WHEN: 16 December 2022 at 14:00 - 16:00 CET / 08:00 - 10:00 EST

WHEN: 16 December 2022 at 14:00 - 16:00 CET / 08:00 - 10:00 EST

The OECD Integrated Approaches to Testing and Assessment (IATA) Case Studies Project was created as a forum to allow stakeholders to share experiences using New Approach Methods (NAMs) to assess chemical hazards. IATAs used combinations of methods to evaluate the potential toxicity of substances and may be developed around an Adverse Outcome Pathway (AOP) framework, though AOPs are not a requirement for IATAs. IATA Case Studies are drafted by authors to address a specific regulatory decision context, submitted, and peer reviewed by a group of independent experts.  Following discussion of reviewer comments, revised IATA Case Studies are published on the OECD website.

Now in the eighth annual cycle, 35 IATA Case Studies that address a variety of toxicity endpoints have been published and provide examples of how some of the most innovative approaches can be applied to chemical safety assessment. Lessons learned through the submission and review have contributed to the development of internationally harmonised OECD Test Guidelines using NAMs, including the first Defined Approach Test Guideline, and topic-specific guidance for regulators on the use of innovative approaches.

This webinar will provide an overview of IATA concepts and the OECD IATA Case Studies project. In addition, speakers will give examples of IATA Case Studies submitted for review and discuss the impact of the project in their areas.

REGISTER HERE.

Case Studies on IATA

The OECD IATA Case Studies Project allows countries to share and explore the use of novel methodologies in IATA for chemical hazard characterisation within a regulatory context. In the interactive reports below, you will find: 

  • The total number of case studies by endpoints, assessment type and IATA topics
  • The full list and links to the case studies 
  • The consideration documents captures learnings and lessons from the review experience.

 

More information on IATA

What information is integrated in an Integrated Approaches to Testing and Assessment?

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.

How do IATAs help reduce animal testing?

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.

Are IATAs New Approach Methods (NAMs)?

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.

IATA and Adverse Outcome Pathways (AOPs)

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.

What are some other advantages of using IATAs?

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 information is limited (e.g. “data-poor chemicals”).

Is there a standard way of developing and reporting IATAs and their elements?

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:

OECD guidance documents and dashboards

Overview of Concepts and Available Guidance related to IATA

Dashboard of the mapped guidance documents related to IATA

The Reporting of Defined Approaches to be Used Within IATA

The Reporting of Defined Approaches and Individual Information Sources to be Used within IATA for Skin Sensitisation

Characterisation, Validation and Reporting of PBK Models for regulatory purposes

Use of Adverse Outcome Pathways in Developing IATA

Principles and Key Elements for Establishing a Weight of Evidence for Chemical Assessment

Guidance on Grouping of Chemicals, Second Edition

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