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Integrated Approaches for Hazard Identification and Characterisation

Performing the necessary tests on a chemical in the product development pipeline can yield hundreds of gigabytes of data. Additionally, prior testing of other substances may have yielded information relevant to your own testing schedule. Integrated Approaches to Testing and Assessment (IATA) are “structured approaches that integrate and weigh different types of data for the purposes of performing hazard identification, hazard characterization, and/or safety assessment of a chemical or group of chemicals.”1 A similar methodology under REACH is called ITS (Integrated Testing Strategies). The goal of both these frameworks is to use existing data to minimise the amount of testing needed, thereby reducing or replacing animal testing requirements.

Not all data is weighted equally, however. In general, individual data sources are a less dependable foundation on which to build conclusions, versus a combined data set that has been built from multiple sources and appropriately weighted. While there isn’t a single formula for weighting data, formalised procedures that incorporate factors like data quality, consistency of results, severity of effects and the data’s relationship to the endpoint can be established to help maintain objectivity. Measuring data reliability can itself be at risk for subjective evaluation, so tools have been developed to preserve objectivity. The table below illustrates how to determine a Klimisch score2 for assessment of reliability of toxicological and ecotoxicological data. The approach relates the quality of the data to the methodology used and if specific guidelines or quality procedures were followed.

Klimisch score

To learn more about integrated approaches for assessing chemicals, download a copy of our free guide to Chemical and Cosmetics testing.

 

1 Tollefsen KE et al., (2014) Applying Adverse Outcome Pathways (AOPs) to support Integrated Approaches to Testing and Assessment (IATA). Regul Toxicol Pharm 70(3); 629-640

2 Klimisch H-J et al., (1997) A systemic approach for evaluating the quality of experimental toxicological and ecotoxicological data Regul Toxicol Pharm 25; 1-5

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