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  • Clive Roper

OECD Case Study for Respiratory Toxicology (No. 367)



The OECD has published a series of Case Studies; Series on Testing and Assessment: publications by number - OECD. I am very proud to announce the publication of "Case Study on the use of an Integrated Approach for Testing and Assessment (IATA) for New Approach Methodology (NAM) for Refining Inhalation Risk Assessment from Point of Contact Toxicity of the Pesticide, Chlorothalonil. Series on Testing and Assessment No. 367", see https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/cbc/mono(2022)31&doclanguage=en

This is Case Study summarises the work and discussions leading to the US EPA published risk assessment; EPA (2021). Chlorothalonil: revised human health draft risk assessment for registration review https://www.regulations.gov/document/EPA-HQ-OPP-2011-0840-0080). This indirectly resulted in a full replacement of animals with a waiving of the 90 day repeat dose rat inhalation toxicity test. The full list of publications from this programme, as well as supporting publications are referenced in the Case Study.

We are especially proud to have shared some of the many thought processes that went into shaping and performing this series of computational, chemical and human in vitro tests. We do not expect researchers to fully reproduce this work for regulatory submissions, but instead follow the considerations in Section 10 (and add your own thought processes) in developing and performing the test.

I believe that this Case Study is the basis for testing respiratory toxicology and efficacy for pharmaceuticals, chemicals, cosmetic chemical etc, as well as crop protection products.

I look forward to consulting on your respiratory toxicology programme.

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