Difficulties in translating in vitro hazards of local acute irritants to relevant human risk: Learnings from Captan and Folpet.

Felix M Kluxen

Regulatory toxicology and pharmacology : RTP 2023 Sep

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In order to assess the regulatory value of New Approach Methodologies (NAMs), authors should provide their opinion on the physiological and exposure relevance of observed in vitro effects for correlation with predicted in vivo effects. Further, peer-reviewers should be encouraged to request such information during review. This is critical to scientifically transition to animal-free, reliable, robust and -- most importantly -- relevant regulatory toxicology and risk assessment approaches. Recently published studies using NAMs for the fungicides Captan and Folpet illustrate the difficulties and limitations of applying NAMs to adequately assess the toxicological relevance of these substances. Copyright © 2023 Elsevier Inc. All rights reserved.

Citation

Felix M Kluxen. Difficulties in translating in vitro hazards of local acute irritants to relevant human risk: Learnings from Captan and Folpet. Regulatory toxicology and pharmacology : RTP. 2023 Sep;143:105467