Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC).

Autor: Simon TW; Ted Simon LLC, USA. Electronic address: ted@tedsimon-toxicology.com., Ryman J; American Chemistry Council, Washington DC, USA., Becker RA; American Chemistry Council, Washington DC, USA.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105594. Date of Electronic Publication: 2024 Mar 28.
DOI: 10.1016/j.yrtph.2024.105594
Abstrakt: A Value of Information (VOI) analysis can play a key role in decision-making for adopting new approach methodologies (NAMs). We applied EPA's recently developed VOI framework to the Threshold of Toxicological Concern (TTC). Obtaining/deriving a TTC value for use as a toxicity reference value (TRV) for substances with limited toxicity data was shown to provide equivalent or greater health protection, immense return on investment (ROI), greater net benefit, and substantially lower costs of delay (CoD) compared with TRVs derived from either traditional human health assessment (THHA) chronic toxicity testing in lab animals or the 5-day in vivo EPA Transcriptomic Assessment Product (ETAP). For all nine exposure scenarios examined, the TTC was more economical terms of CoD and ROI than the ETAP or the THHA; expected net benefit was similar for the TTC and ETAP with both of these more economical than the THHA The TTC ROI was immensely greater (5,000,000-fold on average) than the ROI for THHA and the ETAP ROI (100,000-fold on average). These results support the use of the TTC for substances within its domain of applicability to waive requiring certain in vivo tests, or at a minimum, as an initial screening step before conducting either the ETAP or THHA in vivo studies.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ted W. Simon reports financial support and writing assistance were provided by American Chemistry Council. Ted W. Simon reports financial support, article publishing charges, and writing assistance were provided by American Chemistry Council. Ted W. Simon reports a relationship with Center for Truth in Science that includes: board membership. Member of the editorial board of Regulatory Toxicology and Pharmacology If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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