Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC).
Regul Toxicol Pharmacol
; 149: 105594, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38555099
ABSTRACT
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.
Palabras clave
Cost of testing (CoT); Expected net benefit of sampling (ENBS); Expected value given current information (EV|CI); Expected value of delayed sample information (EVDSI). cost of delay (COD); Expected value of immediate sample information (EVISI); Return on investment (ROI); Threshold of toxicological concern (TTC)
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
United States Environmental Protection Agency
Límite:
Animals
/
Humans
País como asunto:
America do norte
Idioma:
En
Año:
2024
Tipo del documento:
Article