IVIVE: Facilitating the use of in vitro toxicity data in risk assessment and decision making

During the past few decades, the science of toxicology has been undergoing transformation from an observational to a predictive science. New approach methodologies (NAMs) including in vitro, in silico models, read across, and in vitro to in vivo extrapolation (IVIVE) are being developed to reduce, refine or replace whole animal testing encouraging judicious use of time and resources. Some of these methods have advanced past the exploratory research stage and are beginning to gain acceptance for risk assessment of chemicals. Review of the recent literature reveals a burst of IVIVE publications over the past decade. In this review we proposed operational definitions for IVIVE, present specific case histories for several common toxicity endpoints and highlight their implications in decision making processes across various federal agencies, as well as European organizations including the European Commission (EC). The translational application of these methods to toxicity assessment and associated uncertainties are presented. In addition to refining and reducing the use of animals in traditional toxicity testing protocols and being used for prioritizing chemical testing, the goal to use IVIVE to facilitate replacement of animal models can be achieved through their continued evolution and development including a strategic plan of qualification towards acceptance.

CHANG Xiaoqing;  TAN Yu-Mei;  ALLEN D;  BELL Shannon;  BROWN Paul;  BROWNING Lauren;  CEGER Patricia;  GEARHART Jeffery;  HAKKINEN Pertti;  KABADI Shruti;  KLEINSTREUER Nicole;  LUMEN Annie;  MATHESON Joanna;  PAINI Alicia;  PANGBURN Heather;  PETERSEN Elijah J;  REINKE Emily;  RIBEIRO Alexandre J. S.;  SIPES Nisha;  SWEENEY Lisa;  WAMBAUGH John;  WANGE Ronald;  WETMORE Barbara;  MUMTAZ Moiz; 

2022-05-04

MDPI

JRC126919

2305-6304 (online),   

https://www.mdpi.com/2305-6304/10/5/232,    https://publications.jrc.ec.europa.eu/repository/handle/JRC126919,   

10.3390/toxics10050232 (online),