Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment

The rodent cancer bioassay has been the standard approach to fulfill regulatory requirements for assessing human carcinogenic potential of agrochemicals, industrial chemicals and pharmaceuticals. However, decades of research have described the limitations of the rodent cancer bioassay for identifying human carcinogenicity hazard and risk. These limitations have led to several international initiatives to establish approaches that modernize carcinogenicity assessment. One approach that can be used currently includes a weight of evidence (WoE) assessment of in silico, in vitro, and short-term in vivo tests, which has the potential to increase public health protection through well informed and scientifically robust regulatory decisions while substantially reducing animal use. Available alternative approaches can provide more mechanistic granularity, increase testing efficiency, and be more biologically relevant for evaluating hazard and risk of chemical carcinogenicity to humans. The feasibility assessment presented in this publication outlines the current regulatory landscape and identifies opportunities to build confidence in fit-for-purpose, scientifically defensible approaches for human-relevant carcinogenicity assessment of agrochemicals.

HILTON Gina;  CORVI Raffaella;  LUIJTEN Mirjam;  MEHTA Jyotigna;  WOLF Douglas C.; 

2023-01-31

ACADEMIC PRESS INC ELSEVIER SCIENCE

JRC128902

0273-2300 (online),   

https://www.sciencedirect.com/science/article/pii/S027323002200188X,    https://publications.jrc.ec.europa.eu/repository/handle/JRC128902,   

10.1016/j.yrtph.2022.105301 (online),