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

Area of Science:

• Toxicology
• Regulatory Science
• Chemical Safety

Background:

• The rodent cancer bioassay is the traditional method for evaluating chemical carcinogenicity for regulatory purposes.
• Limitations of the rodent bioassay have driven international efforts to develop alternative, modernized approaches.
• Existing methods lack human-relevance and mechanistic insights, necessitating advancements in carcinogenicity assessment.

Purpose of the Study:

• To outline challenges and opportunities in developing a roadmap for global acceptance of new carcinogenicity assessment approaches.
• To advocate for the incorporation of scientifically defensible, fit-for-purpose methods in regulatory evaluations.
• To highlight the importance of human-relevant mechanistic understanding in modernizing chemical risk assessment.

Main Methods:

• Review of existing literature on rodent cancer bioassays and their limitations.
• Analysis of international initiatives focused on alternative methods for carcinogenicity assessment.
• Discussion of the integration of mechanistic data into regulatory frameworks.

Main Results:

• Decades of research confirm the limitations of the rodent cancer bioassay.
• Biologically relevant approaches offer enhanced efficiency and mechanistic information.
• New approaches are crucial for accurate human risk assessment of chemical carcinogens.

Conclusions:

• A global roadmap is needed to facilitate the adoption of new, scientifically sound carcinogenicity assessment methods.
• Incorporating human-relevant mechanistic data is key to modernizing regulatory evaluations.
• Transitioning from rodent bioassays to advanced approaches will improve the safety assessment of agrochemicals and other chemicals.