Filling Data Gaps by Read-across: A Mini Review on its Application, Developments and Challenges

Area of Science:

• Toxicology
• Chemical Risk Assessment
• In Silico Methods

Background:

• Read-across is a key non-testing data gap filling technique in toxicology.
• Driven by cost, time, and ethical considerations of in vivo testing, its use is promoted by regulations like EU-REACH to minimize animal testing.
• Regulatory bodies (ECHA, OECD) and the scientific community have developed guidance and frameworks to support its application.

Purpose of the Study:

• To review key developments in the application of read-across.
• To discuss regulatory and scientific expectations for read-across studies.
• To highlight practical hurdles and open challenges in the evolving field of read-across.

Main Methods:

• Review of published guidance documents from ECHA and OECD.
• Analysis of scientific literature on read-across practices and frameworks.
• Synthesis of information on regulatory expectations and practical implementation.

Main Results:

• Read-across is increasingly utilized due to its benefits over in vivo testing.
• Established guidelines exist for performing, assessing, and documenting read-across.
• Despite advancements, the method faces ongoing challenges and offers opportunities for further development.

Conclusions:

• Read-across is a valuable and evolving tool in toxicological assessment, supported by regulatory frameworks and scientific efforts.
• Continued research and collaboration are needed to address open issues and enhance the validity and application of read-across.
• The future of read-across involves refining methodologies to meet scientific and regulatory expectations while minimizing animal use.