Toxicogenomics: regulatory perspective on current position

Area of Science:

• Toxicology
• Genomics
• Biochemistry

Background:

• Toxicogenomic approaches, including transcriptomics, proteomics, and metabonomics, are increasingly utilized in toxicology.
• Published studies have reviewed the utility of these methods for screening toxicological mechanisms and evaluating dose-response effects.

Purpose of the Study:

• To review the utility of toxicogenomic approaches in toxicology.
• To evaluate their application in screening for toxicological mechanisms and dose-response effects.

Main Methods:

• Systematic review of published studies on toxicogenomic approaches.
• Analysis of transcriptomics, proteomics, and metabonomics data in toxicological screening.

Main Results:

• Transcriptomics can screen for specific toxicological mechanisms with a priori hypotheses, but has limited value for mutagenicity testing.
• Toxicogenomic screening data cannot exclude toxicity; targeted transcriptomics may help identify human-irrelevant mechanisms.
• An integrated approach using multiple toxicogenomic methods alongside conventional toxicology is suggested for dose-response assessment.

Conclusions:

• Toxicogenomic approaches offer valuable adjuncts to conventional toxicology for specific applications.
• Further data are required for formal regulatory use in decision-making processes.
• Integrated toxicogenomic strategies can refine chemical risk assessment and reduce extensive testing.