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The Research Institute for Fragrance Materials (RIFM) is pioneering an innovative approach to address a growing regulatory concern regarding in vivo genotoxicity studies. Many of RIFM’s legacy safety studies lack toxicokinetic (TK) or plasma exposure data, which regulatory agencies are increasingly requesting to demonstrate that the test substance reached the target tissue. To avoid repeating animal studies, RIFM has initiated a pilot study using physiologically based pharmacokinetic (PB/PK) modeling to reinforce the validity of the original genotoxicity findings.

The pilot study, which utilizes the Certara Simcyp® Simulator platform, provides a scientifically robust and ethically responsible alternative to additional animal testing to support the safety assessments of fragrance ingredients. By using PB/PK modeling, RIFM can simulate how a substance is absorbed, distributed, metabolized, and excreted in the body, providing a scientific basis for target tissue exposure.

“The genetox team at RIFM is excited about this pilot study, as it highlights the utility of PB/PK modeling in bridging data gaps and supporting safety assessments for fragrance materials,” said RIFM Postdoctoral Researcher Kayla Farrell, PhD, MPH. “Our future work will expand this modeling approach to a broader set of chemicals to further strengthen the safety substantiation.”

This research will be presented during a poster session at the Environmental Mutagenesis and Genomics Society’s 56^th Annual Meeting next week.