A Vision for the Future: RIFM and collaborators reach critical toxicology milestone
For more than a decade, the Research Institute for Fragrance Materials (RIFM) has been committed to avoiding animal testing while maintaining a robust program for scientifically assessing the safety of fragrance materials. As part of its commitment, RIFM integrated the Threshold of Toxicological Concern (TTC) methodology into its Safety Assessment program in 2013.
RIFM scientists may use the TTC for fragrance ingredients with limited or no toxicity data and for which no read-across ingredient exists. (“Read-across” refers to using one ingredient as a proxy to support the safe use of a structurally similar ingredient lacking study data. Read more here.)
Since generating data would require animal testing, TTC offers a reliable method for conducting a risk assessment based on the level of exposure. If the current exposure to a fragrance material is below the TTC, then there are no concerns for adverse effects in humans.
Now, RIFM scientists are collaborating with experts worldwide to bring about the next step in the evolution of TTC: the iTTC, or internal TTC, which refers to exposures resulting from ingestion, inhalation, or dermal absorption. The iTTC combines the TTC concept from toxicology with the internal dose from pharmacokinetics/pharmacodynamics (PBPK). Thus, iTTC is a safe level representative of internal exposures. As long as internal exposure levels of fragrance materials remain below the iTTC, there is no concern for adverse effects.
RIFM and its collaborators recently reached a key milestone in developing iTTC values, completing crucial in vitro (in test tubes/Petri dishes) permeability and metabolism studies needed to refine the understanding of iTTC. Read more about this critical work.
As RIFM scientist Kaushal Joshi, PhD, explains, “The collaborative research to develop the iTTC is advancing well. With increased focus on the use of animal alternative strategies, the iTTC will be an important additional tool for future use.