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A new collaborative paper published in Regulatory Toxicology and Pharmacology provides a clear, data-driven roadmap for evaluating the safety of fragrance materials using entirely animal-free methods. The study is a joint effort between RIFM scientists Anne Marie Api and Isabelle Lee, and scientists at global companies (Andreas Natsch, Givaudan; Peter Griem, Symrise; Petra Kern, Procter & Gamble), academia (James Bridges, University of Surrey; Ian Kimber, University of Manchester), a trade association (Amaia Irizar and Matthias Vey, International Fragrance Association).

“Building on more than a decade of RIFM-led scientific work, this collaboration reflects the Institute’s pioneering role in advancing the derivation of NESILs without using animal or human testing.” RIFM President Anne Marie Api, PhD, Fellow ATS, added. “Through the development, evaluation, and application of in vitro assays and data-driven modeling, RIFM and its partners have helped establish confidence in NAM-based points of departure. The current framework integrates and formalizes this body of work, demonstrating how these methods can be consistently applied within a next-generation risk assessment (NGRA) context for fragrance materials.”

While RIFM does not test on animals for any of its human health endpoints, its safety assessments have historically utilized a weight-of-evidence approach that included legacy animal data and human confirmatory tests. This new research builds on that commitment by establishing a standardized framework for using New Approach Methodologies (NAMs)—such as SARA-ICE, Regression DA, and GARDskin—to determine the “No Expected Sensitization Induction Level” (NESIL) for skin sensitization solely through in vitro data.

“This work is a testament to the power of collaboration in advancing science-based safety standards,” said RIFM’s Isabelle Lee, PhD, Principal Scientist, Dermatotoxicology. “By rigorously comparing these new methods against established data, we’ve shown that we can maintain our high standards for consumer protection through a purely animal-free framework.”

The study evaluated 110 chemicals, with a focus on fragrance materials, to ensure the framework is robust and applicable to the industry’s unique needs. It serves as a vital resource for toxicologists and regulatory bodies worldwide, offering a validated method for determining points of departure in safety assessments without new animal data.

Read the open-access, peer-reviewed paper here.

Related papers:

Derivation of points of departure using GARDskin Dose Response (GSDR):
Determining a point of departure for skin sensitization potency and quantitative risk assessment of fragrance ingredients using the GARDskin dose-response assay

Proposal for incorporation of GSDR into an NGRA framework (collaboration with IFF):GARDskin dose-response assay and its application in conducting Quantitative Risk Assessment (QRA) for fragrance materials using a Next Generation Risk Assessment (NGRA) framework

Derivation of points of departure using regression models:
Predicting points of departure and potency categories for fragrance ingredients by integrating OECD in vitro models

Application of regression models within an NGRA framework:
Quantitative next-generation risk assessment for skin sensitization – application of regression models based on in vitro data to estimate point of departure