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As regulatory expectations evolve and industry demand for non‑animal testing grows, the need for validated New Approach Methodologies (NAMs) continues to increase.
At ESTIV 2026, SenzaGen and peers explored how validated NAMs are advancing safety assessment, supporting innovation, and shaping the future of toxicology. |
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Recent regulatory developments in the EU and U.S. support the shift toward human-relevant, non-animal safety assessment in sensitization testing.
EU: Published a roadmap to phase out animal testing across chemicals, pesticides, medical devices, and other sectors, outlining actions and opportunities, including the potential to fully replace animal testing for skin sensitization by 2029. Read EU roadmap
EPA (USA): Updated its list of accepted NAMs for the first time since 2021, including OECD TG 497, and introduced a new nomination process to support uptake of alternative methods. Read EPA announcement
Together, these developments highlight the growing need for non-animal testing strategies and quantitative data to support decision-making. |
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For professionals in toxicology, regulatory affairs, and product development, reliable potency data enables informed decision‑making early in the development pipeline, helping reduce time to market while ensuring safety and regulatory compliance. Common needs include the following:
1.Establish a Point-of-Departure (PoD) for quantitative risk assessment.
2. Define safe dose levels for materials with expected sensitizing potential.
3.Derive reference NESIL values to support confirmatory human patch testing.
4.Detect low levels of sensitizers in complex cosmetic formulations.
5.Guide formulation optimization decisions.
Explore typical use scenarios |
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Our two‑part webinar series highlights practical applications for natural complex substances, novel raw materials with challenging properties, and cosmetic formulations, featuring new data generated in collaboration with dōTERRA, Bayer, The Honest Company, and RIFM.
Now available on demand—watch the full series at your convenience. |
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To support the transition toward NAMs, SenzaGen has added DPRA and ADRA to its service portfolio. These assays complement GARD®skin and support Defined Approaches for Skin Sensitization (DASS) under OECD TG 497.
With test methods covering all key events in the skin sensitization pathway, SenzaGen enables 2o3 DA and ITS strategies tailored to the testing needs:
- Key Event 1 | OECD TG 442C: DPRA, ADRA
- Key Event 2 | OECD TG 442D: EpiSensA, KeratinoSens
- Key Event 3 | OECD TG 442E: GARD®skin
- In silico predictions
Build a DASS strategy tailored to your substance’s properties |
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🌎 Conference: Eurotox 2026 | Vienna, Austria | September 13-16
🌎 Conference: ACT 2026 | San Antonio, TX, USA | November 15-18
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