Tag Archive for: Newsletter

SenzaGen’s Newsletter Q3 2025

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Safe dose levels for sensitizers, NESIL values for HRIPT, and PoD-based QRA
Skin sensitization potency assessment has been in the spotlight at several toxicology conferences this summer, particularly for fragrances where defining safe dose levels, establishing NESIL values, and applying Point of Departure (PoD)-based Quantitative Risk Assessment (QRA) remain key challenges.

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Webinar: In vitro skin sensitization potency assessment
Our on-demand webinar demonstrates how GARD®skin contributes to these needs with case studies on fragrances, essential oils, botanical extracts, and complex mixtures, in collaboration with Unilever, BIC, Takasago, dōTERRA, IFF, and RIFM.
WATCH THE RECORDING
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OECD TG 497 regulatory update at Eurotox
Thank you to everyone who visited us at this year’s Eurotox and joined the discussions on what GARD®skin’s inclusion in OECD TG 497 means for high performance and extended applicability within the DASS framework. We presented posters and led an interactive session demonstrating applications across complex substance categories such as UVCBs, natural extracts, hydrophobic materials, and formulations.

Connect with our specialists to discuss what this means for your regulatory testing strategy
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GARD® enters final ISO validation

– 100% reproducibility and 97% concordance
At the recent ISO TC 194/WG 8 meeting, SenzaGen presented pre-validation results for GARD®skin Medical Device. The assay achieved 100% reproducibility and 97% concordance with animal data, confirming it is robust and ready for the next step: interlaboratory ring trial validation. This milestone advances NAMs in ISO standards, supporting the shift to non-animal skin sensitization assessments.

Request the poster with full pre-validation data

Upcoming events
🌎 ICT 2025 | Beijing, China | Oct 15-18
🌎 ASCCT 2025 | Gaithersburg, USA | Oct 21-23
🌎 3rd Annual Medical Device Biocompatibility Conference | Berlin | Nov 6-7
🎧 Webinar: How GARDskin fits into OECD TG 497 | Nov 20

SenzaGen’s Newsletter Q2 2025

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SenzaGen Newsletter 2025 Q2


SenzaGen Newsletter 2025 Q2

GARD®skin is now included in OECD TG 497
We are excited to announce that the GARDskin assay (OECD TG 442E) is now included in OECD TG 497’s Defined Approaches for Skin Sensitization (DASS), bringing high performance and extended applicability to the DASS framework. The assay is part of two key Defined Approaches:

  • The “2 out of 3” DA for hazard identification
  • The Integrated Testing Strategy (ITS) for hazard identification and potency subcategorization (1A, 1B, NC).

Learn more about how GARDskin fits into TG 497.
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Webcast: How GARDskin enhances Defined Approaches for Skin Sensitization
Watch the webcast to learn what the inclusion of GARDskin in OECD TG 497 means in practice – and how it can support your regulatory testing strategy. The webcast is now available on demand.
WATCH THE RECORDING
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FDA shift highlights need for innovative, human-relevant test methods
The FDA’s recent decision to phase out mandatory animal testing in drug development marks a major regulatory step toward wider adoption of human-relevant, non-animal methods. For SenzaGen, this shift highlights the growing value of technologies like machine learning, genomics, and organoid-based testing.

Read more in the full FDA article
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Expanded collaboration with RIFM to advance fragrance safety
Our long-standing collaboration with the Research Institute for Fragrance Materials (RIFM) continues to grow, driven by a shared commitment to non-animal methods and scientific excellence. Recent projects expand the scope of our work, including new in vitro studies in areas such as photosensitization.

Learn more about our work with RIFM

Upcoming events
🌎 World Congress 13 | Rio de Janeiro, Brazil | Aug 31-Sep 4
🌎 Eurotox 2025 | Athens, Greece | Sep 14-17
🌎 ICT 2025 | Beijing, China | Oct 15-18
🌎 ASCCT 2025 | Gaithersburg, USA | Oct 21-23