Advancing NAMs for Fragrance Safety: Collaborative Research with RIFM and IFF.
As innovators in in vitro skin sensitization testing, addressing key data gaps, we are pleased to share the publication of a new peer-reviewed article in ALTEX, which underscores the performance of GARD®skin Dose-Response in predicting the skin sensitization potency of fragrance ingredients. This study, conducted in collaboration with the expert teams at the Research Institute for Fragrance Materials, Inc. (RIFM) and IFF, contributes valuable insights to the growing body of research supporting more reliable, non-animal testing methods.
The article presents a comprehensive dataset of 100 fragrance ingredients, covering a broad chemical domain with diverse structural reactivity domains and potency levels. The results confirm GARD®skin Dose-Response‘s robust predictivity for skin sensitization potency across this wide chemical spectrum, strengthening its application for deriving No Expected Sensitization Induction Level (NESIL) values in Quantitative Risk Assessment (QRA) within frameworks like Next Generation Risk Assessment (NGRA). These advancements are pivotal in further reducing reliance on animal testing while enhancing risk assessment capabilities.
We would like to extend our gratitude to the exceptional teams who contributed to this collaboration: Isabelle Lee, Andy Forreryd, Mihwa Na, Isabella Schember, Maura Lavelle, Robin Gradin, Ulrika Mattson, Henrik Johansson, Shashi Donthamsetty, Gregory Ladics, and Anne Marie Api.
Isabelle Lee, Andy Forreryd, Mihwa Na, Isabella Schember, Maura Lavelle, Robin Gradin, Ulrika Mattson, Henrik Johansson, Shashi Donthamsetty, Gregory Ladics, and Anne Marie Api.
ALTEX - Alternatives to animal experimentation.(2025)
https://www.altex.org/index.php/altex/article/view/2810
Keywords
skin sensitization, fragrance materials, point of departure, OECD TG 442E, GARDskin, new approach methodology
Abstract
Potency and quantitative risk assessment are essential for determining safe concentrations for the formulation of potential skin sensitizers into consumer products. Several new approach methodologies (NAMs) for skin sensitization hazard assessment have been developed, validated, and adopted in OECD test guidelines. However, work is ongoing to develop NAMs for predicting skin sensitization potency on a quantitative scale for use as a point of departure (POD) in next-generation risk assessment (NGRA). GARDskin Dose-Response (DR) is an adaptation of the validated GARDskin assay (OECD TG 442E), and the readout of the assay is a quantitative potency prediction similar to the No Expected Sensitization Induction Level (NESIL) value (µg/cm2). The goal of this study was to evaluate the performance of the GARDskin DR assay for potency prediction of fragrance ingredients. One hundred (100) fragrance ingredients from a reference database covering varied structural reactivity domains and potency were tested in GARDskin DR. Materials tested had varied protein-binding reactivity alerts, including Schiff base, Michael addition, SN2, and acylation. Potency categories were predicted with a total accuracy of 37% and an approximate accuracy (exact match or off by 1 category) of 81%. Combining predicted weak and very weak categories increased total accuracy to 53% and approximate accuracy to 98%. The mean prediction error for the NESIL and local lymph node assay (LLNA) EC3 was 3.15- and 3.36-fold, respectively. Based on the results of this study, GARDskin DR is a promising predictor of skin sensitization potency with an applicability domain covering a wide range of fragrance ingredient reaction mechanisms, increasing the confidence in using the assay to conduct NGRA, ultimately reducing the need for animal testing.
Plain language summary
This study focused on testing a new in vitro method, GARDskin Dose-Response (DR), to predict the quantitative potency of fragrance ingredients in causing skin sensitization. This potency is important for setting safe levels of chemicals in consumer products. The GARDskin DR assay, based on an existing skin sensitization test (OECD TG 442E), provides a quantitative measure of potency similar to the No Expected Sensitization Induction Level (NESIL). One hundred (100) fragrance ingredients with different chemical structures and reactivity patterns were tested. The assay accurately distinguished between sensitizers and non-sensitizers for 81% of the materials, and also correctly predicted their approximate potency categories. The results show that GARDskin DR is a promising tool for predicting quantitative potency for skin sensitization risk, helping to reduce animal testing and support safer product development.
SenzaGen at 2025 SOT: Advancing NAMs for Skin Sensitization Testing
The SenzaGen team had a fantastic time at SOT this year in Orlando, connecting with peers and presenting the latest GARD® data from our industry collaborations.
A special thank you to everyone who joined our scientific sessions and to our guest speakers, Ron Brown and Joe Dawson, for their insightful talks on emerging trends and New Approach Methodologies (NAMs) in skin sensitization assessment of chemicals and Medical Devices.
Refresh your mind with science and Swedish fika at our hosted session at 2025 SOT!
Join us for an interactive session that combines regulatory updates, case studies, and a live Q&A. You’ll gain exclusive insights on the latest GARD® data from SenzaGen’s research and industry collaborations.
📅 Tuesday, March 18
Exhibitor Hosted Session: Advancing NAMS for skin sensitization testing
10:45 am – 11.45 am | Room W208B
Key Topics
Speakers
Don’t miss these thought leadership presentations and networking opportunities. Our experts will be available to discuss how GARD® innovations can address your needs and advance your work in skin sensitization testing.
Advancing in vitro skin sensitization testing with GARD® and EpiSensA
Exciting news from the SenzaGen Group! Our Group company VitroScreen has recently validated and implemented the in vitro skin sensitization assay EpiSensA (OECD TG 442D).
With this new achievement, we are proud to be the first service provider in Europe offering both GARDskin (OECD TG 442E) and EpiSensA (OECD TG 442D) for in vitro skin sensitization testing!
By integrating GARD®skin’s genomic biomarker approach with EpiSensA’s reconstructed human epidermis (RhE) model, we provide a complementary platform to address KE2 and KE3 in the AOP and strengthen your skin sensitization testing strategy. This synergy enhances predictivity and supports regulatory compliance, reinforcing our commitment to advancing NAMs for in vitro skin sensitization testing.
Want to learn how this can support your safety assessments?
Get in touch!
Bring your questions and testing challenges to our booth and scientific sessions at 2025 SOT!
The SenzaGen team is ready to connect at this year’s SOT in Orlando, USA! Join us for an interactive program featuring a hosted session and multiple poster presentations showcasing advancements in skin sensitization testing.
Our experts will be on-site to discuss how GARD® innovations can support your testing needs and accelerate your research:
A Quick Guide to Skin Sensitization Testing
Joint publication with RIFM and IFF: Determining a Point of Departure for Skin Sensitization Potency and Quantitative Risk Assessment of Fragrance Ingredients Using the GARD®skin Dose-Response Assay
Advancing NAMs for Fragrance Safety: Collaborative Research with RIFM and IFF.
As innovators in in vitro skin sensitization testing, addressing key data gaps, we are pleased to share the publication of a new peer-reviewed article in ALTEX, which underscores the performance of GARD®skin Dose-Response in predicting the skin sensitization potency of fragrance ingredients. This study, conducted in collaboration with the expert teams at the Research Institute for Fragrance Materials, Inc. (RIFM) and IFF, contributes valuable insights to the growing body of research supporting more reliable, non-animal testing methods.
The article presents a comprehensive dataset of 100 fragrance ingredients, covering a broad chemical domain with diverse structural reactivity domains and potency levels. The results confirm GARD®skin Dose-Response‘s robust predictivity for skin sensitization potency across this wide chemical spectrum, strengthening its application for deriving No Expected Sensitization Induction Level (NESIL) values in Quantitative Risk Assessment (QRA) within frameworks like Next Generation Risk Assessment (NGRA). These advancements are pivotal in further reducing reliance on animal testing while enhancing risk assessment capabilities.
We would like to extend our gratitude to the exceptional teams who contributed to this collaboration: Isabelle Lee, Andy Forreryd, Mihwa Na, Isabella Schember, Maura Lavelle, Robin Gradin, Ulrika Mattson, Henrik Johansson, Shashi Donthamsetty, Gregory Ladics, and Anne Marie Api.
Keywords
skin sensitization, fragrance materials, point of departure, OECD TG 442E, GARDskin, new approach methodology
Abstract
Potency and quantitative risk assessment are essential for determining safe concentrations for the formulation of potential skin sensitizers into consumer products. Several new approach methodologies (NAMs) for skin sensitization hazard assessment have been developed, validated, and adopted in OECD test guidelines. However, work is ongoing to develop NAMs for predicting skin sensitization potency on a quantitative scale for use as a point of departure (POD) in next-generation risk assessment (NGRA). GARDskin Dose-Response (DR) is an adaptation of the validated GARDskin assay (OECD TG 442E), and the readout of the assay is a quantitative potency prediction similar to the No Expected Sensitization Induction Level (NESIL) value (µg/cm2). The goal of this study was to evaluate the performance of the GARDskin DR assay for potency prediction of fragrance ingredients. One hundred (100) fragrance ingredients from a reference database covering varied structural reactivity domains and potency were tested in GARDskin DR. Materials tested had varied protein-binding reactivity alerts, including Schiff base, Michael addition, SN2, and acylation. Potency categories were predicted with a total accuracy of 37% and an approximate accuracy (exact match or off by 1 category) of 81%. Combining predicted weak and very weak categories increased total accuracy to 53% and approximate accuracy to 98%. The mean prediction error for the NESIL and local lymph node assay (LLNA) EC3 was 3.15- and 3.36-fold, respectively. Based on the results of this study, GARDskin DR is a promising predictor of skin sensitization potency with an applicability domain covering a wide range of fragrance ingredient reaction mechanisms, increasing the confidence in using the assay to conduct NGRA, ultimately reducing the need for animal testing.
Plain language summary
This study focused on testing a new in vitro method, GARDskin Dose-Response (DR), to predict the quantitative potency of fragrance ingredients in causing skin sensitization. This potency is important for setting safe levels of chemicals in consumer products. The GARDskin DR assay, based on an existing skin sensitization test (OECD TG 442E), provides a quantitative measure of potency similar to the No Expected Sensitization Induction Level (NESIL). One hundred (100) fragrance ingredients with different chemical structures and reactivity patterns were tested. The assay accurately distinguished between sensitizers and non-sensitizers for 81% of the materials, and also correctly predicted their approximate potency categories. The results show that GARDskin DR is a promising tool for predicting quantitative potency for skin sensitization risk, helping to reduce animal testing and support safer product development.
SenzaGen’s Newsletter Dec 2024
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Text-only version:
SenzaGen’s Newsletter Dec 2024
As 2024 ends:
We’re proud to share how our innovative GARD® method is addressing key challenges in skin sensitization testing. In Q4, we’ve focused on filling data gaps in areas like Medical Devices, Safe Dose Levels, and Complex Mixtures—driving the shift to reliable, human-relevant solutions.
Building confidence in NAMs for Biological safety testing of Medical Devices
Progress is underway to integrate New Approach Methodologies (NAMs) into skin sensitization testing standards for Medical Devices within ISO. At the recent ISO TC 194/WG 8 meeting in Paris, SenzaGen’s Andy Forreryd presented data from the GARD®skin Medical Device pre-validation study—an important step toward its inclusion in the normative section of ISO 10993-10.
Since 2021, GARD®skin has been recognized in Annex C of the standard, and its further integration underscores the advancement of NAMs in improving biological safety assessments while reducing reliance on animal testing.
Explore how you can use in vitro methods for Biocompatibility testing
Discussing safe dose levels at ASCCT
At the recent ASCCT conference, SenzaGen presented exciting new data on assessing skin sensitizing potency, including a poster that highlighted the GARD®skin Dose-Response assay’s performance on the Reference Chemical Potency List (RCPL).
Further confirmation of the assay’s effectiveness comes from two recent publications, developed in collaboration with industry leaders L’Oréal, RIFM, and IFF. These studies demonstrate the assay’s ability to:
Access our latest publications for more insights
Conclusive testing results for Natural Extracts
In our latest webinar, we explored advancements in skin sensitization testing, focusing on challenging samples—specifically, substances that fall outside the applicability domains of conventional in vitro assays outlined in OECD Test Guidelines.
GARD®skin (OECD TG 442E) stands out as a reliable method for testing complex mixtures like natural extracts, backed by scientific data and successful industry collaborations.
Contact us for a case study on Natural Extracts
Discovery our advisory service
Toxicology, Pharmacology and Regulatory Compliance
Area of Expertise
Redeye: CEO interview Q3 2024
Redeye interviewed the CEO of SenzaGen, Peter Nählstedt, where they discussed the company’s recently released Q3 2024 report.
View CEO interview
Penser Access by Carnegie: CEO interview (in Swedish)
Penser Access by Carnegie har intervjuat SenzaGens VD, Peter Nählstedt, i samband med bolagets Q3-rapport.
Intervjun behandlar utvecklingen under kvartalet, bolagets syn på det aktuella marknadsläget samt framtidsutsikter och strategiska prioriteringar framöver.
VD-intervju – Stark tillväxt i Q3
Penser Play
SenzaGen’s Newsletter Oct 2024
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