GARD®skin Dose-Response.
In vitro skin sensitization potency assessment
GARD®skin Dose-Response is an in vitro test assay designed to predict skin sensitization potency of chemicals.
The assay provides a Point-of-Departure (PoD) for risk assessment, enabling potency ranking and sub-classification of candidate ingredients. This makes it a valuable tool for both product development and regulatory decision-making.
By estimating the threshold concentration at which a test substance induces skin sensitization, the assay allows for potency assessment, where lower concentrations indicate higher potency. These data support the prediction of LLNA EC3 values, human skin sensitizing potency NOEL/NESIL, and UN GHS/CLP classification 1A or 1B, all with high statistical significance.
GARD®skin Dose-Response is adapted from GARD®skin (OECD TG 442E) and is currently included in the OECD Test Guideline Program (TGP 4.106).
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Potency prediction:
- LLNA EC3 value
- Human skin sensitizing potency (NESIL/NOEL)
- GHS/CLP classification (1A or 1B)
Joint publication with RIFM and IFF
Joint publication with L’Oréal
Toxics 2024. In Vitro Prediction of Skin-Sensitizing Potency Using the GARDskin Dose–Response Assay: A Simple Regression Approach.
Joint publication with RIFM and IFF
Regulatory Toxicology and Pharmacology 2024. GARDskin dose-response assay and its application in conducting Quantitative Risk Assessment (QRA) for fragrance materials using a Next Generation Risk Assessment (NGRA) framework.
SenzaGen proof of concept study
Nature Scientific Reports 2021. Quantitative assessment of sensitizing potency using a dose-response adaptation of GARDskin.
The number of biomarkers used in GARDskin Dose-Response.