GARD®skin Dose-Response.
In vitro skin sensitization potency assessment
With broad applicability to complex mixtures and new raw materials with challenging properties, GARDskin Dose-Response offers a powerful non-animal solution for skin sensitization potency assessment.
Establishing PoD for Quantitative Risk Assessment
The assay enables derivation of a Point-of-Departure (PoD) for Quantitative Risk Assessment (QRA), establishment of safe dose levels, and subclassification of candidate ingredients, to support both product development and regulatory decision-making.
By estimating the threshold concentration at which a test substance induces skin sensitization, the assay provides quantitative potency information.
Its readout supports the prediction of:
- LLNA EC3 values.
- Human skin sensitizing potency NOEL/NESIL.
- UN GHS/CLP potency subcategorization 1A or 1B
GARDskin Dose-Response is adapted from GARDskin (OECD TG 442E, 497) and included in the OECD Test Guideline Program (TGP 4.106).
DOWNLOAD PRODUCT FACTS
Do you have expected sensitizers?
Obtain quantitative potency data by using GARDskin Dose-Response to support critical decisions during product development.
Three typical use scenarios:
-
Defining safe dose levels: Assess whether sensitizers can be used in specific product categories and at which concentrations.
-
Preparing for confirmatory human patch testing: Support derivation of a NESIL to inform study design and ethical decision-making.
-
Enabling quantitative risk assessment: Establish a Point-of-Departure (PoD) to inform safe exposure limits.
Publication by IDEA QRA-NAMs Working Group
Regulatory Toxicology and Pharmacology 2026. Derivation of a Point of Departure using NAMs for application in Quantitative Risk Assessment of fragrance materials.
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.
