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In Vitro Prediction of Skin-Sensitizing Potency Using the GARDskin Dose-Response Assay: A Simple Regression Approach.

Robin Gradin¹, Fleur Tourneix², Ulrika Mattson¹

¹Senzagen AB, 22381 Lund, Sweden.

|September 27, 2024

Summary

The GARDskin Dose-Response assay accurately estimates skin sensitizer potency using non-animal methods. This approach correlates well with existing animal and human data, offering a reliable alternative for toxicological assessments.

Keywords:

GARDskin Dose–Response NAM point of departure quantitative risk assessment sensitizing potency

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Area of Science:

Toxicology
Dermatology
In vitro toxicology

Background:

Non-animal testing methods are increasingly crucial for toxicological assessments of skin sensitizers.
Accurately characterizing the potency of skin sensitizers using non-animal methods is an ongoing technological goal.

Purpose of the Study:

To evaluate the GARDskin Dose-Response assay's ability to predict skin sensitizer potency.
To assess the correlation between the assay's main readout (cDV0 concentration) and established potency measures like LLNA EC3 and human NOELs.

Main Methods:

Utilized the GARDskin Dose-Response assay to measure cDV0 concentration for 30 chemicals.
Correlated cDV0 values with data from Local Lymph Node Assays (LLNAs) and human No Observed Effect Levels (NOELs).
Developed a composite potency model combining LLNA and human data to predict No Observed Effect Levels (NESILs).

Main Results:

A strong and significant correlation was observed between cDV0 values and both LLNA EC3 and human NOEL values (ρ = 0.645-0.787).
The developed potency model accurately predicted NESILs, with cross-validation errors of 2.75-fold for LLNA-derived NESILs and 3.22-fold for human-derived NESILs.
The cDV0 concentration effectively serves as a quantitative measure of skin-sensitizing potency.

Conclusions:

The GARDskin Dose-Response assay demonstrates significant potential for accurately quantifying skin sensitizer potency.
This non-animal method provides a reliable alternative for potency assessment, aligning with current toxicological trends.
The assay's results support its use in deriving quantitative, continuous potency estimates for skin sensitizers.