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).

Do you have expected sensitizers?

Generate quantitative potency data using GARDskin Dose-Response to support critical decisions throughout product development.

Three typical use scenarios:

  • Enabling quantitative risk assessment: Establish a Point-of-Departure (PoD) to inform safe dose levels and exposure limits.

  • Defining safe dose levels: Evaluate whether sensitizers can be safely used in specific product categories and at what concentrations.

  • Preparing for confirmatory human patch testing: Support NESIL derivation to guide study design and enable informed, ethical decision‑making.

GET A QUOTE CONNECT WITH SCIENTIFIC EXPERT

196 genes

The number of biomarkers used in GARDskin Dose-Response.

At a glance

TEST SYSTEM SenzaCell® (human dendritic-like cell line).
What it measures Response values in a titrated range of multiple concentrations in GARDskin.
Readout and prediction1. Hazard readout: Skin sensitizer or Non-sensitizer.
2. Potency readout: cDV0*.
3. Potency prediction: LLNA EC3 value; Human potency NOEL/NESIL; GHS/CLP classification 1A or 1B.
4. Dose-response curve.

ComplianceAdapted from GARDskin (OECD TG 442E) and included in the OECD Test Guideline Program (TGP 4.106).

GLP-compliant laboratory.

Turnaround time6-8 weeks for standard studies.
Fast track available.

*cDV0 is the concentration for the test substance to induce a positive response in GARDskin.

How it works

The GARD®skin Dose-Response investigates the GARDskin response values in a titrated range of multiple concentrations in a dose-response manner to find the concentration threshold required to induce a positive Decision Value (DV).

This threshold concentration, cDV0, is used to estimate the inherent sensitizing potency of a chemical. A low value indicates high inherent skin sensitizing potency and a high value indicates low inherent skin sensitizing potency.  The cDV0 can also be used to predict the traditional EC3 value from Local Lymph Node Assay (LLNA), human skin sensitizing potency NOEL/NESIL, and UN GHS/CLP classification 1A or 1B depending on the need.

All the GARD assays are based on the same technology platform. Read more about the GARD technology platform and assay development principles on the Science page of our website.

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