GARD®skin Dose-Response.

In vitro skin sensitization potency assessment

GARDskin Dose-Response is an in vitro test designed to predict skin sensitization potency of chemicals, adapted from the standard GARDskin assay (OECD TG 442E, 497).

Establishing PoD for Quantitative Risk Assessment

The assay provides a Point-of-Departure (PoD) for Quantitative Risk Assessment (QRA), 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 quantitative potency assessment, where lower concentrations indicate higher potency.

GARDskin Dose-Response supports the prediction of:

  • LLNA EC3 values
  • Human skin sensitizing potency NOEL/NESIL
  • UN GHS/CLP classification 1A or 1B

GARDskin Dose-Response is included in the OECD Test Guideline Program (TGP 4.106).

Do you have expected sensitizers?

Obtain quantitative potency data by using GARDskin Dose-Response to support critical decisions during product development, including:

  • 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.

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196 genes

The number of biomarkers used in GARDskin Dose-Response.