GARD^®potency.

Skin sensitizing potency classification according to GHS/CLP

GARDpotency is an in vitro add-on test to GARDskin for potency classification according to GHS/CLP. The assay can subcategorize sensitizers that have been identified by GARDskin (OECD TG 442E) into strong sensitizers (1A) or weak sensitizers (1B).

Compliance

GARDpotency is included in the OECD Test Guideline Program (TGP 4.106). The ESAC considers that GARDpotency is a functional and valid test method ready for use in industrial screening applications.

GARDpotency is accepted by the ECHA and the results can be used as weight-of-evidence in REACH dossiers for sub-categorization of confirmed skin sensitizers into 1A or 1B according to the GHS/CLP system.

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Strong or weak sensitizers?

GARDpotency offers a unique in vitro alternative for labeling identified sensitizers according to GHS/CLP.

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51 genes

The number of biomarkers used in GARDpotency.

At a glance

TEST SYSTEM	SenzaCell® (human dendritic-like cell line)
What it measures	Gene expression profile of 51 genomic biomarkers
Readout	1A (strong sensitizer) or 1B (weak sensitizer)
Performance	88% accuracy*
Compliance	OECD TGP 4.106, GLP or non-GLP
Turnaround time	4-8 weeks for standard studies

*Gradin et al. The GARDpotency assay for potency-associated subclassification of chemical skin sensitizers – Rationale, method development and ring trial results of predictive performance and reproducibility. Toxicological Sciences 2020.

How it works

GARDpotency is an add-on test to GARDskin. They are performed in a tiered approach for GHS/CLP potency classification.

In the first tier, a test sample is classified by GARDskin as either skin sensitizer or non-sensitizer. If the test sample is classified as a skin sensitizer, it then can be further classified by GARDpotency in the second tier testing. As a result, the test sample can be sub-categorized as 1A (strong) or 1B (weak) skin sensitizer according to the GHS/CLP system.

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.