GARD®skin.

OECD TG 442E, TG 497

In vitro skin sensitization testing

GARDskin is a robust in vitro test to identify potential chemical skin sensitizers with broad applicability and over 90% prediction accuracy.

Full regulatory compliance

GARDskin is included in the OECD Test Guideline (TG) 442E for in vitro skin sensitization and is approved for addressing the Key Event 3 (KE3) of the Adverse Outcome Pathway (AOP) for skin sensitization. It is also included in OECD TG 497: Defined Approaches for Skin Sensitization (DASS), where it is part of two Defined Approaches (DAs):

  • The “2 out of 3” DA for hazard identification.
  • The Integrated Testing Strategy (ITS) for hazard identification and potency sub-categorization (1A, 1B, NC).

Bringing high performance and extended applicability to DASS

With demonstrated high performance and broad applicability to hydrophobic substances (Log P > 3.5) and other challenging chemical groups, GARDskin extends the overall applicability of DASS, helping to fill data gaps in regulatory skin sensitization testing.

Learn more about how GARDskin enhances the overall performance of DASS from the recently published NICEATM report.

Powered by genomics and machine-learning

GARDskin analyses the expression of 196 biomarkers following exposure to potential skin sensitizers. Many of these biomarkers are well-established genes associated with different KEs in the AOP*.

By capturing a broad and mechanistically relevant gene signature, the assay offers a comprehensive view of the immunological response to potential skin sensitizers in humans. This rich dataset supports informed and reliable decision-making during product development. Learn more about the gene signature and mechanistic pathways.

* ESAC opinion on the scientific validity of the GARDskin and GARDpotency test methods, 2021.

Do you have “difficult-to-test” samples?

GARDskin works for a wide variety of test chemicals, with demonstrated applicability to evaluate “difficult-to-test” samples, including:

  • Complex mixtures
  • Indirectly acting haptens
  • Hydrophobic/lipophilic compounds
  • Metal and metal salts
  • Solid materials
GET A QUOTE EXPLORE MORE
196 genes

The number of biomarkers used in GARDskin.

GARDskin OECD 442E: at a glance

TEST SYSTEM SenzaCell® (human dendritic-like cell line).
What it measures Gene expression profile of 196 genomic biomarkers.
ReadoutSkin sensitizer or non-sensitizer.
ComplianceOECD TG 442E, TG 497, GLP-compliant laboratory.
Turnaround time4-8 weeks for standard studies.
Fast track available.

GARDskin OECD 442E: how it works

GARDskin uses a human dendritic-like cell line, SenzaCell®, which mimics a critical part of the human immune system and is able to recognize allergens.

In each test case, the cells are exposed to the test sample after which genomic biomarker signature is measured. The gene expression pattern of the exposed cells is then compared to existing patterns induced by well-known chemicals and analysed by pattern recognition and machine-learning technology. As a result, the test sample is classified as a sensitizer or non-sensitizer.

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.

Information related to GARDskin OECD 442E

Subscribe


Prenumerera