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.