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.

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 No. 2021-01, 8 July 2021. ESAC opinion on the scientific validity of the GARDskin and GARDpotency test methods.