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Lhasa Limited's Defined Approach

Lhasa Limited are pleased to announce the launch of Skin Sensitisation Defined Approach ITSv1 1.0, a web application which supports the ITSv1 Defined Approach (DA); one of the three approved DAs in the 2021 OECD no. 497 guideline.

Skin sens ITSv1 DA button

Defined Approaches for Skin Sensitisation

In accordance with the OECD website, “a Defined Approach (DA) consists of a selection of information sources (e.g. in silico predictions, in chemico, in vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a mathematical, rule-based model).”

The first three DAs in the latest OECD Guideline No. 497: Defined Approaches on Skin Sensitisation, have shown to either provide the same level of information or be more informative than the murine Local Lymph Node Assay (LLNA) for hazard identification. Derek Nexus is used within one of the approved DAs, ITSv1 by Kao, which provides information for sensitisation potency categorisation that is equivalent to the LLNA potency categorisation information.

For existing Derek Nexus users, access Skin Sensitisation Defined Approach ITSv1 1.0 here.

If you are interested in gaining access to the tool, please contact our Applied Sciences Team

Lhasa Limited’s Previous Defined Approach

We have also created our own Defined Approach for skin sensitisation, as published in Regulatory Toxicology and Pharmacology, "A defined approach for predicting skin sensitisation hazard and potency based on the guided integration of in silico, in chemico and in vitro data using exclusion criteria". This DA combines in silico predictions from Derek with results from OECD-validated in chemico/in vitro assays (DPRA, KeratinoSens™, LuSens, h-CLAT, U-SENS™) to provide a hazard and potency prediction without the use of in vivo animal tests. It is yet to be approved by the OECD as a DA but has been included in the list of DAs to be evaluated in the future.

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