Test No. 442E: In Vitro Skin Sensitisation
In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic
cells on the Adverse Outcome Pathway for Skin Sensitisation
The present Key Event based Test Guideline (TG) addresses the human health hazard
endpoint skin sensitisation, following exposure to a test chemical. More specifically,
it addresses the activation of dendritic cells, which is one Key Event on the Adverse
Outcome Pathway (AOP) for Skin Sensitisation. Skin sensitisation refers to an allergic
response following skin contact with the tested chemical, as defined by the United
Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN
GHS). This TG provides three in vitro test methods addressing the same Key Event on
the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell
Line Activation Test or U-SENS and (iii) the Interleukin-8 Reporter Gene Assay or
IL-8 Luc assay. All of them are used for supporting the discrimination between skin
sensitisers and non-sensitisers in accordance with the UN GHS. Test methods described
in this TG either quantify the change in the expression of cell surface marker(s)
associated with the process of activation of monocytes and DC following exposure to
sensitisers (e.g. CD54, CD86) or the changes in IL-8 expression, a cytokine associated
with the activation of DC. In the h-CLAT and U-SENS assays, the changes of surface
marker expression are measured by flow cytometry following cell staining with fluorochrome-tagged
antibodies. In the IL-8 Luc assay, the changes in IL-8 expression are measured indirectly
via the activity of a luciferase gene under the control of the IL-8 promoter. The
relative fluorescence or luminescence intensity of the treated cells compared to solvent/vehicle
control are calculated and used in the prediction model, to support the discrimination
between sensitisers and non-sensitisers.
Available from June 30, 2022Also available in: French
In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles