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Human Cell Line Activation Test

Topic : Skin sensitisation

Test Method Number: TM2008-05 (EU)
Short Name of TM: hCLAT
Submission received on: Monday, December 15, 2008
Responsible Organisation: EURL ECVAM - European Union
Stage of Submission: Assessment Finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Published
Stage of Regulatory acceptance/Standards: Published
General Comments: Test Guideline has been adopted as TG442E in July 2016

Method Description

The h-CLAT supports the discrimination between sensitizing and non-sensitizing chemicals

The h-CLAT quantifies in vitro changes in the expression of the CD86 and CD54 membrane phenotypic markers in a human monocytic leukemia cell line (THP-1 cells).

THP-1 cells are monocyte-derived cells that have shown to produce DC-like responses following exposure to skin sensitising chemicals (e.g. upregulation of surface markes (e.g. CD86 and CD54) and cytokine production (e.g. TNF-α).

The CD86 (a co-stimulatory molecule) and the CD54 (an adhesion molecule) are upregulated in activated Dendritic Cells (DC) and play a critical role in DC presentation of antigens to T cells (T-cell priming).

By studying the potential of test chemicals to up-regulate markers of DC activation, the h-CLAT generates information addressing key event 3 (dendritic cell activation) of the skin sensitization Adverse Outcome Pathway.

Track Approval Status

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    Regulatory acceptance/Standards
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