HepaRG™ as a test for hepatotoxicity
Validated Method 2009
European Union Reference Laboratory for Alternatives to Animal Testing, Ispra, Italy
HepaRG™ is a human-based liver metabolism test system. It is based on the activation of three specific liver enzymes upon HepaRG™ cells exposure to liver-damaging substances. First, the liver cells are exposed to the test chemical. Next, enzyme substrates are added to the cells and the enzyme activity, as well as the metabolite formation of the substrates, is measured by liquid chromatography/mass spectrometry (LC/MS) to determine the liver toxic potential of the test chemical.
The method has been validated under TM2009-14 (EU) and regulatory acceptance is ongoing.
Cytochrome P450 (CYP) enzyme induction in vitro method using cryopreserved differentiated human HepaRG™ cells
EURL ECVAM
Added on: 07-02-2020
[1] https://tsar.jrc.ec.europa.eu/test-method/tm2009-14[2] https://dmd.aspetjournals.org/content/36/1/137.long
