LAUS NEWS: All three in vitro skin sensitisation studies available under GLP
LAUS has established and fully validated the h-CLAT (human Cell Line Activation Test, OECD 442E) and is now able to perform all three studies available for in vitro skin sensitisation testing under GLP conditions (h-CLAT, DPRA, LuSens).
The h-CLAT (human Cell Line Activation Test) uses the human monocytic leukemia cell line THP-1. The up-regulation of the surface molecules CD54 and CD86 as markers of dendritic cell activation is measured by flow cytometry following cell staining with fluorochrome-tagged antibodies.
In vitro skin sensitisation testing can substitute the corresponding in vivo study, the LLNA (OECD 442B and 429), in many cases. Unlike the LLNA, which is a stand-alone study, in vitro skin sensitisation testing consists of an array of three studies, each of them targeting a key event in the Adverse Outcome Pathway (AOP) of skin sensitisation. A substance can be rated as a sensitiser with two consistent positive results.
Key event of AOP
Study
OECD
1
covalent interaction with skin proteins
DPRA
442C
2
keratinocyte response
LuSens
based on 442D
3
dendritic cell activation
h-CLAT
442E
The tests are interesting for clients from the following regulatory areas:
REACH (EC 1907/2006)
The CLP Regulation (EC 1272/2008)
The Biocidal Products Regulation (EC 528/2012)
The Plant Protection Products Regulation (EC 1107/2009)
The Cosmetics Regulation (EC 1223/2009)
And screening at non-regulatory stages of product development
