Today LAUS received the newest Statement of GLP Compliance documenting that we passed the latest inspection by the authorities in November 2017. We are proud to say that we have been GLP compliant since 1999.
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
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