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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

 

Want to know more? Contact us at info@laus.group or http://www.laus.group

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