Since the Ames study (OECD 471) is not recommended for Nanomaterials, Genotoxicity/Mutagenicity shall be evaluated using one or more in vitro studies on mammalian cells
Our company philosophy is not only to provide scientific expertise in testing products for different products groups and registration purposes, but also to give back something to our society. Everybody is talking about the protection of our environment. But how can we do this? Big impact has always started with small steps. We in LAUS are also going step by step, searching for new ways to reduce waste. Using state of the art equipment is more efficient and will reduce wastage. This way we reduce our ecological foot print and conserve resources.
Medical Devices are an important product group. This group receives more and more importance with the upcoming new MD regulation which will come into action in 2020.
To stay up to date and to get in touch with our customers our colleague Mr. Martin Schaaf will participate in this year’s SwissMedTech in Luzern, Switzerland, from the 10th – 11th of September.
We are looking forward to meeting you there and to having inspiring and fruitful conversations.
We now offer Spray Pattern Testing for Biocides and Pesticides acc. FEA 644 (European Aerosol Federation) under GLP. This method is helpful for the rapid characterisation of aerosol sprays and will provide a guide to the size and distribution of droplets within a spray pattern. It is a required parameter during storage stability testing for spray applications.
LAUS provides testing services for the international chemical industry as Physico-Chemical Properties, In vitro Toxicology, Mutagenicity, Genotoxicity, Ecotoxicology, Biodegradation, Environmental Fate and Analytical Chemistry.
The British government has submitted a draft law to Parliament which aims to incorporate the European chemicals regulation REACH as well as the testing methods, data sharing and fees regulation into British law ("UK REACH") largely unchanged after the Brexit.
We will present our testing services in the area of in vitrotoxicology and genotoxicity/mutagenicity at this year’s SOT 58th Annual Meeting and ToxExpo.
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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