Chemicals

VitroScreen is certificated GLP for toxicity and biocompatibility studies, pharmacokinetics/toxicokinetics and ADME studies (certification number 2012/33).

VitroScreen laboratories perform in compliance with GLP regulations  the following Replacement alternatives:

End-point EU validated
replacement alternatives
Test
guidelines
Regulatory
classification
Phototoxicity 3T3 NRU phototoxicity OECD TG 432 Photo-Toxic
Skin corrosion Human skin model OECD TG 431 Corrosive
Skin irritation In vitro skin irritation OECD TG 439 Irritant
Skin sensitization Human-cell line activation Included in EURL-ECVAM replacement strategy 2013 Skin sensitizer
Eye irritation Fluorescein leakage OECD TG 460 Eye corrosive/severe irritant
Eye irritation Human corneal epithelium under ECVAM validation 2013 Eye irritant /not classified
Percutaneous absorption In vitro method for skin absorption OECD  TG 428 Dermal toxicity/penetration
Acute toxicity BALB 3T3 NRU cytotoxicity assay OECD TG 129 Chemicals
acute oral LD50 > 2000 mg/Kg b.w.
Mutagenicity In vitro mammalian chromosome aberration test (2014) OECD TG 473 Mutagenic
Genotoxicity In vitro mammalian cell micronucleus test (2014) OECD TG 487 Genotoxic

 

The regulatory framework in Europe (2010/63/UE) suggests a shift from animal testing to alternative approaches, including in vitro testing. This is particularly the case in Cosmetics (Regulation 1223/2009/EC) and Chemicals Regulations (REACH and CLP), and in the recent Regulations on Plant Protection Products (1107/2009/EC) and Biocides (528/2012/EU).
VitroScreen is committed to in vitro science since 2001 and aims to be a partner to companies approaching in vitro alternatives to identify the most suitable and predictive in vitro safety testing strategy for regulatory needs.