All substances, whether used in a pharmaceutical, cosmetic, or chemical application, have to comply with stringent regulations guaranteeing consumer protection and the well-being of industry employees.

Globally, with Europe as a trendsetter, alternatives to animal testing are promoted where possible for the safety evaluation. Consequently, alternative methods, whenever available and validated, are required by the legal authorities for toxicity assessment. This is the case for instance for the EU regulation No 1970/2006 better known as REACH (Registration, Evaluation, Authorization, and restriction of Chemicals), which has its impact on substances produced in the EU and on substances imported in the EU. For the evaluation of cosmetic ingredients and finished products the EU goes even further by banning all animal testing in its 7th amendment of the Cosmetic Directive 76/768/EEC.

With the program "REACH-it with in vitro testing", StratiCELL aims to be, among its other in vitro testing activities, the reference service provider for regulatory in vitro safety testing.

StratiCELL offers the full panel of in vitro tests under the different EU legislations, and has therefore implemented validated, valid, and scientifically accepted in vitro toxicity tests described by international guidelines (OECD, ECVAM, ICCVAM, ICH, ...) for the safety assessment of a substance.
StratiCELL presently works in a GLP-like environment (Formal accreditation is ongoing).

An overview of the regulatory in vitro toxicity tests 

In Vitro SKIN CORROSION: OECD TEST GUIDELINE 431 The corrosive potential of a compound can be evaluated by testing its toxic potential after application on a reconstituted epidermis, by means of an MTT viability assay and a prediction model. Products can be ranked as R35 and R34. In Vitro Skin Irritation: Human Skin Model Test: OECD TEST GUIDELINE DRAFT PROPOSAL Irritant substances can be distinguished from non-irritants by testing their toxic effect using the MTT viability assay. StratiCELL performs skin irritation tests according to the ECVAM protocol, and draft OECD test guideline. In Vitro 3T3 NRU Phototoxicity Test : OECD TEST GUIDELINE 432 This OECD test assesses toxicity after exposure to UV-light through the 3T3 Neutral Red Uptake. The phototoxic potential of a substance can be predicted using in vitro cellular models or reconstituted skin models. Skin Absorption: In Vitro Method: OECD TEST GUIDELINE 428 The OECD Test Guideline 428 "Skin Absorption: In Vitro Method", provides information on the absorption of a substance applied to human and animal skin biopsies. Genotoxicity Bacterial Reverse Mutation Test: OECD TEST GUIDELINE 471 The bacterial reverse mutation test (the AMES test) uses amino-acid requiring bacterial strains, to detect mutations induced by substances that restore the functional capability of the bacteria to synthesize an essential amino acid. In vitro Mammalian Cell Micronucleus Test: OECD DRAFT TEST GUIDELINE 487 The in vitro micronucleus assay detects genotoxicity induced by substances or their metabolites. Embryotoxicity Rodent Embryonic Stem Cell Test : INVITTOX n° 113 This test is used for the assessment of the embryotoxic potential of chemicals.

Back to the Overwiew Page on In Vitro Toxicity Testing