The extent of percutaneous absorption of chemicals, part of regulatory testing requirements and important for safety assessments, can be determined with various in vitro techniques described in the method summary data sheets of the DB-ALM. Most widespread are Static and Flow-Through Diffusion Cells, which are already included in the OECD TG 428 (OECD, 2004), employing human or animal skin. Reconstructed Skin Models, also to be used in diffusion cells, are currently evaluated in formal assessment studies.
The other techniques described in the DB-ALM (e.g. methods based on physicochemical principles such as ATR-FTIR Spectroscopy and non-experimental approaches such as Mathematical Models) are at early development stages and are mostly used for research purposes.
A broad range of methods, which provide alternatives or "Replacement" to animal experimentation, is available to investigate the effects of chemical substances on reproduction, including impairment of fertility and developmental toxicity such as teratogenicity and embryotoxicity. The methods (models, test systems) range from whole organ cultures to tissue explants, primary cells and established cell lines (including embryonic stem cells). None of these ex vivo / in vitro / in silico methods have gained regulatory acceptance to date. For this reason, these alternative methods do not allow for full replacement of animal testing. The methods are mostly used for screening purposes and are intended to be applied in test batteries and as part of integrated testing strategies. However, with reference to "Reduction and Refinement" of animal use, the Extended One-Generation Reproductive Toxicity Study (EOGRTS) has been adopted as OECD Test Guideline 443 (OECD, 2012).
The ultimate goal of alternative methods to animal experimentation in the topic area of Eye Irritation is to replace the Draize rabbit eye irritation test (OECD Test Guideline 405 corresponding to the Method B.5 of the Council Regulation (EC) No 440/2008), by an alternative test alone, by a battery of tests, or by embedding alternative methods in testing strategies. In fact, a sequential testing strategy has been included in the guidelines, and makes use of physico-chemical data, structure-activity relationships and results of validated in vitro methods. Both in vivo and in vitro alternative methods to the Draize test have been developed so far.