A pioneer role of BSL BIOSERVICE in the in vitro alternative method and models development

By Hana Hofman-Hüther, BSL BIOSERVICE GmbH (a Eurofins partner laboratory), hhofman-huether@bioservice.com

The use of non-animal test methods, including in vitro studies, provides important tools to enhance our understanding of hazardous effects by chemicals and for predicting these effects on humans. The reduction of animals in toxicology research by encouragement of the development and validation of effective in vitro and alternative methods or models is one of the outmost concerns at BSL BIOSERVICE.

To address this, BSL BIOSERVICE offers a variety of cell-based alternative methods or models under GLP to examine the hazardous effects of chemicals, herbals, cosmetic and food ingredients or medical devices. The suitable test design is chosen depending on the material of the product and the aim of the study.

BSL BIOSERVICE is establishing a method to assess the potential of a substance to cause a skin allergy in humans that incorporates a tissue model, a 3-dimensional human cell skin model that replicates key characteristics of normal human skin. RHE IL-18 potency test is a part of a validation project sponsored by industry (including BSL BIOSERVICE) and involving nine partners and four skin models (Gibbs et al. 2014). It will replace the use of guinea pigs, rats or mice, which would have been injected with a substance or had it applied to their shaved skin to determine an allergic response. Skin or Eye models are also being used to replace rabbits that have traditionally been used to evaluate chemicals for their ability to corrode or irritate the skin or eye.

Thus, in vitro 3D human tissue equivalents have made significant contributions to the reduction of animal use in industrial product development and regulatory testing, of which two are accepted from a regulatory standpoint as full replacement methods for testing dermal corrosion and irritation. Other models/methods are recommended as components of tiered testing strategies.

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