Gina Wentling   Posted in    Mar 21st, 2017

Human In Vitro Developmental Toxicity Assay Combined with a Read-Across Approach for Chemical Assessment – FutureTox III (2015)

Presented at FutureTox III: Bridges for Translation in Arlington, Virginia in November 2015 by Stemina’s Associated Director of Toxicology, Jessica Palmer.

The reproductive and developmental toxicity requirements for registering chemical substances under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) using whole-animal models could cost up to $8 billion and require the use of up to 22 million animals. However, the law encourages the use of alternative methods, such as in vitro assays and structure-activity relationship (SAR) methods for addressing data gaps and requires authorization for animal testing from the European Chemical Agency (ECHA). The ECHA guidance documents state that alternative methods are not suitable replacements for in vivo testing. The utility of these approaches in developmental toxicology, when used alone, is still uncertain. Data generated from in vitro assays could complement these approaches.