Session 5: Skin irritation and corrosion

An integrated approach on testing and assessment for skin irritation and corrosion
An integrated approach on testing and assessment for skin irritation and corrosion

Michael Oelgeschläger


Federal Institute for Risk Assessment, Germany


Michael Oelgeschläger

Wed, 24. Sep. 2014

During the last years, several in vitro methods for skin corrosion or irritation have received regulatory acceptance that might allow the classification of substances according to UN GHS, including OECD TG 439 (2013), OECD TGs 430 (2013), 431 (2013) and 435 (2006).

However, the OECD TG 404 on in vivo acute dermal irritation and corrosion testing contains a supplement describing a sequential testing and evaluation strategy that still requires confirmatory in vivo testing in case of negative in vitro tests. In addition, the experience gained by regulatory authorities revealed a need for guidance for users as well as regulatory agencies on the appropriate use of in vitro methods as well as the evaluation of the results.

Therefore, the Federal Institute for Risk Assessment (BfR) initiated an OECD project with the aim to develop a Guidance Document (GD). This document now describes an “Integrated Approach on Testing and Assessment” (IATA) for skin corrosion and irritation to replace the "Testing and Evaluation Strategy" currently provided in the supplement to OECD TG 404. The GD provides information on key performance characteristics of the individual information sources and guidance on how to integrate the information for classification and labeling.

The IATA is composed of “Modules” according to the type of information. The eight modules of the IATA are integrated into three main parts that describe the evaluation of existing data in a Weight of Evidence approach as well as the use of in vitro methods, if additional testing is required. Animal testing is foreseen only as a last resort. Thus, this document might help to minimize the use of animals to the extent possible, while ensuring human safety.