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Read-across approaches – misconceptions, promises and challenges ahead

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Grace Patlewicz1, Nicholas Ball2, Richard A. Becker3, Ewan D. Booth4, Mark T. D. Cronin5, Dinant Kroese6, David Steup7, Ben van Ravenzwaay8 and Thomas Hartung9
1 DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE, USA;
2 Toxicology & Environmental Research and Consulting (TERC), The Dow Chemical Company, Midland, MI, USA;
3 Regulatory and Technical Affairs Department, American Chemistry Council (ACC), Washington, DC, USA;
4 Syngenta Ltd, Jealott’s Hill International Research Centre, Bracknell, Berkshire, UK;
5 Liverpool John Moores University, School of Pharmacy and Biomolecular Sciences, Liverpool, UK;
6 TNO, Zeist,Tthe Netherlands;
7 Shell Oil Company, Shell Health Risk Science Team, Houston, TX, USA;
8 BASF Aktiengesellschaft, Experimental Toxicology and Ecology, Ludwigshafen, Germany;
9 Johns Hopkins University, Bloomberg School of Public Health, Center for Alternatives to Animal testing (CAAT), Baltimore, USA and University of Konstanz, CAAT-Europe, Germany

Summary


Read-across is a data gap filling technique used within category and analogue approaches. It has been utilized as an alternative approach to address information requirements under various past and present regulatory programs such as the OECD High Production Volume Programme as well as the EU’s Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) regulation. Although read-across raises a number of expectations, many misconceptions still remain around what it truly represents; how to address its associated justification in a robust and scientifically credible manner; what challenges/issues exist in terms of its application and acceptance; and what future efforts are needed to resolve them. In terms of future enhancements, read-across is likely to embrace more biologically-orientated approaches consistent with the Toxicity in the 21st  Century vision (Tox-21c). This Food for Thought article, which is notably not a consensus report, aims to discuss a number of these aspects and, in doing so, to raise awareness of the ongoing efforts and activities to enhance read-across. It also intends to set the agenda for a CAAT read-across initiative in 2014-2015 to facilitate the proper use of this technique.

 

Keywords: analogue approach, category approach, (Q)SARs, adverse outcome pathways (AOP), scientific confidence framework

 

 

ALTEX (31)4: 387-396

DOI: http://dx.doi.org/10.14573/altex.1410071


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