Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making

Background: Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the Proof-of-Concept ambitions of SEURAT-1, the largest ever EU research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This paper is based on the discussion and outcome of a workshop organised on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. Objectives: The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data, e.g., information from in vitro molecular screening, '-omics' assays and computational models, to reach regulatory acceptance. Methods: We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across is possible or not between group members considering both chemical and biological similarities. Conclusions: We agreed to carry out the complete read-across exercise for one chemical category per read-across scenario in the context of SEURAT-1 and the results of this exercise will be completed and presented by the end of the research initiative in December 2015. External collaborative partners are invited to follow the same systematic read-across approach and to contribute to the final Proof-of-Concept.

BERGGREN Elisabet;  AMCOFF Patric;  BENIGNI Romualdo;  BLACKBURN Karen;  CARNEY Edward;  CRONIN Mark;  DELUYKER Hubert;  GAUTIER Francoise;  JUDSON Richard;  KASS George;  KELLER Detleff;  KNIGHT Derek;  LILIENBLUM Werner;  MAHONY Catherine;  RUSYN Ivan;  SCHULTZ Terry;  SCHWARZ Michael;  SCHÜÜRMANN Gerrit;  WHITE A.;  BURTON Julien;  LOSTIA Alfonso;  MUNN Sharon;  WORTH Andrew; 

2015-08-17

US DEPT HEALTH HUMAN SCIENCES PUBLIC HEALTH SCIENCE

JRC94006

0091-6765,   

http://ehp.niehs.nih.gov/1409342/,    https://publications.jrc.ec.europa.eu/repository/handle/JRC94006,   

10.1289/ehp.1409342,