Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 68, Issue 2, Pages 212-221Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2013.12.007
Keywords
Read-across; REACH; Dipropylene glycol methyl ether acetate; (DPMA); CAS No. 88917-22-0; Uncertainty
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The use of read-across of data within a group of structurally similar substances potentially allows one to characterise the hazards of a substance without resorting to additional animal studies. However the use of read-across is not without challenges, particularly when used to address the needs of a regulatory programme such as the EU REACH regulation. This paper presents a case study where a previously accepted read-across approach was used to address several data gaps in a REACH registration dossier but was subsequently rejected in part by the European Chemicals Agency (ECHA), resulting in the requirement to perform a developmental toxicity study in rodents. Using this case study, this paper illustrates some of the practical challenges faced when making use of read-across, particularly with respect to addressing the uncertainty associated with the use of read-across; showcasing the scientific justification and highlighting some of the potential implications/opportunities for future cases. (C) 2013 Elsevier Inc. All rights reserved.
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