Affordable Access

Publisher Website

The challenge of using read-across within the EU REACH regulatory framework; how much uncertainty is too much? Dipropylene glycol methyl ether acetate, an exemplary case study

Authors
Journal
Regulatory Toxicology and Pharmacology
0273-2300
Publisher
Elsevier
Volume
68
Issue
2
Identifiers
DOI: 10.1016/j.yrtph.2013.12.007
Keywords
  • Read-Across
  • Reach
  • Dipropylene Glycol Methyl Ether Acetate (Dpma)
  • Cas No. 88917-22-0
  • Uncertainty

Abstract

Abstract 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.

There are no comments yet on this publication. Be the first to share your thoughts.