US EPA

4946621 

Journal Article 

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 

Ball, N; Bartels, M; Budinsky, R; Klapacz, J; Hays, S; Kirman, C; Patlewicz, G 

2014 

1 

Regulatory Toxicology and Pharmacology
ISSN: 0273-2300
EISSN: 1096-0295 

68 

2 (March 2014) 

212-221 

English 

24378700 

10.1016/j.yrtph.2013.12.007 

WOS:000332131100003 

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. 

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