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

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• 作者：Nicholas Ball ; Michael Bartels ; Robert Budinsky ; Joanna Klapacz ; Sean Hays ; Christopher Kirman ; Grace Patlewicz
• 关键词：Read-across ; REACH ; Dipropylene glycol methyl ether acetate (DPMA) ; CAS No. 88917-22-0 ; Uncertainty
• 刊名：Regulatory Toxicology and Pharmacology
• 出版年：March, 2014
• 年：2014
• 卷：68
• 期：2
• 页码：212-221
• 全文大小：1082 K

文摘

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.