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
HERO ID
4946621
Reference Type
Journal Article
Year
2014
Language
English
PMID
| HERO ID | 4946621 |
|---|---|
| In Press | No |
| Year | 2014 |
| Title | 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 | Ball, N; Bartels, M; Budinsky, R; Klapacz, J; Hays, S; Kirman, C; Patlewicz, G |
| Journal | Regulatory Toxicology and Pharmacology |
| Volume | 68 |
| Issue | 2 (March 2014) |
| Page Numbers | 212-221 |
| 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. |
| Doi | 10.1016/j.yrtph.2013.12.007 |
| Pmid | 24378700 |
| Wosid | WOS:000332131100003 |
| Is Certified Translation | No |
| Dupe Override | No |
| Is Public | Yes |
| Language Text | English |
| Keyword | Index Medicus |
| Relationship(s) |
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