title: Use of category approaches, read-across and (Q)SAR: general considerations.
abstract: Read-across has generated much attention since it may be used as an alternative approach for addressing the information requirements under regulatory programmes, notably the EU's REACH regulation. Read-across approaches are conceptually accepted by ECHA and Member State Authorities (MS) but difficulties remain in applying them consistently in practice. Technical guidance is available and there are a plethora of models and tools that can assist in the development of categories and read-across, but guidance on how to practically apply categorisation approaches is still missing. This paper was prepared following an ECETOC (European Centre for Ecotoxicology and Toxicology) Task Force that had the objective of summarising guidance and tools available, reviewing their practical utility and considering what technical recommendations and learnings could be shared more widely to refine and inform on the current use of read-across. The full insights are recorded in ECETOC Technical Report TR No. 116. The focus of this present paper is to describe some of the technical and practical considerations when applying read-across under REACH. Since many of the deliberations helped identify the issues for discussion at a recent ECHA/Cefic LRI workshop on "read-across", summary outcomes from this workshop are captured where appropriate for completeness.
authors.affiliation: DuPont Haskell Global Centers for Health and Environmental Sciences, 1090 Elkton Road, Newark, DE 19711, USA. Electronic address: patlewig@hotmail.com.
authors.forename: Grace
authors.initials: G
authors.lastname: Patlewicz
authors.forename: Nicholas
authors.initials: N
authors.lastname: Ball
authors.forename: Ewan D
authors.initials: ED
authors.lastname: Booth
authors.forename: Etje
authors.initials: E
authors.lastname: Hulzebos
authors.forename: Elton
authors.initials: E
authors.lastname: Zvinavashe
authors.forename: Christa
authors.initials: C
authors.lastname: Hennes
mesh_terms: D026683:Advisory Committees; D000818:Animals; D054750:Ecotoxicology / Q000379:methods*; D005060:Europe; D015386:Hazardous Substances / Q000737:chemistry* / Q000633:toxicity*; D006801:Humans; D021281:Quantitative Structure-Activity Relationship; D014116:Toxicology / Q000379:methods*
chemical_list: D015386:Hazardous Substances
keywords: (Q)SAR; Analogue approach; Category approach; Data gap filling; REACH; Read-across