Eskes C, Corsini E, Hanley V, Karadjova I, Kopp-Schneider A, Suh M, Alves P, Clewell R, Cotgreave I, Navas J, Piersma A, Westmoreland C. 2020. ESAC opinion on the scientific validity of the bioelution test method. In: Viegas Barroso J (ed), EUR 30281 EN. Publications Office of the European Union, Luxembourg, ISBN 978-92-76-20004-8 (online), doi:10.2760/023005 (online), JRC121143.
Abstract
ESAC, the EURL ECVAM Scientific Advisory Committee, advises EURL ECVAM on scientific issues. Its main role is to conduct independent peer review of validation studies of alternative test methods and to assess their scientific validity for a given purpose. The committee reviews the appropriateness of study design and management, the quality of results obtained and the plausibility of the conclusions drawn. ESAC peer reviews are formally initiated with a EURL ECVAM Request for ESAC Advice, which provides the necessary background for the peer-review and establishes its objectives, timelines and the questions to be addressed. The peer review is normally prepared by specialised ESAC Working Groups. ESAC’s advice to EURL ECVAM is formally provided as ‘ESAC Opinions’ and ‘Working Group Reports’ at the end of the peer review. ESAC may also issue Opinions on other scientific issues of relevance to the work and mission of EURL ECVAM but not directly related to a specific alternative test method.
The ESAC Opinion expressed in this report relates to the peer-review of the Bioelution in vitro test method.
The ESAC concludes that the Bioelution test method is scientifically valid for determining the relative IVBA of metals and metalloids in inorganic metal compounds and metal (metalloid)-containing materials to be used in the context of their classification. Thus, the ESAC recommends that the Bioelution test method [progress] to Test Guideline development at OECD level to achieve international harmonisation.