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Author Henderson, R.G.; Verougstraete, V.; Anderson, K.; Arbildua, J.J.; Brock, T.O.; Brouwers, T.; Cappellini, D.; Delbeke, K.; Herting, G.; Hixon, G.; Wallinder, I.O.; Rodriguez, P.H.; Van Assche, F.; Wilrich, P.; Oller, A.R.
Title Inter-laboratory validation of bioaccessibility testing for metals Type
Year 2014 Publication Regulatory Toxicology And Pharmacology Abbreviated Journal Regul. Toxicol. Pharmacol.
Volume 70 Issue 1 Pages 170-181
Keywords Metals; Alloys; UVCBs; Classification; Bioelution; Bioaccessibility; Read-across; Inter-laboratory validation
Abstract Bioelution assays are fast, simple alternatives to in vivo testing. In this study, the intra- and inter-laboratory variability in bioaccessibility data generated by bioelution tests were evaluated in synthetic fluids relevant to oral, inhalation, and dermal exposure. Using one defined protocol, five laboratories measured metal release from cobalt oxide, cobalt powder, copper concentrate, Inconel alloy, leaded brass alloy, and nickel sulfate hexahydrate. Standard deviations of repeatability (S-r) and reproducibility (S-R) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the s(R):s(r) ratios demonstrated that, while gastric and lysosomal fluids had reasonably good reproducibility, other fluids did not show as good concordance between laboratories. Relative standard deviation (RSD) analysis showed more favorable reproducibility outcomes for some data sets; overall results varied more between- than within-laboratories. RSD analysis of s(r) showed good within-laboratory variability for all conditions except some metals in interstitial fluid. In general, these findings indicate that absolute bioaccessibility results in some biological fluids may vary between different laboratories. However, for most applications, measures of relative bioaccessibility are needed, diminishing the requirement for high inter-laboratory reproducibility in absolute metal releases. The inter-laboratory exercise suggests that the degrees of freedom within the protocol need to be addressed. (C) 2014 Elsevier Inc. All rights reserved.
Address [Henderson, Rayetta G.; Hixon, Greg] ToxStrategies Inc, Raleigh, NC 27615 USA, Email: rhenderson@toxstrategies.com;
Corporate Author Thesis
Publisher Academic Press Inc Elsevier Science Place of Publication Editor
Language English Summary Language Original Title
Series Editor Series Title Abbreviated Series Title
Series Volume Series Issue Edition
ISSN 0273-2300 ISBN Medium
Area Expedition Conference
Notes WOS:000342482200018 Approved
Call Number UAI @ eduardo.moreno @ Serial 412
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