Inter-laboratory validation of bioaccessibility testing for metals
2014 (English)In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 70, no 1, 170-181 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2014. Vol. 70, no 1, 170-181 p.
Metals, Alloys, UVCBs, Classification, Bioelution, Bioaccessibility, Read-across, Inter-laboratory validation
Pharmacology and Toxicology
IdentifiersURN: urn:nbn:se:kth:diva-154753DOI: 10.1016/j.yrtph.2014.06.021ISI: 000342482200018ScopusID: 2-s2.0-84904408802OAI: oai:DiVA.org:kth-154753DiVA: diva2:763118
QC 201411132014-11-132014-10-272014-11-13Bibliographically approved