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Regul Toxicol Pharmacol. 2014 Oct;70(1):170-81. doi: 10.1016/j.yrtph.2014.06.021. Epub 2014 Jun 28.

Inter-laboratory validation of bioaccessibility testing for metals.

Author information

1
ToxStrategies, Inc., 9650 Strickland Rd., Suite 103-195, Raleigh, NC 27615, USA. Electronic address: rhenderson@toxstrategies.com.
2
Eurometaux, Avenue de Broqueville 12, 1150 Brussels, Belgium. Electronic address: verougstraete@eurometaux.be.
3
Oregon State University, Corvallis, OR 97331, USA. Electronic address: kim.anderson@oregonstate.edu.
4
CECM, Adolfo Ibañez University, Diagonal Las Torres 2640, Peñalolen, Santiago, Chile. Electronic address: jose.arbildua@uai.cl.
5
Duke University, 2200 West Main Street, Suite 400, Durham, NC 27705, USA. Electronic address: thomas.brock@duke.edu.
6
ECTX bvba, Havenstraat 46/0.01, B-3500 Hasselt, Belgium. Electronic address: tony.brouwers@ectx.be.
7
Kirby Memorial Health Center, 71 North Franklin Street, Wilkes-Barre, PA 18701, USA. Electronic address: dcappellini@epix.net.
8
European Copper Institute, 168 Avenue de Tervueren, 1150 Brussels, Belgium. Electronic address: katrien.delbeke@copperalliance.eu.
9
KTH Royal Institute of Technology, Drottning Kristinas väg 51, SE-10044 Stockholm, Sweden. Electronic address: herting@kth.se.
10
ToxStrategies, Inc., 9650 Strickland Rd., Suite 103-195, Raleigh, NC 27615, USA. Electronic address: ghixon@toxstrategies.com.
11
KTH Royal Institute of Technology, Drottning Kristinas väg 51, SE-10044 Stockholm, Sweden. Electronic address: ingero@kth.se.
12
CECM, Adolfo Ibañez University, Diagonal Las Torres 2640, Peñalolen, Santiago, Chile. Electronic address: Patricio.rodriguez@uai.cl.
13
International Zinc Association, Avenue de Tervueren 168/Box 4, B-1150, Belgium. Electronic address: fvanassche@zinc.org.
14
Freie Universität Berlin, Promenadenstr. 16 A, D-12207 Berlin, Germany. Electronic address: wilrich@wiwiss.fu-berlin.de.
15
Nickel Producers Environmental Research Association, Inc., 2525 Meridian Parkway, Suite 240, Durham, NC 27713, USA. Electronic address: aoller@nipera.org.

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 (sr) and reproducibility (sR) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the sR:sr 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 sr 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.

KEYWORDS:

Alloys; Bioaccessibility; Bioelution; Classification; Inter-laboratory validation; Metals; Read-across; UVCBs

PMID:
24979734
DOI:
10.1016/j.yrtph.2014.06.021
[Indexed for MEDLINE]

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