4.4 Article

Inter-laboratory validation of bioaccessibility testing for metals

期刊

REGULATORY TOXICOLOGY AND PHARMACOLOGY
卷 70, 期 1, 页码 170-181

出版社

ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2014.06.021

关键词

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

资金

  1. Nickel Producers Environmental Research Association, Inc. (Durham, NC, USA)
  2. Cobalt Development Institute (Guildford, Surrey UK)
  3. International Zinc Association (Brussels, Belgium)
  4. European Copper Institute (Brussels, Belgium)
  5. Eurometaux (Brussels, Belgium)
  6. Food Safety and Environmental Stewardship Program at OSU

向作者/读者索取更多资源

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.

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