| Contamination of toys and low-cost jewelry with potentially toxic elements is a widespread problem. However, oral bioaccessibility of elements in toys and inexpensive jewelry has not yet been fully evaluated, and children's potential exposure has not been characterized.;In the present work, a literature review has been initially conducted in order to determine and clearly understand the state of scientific knowledge, different toy safety approaches, legislative background, and research needs. The U.S., Canadian, and European Union (EU) legislations regulating metals in toys and jewelry have been evaluated. A literature review on metals in toys and low-cost jewelry (content, bioavailability, children's exposure, and testing) has been performed. Then, the extent of contamination problem in toys and low-cost children's jewelry has been assessed by the first phase of experimental work.;The investigation of total metal concentrations in toys and children's low-cost jewelry bought from the North American market (n=72) has revealed that for the category MJ (n = 24), 20 items had total concentrations exceeding migratable concentration limits defined in the EU Toy Safety Directive. Seven of 17 jewelry items did not comply with total concentration limits in U.S. and Canadian regulations. These samples included articles with very high Cd (37% [w/w]), Pb (65%), and Cu (71%) concentrations. For plastic toys (n = 18), toys with paint or coating (n = 12), and brittle or pliable toys (n = 18), total concentrations were below the EU migration limits (except in one toy for each category). Overall, total concentrations of As, Cd, Cu, Ni, Pb, and Sb were elevated in some of the analyzed samples. Testing for gastro-intestinal bioaccessibility on selected items (n = 4) showed that a tested jewelry item strongly leached Pb (gastric: 698 microg, intestinal: 705 microg) and some Cd (1.38 and 1.42 microg). Therefore, it was found necessary to carry out saliva and gastro-intestinal bioaccessibility tests.;Considering the saliva mobilization of toxic elements following mouthing, elemental bioavailability in toys and low-cost jewelry has been estimated via two different in vitro tests (saliva extraction compartments of the DIN and RIVM bioaccessibility protocols, n = 32). Four metals were mobilized to saliva from 16 MJ in significant quantities (>1 microg for highly toxic Cd and Pb, >10 microg for Cu and Ni). Bioaccessibility increased with extraction time. Bioaccessible concentrations of Cd caused unacceptable risk for young children between 6 mo- and 3 y-old. Total and bioaccessible concentrations were different and not always correlated, encouraging the use of bioaccessibility for more accurate hazard assessments.;Considering the ingestion of toy or jewelry material, gastro-intestinal bioavailability of toxic elements has been assessed via three in vitro bioaccessibility protocols (IVG, PBET, EN 71-3; n = 24). Cd, Cu, Ni, and Pb were mobilized from 19 MJ, and one crayon set. Bioaccessible Cd, Ni, and Pb concentrations exceeded EU migratable concentration limits in four to six MJ, depending on the protocol. Using two-phase (gastric and intestinal) protocols like IVG or PBET would be recommended over one-phase EN 71-3 since the former are more conservative and better represent gastro-intestinal physiology. Total and bioaccessible metal concentrations were also different and not always correlated, and the use of bioaccessibility in risk characterization is recommended.;Finally, risk characterization based on three exposure scenarios (whole ingestion of parts or pieces, ingestion of scraped-of material, saliva mobilization following mouthing; n = 16) showed that whole ingestion of parts or pieces caused unacceptable risk for eight items for Cd, Ni, and Pb (Hazard Index [HI]>1 and as high as 75, 5.8, and 43, respectively). Saliva mobilization scenario caused HI to exceed 1 in three samples (two for Cd, one for Ni), indicating a lower risk than ingestion of parts or pieces. Ingestion of scraped-off material lead to limited risk as HI was less than 1 for all samples (up to 0.287 for Cd, 0.156 for Pb). Potentially hazardous items identified via the risk characterization were different than the ones identified via the U.S., Canadian, and EU toy safety approaches. A comprehensive methodology has been developed to deal with the shortcomings of various approaches of toy safety and complexity due to different toy and jewelry definitions, test methods, exposure scenarios, and regulated elements. The presented approach provides definitions, testing recommendations, and guidelines for risk characterization, together with bioaccessible quantity limits for eight priority elements for different exposure scenarios. (Abstract shortened by UMI.). |