A quantitative analysis of solubility difference (relative to ethanol) among these commonly used semipolar organic solvents over a wide hydrophobicity range based on Abraham general solvation model is presented. The solvents studied include methanol, ethanol, 1-propanol, 2-propanol (IPA), acetonitrile (ACN), acetone, dioxane, dimethylacetamide (DMA), dimethylformamide (DMF), dimethyl sulfoxide (DMSO), and ethylene glycol. This study evaluates the difference in solubility of semipolar solvents relative to ethanol for a wide range of E/L in hydrophobicity to help the selection of semipolar solvents for extraction studies.
DEADLOCK COATINGS ISO
Organic solvents of different polarities (polar, semipolar, and nonpolar) are typically used in extraction studies on medical devices for chemical characterization of their constituents (called extractables or leachables, E/L) potentially exposed to patients during clinical uses per ISO 10993-18 (2020). This study shows the high potential of non-targeted approaches using high resolution accurate mass spectrometry (HRAMS) with SWATH acquisition for the characterization of food packaging materials aimed at food safety evaluation. Most of the compounds detected in this study were previously reported in other studies of NIAS migration from plastic packaging materials, except for five of the tentatively identified oligomers that were found for the first time in this study. Evaluation of the toxicity of the tentatively identified migrants was carried out, showing that most of them were classified in the higher toxicity class according to Cramer rules. Cyclic oligomers, possibly coming from polyurethane adhesives, were the main migrants in the studied materials. This approach has allowed the identification of 26 potential migrants, of which 23 were NIAS. MS and MS/MS data from the most abundant ions in the samples were processed using formula finding and searched against open chemical and spectral databases, such as ChemSpider and METLIN, combined with bibliographic search. Identification of non-target peaks followed by filtering strategies facilitated the comprehensive identification procedure of unexpected migrants present in the food simulants. In this study, the benefits of using LC-ESI-Q-TOF-MS equipment combined with the data-independent acquisition method SWATH (Sequential Windowed Acquisition of All THeoretical MS) have been evaluated for the identification of unexpected migrants from multilayer plastic packaging materials.
The identification of all potential migrants, including non-intentionally added substances (NIAS), is required to assess the safety of these materials.
A proper safety assessment must go further than simply testing for known ingredients used to make the packaging materials. The system introduces flexibility and is promising to get the present situation out of the deadlock.ĮU legislation requires that chemicals migrating from food packaging into food do not endanger human health. Such gap descriptions can be listed in compliance declarations for an honest statement on compliance.
These plans have to be realistic in terms of feasibility and timelines. The owners of the gap description elaborate work plans, which have to be discussed and approved by competent authorities. A system is proposed rendering the gaps in the compliance work temporarily tolerable, provided these are described and registered with the business operators behind them. This is not new, but the legally required compliance declarations render it more evident: even though most FCM do not fully comply with the legal requirement, the declarations have to state this, as FCM cannot be marketed otherwise – which is an awkward situation. However, usually the larger part of the migrates consists of oligomers, reaction products and impurities (ORPIs), of which often not even the composition is known. At best the starting substances were evaluated. Hardly any FCM has been investigated to the extent complying with this requirement. EU legislation requires that the materials migrating from packaging and other food contact materials (FCM) into food do not endanger human health, which means the absence of a substance transferred to food in potentially health-relevant amounts.
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