Abstract: Leachable materials in product packaging present a possible hazard to consumers. Toxic materials may migrate out of the packaging into the e-liquid product and be inhaled by the consumer during use of the product. The classical approach to evaluating the potential of packaging material chemicals to migrate into the product is first to perform an extraction study using model solvent systems, and if materials are found at levels of toxicological concern, then a leachables study is performed throughout the shelf life of the product to confirm if the packaging material has the potential to migrate into the product during intended storage and use. The Product Quality Research Institute (“PQRI”) Leachables and Extractables Working Group’s recommended approach was followed to evaluate a Chubby Gorilla® e-liquid bottle. Specifically, the bottle and cap were tested using the USP 1663 method (Assessment of Extractables Associated with Pharmaceutical Packaging/Deliver Systems). Samples were extracted with aqueous solutions at pH 5.2 and 9.5 and a 50/50% solution of isopropanol and deionized water. The solutions were analyzed by GC/MS (volatiles and semi-volatiles), LC/MS (non-volatiles) and ICP/MS (metals). The bottle and cap did not appear to have the potential to leach materials of toxicological concern above the Safety Concern Threshold (SCT) or Toxicological Threshold of Concern (TTC). Under the conditions of use, the bottle was deemed acceptable as a packaging container for e-liquids.
Ed Carmines, Lise Fraissinet,Tom Barrett
Affiliations: Chemular, Inc, Hudson, MI, Legend Technical Services, Inc. St Paul, MN