Abstract: The Glas G2 ENDS is a temperature-regulated nicotine salt pre-filled disposable pod connected system (Glas system) designed to minimize the combustion byproducts across a range of operating conditions. Aerosol generated from Glas system was evaluated for cytotoxicity, mutagenicity and genotoxicity potential. Testing was conducted by an accredited ISO 17025 laboratory using validated methods. Seven different flavored e-liquids (three tobacco, two menthol, two fruit; 50 mg/ml nicotine) were vaped following CRM81 non-intense puffing conditions and aerosol collected mass (ACM) was prepared using an ethanol extraction methodology. For toxicological assys, ACM exposure was conducted in a dose-dependent manner. The cytotoxicity was assessed by the neutral red uptake in vitro assay in BALBc/3T3 cells (OECD, TG 129). The mutagenicity was assessed by bacteria reverse mutation assay (OECD TG 471) using 5 tester strains of (TA98, TA100, TA102, TA1535, and TA1537) in the presence and absence of rat liver S9 fraction metabolic activation system. The genotoxicity was assessed by MN assay (OECD TG 487) in human lymphoblast TK6 cells. Appropriate negative and positive controls were included in assays. In conclusion, under the experimental conditions and based on the criteria for evaluation of various assays, no aerosol mediated cytotoxicity, mutagenicity or genotoxicity was observed at any of the tested Glas flavors. EC50 for the Glas aerosol could not be calculated for any assay because the lack of dose-response. This in vitro toxicological analysis of aerosol generated with seven Glas e-liquid products in combination testing with the Glas G2 device did not induce cytotoxic, mutagenic or genotoxic response.
Manoj Misra, Ed Carmines, Lise Fraissinet
Affiliations: Chemular, Inc, Hudson, MI, USA