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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 33

Non-clinical toxicological assessment of flavored e-liquids and closed system pod-based ends flavor formulations

Chemular Inc., Hudson, MI, USA

The aerosol from various market flavored e-liquids and pod-based ENDS flavor formulations (tobacco, menthol and non-tobacco) were evaluated for their potential in vitro toxicity.

A closed system pod-based temperature-regulated ENDS device and a open tank ENDS (Aegis Mini Mod with a Nautilus Aspire tank and a Nautilus BVC 1.8 Ohms, non-mesh coil) were used to generate the aerosols. All e-liquids were nicotine-salt of 50 mg/mL concentrations. The formulations were vaped following CRM81 non-intense puffing conditions and aerosol collected mass (ACM) was prepared using an ethanol extraction methodology. Progressive doses of ACM were tested in the in vitro toxicological assays. 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.

Under the experimental conditions and based on the established criteria for evaluation of various assays, no aerosol mediated cytotoxicity, mutagenicity or genotoxicity was observed in any of the tested flavors. EC50 for all aerosols could not be calculated for any assay because the lack of dose-response. This in vitro toxicological analysis of aerosol generated either with pod-based temperature-regulated ENDS device and an open tank ENDS with three different flavors (tobacco, menthol and non-tobacco,) containing nicotine-salt at 50 mg/mL did not induce cytotoxic, mutagenic or genotoxic response.