Event name:
IN VITRO TOXICOLOGICAL ASSESSMENT OF SIBERIA AND BULLDOG BRAND MODERN ORAL NICOTINE POUCH PRODUCTSSession Date:
–
Session Speakers:
The in vitro toxicological assessment of Modern Oral Nicotine Products (MONP) is enessential part of the US FDA’s premarket tobacco product application (PMTA) process. This assessment was conducted using a battery of well-established regulatory assays, including the Bacterial Reverse Mutation (Ames), in vitro Micronucleus (ivMN) and Neutral Red Uptake (NRU) regulatory assays to assess potential mutagenicity, genotoxicity, and cytotoxicity, respectively. The Swedish Smokeless Solutions AB (SSA) Siberia and Bulldog brand pouches contain synthetic nicotine with flavors. The principal difference between the tested products is the amount of nicotine and the size of the pouch. The tested products contained different nicotine levels (15-29 mg/pouch). The pouch products were extracted with dimethyl sulfoxide (DMSO) and used for toxicological assessment Multiple doses (dose-response) of the high nicotine strength of a representative sample of each brand were tested in the toxicology assays. All other product samples were only tested at the top dose. Under the experimental conditions and based on the established criteria for evaluation of various assays, no cytotoxicity, mutagenicity nor genotoxicity was observed for any of the SSA Siberia and Bulldog pouch products.