Biocompatibility testing was conducted to support the biological safety assessment of the NEO 4mg oral nicotine pouch for a Natural Health Product (NHP) product license application in Canada. Because the product is intended for repeated contact with buccal mucosal tissues, the assessment included cytotoxicity, oral mucosal irritation, and skin sensitization testing using ISO 10993-based methods.
The NEO oral 4mg nicotine pouch, manufactured by Swedish Smokeless Solution AB, was tested for cytotoxicity, buccal mucosal irritation and sensitization in product extracts following ISO 10993-5, ISO 10993-23 and ISO 10993-10 guidelines, respectively. These studies were conducted in compliance with FDA GLP regulations and OECD Principles of GLP.
The in vitro cytotoxicity study demonstrated that NEO 4mg pouch product extract was not cytotoxic in L929 mouse cell line under experimental conditions. In the oral mucosal irritation study in male Golden Syrian hamsters, the polar extract produced an irritation index score of 3, corresponding to minimal irritation, while the non-polar extract produced an irritation index score of 0, corresponding to no irritation. Under the conditions of the study, the NEO 4mg pouch was considered minimally irritating for the polar extract and non-irritating for the non-polar extract. A guinea pig maximization sensitization test was conducted to determine the potential for NEO 4mg pouch to induce skin sensitization. Based on the results of this study, the Neo pouch product was not considered to be a skin sensitizer under the conditions of the assay.
Overall, NEO 4mg oral nicotine pouch product was not cytotoxic, not sensitizer and non- to minimal-irritant following ISO 10993-5, ISO 10993-10 and ISO 10993-23 guidelines for cytotoxicity, sensitization and buccal mucosal irritation, respectively.
