In vitro evaluation of mutagenic, cytotoxic, genotoxic and oral irritation potential of nicotine pouch products.

Autor: Miller-Holt J; Scientific and Regulatory Affairs, JT International SA, Geneva, Switzerland., Baskerville-Abraham I; Scientific and Regulatory Affairs, JT International SA, Geneva, Switzerland., Sakimura M; Scientific and Regulatory Affairs, JT International SA, Geneva, Switzerland., Fukushima T; Scientific Product Assessment Center, R&D Group, Japan Tobacco Inc., Kanagawa, Japan., Puglisi A; Scientific and Regulatory Affairs, JT International SA, Geneva, Switzerland., Gafner J; Scientific and Regulatory Affairs, JT International SA, Geneva, Switzerland.
Jazyk: angličtina
Zdroj: Toxicology reports [Toxicol Rep] 2022 Jun 15; Vol. 9, pp. 1316-1324. Date of Electronic Publication: 2022 Jun 15 (Print Publication: 2022).
DOI: 10.1016/j.toxrep.2022.06.008
Abstrakt: Non-clinical in vitro studies were conducted to investigate the characteristics of extracts from tobacco free nicotine pouches alongside a reference snus product and/or 1R6F reference cigarette. In vitro investigations were conducted in the Neutral Red Uptake (NRU) cytotoxicity assay, Bacterial Reverse Mutation (Ames) assay, and in vitro Mammalian Cell Micronucleus ( iv MN) assay. These products were also investigated for their oral irritation potential in the EpiGingival™ 3D tissue model. Results from the Ames, in vitro Micronucleus and NRU assays indicated that the tested products were non-mutagenic, non-genotoxic and non-cytotoxic in contrast to results obtained for the 1R6F reference cigarette. Results from Complete Artificial Saliva (CAS) extracts from these products also failed to be classified as irritants (as measured using the MTT assay), in the EpiGingival™ 3D tissue model.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JT International SA funded the project, and all authors were employees of Japan Tobacco Group at the time of the study. Nordic spirit tobacco-free nicotine pouches are manufactured and supplied by JT International.
(© 2022 The Authors.)
Databáze: MEDLINE