Contact sensitisation risk assessment approach for pouched snus ingredients

Abstract

INTRODUCTION BAT have expanded their product portfolio to meet the needs of the modern consumer. This has resulted in innovation in the arena of smokeless tobacco products (snus). With this expansion, BAT’s risk assessment approach needed to adapt to account for the differences in consumer exposure and resulting potential toxicological endpoints between pouched snus and traditional combustible products. Pouched snus is pre-packaged moist tobacco in small teabag-like sachets. The product is used by placing the pouch under the upper lip for extended periods of time, meaning the consumer exposure is prolonged contact with the buccal vestibular mucosa. As with other tobacco products, pouched snus contains added ingredients. These ingredients in prolonged contact with the buccal mucosa could result in contact sensitisation if the ingredient is associated with this endpoint. Therefore, in order to conduct the risk assessment for contact sensitisation an appropriate exposure scenario taking into account product use (see Table 1) needed to be developed.