The estimation of permitted daily exposure (PDE) values for (L.) Harms var. (Royle) Harms, balsamum (balsam of Peru) for regulatory toxicology purposes: application of various toxicological strategies.

Myroxylon pereirae resin (MP; balsam of Peru) is a botanical balsam which is derived from a tree known as Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum. This natural substance has a long history of medicinal use (antiseptic and for wound healing) but surprisingly there is a lack of toxicological data. The medicinal application of Peru balsam has been documented throughout a period of at least 30 years, however, due to the high risk of sensitisation and other treatment options available in the proposed indication, the medicinal use of MP in EU today is limited. The aim of this article is deriving Permitted Daily Exposure (PDE) values for MP for regulatory purposes using various toxicological strategies due to the problems with toxicological data. The results described in this article fills a gap in the literature on toxicological aspects of MP for the first time.