The estimation of permitted daily exposure (PDE) values for Myroxylon balsamum (L.) Harms var. pereirae (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.

Permitted daily exposure from preclinical studies of Ginkgo biloba L. dry extract

Abstract Resolution 658/2022 of the Brazilian Regulatory Agency requires the determination of the permitted daily exposure (PDE) of pharmaceutical agents. Ginkgo biloba L. is used therapeutically to treat memory deficits and other brain diseases. However, published results indicate that more studies are needed to confirm the safety of Ginkgo biloba. This study aimed to evaluate the dry extract of Ginkgo biloba L. leaves PDE as an ingredient in an oral pharmaceutical product in preclinical studies using mice. Acute oral toxicity and repeated dose experiments were performed based on OECD guidelines, as well as genotoxicity tests. The results indicate that Ginkgo biloba L. has low acute toxicity, no liver toxicity, and does not alter blood glucose levels. No changes in weight gain were observed, but food intake decreased in males during the first week of treatment at the highest dose. Hematological parameters were not altered in males, whereas females presented lower leukocyte and lymphocyte counts and higher neutrophil counts at the highest dose. The lipid profile was not altered in males, whereas total cholesterol was increased in females. The estimated PDE was 0.1 mg/day and, when related to the maximum residual concentration, indicates that the cleaning process used is safe and does not require reassessment.