Acute and Reproductive Toxicity Evaluation of Ormona® SI and Ormona® RC—Two New Nutraceuticals with Geranylgeraniol, Tocotrienols, Anthocyanins, and Isoflavones—In Adult Zebrafish

Abstract

The zebrafish is a popular organism to test the toxicity of compounds. Here, we evaluate the acute and reproductive toxicity of Ormona SI® (OSI) and RC® (ORC), two herbal products developed for menopausal women with tocotrienols, geranylgeraniol, isoflavones, and anthocyanins. The acute toxicity was evaluated by behavioral alterations, lethality, and tissue changes (intestine, liver, kidney) after oral treatment with high product doses (500, 1000, and 2000 mg/kg). The reproductive toxicity was evaluated after 21 days of oral treatment with OSI and ORC at 200 mg/kg. Our results show that the LD50 could not be assessed due to the low mortality rate even with the highest dose; the behavioral alterations were not different from those of the group treated only with the vehicle (2% DMSO). The tissue changes were minor in OSI and more severe in ORC at the highest (2000 mg/kg) dose, while no tissue abnormality was observed at 500 mg/kg. In the reproductive assessment, continuous treatment could decrease the maturation of the reproductive cells, which also significantly decreases the egg spawning. This effect was attributed to the estrogenic activity of the isoflavones. In conclusion, the acute toxicity analysis shows that the products did not elicit lethal or sublethal effects observed in the model when used up to 500 mg/kg. Regarding the reproductive toxicity, decreased fertility was observed, which was expected due to the presence of isoflavones (phytoestrogens). Considering that the product is intended for menopausal and postmenopausal women, the presence of isoflavones is beneficial. Further studies should be performed to corroborate these results in mammals.

Technology Readiness Level Roadmap for Developing Innovative Herbal Medicinal Products

“…The comparison encompasses composition, clinical application, exposure (dose and duration), and the frequency and severity of any known adverse reactions [ 16 , 79 ]. Nonetheless, genotoxicity and reproductive toxicity, whose risks are difficult to detect clinically should be addressed, but exemptions apply [ 79 , 114 , 115 ]. The potential interaction with other medicines also needs to be addressed [ 116 , 117 ].…”

Osteoprotective Effect of the Phytonutraceutical Ormona® on Ovariectomy-Induced Osteoporosis in Wistar Rats

“…In contrast to the clear bone-related benefits of HRT, its uncertain popularity has culminated in a clinical need for well-tolerated nutritional options that can be used safely after menopause and that effectively prevent bone loss and the development of osteoporosis [4]. The phytonutraceutical Ormona ® is a phytocomplex composed of 40% oil extract of annatto (Bixa orellana), with the same composition as Chronic ® [10]. Of this 40%, ~10% is mainly δ-tocotrienols and ~28% is geranylgeraniol.…”