RESUMO
Turmeric (Curcuma longa L.) extracts have a long history of use worldwide, but a major limitation of these extracts is their extremely low oral bioavailability, caused by low absorption, rapid metabolism and rapid excretion following ingestion. Thus, a new highly bioavailable turmeric extract formulation (comprising turmeric extract, acacia gum, sunflower oil and quillaia extract) has been developed and is intended for use as a food ingredient. Safety of this novel extract was evaluated using the standard Tier 1 battery of in vitro genotoxicity tests (bacterial reverse mutation test and an in vitro mammalian cell micronucleus test) followed by repeated-dose 28- and 90-day oral toxicity studies in rats. In the 90-day study, male and female Sprague-Dawley rats were dosed once daily, by oral gavage, either with the vehicle or the test item at 500, 1500 or 3000 mg/kg body weight/day. Clinical examinations were conducted regularly, and body weights and food consumption were recorded weekly throughout the study. At the end of the study, blood samples were analyzed for clinical pathology parameters, before a macroscopic necropsy was conducted and a full list of tissues were examined histopathologically. There was no evidence of genotoxicity in vitro. No test item-related adverse effects were observed in the 28- or 90-day studies; therefore, 3000 mg/kg body weight/day (the maximum feasible dose and highest dose tested in rats) was established as the no-observed-adverse-effect level.
Assuntos
Disponibilidade Biológica , Células Cultivadas/efeitos dos fármacos , Curcuma/química , Curcuma/toxicidade , Extratos Vegetais/farmacocinética , Extratos Vegetais/toxicidade , Plantas Medicinais/toxicidade , Animais , Feminino , França , Humanos , Masculino , Testes de Mutagenicidade , Extratos Vegetais/química , Ratos , Ratos Sprague-DawleyRESUMO
Data on the biological impact of oil dispersion in deep-sea environment are scarce. Hence, the aim of this study was to evaluate the potential interest of a pressure challenge as a new experimental approach for the assessment of consequences of chemically dispersed oil, followed by a high hydrostatic pressure challenge. This work was conducted on a model fish: juvenile Dicentrarchus labrax. Seabass were exposed for 48 h to dispersant alone (nominal concentration (NC) = 4 mg L-1), mechanically dispersed oil (NC = 80 mg L-1), two chemically dispersed types of oil (NC = 50 and 80 mg L-1 with a dispersant/oil ratio of 1/20), or kept in clean seawater. Fish were then exposed for 30 min at a simulated depth of 1350 m, corresponding to pressure of 136 absolute atmospheres (ATA). The probability of fish exhibiting normal activity after the pressure challenge significantly increased from 0.40 to 0.55 when they were exposed to the dispersant but decreased to 0.26 and 0.11 in the case of chemical dispersion of oil (at 50 and 80 mg L-1, respectively). The chemical dispersion at 80 mg L-1 also induced an increase in probability of death after the pressure challenge (from 0.08 to 0.26). This study clearly demonstrates the ability of a pressure challenge test to give evidence of the effects of a contaminant on the capacity of fish to face hydrostatic pressure. It opens new perspectives on the analysis of the biological impact of chemical dispersion of oil at depth, especially on marine species performing vertical migrations.