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Acute and Repeated 28-Day Oral Dose Toxicity Studies of Thymus vulgaris L. Essential Oil in Rats
Juan Rojas Armas,Jorge Arroyo-Acevedo,Manuel Ortiz-Sánchez,Miriam Palomino-Pacheco,Américo Castro-Luna,Norma Ramos-Cevallos,Hugo Justil-Guerrero,Julio Hilario-Vargas,Oscar Herrera-Calderón 한국독성학회 2019 Toxicological Research Vol.35 No.3
Thymus vulgaris L. is widely used as an ingredient in cooking and in herbal medicine. However, there is little information about its toxicity. The present study was performed to evaluate the acute and repeated 28-day oral dose toxicity of thyme essential oil in rats. For the acute toxicity test, two groups of three rats were used. The rats received a single dose of essential oil: 300 or 2,000 mg/kg of body weight (bw). The rats were observed individually during the first four hours, and then daily until day 14. For the toxicity test with repeated doses, four groups of 10 rats were used. Doses of 100, 250, and 500 mg/kg/day were tested for 28 days. At the end of the experiment, blood was collected and the animals were sacrificed. Histopathological examination showed that in the lungs of rats given the 2,000 mg/kg bw dose, polymorph nuclear infiltrates, hemosiderin macrophages, and interstitial space thickening were present. In the repeated dose study, all rats survived the 28-day treatment period and apparently showed no signs of toxicity. The hematological and biochemical parameters were not altered. The histopathological study of the organs showed severe changes in the lung, with the dose of 500 mg/kg/day; in the other organs, no alterations were observed or the changes were slight. The body weight was only altered in male rats given the 500 mg/kg dose. The relative weight of the organs did not show any significant changes. Our studies revealed that the essential oil of Thymus vulgaris has moderate oral toxicity according to the results of the acute test, whereas the results of the 28-day oral toxicity test suggest that the no-observed-adverse effect level (NOAEL) is greater than 250 mg/kg/day.
Acute and Repeated 28-Day Oral Dose Toxicity Studies of Thymus vulgaris L. Essential Oil in Rats
Rojas-Armas, Juan,Arroyo-Acevedo, Jorge,Ortiz-Sanchez, Manuel,Palomino-Pacheco, Miriam,Castro-Luna, Americo,Ramos-Cevallos, Norma,Justil-Guerrero, Hugo,Hilario-Vargas, Julio,Herrera-Calderon, Oscar Korean Society of ToxicologyKorea Environmental Mu 2019 Toxicological Research Vol.35 No.3
Thymus vulgaris L. is widely used as an ingredient in cooking and in herbal medicine. However, there is little information about its toxicity. The present study was performed to evaluate the acute and repeated 28-day oral dose toxicity of thyme essential oil in rats. For the acute toxicity test, two groups of three rats were used. The rats received a single dose of essential oil: 300 or 2,000 mg/kg of body weight (bw). The rats were observed individually during the first four hours, and then daily until day 14. For the toxicity test with repeated doses, four groups of 10 rats were used. Doses of 100, 250, and 500 mg/kg/day were tested for 28 days. At the end of the experiment, blood was collected and the animals were sacrificed. Histopathological examination showed that in the lungs of rats given the 2,000 mg/kg bw dose, polymorph nuclear infiltrates, hemosiderin macrophages, and interstitial space thickening were present. In the repeated dose study, all rats survived the 28-day treatment period and apparently showed no signs of toxicity. The hematological and biochemical parameters were not altered. The histopathological study of the organs showed severe changes in the lung, with the dose of 500 mg/kg/day; in the other organs, no alterations were observed or the changes were slight. The body weight was only altered in male rats given the 500 mg/kg dose. The relative weight of the organs did not show any significant changes. Our studies revealed that the essential oil of Thymus vulgaris has moderate oral toxicity according to the results of the acute test, whereas the results of the 28-day oral toxicity test suggest that the no-observed-adverse effect level (NOAEL) is greater than 250 mg/kg/day.
( Beat Müllhaupt ),( Paul Kwo ),( Kosh Agarwal ),( Christophe Duvoux ),( Francois Durand ),( Marcus Peck-Radosavljevic ),( Eric M. Yoshida ),( Leslie Lilly ),( Bernard Willems ),( Hugo Vargas ),( Prin 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The aim of this analysis is to evaluate outcomes in patients who underwent liver transplant after initiating treatment with ledipasvir (LDV)/sofosbuvir (SOF)+ribavirin (RBV) in the SOLAR-1 and SOLAR-2 trials. Methods: We combined data from the SOLAR-1 and SOLAR-2 studies, in which 7 groups of patients with HCV genotype (GT) 1 or 4 were randomized to receive 12 or 24 weeks of LDV/SOF+ RBV: patients without a transplant with 1) Child-Pugh-Turcotte (CPT) B or 2) CPT C cirrhosis; or transplanted patients with 3) no cirrhosis (F0 to F3), 4) CPT A, 5) CPT B or, 6) CPT C cirrhosis, or 7) fibrosing cholestatic hepatitis. Results: Seventeen patients underwent liver transplantation during the study. For all but one patient, this was the first liver transplant. Six were CPT B at screening (5 Group 1, 1 Group 5) and 11 were CPT C (Group 2). Median baseline MELD score was 17 (range 7-23), with the majority (11/17) having scores ≥15. Seven patients underwent transplant prior to completing their full course of treatment. All patients were HCV RNA <LLOQ at the time of liver transplant. All but one patient (94%, 16/17) maintained virologic response 12 weeks after transplant (pTVR12). All patients who achieved pTVR12 received at least 11 weeks of LDV/SOF+RBV. The one patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. Conclusions: Few patients with decompensated cirrhosis treated in the SOLAR studies underwent liver transplantation after initiating LDV/SOF+RBV therapy. For the 17 who did undergo transplant, 94% achieved pTVR12. The data suggest that 11 weeks of treatment prior to transplantation can prevent reinfection of the graft. Future studies are needed to assess the optimal timing and length of treatment in the peri-transplant setting.