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Toxicidad oral a 60 días del aceite de sacha inchi (Plukenetia volubilis L.) y linaza (Linum usitatissimum L.) y determinación de la dosis letal 50 en roedores Oral toxicity at 60-days of sacha inchi oil (Plukenetia volubilis L.) and linseed (Linum usitatissimum L.), and determination of lethal dose 50 in rodents  [cached]
Arilmi Gorriti,Jorge Arroyo,Fredy Quispe,Braulio Cisneros
Revista Peruana de Medicina Experimental y Salud Pública , 2010,
Abstract: Objetivos. Evaluar la toxicidad oral a 60 días y determinar la dosis letal 50 (DL 50) de los aceites crudos de sacha inchi (Plukenetia volubilis L.) y linaza (Linum ussitatisimum) en ratas Holtzman y en ratones cepa Balb C57, respectivamente. Materiales y métodos. Para la evaluación de la toxicidad oral a dosis repetida por 60 días se utilizó 24 ratas macho Holtzman divididos en tres grupos de ocho cada uno, los grupos fueron: solución salina fisiológica 4 mL/kg (SSF), aceite de sacha inchi 0,5 mL/kg (SI05) y aceite de linaza 0,5 mL/kg (L05), durante el experimento se controló semanalmente el peso corporal y signos de toxicidad en los grupos investigados, así como colesterol total, HDL, triglicéridos, glucosa, urea, TGP y fosfatasa alcalina a los 30 y 60 días de iniciado el experimento. Para la evaluación de la DL50 se usó ratones macho cepa Balb C57 en grupos de diez animales, se administró por vía oral dosis crecientes de aceites crudos hasta alcanzar 1 mL/kg (37 g/kg); Resultados. Los parámetros séricos en las ratas indican que no existe toxicidad alguna a los 60 días y que la administración de los aceites disminuyeron los niveles de colesterol, triglicéridos e incrementaron el HDL con respecto al grupo control. La DL50 muestra que los aceites crudos de sacha inchi y linaza presentan dosis por encima de los 37 g/kg de masa corporal. Conclusiones. Los aceites de sacha inchi y linaza son inocuos a 60 días y presentan una DL50 por encima de los 37 g/kg de animal. Objectives. To evaluate the oral toxicity at 60 days and to determine the lethal dose 50 (LD 50) of raw sacha inchi (Plukenetia volubilis L.) and linseed (Linum ussitatisimum) oils in Holtzman rats and mice of the strain Balb C57 respectively. Materials and methods. For the evaluation of the oral toxicity of repeated doses for 60 days, 24 male Holtzman rats were used, divided in three groups of 8 each, the groups were: physiologic saline solution 4 mL/kg (FSS), sacha inchi oil 0.5 mL/kg (SI05) and linseed oil 0.5 mL/kg (L05), during the experiment the body weight was controlled weekly, and signs of toxicity in the research groups, as well as total cholesterol, HDL, glucose, triglycerides and alkaline phosphatase at days 30 and 60 after initiating the experiment. For the evaluation of the LD50 male mice of the Balb C57 strain were used in groups of 10 animals, and they were administered increasing oral doses of raw oils until reaching 1 mL/kg (37 g/kg). Results. The serum parameters in the rats indicated there is no toxicity at 60 days and that the administration of the oils lowered the levels o
Evaluation of acute and sub-chronic toxicity of Semelil (ANGIPARSTM), a new phytotherapeutic drug for wound healing in rodents
Abdollahi M,Farzamfar B,Salari P,Khorram Khorshid HR
DARU : Journal of Pharmaceutical Sciences , 2008,
Abstract: Semelil (ANGIPARSTM), an herbal formulation containing Melilotus officinalis extract, is a novel compound being developed for treatment of chronic wounds, particularly diabetic foot ulcers. The purpose of this study was to investigate toxicological, pharmacological, and pathomorphological effects of I.M. and I.P. administration of Semelil in animals."nThe acute toxicity parameters of Semelil diluted in normal saline (1:10 or 1:5) were determined after a single injection into BALB/c mice and Wistar rats in two steps. First, the LD50 was approximately assessed and then the precise lethal dose indices were estimated by the probit-analysis method. Specific single-dose effects of Semelil were monitored for clinical signs of toxicity, including general state of the animals, changes in their behavior, hematological and biochemical parameters for 14 days after drug administration. Then, subacute-chronic toxicity was evaluated in rats treated with Semelil for 3 months. "nIn acute toxicity study, the calculated LD50 for drug diluted at 1:5 was in the range of 44-52 ml/kg. The adverse effects at drug doses close to the LD50 included depressed mood, narcosis, and sleep. No adverse pharmacological or toxicological effects of the drug diluted at 1:10 and administered in the single-dose (25-50 ml/kg body wt.) or chronically (daily doses of 0.07 and 0.21 ml/kg body wt.) were noted. Thus, the animal studies demonstrated a favorable safety profile for the phytotherapeutic Semelil.
Toxicity Studies of Vicotoria Capsules Herbal Medicine
E.A. Gadkariem,R.M. Al-Ashban,L.B. Babikir,H.I. AL-Johar
Research Journal of Pharmacology , 2013, DOI: 10.3923/rjpharm.2011.35.39
Abstract: The acute, sub-acute and chronic toxicity were conducted on Victoria 1500 and 2000 capsules which contains royal jelly, panax ginseng and yohimbe park, all individually have not shown any toxicity on long term administration. Study was planned to assess the safety of the combination by doing toxicity studies. Toxicity studies were done in two animal models by using mice and rats. Acute, sub-acute and chronic toxicity studies were undertaken by treating nimals with a single dose of 15 times the recommended dose for acute, 5 times recommended dose administered orally each other day for 7 days for sub-acute and a daily recommended dose for 6 months for chronic toxicity studies. In acute and sub-acute toxicity studies histopathological results confirmed all vital organs to be normal. The results of the biochemical and hematological studies revealed some changes in some parameters of the treated animals. In sub-acute an increase in RBC and hemoglobin levels was shown. Treatment showed no spermatotoxic activity. During chronic toxicity study, the visceral condition of the animals and histopathological investigations were found to be normal. There were no drastic changes in the biochemical and hematological parameters and the results of the sperm count, sperm motility and sperm viability, respectively were found to be: ≥14x106 mL-1, ≥50 and ≥50%.
Acute toxicity study of Vilocym Premix (herbal growth promoter for Livestock)in Wistar Albino Rat
A.H. Ahmad,D.S.Rekhe,K.Ravikanth,S.Maini
Veterinary World , 2009,
Abstract: An experimental study with the objective of safety evaluation of Vilocym Premix, herbal growth promoter for Livestock (supplied by Ayurvet Ltd., Baddi, India), was done as per standard guidelines of OECD-423 for acute toxicity testing. Vilocym Premix is a scientifically developed combination of herbs that contains herbal ingredients namely Azadirachta indica, Curcuma longa & many more alongwith natural zeolites. The study was done in 3 males and 3 female Wistar Albino rats, which were administered an initial dose of 50 mg/kg body weight followed by dose rates of 300, 500 & 5000 mg/kg body weight of test compound. The animals were observed for signs of convulsions, tremors, circling, depression, excitement and mortality. Body weight was recorded at 0,7th and 14th day and plasma total protein, albumin; AST and ALT were measured after 3rd day of experiment. No abnormal sign of symptoms were observed in any of the animal fed with Vilocym Premix at the dose rate of 50, 300, 500 & 5000 mg/kg. No mortality was observed indicating safety of herbal premix. [Vet. World 2009; 2(3.000): 100-102]
Analysis of toxicity of traditional Chinese herbal medicine and its connotation  [cached]
Zhong Xi Yi Jie He Xue Bao , 2009,
Abstract: : Based on traditional Chinese medicine theory and clinical experience, traditional Chinese herbal drug toxicity has its own special connotation. From the perspective of history and logic, the different comprehension of toxicity between Western medicine and traditional Chinese medicine was discussed after retracing the meaning of "drug toxicity" in traditional Chinese medicine. The authors suggest that it's not feasible to study the Chinese medicine coping mechanically and applying indiscriminately the concept and the research idea about modern drug toxicity since there is different understanding of "drug toxicity" between traditional Chinese medicine and Western medicine. Many control elements are involved in the use of traditional Chinese herbal drugs, and Chinese drug components and actions are complex as compared with Western drugs. More and more drugs with toxicity will be found due to the relativity of drug toxicity. Currently, the study of Chinese drug toxicity should pay more attention to the relation between the toxicity and Chinese drug nature, compatibility and the corresponding disease or syndrome pattern after making definition of Chinese drug toxicity and its connotation.
Toxicity Studies on Devil's Claw Herbal Medicine
K.E. Ibrahim,R.M. Al-Ashban,S.A. El-Sammani
Research Journal of Pharmacology , 2013, DOI: 10.3923/rjpharm.2010.69.73
Abstract: Toxicity studies on Devil's claw capsules were conducted using mice by investigating the possible biochemical, hematological and histopathological changes. Acute, subacute and chronic toxicity studies were undertaken by treating mice with a single dose of (81 mg kg-1) body weight for acute (27 mg kg-1) body weight administered orally each other day for 7 days for subacute and an oral dose of (5.4 mg/kg/day) body weight of the drug daily for 90 days for chronic toxicity studies. Devil s claw treated animals did not show any sign of toxicity and none of the animals died during the observation period. Hematological and biochemical studies showed non significant differences among the animals in the treatment groups and control groups.
Toxicity Study of Korean Ginseng Herbal medicine
E.A. Gadkariem,R.M. Al-Ashban,L.B. Babikir,H.I. Al-Joher
Research Journal of Pharmacology , 2013, DOI: 10.3923/rjpharm.2010.86.90
Abstract: The toxicity studies of Korean ginseng capsules were evaluated in mice through examination of possible biochemical, hematological and histopathological changes. Acute, sub-acute and chronic toxicity studies were undertaken by treating mice with a single dose of 300 mg kg-1 body weight for acute, 100 mg kg-1 body weight administered orally each other day for 7 days for sub-acute and an oral dose of 20 mg kg-1 body weight of the drug daily for 90 days for chronic toxicity studies. In acute, sub-acute and chronic treated mice, biochemical studies revealed a significant decrease in the blood glucose level in all treated animals. Hematological studies revealed an increase in RBC and hemoglobin contents in the treated male group as compared to the control. Absent of signs of visceral toxicity and histopathology result confirmed that all the studied organs were normal compared to the control.
Subacute toxicity and stability of Soshiho-tang, a traditional herbal formula, in Sprague–Dawley rats  [cached]
Shin In Sik,Lee Mee Young,Kim Yongbum,Seo Chang Seob
BMC Complementary and Alternative Medicine , 2012, DOI: 10.1186/1472-6882-12-266
Abstract: Backgroud Soshiho-tang (SST, Xiao-chai-hu-tang in Chinese and Sho-saiko-to in Japanese), an oriental herbal formula, is used for treatment of chronic liver diseases. Although many researchers have studied the pharmacological properties of SST, information about its safety and toxicity is limited. Therefore, we evaluated the potential safety of SST in Sprague–Dawley rats over a period of 4-weeks. Methods The SST was administered once daily by gavage to male and female rats at doses of 0, 500, 1000 and 2000 mg/kg/day for 4 weeks. We measured the body weight, mortality, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross pathological findings, absolute/relative organ weights and histopathology. In addition, we analyzed the component of SST and measured the stability of its component in SST according to study periods using high performance liquid chromatography. Results The SST treatment did not result in any toxicologically significant changes in mortality, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross pathological findings, absolute/relative organ weights and histopathology, except for salivation and reduction in body weight in the 2000 mg/kg/day male group. These findings in the 2000 mg/kg/day male group are considered toxicologically insignificant because they are not accompanied by other pathological findings, including in hematology, serum biochemistry and histopatholgy, and they do not exhibit a dose–response relationship. SST is detected three components including liquiritin, baicalin, and glycyrrhizin. In addition, there were not observed the significant differences among the contents of three components in SST according to storage periods. Conclusion These results indicate that SST may be a safe material. Based on these results, the no-observed-adverse-effect level was more than 2000 mg/kg for both genders.
Acute Human Lethal Toxicity of Agricultural Pesticides: A Prospective Cohort Study  [PDF]
Andrew H. Dawson equal contributor ,Michael Eddleston equal contributor,Lalith Senarathna,Fahim Mohamed,Indika Gawarammana,Steven J. Bowe,Gamini Manuweera,Nicholas A. Buckley
PLOS Medicine , 2010, DOI: 10.1371/journal.pmed.1000357
Abstract: Background Agricultural pesticide poisoning is a major public health problem in the developing world, killing at least 250,000–370,000 people each year. Targeted pesticide restrictions in Sri Lanka over the last 20 years have reduced pesticide deaths by 50% without decreasing agricultural output. However, regulatory decisions have thus far not been based on the human toxicity of formulated agricultural pesticides but on the surrogate of rat toxicity using pure unformulated pesticides. We aimed to determine the relative human toxicity of formulated agricultural pesticides to improve the effectiveness of regulatory policy. Methods and Findings We examined the case fatality of different agricultural pesticides in a prospective cohort of patients presenting with pesticide self-poisoning to two clinical trial centers from April 2002 to November 2008. Identification of the pesticide ingested was based on history or positive identification of the container. A single pesticide was ingested by 9,302 patients. A specific pesticide was identified in 7,461 patients; 1,841 ingested an unknown pesticide. In a subset of 808 patients, the history of ingestion was confirmed by laboratory analysis in 95% of patients. There was a large variation in case fatality between pesticides—from 0% to 42%. This marked variation in lethality was observed for compounds within the same chemical and/or WHO toxicity classification of pesticides and for those used for similar agricultural indications. Conclusion The human data provided toxicity rankings for some pesticides that contrasted strongly with the WHO toxicity classification based on rat toxicity. Basing regulation on human toxicity will make pesticide poisoning less hazardous, preventing hundreds of thousands of deaths globally without compromising agricultural needs. Ongoing monitoring of patterns of use and clinical toxicity for new pesticides is needed to identify highly toxic pesticides in a timely manner. Please see later in the article for the Editors' Summary
Acute toxicity of Brosimum gaudichaudii Trécul. root extract in mice: determination of both approximate and median lethal doses
Cunha, Luiz Carlos da;Paula, José Realino de;Sá, Vinícius Augusto de;Amorim, Marcos Evaristo da Paix?o e;Barros, Isabel Cristina Medeiros;Brito, Luiz Augusto Batista;Silveira, Nusa da;
Revista Brasileira de Farmacognosia , 2008, DOI: 10.1590/S0102-695X2008000400006
Abstract: the brosimum gaudichaudii trécul. (bg) moraceae, with a high frequency in regions of the brazilian cerrado (shrubland) and popularly known as "mamacadela", holds photosensitizing furocoumarins. the bg's main therapeutic use is the treatment of vitiligo, a skin depigmentation disease that takes hold of approximately 1-2 % of the world population. there is one product on the marketplace (viticromin?), for which there is no scientific research available about its experimental toxicity, in spite of its proven clinical efficacy. therefore, the development of acute pre-clinical toxicity trials has been proposed (approximate lethal dose, ald, and median lethal dose, ld50) of the bg root exsudate in laboratory animals. male, albino mice weighing between 25 and 30 g, in good sanitation conditions have been used. the mice received water and food ad libitum. the bg powder was mixed in 0.9% saline solution and 0.5% cremophor and was administered po and ip. the ld50 was obtained through the lichtfield and wilcoxon (1949) method. a public domain software was used for the calculations. ten mice/dose were used - 6 groups for each administration via, including the control group - and the number of deaths within up to 14 days was considered; the control group received an emulsion made up by 0.9 saline solution and 0.5% cremophor. before establishing the ld50 and aiming at reducing the number of animals used, the dla was determined when 1 animal per dose was used (the next dose always 50% higher than the previous dose), until identifying the dose that led to the death of 1 animal. thus, the dla po was 3750 mg/kg and the dla ip, 2920 mg/kg. the ld50 po was 3517.54 mg/kg and the ld50 ip was 2871.76 mg/kg. the product was considered as of being of low toxicity, taking into account only the single dose acute toxicity.
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