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In Thailand, Siamese crocodile (Crocodylus siamensis) is an economic animal. Dried form of Siamese crocodile bile was used as traditional medicine and exported for a long time. The purpose of the study is to provide information on the possible major toxic effects, indicate target organs and the possibility of accumulation and estimate of a no-observed-adverse-effect level (NOAEL) of Siamese crocodile bile in Sprague Dawley rats in compliance with OECD/OCDE, OECD Guidelines for the testing of chemicals 452, Chronic Toxicity Studies. Chronic oral toxicity was studied by daily administration at dose levels of 2.5, 25 and 250 mg/kg body weight of Siamese crocodile bile for 365 days. The Siamese crocodile bile was not shown treatment related mortality and clinical signs of toxicity in Sprague Dawley rats. The body weights of all animals were continued to gain throughout the study. The treatment-relates changes were not observed in necropsy findings and histopathological finding in both sexes based on a result, under present experimental condition. The significantly different results of hematological tests and clinical biochemistry tests were not considered as a treatment-related toxicity effect. These results were recovered in recovery period (28 days). The NOAEL of Siamese crocodile bile in chronic oral toxicity studies were considered to be 250 mg/kg body weight per day for Sprague Dawley rats.
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