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The use of smokeless tobacco (ST) is growing rapidly and globally.The consumption of ST is associated with an increased risk for developing chronic diseases, such as diabetes, hypercholesterolemia, and myocardial infarction, and has led to many public health problems.It is very important to access the toxicity of ST.This experiment presents data from 184-day toxicology studies in Sprague-Dawley (SD) rats designed to characterize the chronic effects of a smokeless tobacco extract (STE).The control group and treatment groups were matched for a range of nicotine levels.Animals were given STE by oral gavage with doses of 3.75 (low-dose), 7.50 (mid-dose) and 15.00 (high-dose) mg nicotine/kg body weight/day for 184 days, followed by 30 days for recovery.Variables evaluated included body weights, feed consumption, clinical observations, clinical and anatomic pathology (including organ weights), and histopathology.Decreased body weights and organ weights (heart, liver and kidney) were found in animals in the mid-dose and high-dose groups.STE also showed moderate and reversible toxicity in esophagus, stomach, liver, kidney and lung.