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EC number: 620-097-9 | CAS number: 54299-17-1
Repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using male and female Tif:RAIf, SPF strain rats. The test chemical was mixed with feed at dose levels of 0, 500, 5000, or 50,000 ppm (19, 190, and 2300 mg/kg/day in males and 21, 226, and 2620 mg/kg/day in females). During the chronic study period, the test animals were observed for mortality, clinical signs, changes in body weight, food and water consumption, urinanalysis, hematology and clinical chemistry parameters.The test substance did not affect appearance and behavior and was similar in all groups of test. Mortality was unaffected by the test chemical. 10% decrease in body weight were observed in 2300 mg/Kg/day dose group in males and 2620 mg/Kg/day dose group in females. Increased food consumption was observed in 2300 mg/Kg/day dose group in males and 2620 mg/Kg/day dose group in females. Water consumption showed a dose-related increase in the two highest dose groups (190 and 2300 mg/Kg/day and 226 and 2620 mg/Kg/day) and was associated with corresponding urine output. Hematology and chemistry parameters did not show treatment-related effects. An increase in urine output was observed in the two highest dose groups (190 and 2300 mg/Kg/day and 226 and 2620 mg/Kg/day). In the high dose group, significantly increased organ-to-body weight ratios for liver (p<0.01) were seen in males (2300 mg/Kg/day), and in males and females for kidney (p<0.05) (2300 mg/Kg/day for males and 2620 mg/Kg/day for females). The test substance did not adversely affect other parameters. Macroscopic examinations at necropsy revealed an increased incidence of pancreateic nodules and masses in the 2300 mg/kg/day males and 2620 mg/Kg/day females. Histopathology revealed statistically significant test article-related neoplastic effects to the pancreas of high dose males and females. Nodular hyperplasia of the exocrine pancreas was observed in 51 of 78 (p<0.001) high dose (2300 mg/Kg/day) males versus 6 of 78 control group males, and in 10 of 79 (p<0.05) high dose (2620 mg/Kg/day) females versus 1 of 78 control group females. Other non-neoplastic lesions seen in the dosed animals were not related to treatment with FWA-5. Exocrine pancreas adenoma, a benign tumor, was observed in males of the 5,000 and 50,000 ppm dose groups at an incidence of 2/79 and 18/78 (p<0.05), respectively, compared with 0/78 in control. Pancreatic carcinoma, a malignant tumor, was also observed in 2/78 high-dose males and although not statistically significantly increased, the rarity of this tumor and the treatment-related finding of adenomas in this group suggest the carcinomas could be related to the treatment. In females, adenomas in exocrine pancreas occurred only in the high dose (2620 mg/Kg/day) group (2/79) and were within the historical control range; carcinomas were not observed in any of the females. Based on the observations made, the No observed adverse effect level (NOAEL) for the test chemical is considered to be 190 mg/kg/day for males and 226 mg/kg/day for females when they were exposed to the test chemical during the chronic exposure period.
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