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EC number: 201-906-0 | CAS number: 89-41-8
Groups of 5 male and 5 female Wlstar rats received Nitroanissäure TTR by oral gavage at dose levels of 0, 40, 200 or 1000 mg/kg body weight per day for 28 days and were necropsied at day 29. Behaviour and state of health were observed dally in all groups. Body weights and food consumption were recorded twice weekly, and water consulmption once weekly. Hematologlcal examinations and clinical chemistry were carried out at the termination of the study. Urine analysis was also performed at the end of the study. During necropsy the animals were examined for macroscopically visible abnormalities, the main organs weighed and the organ to body weight ratios calculated. The major organs and tissues were processed for hi stopathological examination and checked for microscopically visible changes. Body weights, hematologlcal and clinical chemistry data, urine data (pH value, specific weight), absolute and relative organ weights were analysed with the aid of a statistical program to show differences compared with the controls.
Increased salivation was observed sporadically in the highest dose group starting from day five up to the end of the study. Behaviour and general health condition of the other animals remained normal throughout the study . Body weight gain and food consumption remained unaffected by the treatment during the whole study. Water consumption was increased from day twelve up to end of study in the highest dose group. pH-value of the urine was decreased in both sexes of the high dose group and in males of the intermediate dose group, probably due to the acidity of the test compound. Hematological examinations showed no compound related effect. Clinical chemistry investigations revealed increased aspartate aminotransferase (ASAT/ GOT) values in females and increased alanine aminotransferase (ALAT/GPT) values in both sexes of the 1000 mg/ kg body weight group. Relative liver weights were increased in males of the 200 mg/kg body weight group and in both sexes of the 1000 mg/kg body weight group, showing a dose-dependency in males. No compound-related macroscopically visible changes were found at necropsy. The histopathological examinations revealed evidence for slight liver damge in the animals of the high dose group, consisting of hepatocellular hypertrophy, increased mitotic indices and increased incidences of stellate cell proliferation.
In conclusion repeated application of 1000 mg Nitroanissäure TTR / kg body weight caused slight liver damage, reflected in elevation of ASAT- and ALAT-values and in histopathological changes . These findings were accompanied with increased liver to body weight ratios. Additionally increased salivation and Increased water consumption was observed. After repeated treatment with 200 mg Nitroanissäure TTR / kg body welght, increased liver to body weight ratios were still observed in males. However, these effects were not accompanied by any change in clinical chemistry, which might be indicative for liver damage. Furthermore, histopathological examinations revealed no changes of liver structure. No compound-related effects occurred in females. Nitroanissäure TTR caused no detectable effects at the dose of 40 mg/kg body weight in male and female Wistar rats when administered 28 times during 29 days. With regard to the present study the "no observed effect level" is 40 mg/kg body weight per day in males and 200 mg/kg body weight per day in females. The the "no observed adverse effect level" is considered to be 200 mg/kg body weight for both sexes.
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