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Food and active ingredient intake
The 50 male and 50 female rats (100 animals in the control group) received test substance administered for 2 years in the following concentrations with the feed: 0 (control), 100, 1000, 10000 ppm.
Appearance, behavior, feed intake, body weights and mortality were not influenced in male and female animals of doses up to and including 10,000 ppm. The animals in the dose groups to 10,000 ppm did not show during the entire experimental period any treatment-related symptoms. The growth of the rats was not affected until the dose of 10,000 ppm. The haematological investigations performed during and at the end of the test showed no dose of injuries. The significantly lower reticulocyte numbers in the blood of the male rats dosed at 1000 and 10,000 ppm after 24 months was not considered as compound-related toxic effect. The studies of male animals to the remaining time points and all investigations in the female animals showed no evidence for corresponding findings. The clinical chemical analysis, sections and histopathological examinations revealed no evidence for treatment-related damage to the liver. Urinalysis, urea and creatinine concentrations in serum as well as macroscopic and histopathological organ findings did not indicate any influence on the kidneys because the incidence is low (<10%) and the significantly increased kidney weights in male and female rats in the 10,000 ppm dose group was not regarded as an expression of injury. Blood sugar and cholesterol levels were not substance-related altered.
The difference in GOT and GPT activity in male animals after 10,000 ppm and GPT activity in the females after 1000 and 10,000 pm are not considered signs of liver damage, because all values are in the range of physiological fluctuation band and the investigation into later trial dates did not revealed any findings. The sections of dead and killed rats did not show reference to a specific ending damage that could be caused by the substance. Histopathological examination of the brain, pituitary, aorta, eyes, intestine (duodenum, jejunum, colon), femur, bladder, heart, testis, lung, lymph nodes, stomach, spleen, Nebenhcden, adrenal glands, sciatic nerve, esophagus, parotid gland, ovaries , pancreas, prostate, seminal vesicles, thyroid, skeletal muscle, sternum, thymus, trachea and uterus showed the usual age-related spontaneous alterations. Changes that might be associated with the administration of the substance, not revealed.
From nature, localization, abundance and time of occurrence of the identified benign and malignant tumors was no evidence of a carcinogenic effect of the test item. Thus, the doses of 1000 ppm were well tolerated.
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