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EC number: 232-589-7 | CAS number: 9001-22-3
The present study was undertaken in order to evaluate the toxicity of beta-glucosidase batch DCN 0005 in the rat, while incorporated in the diet for four weeks. Three groups each of twenty rats (10 males and 10 females) received beta-glucosidase batch DCN 0005. The dose levels were 0.25, 1 and 4 % (w/w) in the diet. A control group similarly constituted was given the standard diet only. Throughout the study clinical signs of reaction to the treatment were recorded. Body weights and food consumption were measured weekly. The rats were subjected to ophthalmoscopic examination. Before termination, blood samples were taken from all animals for hematology and blood chemistry. At the end of the treatment period all rats were killed and subject to detailed pathology. A number of organs were weighed. Specimens of a list of organs and tissues were fixed. Specified organs and tissues were examined microscopically.
Throughout the dosing period there were no clinical symptoms of adverse reaction to the treatment. Throughout the dosing period, the food consumption in the high dose group (4% in the diet) was higher for both sexes compared to the controls, but only statistically significantly higher for females in weeks 2 and 3. Throughout the dosing period, the food conversion ratio of the treated groups was comparable to that of the control group. The mean body weight and body weight gain in the dosing period of the high dose group was slightly, but not statistically significantly increased for both sexes. The eyes of the rats were not affected by the treatment. Hematological examination showed a decrease of hemoglobin in female rats in the high dose group. Total protein was lower in male rats of the low and high dose groups, and serum carbamide had decreased in male rats of the intermediate and high dose groups. ASAT was lower in female rats of the intermediate and high dose groups. Gamma globulin had increased in female rats of the high dose group. As all ASAT and serum carbamide values are within range of historical data and as an adverse effect is expected to be followed by an increase, the decreased ASAT and serum carbamide values are considered to be of no toxicological importance. The deviations in total protein and gammaglobulin values are not considered to be toxic effects of the treatment. The absolute and relative organ weights of the treated groups were comparable to those of the control group. At the gross pathological and histopathological examination no treatment-related findings were found.
It is concluded that no effect level of beta-glucosidase batch DCN 0005 dosed to rats for 4 weeks up to a level of 0.25% in the diet was without any effect. At a dosage of 1 and 4% in the diet only minor lowerings in serum carbamide and ASAT were registered, and therefore the high dosage (4%) can be considered as the no ill effect level.
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