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EC number: 201-064-4 | CAS number: 77-86-1
The purpose of this study was to obtain information on the toxicity of 2-aminopropane-1,3-diol when administered daily for 90 days by oral gavage to the rat at 3 dose levels, based on previous data available, including the results of a 14-day DRF study by oral gavage in rats. Male and female Wistar rats were treated once daily for 90 days by oral gavage administration. The dose levels used were 0, 62.5, 250 and 1000 mg/kg bw. Control animals were treated with the vehicle (distilled water).
There was no death and no test item related clinical signs during the study. There were no findings in the animal behaviour, general physical condition, in the reactions to different type of stimuli in the control or treated groups. There were no test item related effects observed on the animal body weights or body weight gain and food consumption values during the study. All examined animals were found to be normal during the ophthalmoscopy examinations. Haematology parameters evaluated at the completion of the 90-day treatment period showed adverse effects or findings that were test item related. In high dose animals in both sexes the results indicated test item related slight anaemia, with statistically significantly lower RBC, HGB, Haematocrit. Also the reticulocytes percentage was increased statistically significantly in the high dose group (in high dose females without statistical significance), suggesting a compensated anaemia in the high dose group. There was a slight test item related effect with apparently increased serum calcium at the high dose in both sexes. There were no adverse test item related effects on the urinary parameters evaluated at the completion of the treatment period. There were no adverse or test item related observations in the animal oestrus cycle
evaluated prior to necropsy and the animals showed the normal distribution of the oestrus phases. Test item-related dark/red multifocal discolorations of the glandular stomach mucosa were visualized at necropsy in 7/10 males dosed at 1000 mg/kg bw/day. These changes correlated with erosions/ulcers microscopically observed. These observations were compatible with the slight, compensated anaemia which is common in the event of stomach ulcers. There were test item related higher liver, epididymis and kidney organ weights at the high dose in both sexes. Microscopic evaluation identified minor test item-related findings in the stomach, liver, kidney and epididymis in animals at 1000 mg/kg bw/day. No test item-related changes were noted in these organs examined from the animals dosed at 250 mg/kg bw/day. Minimal to slight erosion/ulcer of the stomach was present at the high dose level, these lesions were considered as local irritant adverse effects. Minimal to slight hepatocellular hypertrophy in the high dose was considered to be an adaptive non-adverse effect. Minimal to slight tubular vacuolation was seen in less than half the animals at the high dose groups; this change was considered to be non-adverse, since it was not associated with any degenerative/necrotic or inflammatory findings. Minimal to slight vacuolation of the epithelial cells in the caput (proximal) were observed without any accompanied degeneration/necrosis or inflammation, there was no evidence of abnormal sperms by light microscopy, therefore, the vacuolation was considered to be non-adverse.
In conclusion, under the conditions of this study, test item related adverse effects were observed after 90 days of treatment in the high dose group; effects included signs of anaemia and erosion/ulcer in the stomach. There were test item related higher liver,
epididymis and kidney organ weights at the high dose in both sexes. There were no adverse effects of test item in the mid and low dose groups of either sex. The NOAEL (no observed adverse effect level) was considered to be 250 mg/kg bw/day.
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