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EC number: 200-578-6 | CAS number: 64-17-5
The purpose of study was to evaluate three doses of compound with ethanol in water used as a control group in addition to water alone. Although some effects of ethanol administration were reported statistical comparison between the ethanol treatment group and the water treatment group was not reported.
Gonadal tissues were examined for both gross and histopathology and no treatment-related effects were detected.
Note that in humans, the kidney is not normally a target organ for toxicity.
The purpose of this study was to investigate the toxicity of USP Ethanol -190 proof-100% and a mixture containing 16.25% USP ethanol in Sprague-Dawley rats when administered by oral gavage. A single dose of 4ml/kg of pure ethanol was used and three doses of the diluted ethanol solution (5, 10, 20ml/kg). Individual body weights and feed consumptions were obtained weekly and animals were observed twice daily for clinical signs of toxicity. All animals were examined by slit lamp biomicroscopy and ophthalmoscopy prior to the initiation of treatment and again prior to necropsy. Hematology and clinical chemistry analyses were performed on blood samples taken on week 7 on 10 rats (5 per sex per group) from the water control, 100% USP ethanol control and high dose group of the mixture containing 16.25% ethanol and on week 14 on 20 rats (10 per sex per group) from all groups. Urine samples were collected 1 day prior to necropsy for all rats scheduled for the week 7 sacrifice and from 20 rats (10 per sex per group) on week 14.
Detailed necropsies were performed on all rats in the study. Five rats per sex per group randomly chosen from the water control and the ethanol control were sacrificed at week 7. All surviving rats were sacrificed on day 94. The following organs were weighed and organ to body weight ratios were determined on 10 rats per sex per group from all groups: lungs, heart, liver, kidneys, spleen, adrenals, thyroid, pituitary, testes, brain, and ovaries with oviduct. Histopathological evaluations were performed on 10 rats per sex per group from the water control and ethanol control groups.
No statistically significant differences were noted in the weekly body weights and body weight gains between the ethanol mixture treated groups versus the two control groups. Decreased food consumption was observed in the high-dose ethanol mixture males versus the control males during the first half of the study however, these differences between the high-dose ethanol mixture treated group versus the control group were not observed in the second half of the study. No ocular changes were seen in the study. Increased segmented neutrophil counts were noted in the high dose ethanol mixture female group at week 7 however, no treatment-related changes were noted in the hematology data at final sacrifice on week 14.
Oral treatment of rats for 14 weeks with 5, 10, 20 ml/kg of mixture containing 16.25% ethanol resulted in dose-related increases in liver to body weight ratios of female rats at final sacrifice. Both mid and high dose females had significantly higher relative liver weights. However, the absolute liver weights of the high dose ethanol treated group, while significantly increased relative to the 100% ethanol treated group, was not different from the water control group. In addition, increased liver weights were observed in the male rats. Significant increases in kidney weights were observed in the mid and high dose groups treated with 10 or 20 ml/kg of mixture containing 16.25% ethanol. Adrenal weights of female rats were increased in both 100% USP ethanol and the 16.25% ethanol mixture control groups. Ovary weights were significant increased at week 7, but were not significantly different from controls by terminal sacrifice.
Histopathologic lesions observed in this study were mainly considered common for to the findings of the laboratory for the age and species of rats in the study with exception of increased minimal focal to multifocal renal tubular epithelial hyperplasia in the high dose 20 ml/kg mixture containing 16.25% ethanol and the 100% USP ethanol control treated rats versus the water treated controls. This was considered related to ethanol treatment. It should be noted however that renal tubular epithelial hyperplasia is a common incidental finding in laboratory rats and it is uncertain whether the higher incidence of this lesion in the ethanol dosed rats compared with water controls is due to a random variation or to ethanol. All other lesions in the pulmonary alveoli, glossitis, stomach, pancreas and pericardium were interpreted to be directly or indirectly associated with the method of treatment (gavage) rather than the test substance. Gonadal tissues were examined for both gross pathology and histopathology and no treatment-related effects were detected.
The NOAEL for the study is determined at 10 ml/Kg for a mixture containing 16.25% ethanol for increased kidney weight and renal tubular epithelial hyperplasia in males (equivalent to 1.73g/kg). The LOAEL for this study is determined at 4 ml/kg for 100% USP ethanol (3.16g/kg) for increased kidney weight and renal tubular epithelial hyperplasia in males. Both doses are well above the maximum of 1g/kg widely used as a test ceiling for the maximum dose.
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