Objective: The present study was undertaken to evaluate the subchronic oral toxicity of sodium dehydroacetate (DHA-Na) and to determine the point of departure (POD), which is a critical factor in the establishment of an acceptable dietary intake. Methods: DHA-Na was administered once daily by gavage to Sprague-Dawley rats at dose levels of 0.0, 31.0, 62.0, and 124.0 mg/kg BW per day for 90 days, followed by a recovery period of 4 weeks in the control and 124.0 mg/kg BW per day groups. The outcome parameters were mortality, clinical observations, body weights, food consumption, hematology and clinical biochemistry, endocrine hormone levels, and ophthalmic, urinary, and histopathologic indicators. The benchmark dose (BMD) approach was applied to estimate the POD. Results: Significant decreases were found in the 62.0 and 124.0 mg/kg BW groups in terms of the body weight and food utilization rate, whereas a significant increase was found in the thyroid stimulating hormone levels of the 124.0 mg/kg BW group. Importantly, the 95% lower confidence limit on the BMD of 51.7 mg/kg BW was modeled for a reduction in body weight. Conclusion The repeated-dose study indicated the slight systemic toxicity of DHA-Na at certain levels (62.0 and 124.0 mg/kg BW) after a 90-day oral exposure.
Animals ; Body Weight ; Organ Size ; Pyrones ; Rats ; Rats, Sprague-Dawley

The purpose of this paper is to provide reference data related to the body weight, food & water consumptions, urinalysis, hematology and serum biochemistry parameters and absolute & relative organ weights obtained from control Sprague-Dawley rats, used in the 4-week and 13-week repeated-dose toxicity studies conducted in our laboratory between 2005 and 2008. The mean, standard deviation, minimum and maximum range values for hematology and serum biochemistry parameters, data of absolute & relative organ weights, and the difference between sexes and study duration of week 4 versus 13 week are presented. The studies were conducted according to "the standards of Toxicity Study for Medicinal Products" (2005) and The KFDA Notification No. 2000-63 'Good Laboratory Practice (GLP)' (2000) issued by KFDA. These data could be used as reference material of Sprague-Dawley rats by conducting the studies to evaluate the toxicological profile of pre-clinical toxicity studies.
Biochemistry ; Body Weight ; Hematology ; Organ Size ; Rats, Sprague-Dawley ; Urinalysis ; Water

PURPOSE: The aim of this study was to establish an anthropometric reference of the stomach for gastric cancer surgery and a modeling formula to predict stomach length. MATERIALS AND METHODS: Data were retrieved for 851 patients who underwent total gastrectomy at the Seoul National University Hospital between 2008 and 2013. Clinicopathological data and measurements from a formalin-fixed specimen were reviewed. The lengths (cm) of the greater curvature (GC) and lesser curvature (LC) were measured. Anthropometric data of the stomach were compared according to age, body weight, height (cm), and body mass index. To predict stomach length, two multiple regression analyses were performed. RESULTS: The mean lengths of the GC and LC were 22.2±3.1 cm and 16.3±2.6 cm, respectively. The men’s GC length was significantly greater than the women’s (22.4±3.1 cm vs. 21.2±2.9 cm, P=0.003). Patients aged >70 years showed significantly longer LC than those aged <50 years (16.9±2.9 cm vs. 15.9±2.4 cm, P=0.002). Patients with body weights >70 kg showed significantly longer GC than those with body weights <55 kg (23.0±2.9 cm vs. 21.4±3.2cm, P<0.001). In the predicted models, 4.11% of the GC was accounted for by age and weight; and 4.94% of the LC, by age, sex, height, and weight. CONCLUSIONS: Sex, age, height, and body weight were associated with the length of the LC, while sex and body weight were the only factors that were associated with the length of the GC. However, the prediction model was not sufficiently strong.
Body Mass Index ; Body Weight ; Gastrectomy ; Humans ; Organ Size ; Seoul ; Stomach Neoplasms ; Stomach*

This study investigated the protective effects of diallyl disulfide (DADS) against cyclophosphamide (CP)-induced testicular toxicity in male rats. DADS was gavaged to rats once daily for 3 days at 100 mg/kg/day. One hour after the final DADS treatment, the rats were given a single intraperitoneal dose of 150 mg/kg CP. All rats were killed and necropsied on day 56 after CP treatment. Parameters of testicular toxicity included reproductive organ weight, testicular sperm head count, epididymal sperm motility and morphology, epididymal index, and histopathologic examinations. The CP treatment caused a decrease in body weight, testicular sperm head count, epididymal sperm motility, and epididymal index. The histopathological examination revealed various morphological alterations, characterized by degeneration of spermatogonia/spermatocytes, vacuolization, and decreased number of spermatids/spermatocytes in the testis, and cell debris and mild oligospermia in the ductus epididymis. In contrast, DADS pretreatment effectively attenuated the testicular toxicity caused by CP, including decreased sperm head count, epididymal sperm motility, and epididymal index and increased histopathological alterations in the testis and epididymis. These results indicate that DADS attenuates testicular toxicity induced by CP in rats.
Animals ; Body Weight ; Cyclophosphamide ; Epididymis ; Humans ; Male ; Oligospermia ; Organ Size ; Rats* ; Sperm Head ; Sperm Motility ; Testis

This study was carried out to investigate the effects of rice germ oil supplement on the lipid metabolism of insulin-dependent diabetic mice. Streptozotocin-induced diabetic mice were fed three kinds of experimental diets with 20% lipid, composed of 20% lard (L) : 10% lard and 10% rice germ oil (LRGO) ; and 20% rice germ oil (RBO), respectively, for 7 weeks. Diet intake, body weight, organ weight and lipid levels of serum, liver and feces were measured. There was no significant difference in diet intake, body weight and organ weight among the experimental groups. But the concentrations of serum triglyceride in the LRGO and RGO groups, and of serum total cholesterol in the RGO group, were significantly lower than those of the L group fed the 20% lard diet. The levels of hepatic total lipid of the RGO group, and of hepatic total cholesterol of the LRGO and RGO groups were significantly lower than those of the L group. The contents of total lipid and total cholesterol excreted in the feces of the LRGO and RGO groups were higher than those of the L group. These results suggest that rice germ oil can reduce the levels of total cholesterol concentrations in the serum or livers of insulin-dependent diabetic mice, and that the hypolipidemic effect of rice germ oil may be due to increasing fecal lipid excretion and decreasing lipid absorptivity.
Animals ; Body Weight ; Cholesterol ; Diet ; Feces ; Lipid Metabolism ; Liver ; Mice* ; Organ Size ; Triglycerides

This study was carried out to investigate the supplementary effects of gamma-oryzanol extracted from rice bran on lipid metabolism in diabetic mice. We supplied 2 kinds of experimental diets (CO without and GO with 0.2% gamma-oryzanol) to diabetic mice for 8 weeks. Diet intake, body weight, organ weight, contents of serum and hepatic lipid profiles, and fecal lipid levels were measured. Though there was no significant difference in diet intake, body weight change and organ weight between experimental groups, the concentration of serum total cholesterol and hepatic total lipid, total cholesterol and HMG-CoA reductase activity was significantly lower in GO group treated with 0.2% gamma-oryzanol of diet than CO group after supplementary period of experimental diets. And total lipid, triglyceride, total cholesterol, and bile acid levels excreted to feces were significantly higher in GO group than CO group. These results suggest that gamma-oryzanol decrease the serum and hepatic lipid levels by lowing HMG-CoA reductase activity or increasing the contents of fecal lipid in diabetic KK mice.
Animals ; Bile ; Body Weight ; Body Weight Changes ; Cholesterol ; Diet ; Feces ; Lipid Metabolism* ; Mice* ; Organ Size ; Oxidoreductases ; Triglycerides

The purpose of this study was to investigate the effects of alpha-lipoic acid on body weight and lipid profiles in Sprague-Dawley rats fed a high fat diet (HFD). After 4 weeks of feeding, rats on the HFD were divided into three groups by randomized block design; the first group received the high-fat-diet (n = 10), and the second group received the HFD administered with 0.25% alpha-lipoic acid (0.25LA), and the third group received the high-fat diet with 0.5% alpha-lipoic acid (0.5LA). The high fat diet with alpha-lipoic acid supplemented groups had significantly inhibited body weight gain, compared to that in the HFD group (P < 0.05). Organ weights of rats were also significantly reduced in liver, kidney, spleen, and visible fat tissues in rats supplemented with alpha-lipoic acid (P < 0.05). Significant differences in plasma lipid profiles, such as total lipids, total cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein, were observed between the HFD and 0.5LA groups. The atherogenic index and the plasma high density lipoprotein-cholesterol/total cholesterol ratio improved significantly with alpha-lipoic acid supplementation in a dose-dependent manner (P < 0.05). Total hepatic cholesterol and total lipid concentration decreased significantly in high fat fed rats supplemented with alpha-lipoic acid in a dose-dependent manner (P < 0.05), whereas liver triglyceride content was not affected. In conclusion, alpha-lipoic acid supplementation had a positive effect on weight gain and plasma and liver lipid profiles in rats.
Animals ; Body Weight ; Cholesterol ; Diet, High-Fat ; Kidney ; Lipoproteins ; Liver ; Organ Size ; Plasma ; Rats ; Rats, Sprague-Dawley ; Spleen ; Thioctic Acid ; Triglycerides ; Weight Gain ; Weight Loss

UG0712 is a new ginsenoside extract processed from ginseng leaves. A subchronic toxicity study of UG0712 was conducted in male and female SD rats. Rats were treated with UG0712 at doses of 100, 400 and 1,600 mg/kg/day for 13 weeks, and observed followed by 4-week recovery period at a highest dose. No-treatment-related effects were observed regarding the mortality, ophthalmic examination, urinalysis and histopathology. Although the changes in clinical sign, body weight, organ weight, hematology, and serum biochemistry were observed, they were temporal and pharmacological effects. Based on the present experiment conditions, the no observed adverse effect level was considered to be more than 1,600 mg/kg/day in both sexes of rats.
Animals ; Biochemistry ; Body Weight ; Female ; Hematology ; Humans ; Male ; Mortality ; No-Observed-Adverse-Effect Level ; Organ Size ; Panax* ; Rats* ; Urinalysis

Reference ranges of standard experimental parameters are useful for comparisons in toxicology. The aim of this study was to collect data from 13-week repeated toxicity studies in Crl:CD (SD) rats, a strain widely used for toxicity and efficacy research, for establishing domestic reference values. Data on body weight, food consumption; urinalysis, hematological, and blood biochemical parameters; and organ weights were collected from 11 toxicity studies in 220 Crl:CD (SD) rats (110 males and 110 females). The studies had been performed at a single testing facility over the last 5 years and involved animals sourced from a single breeder. The findings were collated as means, standard deviations, percentages, and ranges. Urine volume, uterus weight, eosinophil, and basophil counts, and triglyceride, total bilirubin, and gamma-glutamyl transpeptidase levels showed standard deviations of 30% or more. These historical control data would help to interpret the effects of test substances in routine toxicity and efficacy studies.
Animals ; Basophils ; Bilirubin ; Body Weight ; Eosinophils ; gamma-Glutamyltransferase ; Humans ; Male ; Organ Size ; Rats ; Reference Values ; Sprains and Strains ; Toxicology ; Urinalysis ; Uterus

The present study was carried out to examine the toxicity and target organs of oral cholera vaccine (OCV) after repeated oral administration in Sprague-Dawley rats for 6 weeks (3 administrations, once every 2 weeks). OCV is an inactivated oral cholera vaccine that contains Vibrio cholerae and confers protection against cholera caused by V. cholera serogroups O1 (Inaba and Ogawa serotypes) and O139 (strain 4260B). The animals were orally administered either OCV placebo (negative control) or OCV at a dose equivalent to 240 times the anticipated human dose. Throughout the administration period, no significant change was detected in clinical signs, body weight, food or water consumption, urinalysis results, hematological and clinical biochemistry test results, organ weights, necropsy, or histopathological examination results. Minor changes were found in hematological and clinical biochemistry tests; however, these changes were within normal ranges. The above results suggest that oral administration of OCV in rats did not induce any toxicologically meaningful changes, and the target organs could not be determined. This study was conducted in accordance with the guidelines established by Good Laboratory Practice (2009-183, KFDA, December 22, 2009) and the OECD Principles of Good Laboratory Practice (1997).
Administration, Oral ; Animals ; Biochemistry ; Body Weight ; Cholera ; Drinking ; Humans ; Organ Size ; Rats ; Rats, Sprague-Dawley ; Reference Values ; Urinalysis ; Vibrio cholerae