• Toxicological Research
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• v.14 no.3
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• pp.411-414
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• 1998

The acute toxicity of DWP-311 was investigated in Sprague-Dawley rats. DWP-311 was subcutaneously administratered at dose levels of 595, 1,070, 1,930, 3,470, and 6,250mg/kg. In this study, we daily examined numbers of deaths, clinical signs, body weights, and pathological examinations for 7 days after administration of DWP-311. The results indicate that DWP-311 did not show any toxic effect in rats and the oral $LD_{50}$ value was over 6,250mg/kg in Sprague-Dawley rats.

• Herbal Formula Science
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• v.28 no.2
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• pp.169-177
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• 2020

Objectives : This experiment was designed to assess the single oral toxicity of Ethanol Extract Inulae Flos (IF) ethanol extracts. IF is one of the important herbs to remove phlegmy which is the viscous turbid pathological product that can accumulate in the body, causing a variety of diseases. Nevertheless, there has been a lack of research on the pharmacology toxicity of IF. Methods : In this study, IF was orally administered to 5 weeks ICR mice as an oral dose of 2,000 or 3,000 or 5,000 mg/kg. The condition of the mice was observed for 14 days and their weights were measured every two days. Results : None of the mice died for 14 days. The abnormal clinical symptoms and anatomical signs of toxicity were not found in any treatment groups. The gain of net body weight was observed. There was also no significant difference in the organ weight. The serum biochemistry and hematological analysis showed a decrease in BUN, red blood cells, white blood cells and platelets although within the normal ranges. Conclusions : These results suggest that the 50% lethal dose of IF is more than 5,000 mg/kg. This could be thought that IF is a safe drug without acute toxicity and side effects. However, IF showed some weight loss and change in blood test, so it will need to be careful when using it for high doses.

• Toxicological Research
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• v.35 no.2
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• pp.119-129
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• 2019

As the use of cosmetics has greatly increased in a daily life, safety issues with cosmetic ingredients have drawn an attention. Drometrizole [2-(2'-hydroxy-5'-methylphenyl)benzotriazole] is categorized as a sunscreen ingredient and is used in cosmetics and non-cosmetics as a UV light absorber. No significant toxicity has been observed in acute oral, inhalation, or dermal toxicity studies. In a 13-week oral toxicity study in beagle dogs, No observed adverse effect level (NOAEL) was determined as 31.75 mg/kg bw/day in males and 34.6 mg/kg bw/day in females, based on increased serum alanine aminotransferase activity. Although drometrizole was negative for skin sensitization in two Magnusson-Kligman maximization tests in guinea pigs, there were two case reports of consumers presenting with allergic contact dermatitis. Drometrizole showed no teratogenicity in reproductive and developmental toxicity studies in which rats and mice were treated for 6 to 15 days of the gestation period. Ames tests showed that drometrizole was not mutagenic. A long-term carcinogenicity study using mice and rats showed no significant carcinogenic effect. A nail product containing 0.03% drometrizole was nonirritating, non-sensitizing and non-photosensitizing in a test with 147 human subjects. For risk assessment, the NOAEL chosen was 31.75 mg/kg bw/day in a 13-week oral toxicity study. Systemic exposure dosages were 0.27228 mg/kg bw/day and 1.90598 mg/kg bw/day for 1% and 7% drometrizole in cosmetics, respectively. Risk characterization studies demonstrated that when cosmetic products contain 1.0% of drometrizole, the margin of safety was greater than 100. Based on the risk assessment data, the MFDS revised the regulatory concentration of drometrizole from 7% to 1% in 2015. Under current regulation, drometrizole is considered to be safe for use in cosmetics. If new toxicological data are obtained in the future, the risk assessment should be carried out to update the appropriate guidelines.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.2
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• pp.242-245
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• 2011

Socheongryong-tang has been used for the treatment of inflammatory allergic diseases such as allergic rhinitis and bronchial asthma in Asian countries. This study was conducted to investigate the safety of Socheongryong-tang in rats. The safety of this tang on acute toxicity was evaluated by single dose toxicity study. Rats were orally administrated in a single dose of 0 and 2000 mg/kg (limited dose) Socheongryong-tang. There were 7 rats in each groups. All animals were sacrificed after 14 days of treatment. After single administration, mortality, clinlcal signs, body weight changes and gross pathological findings were observed for 14 days. Three parameters were tested: organ weight measurement, clinical chemistry, and hematology. In this study with rats, Socheongryong-tang treatment did not show any acute toxicity. No mortality was noted for 14 days of treatment. There were no adverse effects on clinical signs, body weight, organ eight and gross pathological findings at all treatment groups. The clinical chemistry parameters attesting to liver and kidney functions as well as the hematological parameters were within the normal ranges. From single dose toxicity study with rats, it is considered that $LD_{50}$ of Socheongryong-tang is over 2000 mg/kg in oral administration. This finding of the safety on single dose toxicity study of Socheongryong-tang are expected to strengthen the position of Socheongryong-tang as nontoxic medicine.

• The Korea Journal of Herbology
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• v.39 no.3
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• pp.107-114
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• 2024

Objective : Cicadae Periostracum (CP), which is the discarded shell of the Cryptotympana atrata (Fabricius, 1775), is a recognized component of oriental medicine for treatment sore throat, itching, shock, sedation, edema. However, the safety and toxicity of CP have not yet been established. It has been reported that symptoms of addiction or side effects may occur in patients who take high doses of CP or who are hypersensitive to it. Therefore, we investigated the acute toxicity of an CP extracts in Sprague-Dawley (SD) rats. Methods : To study acute toxicity, five SD rats of each sex per group were treated with CP extracts at single doses of 0, 500, 1000, or 2000 mg/kg administrated by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. At the end of 14-day observation period, all animals were sacrificed and complete hematological and macroscopic examinations were performed. Results : There were no dead animal and test article-related effects on body weight change or the gross finding. No toxicologically significant results were observed between control and treated groups in hematology. Although salivation related to stress at the highest dose was observed in clinical signs immediately after administration, it is considered to have no toxicological significance. Conclusion : As the results, we did not find any adverse effect at the dose levels of 500, 1000, or 2000 mg/kg in rats. The minimal lethal dose was considered to be over 2000 mg/kg body weight in rats.

• Asian Oncology Nursing
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• v.11 no.1
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• pp.33-40
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• 2011

Purpose: This study compared the effect of two oral care agents on preventing stomatitis and discomfort for acute leukemic patients. Methods: A total of forty patients was enrolled and randomly assigned to sodium bicarbonate or chlorhexidine group. WHO oral toxicity scale was used for measuring stomatitis and Beck's subjective oral discomfort scale for evaluating oral comfort. Data was collected from August 2009 to February 2010. The data was analyzed using Chi-square test, Fisher's exact test, and Mann-Whitney test. Results: Data analyzed was thirty five one. The incidence of stomatitis was 47.4%, 68.8% in sodium bicarbonate and chlohexidine group respectively. The onset of stomatitis was about the 10th and 9th day after chemotherapy initiation, and the duration was 8.0 and 8.67 day respectively. The severity of stomatitis was highest on the 21st day after chemotherapy initiation. There were no statistical differences in the status of stomatitis and the levels of oral comfort during treatment periods. Conclusion: Nurses should routinely assess oral cavity and encourage patients to do oral care actively from second to third week after chemotherapy initiation. Also sodium bicarbonate agent can be recommended to for preventing stomatitis.

• The Korean Journal of Pesticide Science
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• v.17 no.4
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• pp.473-477
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• 2013

This study was performed to evaluate the acute contact and oral toxicity of plant extracts (neem, sophora and derris) against Honeybee (Apis mellifera L.). As a result of acute contact toxicity test, $LD_{50}$ of neem and derris extracts were more than 100 ${\mu}g/bee$ while $LD_{50}$ of sophora extracts were 1.7 ${\mu}g/bee$. In case of acute oral toxicity test, $LD_{50}$ of neem and derris extracts were more than 100 ${\mu}g/bee$ while $LD_{50}$ of sophora extracts were 1.7 and 0.3 ${\mu}g/bee$. In conclusion, it is evaluated that neem and derris extracts are practically nontoxic while sophora extracts are highly toxic.

• The Journal of Internal Korean Medicine
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• v.39 no.4
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• pp.676-685
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• 2018

Objectives: The aim of this study was to estimate the single oral toxicity of Peucedani Radix (PR) ethanol extracts. PR is one of the important herbs for removal of phlegm, the viscous turbid pathological product that can accumulate in the body and cause a variety of diseases. However, research on the pharmacologic toxicity of PR is lacking. Methods: In this study, PR was orally administered to 5-week-old male ICR mice at an oral dose of 2,000, 3,000, or 5,000 mg/kg. After a single-dose administration, the mortality and behavioral changes were observed daily and body weights were measured every two days. After 14 days, the organ weight, organ index, macroscopy, hematological analysis, and serum biochemistry analysis were determined. Results: No mortality, body weight changes, abnormal behavioral changes, or anatomical signs of toxicity were found. The organ weight, organ index, hematological analysis, and serum biochemistry analysis were also within the normal ranges. Conclusions: These results suggest that the 50% lethal dose of PR is more than 5,000 mg/kg. This could indicate that PR is a safe drug without acute toxicity and side effects.

• The Journal of the Korea Contents Association
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• v.15 no.6
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• pp.529-538
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• 2015

This study was carried out to evaluate the acute oral toxicity of Corydalis turtschaninovii BESS. in Sprague-Dawley(SD) rats. Male and female rats were administered orally with Corydalis turtschaninovii BESS water extract. We measured the number of death by clinical signs and gross findings for 7 days. After 7 days, we measured the whole body and individual organs' weight. We also analyzed hematological changes. The result, no dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. The results indicated that there were no significant changes of gross body and individual organs weight in SD rats. These results suggest that water soluble extract of Corydalis turtschaninovii BESS. has not acute oral toxicity in SD rats.

• Journal of Preventive Medicine and Public Health
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• v.43 no.2
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• pp.131-137
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• 2010

Objectives: Bisphenol A diglycidyl ether (BADGE) is a liquid compound obtained by condensation of two molecules of epichlorohydrin with one molecule of bisphenol A. General and reproductive toxicity with BADGE has been reported higher than 1000 mg/kg/day. This study was performed to show the effects of acute exposure to BADGE below 1000 mg/kg/day on the testis in adult male rats. Methods: BADGE was administered by gastric lavage in a single dose of 500, 750, 1000, and 2000 mg/kg/day in 8-week old male SPF Sprague-Dawley rats. The right testis was processed for light microscopic analysis. The left testis was homogenized and spermatids were counted to determine the daily sperm production and daily abnormal sperm production. The sperm count, sperm motility, and incidence of abnormal sperm were estimated in the epididymis. In testicular sections, the seminiferous tubules were observed for qualitative changes. The progression of spermatogenesis was arbitrarily classified as full-matured, maturing, and immature. The specimen slide was observed at 3 points and 10 seminiferous tubules were evaluated at each point. Results: The male rats exposed to single oral dose of BADGE at 750, 1000, and 2000 mg/kg/day were significantly increased the number of immature and maturing sperm on the testis. There were no significant differences with respect to sperm head count, sperm motility, and sperm abnormality in the BADGE treatment groups. Conclusions: These results suggest that single oral exposure of BADGE 750 mg/kg/day can affect adult male testis development.