• Title/Summary/Keyword: Toxicity study

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Single and Five-Week Oral Dose Toxicity Studies of Calcitriol and Alendronate Mixtures in Rats

  • Moon, Sung Won;Jin, Ji Yun;Lee, Jin Hee;Sim, Sang Soo;Kim, Chang Jong
    • Toxicological Research
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    • 제20권3호
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    • pp.281-292
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    • 2004
  • The purpose of this study was to assess the single and 5 week oral dose toxicity of calcitriol and alendronate combination (1 : 10,000) treatment for osteoporosis or Paget's disease in male and female rats. In single dose oral toxicity study, the values of $LD_{50}$ of calcitriol and alendronate mixture were 750.075 mg/kg in male rats and 775.0775 mg/kg in female rats, respectively. Body weight and food consumption were continuously increased after adminstration of calcitriol and alendronate mixtures, and there was no significant changes in body weight and food consumption in all groups. In five-week oral toxicity study of calcitriol and alendronate mixture at a dose of 0.2 $\mu\textrm{g}$ + 2 mg, 1 $\mu\textrm{g}$ + 10 mg, 5 $\mu\textrm{g}$ + 50 mg and 25 $\mu\textrm{g}$ + 250 mg, respectively, there was no mortality, abnormal behavior and appearance in all groups throughout the administration period (5 weeks) and recovery period (2 weeks). Dose-dependent changes in parameters of urinalysis and hematological analysis were not observed in male and female rats treated with calcitriol and alendronate mixtures. All the values of the parameters appeared to be in the normal range. These data indicate that both calcitriol and alendronate are drugs having low toxicity in rats. NOAEL of calcitriol and alendronate mixtures were 50.005 mg/kg in 5-week oral toxicity.

동의보감 탕액편에 기재된 식이본초의 독성유무에 대한 분류 연구 (Study of Toxicity Presence Classification about Herbal Diet in Tang-aec-pyeon of Dong-ui-bo-gam)

  • 신호동;정종운
    • 대한한의학회지
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    • 제32권1호
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    • pp.12-35
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    • 2011
  • Objectives: The two criteria to clarify the toxicity of a herbal diet are well known. Although mechanical analysis of effective ingredients, a western approach, is widely used, the toxicity presence classification through the herbal analysis from a viewpoint of a theory of the herbal medicine properties has been disregarded. This study is for the safe use of a herbal diet through classification and study of toxicity presence in the herbal diet from the view of a theory of herbal medicine properties, one of the methods of Oriental Medicine. Methods: We classified and studied the toxicity presence in four kinds of herbal diets, waters and grains, animals groups, fruits and vegetables, and herbs and trees, excluding mineral natural drugs, of 1,400 kinds of medicines in 16 chapters of Tang-aec-pyeon, Dong-ui-bo-gam, for which the herbal analysis from a viewpoint of the theory of the herbal medicine properties has been used. The criteria of the toxicity presence in the herbal diet have been largely classified into the toxicant and the non-toxicant, and the toxicant is in turn classified into the insignificant, the medium and the significant. The category to clarify herbal diet has been limited to simultaneous utilization of food and natural drugs. The main text is Dong-ui-bo-gam, although diverse other references have also been used. Results: There are toxicant diets: a kind of tortoise meat of animals groups; five kinds of grains part in fruits and vegetables: aengdo, peach, oyat, small apple and gingko nut; and 12 kinds of vegetables part in fruits and vegetables: ginger, oriental cabbage, lettuce, chongbaek, onion, garlic, leek, fern, houttuynia cordata (myeol), pyeongji, geundae, and spinach, which should be prohibited from long-term use both as food and medicine. Conclusion: If herbal diet is used as health food supplements or food, the toxicity presence should be considered on the grounds of an Oriental Medicine theory of the herbal medicine properties.

Single and Two-Week Repeated] Oral Dose Toxicity Study of DHP2, a Hydrophobic Drug Delivery Vehicle in Mice

  • Han, Jung-Hee;Chung, He-Sson;Lee, Jong-Hwa;Suh, Jeong-Eun;Lee, Gab-Soo;Kim, Jong-Choon;Kang, Boo-Hyon
    • Toxicological Research
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    • 제20권2호
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    • pp.123-129
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    • 2004
  • The present study was conducted to investigate the single and 2-week repeated dose toxicity of DHP2, a hydrophobic drug delivery vehicle, in ICR mice. The test article was administered orally to mice at the dose levels of 2.5, 12.5 and 37.5 g/kg for single dose toxicity study and at the dose levels of 0, 2.5, 5, and 10 g/kg for repeated dose toxicity study. In both studies, there were no treatment-related effects on mortality, clinical signs, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings and organ weights of all animals treated DHP2. Based on these results, it was concluded that the 2-week repeated oral dose of DHP2 may have no toxic effect in mice at a dose level of 10 g/kg. In the condition of this study, the no-observed-adverse-effect level (NOAEL) was considered to be 10 g/kg/day for both sexes.

갈근탕 추출물의 단회투여 독성 시험 (Single Dose Toxicity Study on Galgeuntang in Mice)

  • 이지혜;이재훈;마충제;마진열
    • 한국한의학연구원논문집
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    • 제15권1호
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    • pp.79-83
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    • 2009
  • In this study, we investigated the single dose toxicity and safety about water-extracted Galgeuntang. To evaluate single dose toxicity, 20 male and 20 female ICR mice were observed survival rates, general toxicity, changes of body weight for 14 days after single oral administration of 0 (control group), 1250, 2500 and 5000mg/kg Galgeuntang. And after 14 day, We observed autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). LD50 of Galgeuntang might be over 5000mg/kg and it is very safe to ICR mice.

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Toxicity characteristics of sewage treatment effluents and potential contribution of micropollutant residuals

  • Kim, Younghee;Farnazo, Danvir Mark
    • Journal of Ecology and Environment
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    • 제41권11호
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    • pp.318-327
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    • 2017
  • Background: A typical sewage treatment plant is designed for organic and nutrient removal from municipal sewage water and not targeted to eliminate micropollutants such as pesticides, pharmaceuticals, and nano-sized metals which become a big concern for sustainable human and ecological system and are mainly discharged from sewage treatment plant. Therefore, despite contaminant removal by wastewater treatment processes, there are still remaining environmental risks by untreated pollutants in STP (sewage treatment plant) effluents. This study performed aquatic toxicity tests of raw wastewater and treated effluents in two sewage treatment plants to evaluate toxicity reduction by wastewater treatment process and analyze concentration of contaminants to reveal potential toxic factors in STP effluents. Methods: Water samples were collected from each treatment steps of two STPs, and acute and chronic toxicity tests were conducted following USEPA (United States Environmental Protection Agency) and OECD (Organization for Economic Cooperation and Development) guidelines. Endpoints were immobility for mortality and reproduction effect for estrogenicity. Results: Acute $EC_{50}s$ (median effective concentration) of influents for Seungki (SK) and Jungnang (JN) STPs are $54.13{\pm}32.64%$ and $30.38{\pm}24.96%$, respectively, and reduced to $96.49{\pm}7.84%$ and 100%. Acute toxicity reduction was clearly correlated with SS (suspended solids) concentration because of filter feeding characteristics of test organisms. Chronic toxicity tests revealed that lethal effect was reduced and low concentration of influents showed higher number of neonates. However, toxicity reduction was not related to nutrient removal. Fecundity effect positively increased in treated wastewater compared to that in raw wastewater, and no significant differences were observed compared to the control group in JN final effluent implying potential effects of estrogenic compounds in the STP effluents. Conclusions: Conventional wastewater treatment process reduced some organics and nutritional compounds from wastewater, and it results in toxicity reduction in lethal effect and positive reproductive effect but not showing correlation. Unknown estrogenic compounds could be a reason causing the increase of brood size. This study suggests that pharmaceutical residues and nanoparticles in STP effluents are one of the major micropollutants and underline as one of estrogenic effect factors.

Comparative Assessment of Skin and Subcutaneous Toxicity in Patients of Advanced Colorectal Carcinoma Treated with Different Schedules of FOLFOX

  • Bano, Nusrat;Najam, Rahila;Mateen, Ahmed
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권3호
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    • pp.1781-1786
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    • 2013
  • Objective: The study was designed to assess the skin and subcutaneous toxicity in patients with advanced colorectal carcinoma treated with four different schedules of FOLFOX. Methods: The patients with histologically confirmed advanced colorectal carcinoma (CRC) were included in the study as per specified inclusion criteria. Toxicity was graded according to CTC v2.0. The frequency of grade 3 and 4 adverse effects were comparatively assessed in each treatment arm. Results: Very severe toxicity was attributed to the FOLFOX7 schedule. The difference between the incidence rate of grade 4 toxicity with all other grades for all parameters of skin and subcutaneous toxicity was highly significant (p=0.00<0.001). Grade 4 hand and foot syndrome was reported only in the FOLFOX7 treatment arm. The most frequent adverse symptom of skin and subcutaneous toxicity reported in the patients treated with modified schedule of FOLFOX was pruritus (grade 1). Frequency and onset of skin and subcutaneous toxic symptoms like alopecia (p=0.000), nail discoloration (p=0.021) and pruritis (p=0.000) was significantly different in each FOLFOX treatment arm. A few cases of oncholysis were also reported in the FOLFOX7 treatment arm. Hand and foot syndrome was fast progressing in patients with grade 1 toxicity. Conclusion: Higher frequency and severity of hand and foot syndrome and pruritus wasa found in the FOLFOX7 treatment arm. Skin and subcutaneous toxicity was comparatively low in the FOLFOX6 treatment arm.

급성 일산화탄소 중독 환자에서 급성 심혈관계, 신경학적 독성의 위험요인과 노출 경로의 역학적 특성 (The Risk Factors of Acute Cardiovascular and Neurological Toxicity in Acute CO Poisoning Patients and Epidemiologic Features of Exposure Routes)

  • 박진수;신승열;서영호;정현민
    • 대한임상독성학회지
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    • 제18권1호
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    • pp.34-41
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    • 2020
  • Purpose: This study evaluated aggressive hyperbaric oxygen therapy (HBOT) by understanding various exposure routes of acute carbon monoxide (CO) poisoning, the risk factors causing acute cardiovascular, and neurological toxicity caused by poisoning. Methods: A retrospective study was conducted based on the medical records of 417 acute CO poisoning patients who visited the emergency care unit from March 2017 to August 2019. The exposure routes, HBOT performance, age, sex, medical history (hypertension, diabetes mellitus, ischemic heart disease, heart failure), intentionality, loss of consciousness (LOC), intake with alcohol or sedatives, and initial test results (carboxyhemoglobin (COHb), troponin-I, electrocardiography, echocardiography, brain MRI) were examined. Comparative analysis of the clinical information was conducted between the groups that showed acute cardiovascular toxicity and neurological toxicity, and groups that did not. Results: Among 417 patients diagnosed with acute CO poisoning, 201 cases (48.2%) were intentional, and charcoal briquette was the most common route (169 patients (40.5%)). Two hundred sixteen cases (51.8%) were accidental, and fire was the most common route (135 patients (32.4%)). The exposure route was more diverse with accidental poisoning. Three hundred ninety-nine patients were studied for acute cardiovascular toxicity, and 62 patients (15.5%) were confirmed to be positive. The result was statistically significant in intentionality, LOC, combined sedatives, initial COHb, HTN, and IHD. One hundred two patients were studied for acute neurological toxicity, which was observed in 26 patients (25.5%). The result was statistically significant in age and LOC. Conclusion: Active HBOT should be performed to minimize damage to the major organs by identifying the various exposure routes of CO poisoning, risk factors for acute cardiovascular toxicity (intentionality, LOC, combined sedatives, initial COHb, HTN, IHD), and the risk factors for acute neurological toxicity (age, LOC).

가미홍화탕의 단회 경구 투여 독성 연구 (Acute Oral Toxicity Study of Kami-honghwa-tang)

  • 성현제;문근아;유충렬;윤유식
    • 한국한의학연구원논문집
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    • 제9권2호
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    • pp.95-105
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    • 2003
  • Kami-honghwa-tang(KH-19) is a prescription for reducing the side effect of radiotherapy. In this study, safety of KH-19 was evaluated by GLP guideline of Korea Food and Drug Administration. In acute oral toxicity study on rat, transient inhibition of weight increase was shown, but change in general symptom was not detected. No dead animal was observed up to 5,000 mg/kg in both male and female animals. In acute oral toxicity study on Beagle dog, transient vomiting, diarrhea, anorexia, and weight reduction was observed. However, no dead animal was observed up to 2,000 mg/kg in both male and female animals.

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비 마약성 진통제 DA-5018의 급성독성시험 (Acute Toxicity Study of DA-5018, A Non-narcotic Analgesic Agent)

  • 강경구;김동환;백남기;김원배;양주익
    • Biomolecules & Therapeutics
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    • 제5권1호
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    • pp.12-22
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    • 1997
  • Intravenous and oral acute toxicity tests in ICR mice and SD rats and percutaneous acute toxicity tests in SD rats and NZW rabbits were conducted to evaluate the toxicity of DA-5018 and DA-5018 cream, respectively Clinical signs observed in mice and rats after the administration of DA-5018 were similar regardless of administration route. The observed clinical signs were jumping, wild running, lacrimation, ataxia, reddening of extremities and ears, ventral or lateral recumbency, respiratory distress, cyanosis, convulsion and death. Pulmonary enlargement and hemorrhage were observed in the animals died immediately after the dosing of DA-5018. At terminal necropsy, pulmonary enlargement and hemorrhage, corneal opacity and focal scabbing and depilation around nose were seen. LD$_{50}$ Values of DA-5018 are 11.5 mg/kg (mice, male), 12.6 mg/kg (mice, female), 88.3 mg/kg (rat, male) and 73.2 mg/kg (rat, female) in oral toxicity tests and 11.0 mg/kg (mice, male), 18.7 mg/kg (mice, female), 0.12 mg/kg (rat, male) and 0.32 mg/kg (rat, female) in i.v. toxicity tests. In the percutaneous acute toxicity tests of DA-5018 cream, no deaths occured in all the tested groups during 14-day observation period. There were also no abnormalities in the general conditions, body weight changes and on necropsy findings in all groups. LD$_{50}$ values of 0.1 ~0.9% DA-5018 creams in male and female rats and rabbits are >2000 mg/kg./kg.

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연명피 사포닌의 독성 및 용혈작용 (Toxicity and Hemolytic Activitiy of Saponin Isolated from Sapindus mukorossi)

  • 박은희
    • 약학회지
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    • 제39권2호
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    • pp.137-140
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    • 1995
  • Saponin isolated from Sapindus mukorossi Gaertn has been shown to contain a strong anti-inflammatory activity. In this study, several pharmacological properties such as acute toxicity, local irritation and hemolytic activity of Sapindus saponin and its genin component, hederagenirl, were examined. The acute toxicity of Sapindus saponin was very low. Estimated from the LD$_{50}$ values, it showed much weaker toxicity in oral administration than in intraperitoneal injection. Hederagenin gave a very high LD$_{50}$ value even in intraperitoneal injection. Sapindus saponin showed a potent local irritation after topical application, whereas hederagenin did a very weak local irritation. Sapindus saponin also gave a high hemolytic activity.

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