• 제목/요약/키워드: No-observed adverse effect level

검색결과 199건 처리시간 0.028초

A Study on Subchronic Inhalation Toxicity of 1-Chloropropane

  • Chung, Yong Hyun;Han, Jeong Hee;Lee, Yong-Hoon
    • Toxicological Research
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    • 제31권4호
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    • pp.393-402
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    • 2015
  • This study was conducted to measure toxicity of 1-chloropropane (CAS No. : 540-54-5). According to the OECD Test Guideline 413 (Subchronic inhalation toxicity: 90-day study), SD rats were exposed to 0, 310, 1,250, and 5,000 ppm of 1-chloropropane for 6 h/day, 5 day/week for 13 weeks via whole-body inhalation. Mortality, clinical signs, body weights, food consumption, motor activity, ophthalmoscopy, hematology, serum chemistry, urinalysis, organ weights, gross and histopathological findings were compared between control and all tested groups. No mortality or remarkable clinical signs were examined during the study. No gross lesions or adverse effects on body weight, food consumption, motor activity, ophthalmoscopy, urinalysis, hematology, organ weights were observed in any of male or female rats in all tested groups. In serum biochemistry, glucose was significantly decreased in males of 1,250 and 5,000 ppm groups compared to control group in dose-dependent relationship. In histopathological examination, vacuolation of acinar cells was observed in pancreas of all male and female groups exposed to 1-chloropropane. In conclusion, no observable adverse effect level (NOAEL) was considered to be below 310 ppm/6 h/day, 5 day/week for rats.

Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs

  • Nam, Chunja;Hwang, Jae-Sik;Kim, Myoung-Jun;Choi, Young Whan;Han, Kyoung-Goo;Kang, Jong-Koo
    • Toxicological Research
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    • 제31권1호
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    • pp.77-88
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    • 2015
  • Lithospermum erythrorhizon has long been used in traditional Asian medicine for the treatment of diseases, including skin cancer. The oral toxicity of a hexane extract of Lithospermum erythrorhizon root (LEH) was investigated in Beagle dogs by using single escalating doses, two-week dose range-finding, and 4-week oral repeat dosing. In the single dose-escalating oral toxicity study, no animal died, showed adverse clinical signs, or changes in body weight gain at LEH doses of up to 2,000 mg/kg. In a 2 week dose range-finding study, no treatment-related adverse effects were detected by urinalysis, hematology, blood biochemistry, organ weights, or gross and histopathological examinations at doses of up to 500 mg LEH/kg/day. In the 4 week repeat-dose toxicity study, a weight loss or decreased weight gain was observed at 300 mg/kg/day. Although levels of serum triglyceride and total bilirubin were increased in a dose dependent manner, there were no related morphological changes. Based on these findings, the sub-acute no observable adverse effect level for 4-week oral administration of LEH in Beagles was 100 mg/kg/day.

A 4-week Repeated Oral Dose Toxicity Study of CJ-10882 in Dogs

  • Cha, Shin-Woo;Kim, Jong-Choon;Kim, Dal-Hyun;Chung, Moon-Koo;Junghee Han
    • Toxicological Research
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    • 제18권3호
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    • pp.241-248
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    • 2002
  • The present study was conducted to investigate the potential subacute toxicity of CJ-10882 by a 4-week repeated oral dose in dogs. The test article was administered once dally by gavage to dogs at dose levels of 0, 2, 10, and 50 mg/kg/day for 4 weeks. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross finding, organ weight, and histopathology were evaluated. Several clinical sign were observed in treated dogs at 50 mg/kg, including salivation and vomiting. Increase in the serum level of ALT and albumin observed in the female 50 mg/kg group was considered as a toxic effect related to the test article since the histopathological change in Liver was accompanied. There were no treatment-related effects on mortality, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings and organ weights in any treatment group. Based on these results, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was 10 mg/kg/day and the absolute toxic dose was 50 mg/kg for both male and female dogs.

ICR 마우스에서 청가시덩굴 추출물의 4주간 반복 투여 독성시험 (Assessment of the 4-week repeated dose oral toxicity test of Smilax sieboldii extract in ICR mice)

  • 이정아;황민희;조영락;안은경
    • Journal of Applied Biological Chemistry
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    • 제65권4호
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    • pp.397-403
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    • 2022
  • 청가시덩굴은 청미래덩굴속에 속하며 청미래덩굴속 식물들은 전세계적으로 열대 및 아열대 지역에 서식하며 전통 의학에서 오랫동안 사용되어 왔다. 본 연구의 목적은 수컷과 암컷 ICR 마우스를 이용하여 청가시덩굴의 안전성을 확인하기 위해 청가시덩굴 추출물을 4주 동안 경구 투여하여 최대무독성용량을 평가하였다. 청가시덩굴 추출물을 500, 1000 및 2000 MPK 용량으로 4주 동안 매일 경구 투여한 결과 투여한 모든군에서 사망률, 임상 증상, 체중 변화, 섭취량, 혈액학적 분석, 혈청 생화학 검사 및 상대 장기 중량에 유의한 차이가 없었다. 본 연구에서 청가시덩굴 추출물은 ICR 마우스에서 어떠한 독성 효과도 나타내지 않았으며 청가시덩굴 추출물의 최대무독성용량은 2000 MPK 이상으로 간주되었음을 시사한다.

Acute and 13-week subchronic toxicological evaluations of turanose in mice

  • Chung, Joo-Yeon;Lee, Jihye;Lee, Daeyeon;Kim, Eunju;Shin, Jae-Ho;Seok, Pu Reum;Yoo, Sang-Ho;Kim, Yuri
    • Nutrition Research and Practice
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    • 제11권6호
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    • pp.452-460
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    • 2017
  • BACKGROUD/OBJECTIVES: Turanose, ${\alpha}$-D-glucosyl-($1{\rightarrow}3$)-${\alpha}$-D-fructose, is a sucrose isomer which naturally exists in honey. To evaluate toxicity of turanose, acute and subchronic oral toxicity studies were conducted with ICR mice. MATERIALS AND METHODS: For the acute oral toxicity study, turanose was administered as a single oral dose [10 g/kg body weight (b.w.)]. In the subchronic toxicity study, ICR mice were administered 0, 1.75, 3.5, and 7 g/kg b.w. doses of turanose daily for 13 weeks. RESULTS: No signs of acute toxicity, including abnormal behavior, adverse effect, or mortality, were observed over the 14-day study period. In addition, no changes in body weight or food consumption were observed and the median lethal dose (LD50) for oral intake of turanose was determined to be greater than 10 g/kg b.w. General clinical behavior, changes in body weight and food consumption, absolute and relative organ weights, and mortality were not affected in any of the treatment group for 13 weeks. These doses also did not affect the macroscopic pathology, histology, hematology, and blood biochemical analysis of the mice examined. CONCLUSION: No toxicity was observed in the acute and 13-week subchronic oral toxicology studies that were conducted with ICR mice. Furthermore, the no-observed-adverse-effect level is greater than 7 g/kg/day for both male and female ICR mice.

ICR 마우스에서 핑크왐피 추출물의 3주간 반복 투여 독성 연구 (3-week repeated dose oral toxicity study of Clausena excavata extract in ICR mice)

  • 박주형;조영락;김영민;강재신;오좌섭;안은경
    • Journal of Applied Biological Chemistry
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    • 제62권2호
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    • pp.123-127
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    • 2019
  • 핑크왐피는 피부병, 말라리아, 복통, 이질 및 장염 치료를 위한 약용 식물로 사용되고 있다. 본 연구의 목적은 핑크왐피의 안전성을 확인하기 위하여, 수컷 ICR 마우스를 이용하여 핑크왐피를 3주 반복 경구 투여하여 최대무독성용량을 평가했다. 핑크왐피를 100, 250, 500, 1000, 및 2000 mg/kg으로 투여한 결과, 모든 시험물질 투여군에서 이상이 관찰되지 않았다. 사망률, 임상 증상, 체중 변화, 혈액 학적 검사 및 혈청 생화학 검사에서 유의적인 차이는 없었고, 경미한 변동은 핑크왐피의 투여로 인한 영향이 아닌 정상 범위 내에서의 변화로 간주 되어진다. 결과적으로, 핑크왐피는 모든 시험물질 투여군에서 독성 영향을 미치지 않았으며, 핑크왐피의 최대무독성용량은 2000 mg/kg 이상으로 간주되었다.

마우스를 이용한 십전대보탕(十全大補湯) 발효물의 단회투여 독성 연구 (Single Oral Dose Toxicity Test of Fermented Sipjeondaebo-tang Extracts in Mice)

  • 이지혜;김태수;곽동훈;마진열
    • 대한한방내과학회지
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    • 제32권3호
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    • pp.334-344
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    • 2011
  • Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

26-Week Repeated Dose Oral Toxicity Study of KCHO-1 in Sprague-Dawley Rats

  • Yang, Muhack;Lee, Seongjin;Wang, Tingting;Cha, Eunhye;Jang, Jongwon;Kim, Dongwoung;Song, Bong-Keun;Son, Ilhong;Kim, Joonyup;Kang, Hyung Won;Kim, Sungchul
    • 대한약침학회지
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    • 제22권3호
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    • pp.192-199
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    • 2019
  • Objectives: KCHO-1(Mecasin), also called Gamijakyakgamchobuja-tang originally, is a combination of some traditional herbal medicines in East Asia. This medicine has been used mainly for alleviating neuropathic pains for centuries in Korean traditional medicine. KCHO-1 was developed to treat pain, joint contracture and muscular weakness in patients with amyotrophic lateral sclerosis. This study was carried out to investigate the chronic toxicity of KCHO-1 oral administration in rats for 26 weeks. Methods: Sprague-Dawely rats were divided into four groups and 10 rats were placed in the control group and the high-dose group, respectively. Group 1 was the control group and the remaining groups were the experimental groups. In the oral toxicity study, 500 mg/kg, 1,000 mg/kg, and 2,000 mg/kg of KCHO-1 were administered to the experimental group, and 10 ml/kg of sterile distilled water was administered to the control group. Survival rate, body weight, feed intake, clinical signs, and visual findings were examined. Urinalysis, ophthalmologic examination, necropsy, organ weight, hematologic examination, blood chemical examination and histopathologic examination were performed. Results: Mortality and toxicological lesions associated with the administration of test substance were not observed in all groups. Conclusion: NOAEL(No observed adverse effect level) of KCHO-1 is higher than 2000 mg/kg/day. And, the above findings suggest that treatment with KCHO-1 is relatively safe.

수용성 DDB 유도체의 3개월 반복투여독성에 관한 연구 (Three Months Subacute Toxicity of Water Soluble Dimethyl Dimethoxy Biphenylate Derivative in Rats)

  • 신민기;손장원;김민영;방명주;김정현;최진혁;김준성;배미옥;문전옥
    • Toxicological Research
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    • 제16권2호
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    • pp.151-161
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    • 2000
  • The Three months subacute toxicity of water soluble dimethyl dimethoxy biphenylate derivative (DDB-S), newly formulated therapeutic agent for hepatitis, was invesgated in SD rats. The body weight and clinical signs were observed after intravenous injection of DDBs at doses of 57, 75 and 100 mg/kg/day for three months. Decrease in motor activity and tremor were observed above 75mg/kg treated groups. Statistically significant changes at serum biochemical analysis were found in some group, how-ever, those changes were within the normal range and had no relationship with dosage. There was no abnormal morphological and pathological findings in relation to DDB-S treatment. The no observable adverse effect level of DDB-S in rats was estimated to be 57 mg/kg/day in this study.

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Sprague-Dawley 랫드에서 2-Bromopropane의 배자치사 및 최기형성 효과 (Embryo lethality and teratogenicity of 2-Bromopropane in the Sprague-Dawley rat)

  • 김종춘;오기석;신동호;김성호;김현영;윤효인;강성철;허정두;정문구
    • 대한수의학회지
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    • 제43권4호
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    • pp.657-666
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    • 2003
  • The present study was undertaken to evaluate the potential adverse effects of 2-BP on pregnant dams and embryo-fetal development after maternal exposure during the gestational days (GD) 6 through 19 in Sprague-Dawley rats. The test chemical was administered subcutaneously to pregnant rats at dose levels of 0, 375, 750 and 1250 mg/kg/day. During the test period, clinical signs, mortality, body weights and food consumption were examined. All dams were subjected to caesarean section on GD 20 and their fetuses were examined for external, visceral and skeletal abnormalities. At above 750 mg/kg, toxic effects including signs of toxicity, suppressed body weight, decreased gravid uterine weight and reduced food intake were observed in pregnant dams. An increase in the fetal deaths, a decrease in the litter size, a reduction in the fetal body weight and an increase in the incidence of fetal morphological alterations were also found. There were no adverse effects on either pregnant dams or embryo-fetal development at a dose level of 375 mg/kg. These results suggest that a 14-day subcutaneous dose of 2-BP is embryolethal and teratogenic at above 750 mg/kg/day in pregnant rats. In the present experimental condition, the no-observed-adverse-effect level of 2-BP is considered to be 375 mg/kg/day for dams and embryo-fetuses, respectively.