• Toxicological Research
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• 제22권4호
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• pp.445-452
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• 2006

Aralia elata, a common medicinal and culinary herb, has beer consumed for centuries without any reported adverse effects. However, due to its limited safety information, we decided to investigate the repeated-dose toxicity of ethanolic extract of Aralia elata. The test was administered once daily by the gavage to male and female rats at doses of 0, 250, 500 and 1,000 mg/kg/day for four weeks. Throughout the study, no treatment-related deaths or clinical signs were observed. Also, no apparent changes were detected in ophthalmoscopy, urinalysis, serum biochemistry, hematology and gross necropsy. The test result showed a significant decrease in body and heart weight of males treated with 250 mg/kg of extract of Aralia elata compared to normal control, a significant increase in relative brain weight and adrenal weight in females treated with 250 mg/kg of extract compared to normal control. However, all these changes were not considered toxicologically important due to irrelevant dose-response relationship to gross and microscopic findings. Histopathologically, abnormal changes were not observed in any target organs. On the basis of these results, the NOAEL of extract of Aralia elata was estimated to be more than 1,000 mg/kg/day under the tested conditions.

• Toxicological Research
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• 제23권1호
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• pp.87-96
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• 2007

Single and repeated-dose toxicity of anti-diabetic herb extract microcapsule (ADHEM) were evaluated according to Toxicity Test Guidelines of Korea Food and Drug Administration using Sprague-Dawley rats. For single-dose toxicity test, kneading ADHEM with sterilized water were administered orally once at dose levels of 0 and 2,000 mg/kg and examined for 14 days. No dead animals, clinical signs and abnormal necropsy findings were observed and also no significant difference in body weights was found. Therefore, the $LD_{50}$ of ADHEM was considered to be higher than 2,000 mg/kg in both male and female rats. For repeated-dose toxicity test, ADHEM were mixed with powder fodder and administerd orally for 28 days at dose levels of 0, 500, 1000 and 2000 mg/kg/day. No dead animals, clinical signs and significant difference in body weights were found. In hematology and serum biochemistry, all values were included within the normal ranges. In relative organ weights, kidney or liver were significantly increased in the 500, 1000 or 2000 mg/kg/day male groups, uterus was significantly increased in the 500 mg/kg/day female group and left adrenal glands were significantly decreased in the 2000 mg/kg/day female group. In histopathological examinations, vacuolation and microgranuloma in the liver, chronic progressive nephropathy and inflammation in the kidney were observed in the 500, 1000 or 2000 mg/kg/day both male and female groups. Therefore, the no observed adverse effect level (NOAEL) of ADHEM was considered to be lower than 500 mg/kg/day in both male and female rats.

• 한국환경농학회지
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• 제33권4호
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• pp.395-402
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• 2014

님추출물은 유효성분(active ingredient)으로 azadirachtin을 함유하여 전세계적으로 충해방제용 유기농업자재로 널리 사용되고 있다. 그러나, 님추출물은 님 원료부위 및 추출용매에 따라 종류가 매우 다양하고 안전성에 크게 차이가 난다고 보고되고 있다. 본 연구에서는 우리나라에서 유기농업자재 제품의 원제로 사용되는 수용성 님추출물이 주요 독성기관인간에 미치는 영향에 대해서 살펴보고자 SD 랫드를 이용하여 4주 반복경구독성시험을 수행하였다. 시험결과, 님추출물 시험물질의 투여 농도가 증가함에 따라 간의 상대중량이 증가하였다(p <0.05). 혈액 생화학분석 결과, 수컷에서 대조군에 비해 시험물질 처리시 혈중 LDH는 감소하였으나 GOT와 GPT가 증가하였으며(p <0.05), 특히 GPT가 시험물질에 농도 의존적으로 증가함에 따라 수컷에서 간 손상의 가능성을 나타내었다. 또한, 고농도로 님추출물 시료를 처리한 경우 수컷의 혈중 GGT가 급격히 증가하였으며 혈중 GLU도 유의적으로 증가하였으나(p <0.05), 뇨 중 GLU는 님추출물의 처리농도증가에 따른 변화가 나타나지 않았다. 간의 조직병리학적 변화를 살펴본 결과 님추출물 시료 처리에 따른 간의 병변도 확인되지 않았다. 따라서 본 시험에 사용된 수용성 님추출물 시료는 혈액 생화학적 분석 결과 수컷에서 간손상의 가능성은 있었으나 조직병리학적 변화는 관찰되지 않았다. 따라서, 수용성 님추출물 2.0 g/Kg 을 4주간 랫드에 경구투여한 결과 간에 독성을 미치지 않고 안전한 것으로 판단된다.