• 제목/요약/키워드: no-observed-adverse-effect level (NOAEL)

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생강나무(Lindera obtusiloba Blume) 잎 70% 에탄올 추출물의 단회와 14일 반복투여 독성시험의 안전성 평가 (Single and 14-Day Repeated Oral Toxicity Studies of 70% Ethanol Extract of Lindera Obtusiloba Blume Leaves)

  • 홍충의;서문영;구윤창;남미현;이현아;김지훈;왕증;양성용;이성희;노수환;이광원
    • 한국식품영양과학회지
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    • 제38권10호
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    • pp.1324-1330
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    • 2009
  • 생강나무는 한국, 일본, 중국 등지에서 자생하며 열, 복통, 타박상, 출혈 등에 민간요법으로 사용되어온 식물이다. 이 논문의 목적은 오래전부터 민간요법으로 사용되어온 생강나무 잎의 안전성을 평가하고자 생강나무 잎 70% 에탄올 추출물을 암수 각 군당 5마리씩 5000(단회투여 독성시험), 0, 500, 1000, 2000(14일 반복투여 독성시험) mg/kg의 용량으로 단회경구투여와 14일 반복경구투여를 실시하여 15일간의 사망률, 일반증상, 체중변화, 조직병리, 혈액학적 및 혈액 생화학적 검사를 실시하였다. 시험기간 중 사망동물은 암수 모든 시험군에서 관찰되지 않았으며, 일반증상, 체중변화, 조직병리, 혈액학적 및 혈액생화학적 검사에서 투여와 관련된 변화는 관찰되지 않았다. 이상의 결과로 보아 생강나무의 단회투여 독성은 5000 mg/kg 용량을 상회하며, 14일 반복투여의 최고용량인 2000 mg/kg 용량에서도 아무런 독성이 나타나지 않는 것으로 보아 최대무독성량은 이 농도를 상회하는 것으로 판단된다. 이로써 생강나무는 안전한 소재로서 식재료 또는 건강기능식품의 원료로서도 사용이 가능하다고 볼 수 있다.

난담반 단독제와 난담반과 죽염 혼합제 경구 투여의 독성 연구 (Study on Oral Administration of Egg White Combined Chalcanthite and Bamboo-Salt with Egg White Combined Chalcanthite)

  • 최은아;이종훈;윤대환;유화승
    • 동의생리병리학회지
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    • 제26권2호
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    • pp.189-198
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    • 2012
  • Our former study indicated efficacy of apoptotic cell death on animal study by using Egg white combined Chalcanthite (EC). Clinically, bamboo salt is using because of safety. Hence we investigated a toxicity study for determining safety by adding bamboo salt in former materiel. We had two studies: toxicity of EC and of Bamboo salt with egg white combined Chalcanthite (BC). Both were studied in 1-week single and 5-week repeated oral dose toxicity tests on male Imprinting Control Region mice. In EC, doses used in 1 week single oral dose toxicity tests were 0, 0.05, 0.5, 5 and 50 mg/kg/day and 0, 0.01, 0.05, 0.25 and 0.5 mg/kg/day. In BC, doses used by 0, 0.08, 8.3, 83.3 and 166.6 mg/kg/day in single oral dose toxicity and 0, 4.2, 8.3, 41.7 and 83.3 mg/kg/day in repeated oral dose toxicity tests. Their blood and urine were assayed and organ morphology were examined. Mann-Whitney U test and ANOVA tests were used by analysing methods. First, significant increased left renal weight in all groups of EC and BC. Second, increased ALT score was found in EC-S2 and increased relative liver weight was found in EC-S3. In addition, increased relative weight and urine bilirubin and urobilinogen were found in EC-R2 and EC-R3. There was no significant toxic change in BC. The Mixture of EC had a possibility of hepatotoxicity in the short and long term. Processed BC appears to be safe and non-toxic in these studies and a no-observed adverse effect level (NOAEL) was established at 83.3 mg/kg/day in mice. Relatively, The BC were safer than The EC.

Balb/c 마우스에서 초과 추출물의 3주간 반복 경구투여 독성평가 (Evaluation of 3-week Repeated Dose Oral Toxicity on Amomum tsao-ko Extract in Balb/c Mice)

  • 박주형;조영락;고혜진;정원식;안은경;오준호;오좌섭
    • Journal of Applied Biological Chemistry
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    • 제58권2호
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    • pp.139-143
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    • 2015
  • 본 연구는 다양한 효능을 지닌 초과(Amomum tsao-ko Crevost et Lemaire)의 안전한 이용을 위한 독성평가로 식품의약품안전처 고시 제2014-6호 '의약품등의 독성시험기준'에 맞는 독성시험법에 따라 Balb/c mouse를 이용하여 3주간 반복경구투여를 통해 초과의 안전성을 확인하고자 하였다. 3주간 반복 경구투여 후 체중, 장기중량 측정, 혈액분석 및 혈액생화학 검사를 실시하여 안전성을 확인 한 결과, 초과에 의한 특별한 증상이나 체중, 장기중량의 변화는 관찰되지 않았으며, 복대동맥으로부터 채혈한 혈액을 통한 혈구분석결과에서도 대조군과 초과 추출물 투여군 간의 통계적인 유의성을 관찰 할 수 없었다. 또한 혈청을 이용하여 간기능(GOT, GPT, LDH, ALB, TP-S, T-BIL, D-BIL), 신장기능(BUN, CRE), 지질영양 관련(TG), 전해질 관련(I.P) 지표들의 생화학분석을 수행한 결과, 대조군과 유사하게 모두 정상 범위 내의 결과를 나타내었다. 이러한 결과를 통하여 초과 추출물의 최대무독성용량은 최고 투여량인 2000 mg/kg 이상으로 판단되며, 본 연구결과는 초과의 기능성 식품, 화장품, 의약품 등 다양한 소재로서의 활용에 안전성 관련 기초자료로 이용될 수 있을 것으로 사료된다.

CMIT/MIT 가습기살균제 사용에 따른 피해구제 신청자의 노출등급 및 노출특성 분석 (Analysis of Exposure Characteristics and Exposure Rating of Participants with Injuries from CMIT/MIT Humidifier Disinfectants)

  • 민기홍;신정현;조은경;이슬아;신지훈;김동준;우재민;최윤형;양원호
    • 한국환경보건학회지
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    • 제49권3호
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    • pp.169-177
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    • 2023
  • Background: The Korea Centers for Disease Control and Prevention (KCDC) has identified cases of people suspected of suffering lung disease potentially caused by chloromethylisothiazolinone/methylisothiazolinone (CMIT/MIT) used in humidifier disinfectants (HDs). The Korean Ministry of Environment (MoE) epidemiological investigation and toxicity test study found that HDs caused health damage such as asthma and lung disease. Objectives: The main purposes of this study were to classify the HD exposure rating and to analyze the exposure characteristics that affect exposure to CMIT/MIT HDs. Methods: The exposure characteristics and socio-demographic characteristics of victim participants using CMIT/MIT HDs were investigated through questionnaires. An inhalation no observed adverse effect level (NOAEL) for CMIT/MIT was produced based on inhalation toxicity values. Exposure ratings (class 1~class 2) were cross-tabulated with clinical ratings (acceptable~unacceptable). A correlation analysis was conducted with the main exposure characteristics that affect the exposure concentration of CMIT/MIT HDs. Results: The concentration in indoor air of CMIT/MIT was 8.75±25.40 ㎍/m3, and the exposure concentration was 2.30±6.29 ㎍/m3. The CMIT/MIT exposure rating of 67 participants with high exposures of not more than MOE 100 were evaluated as 14.5%, while the damage participants who matched the clinical rating made up 4.5%. The exposure concentration of CMIT/MIT showed a positive correlation with the daily usage amount and usage frequency, and a negative correlation with volume of the indoor environment. Conclusions: A new exposure rating could be suggested and calculated based on the MOE, and the factors affecting the exposure concentration could be identified.