• Title/Summary/Keyword: no-observed-adverse-effect level (NOAEL)

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Subacute(13-week) Inhalation Toxicity Study of Methyl Acrylate in Rats (랫드를 이용한 Methyl Acrylate의 아급성(13주) 흡입독성 연구)

  • Han, Jeong Hee;Park, Sang Yong;Kang, Min Gu;Chung, Yong Hyun;Yang, Jung Sun
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.22 no.4
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    • pp.316-328
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    • 2012
  • Objectives: This study was designed to provide the information regarding chemicals classification and health hazard by evaluating the toxicological effect through repeated inhalation exposure of methyl acrylate(MA) in Sprague-Dawley(SD) rat for 13 weeks. Methods: According to the notification with Ministry of Labor(No. 2009-68) and OECD Test Guideline 413, the rats were exposed to MA at concentration of 0, 56, 168, 280 ppm via whole body inhalation for 6 hours per day, 5 days per week, for 13 weeks. All animals were observed for mortality, morbidity and the change of body weight and food consumption were determined during the exposure period. Necropsy finding, organ weight, hematology, clinical biochemistry and histopathological examination following exposure were also performed. Results: There were no death and abnormal clinical signs relate to exposure MA. However, At 160 ppm and 280 ppm exposure groups, body weight and food consumption showed statistically significant decrease and histopathological changes in lung, trachea, nasal cavity, larynx were observed. Conclusions: MA was mainly affected respiratory tract. It is consequently provided to be classified as category 2(0.2 mg/L/6h < category 2 ${\leq}$ 1.0 mg/L/6h) for specific target organ toxicity following repeated exposure according to Standard for Classification and Labeling of Chemical Substance and Material Safety Data Sheet. The NOAEL(no observable adverse effect level) of MA was also determined to be lower than 56 ppm.

Four-Week Repeated Oral Toxicity Study of Clean Natural in Sprague-Dawley Rats (Clean Natural의 Sprague-Dawley 랫드를 이용한 4주 반복경구투여 독성시험)

  • Kim, Eui-Kyung;Kim, Jun-Young;Lee, Hu-Jang
    • Toxicological Research
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    • v.21 no.3
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    • pp.263-269
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    • 2005
  • This study was performed to investigate repeated-dose toxicities of Clean natural, a new disinfectant, in Sprague-Dawley(SD) rats. In the 4-week repeated oral toxicity study, Clean Natural was orally administered once daily via gavage to male and female rats at dose levels of 0, 500, 1,000 and 2,000 mg/kg body weight for 4-weeks. There were no deaths and clinical signs during the dosing period. In both sexes, there were no statistically significant differences between the administered and control groups in urinalysis indicators and hematological parameters. In serum biochemistry, aspartate aminotransferase(AST) was significantly decreased and sodium content was increased in the 2,000 mg/kg male group, while chlorine was significantly decreased in the 2,000 mg/kg female group. Also, albumin, total cholesterol and total bilirubin were significantly increased in the 2,000 mg/kg male and female group. In histopathological examinations, centrilobular hepatocellular hypertrophy in the liver was observed in the 2,000 mg/kg male and female groups. And pigmentation in the spleen was observed in the 2,000 mg/kg male group. In conclusion, four-week repeated oral dose of Clean Natural to rats did not cause apparent toxicological change at the dose less than 2,000 mg/kg body weight. Thus it is suggested that no-observed adverse-effect level(NOAEL) for Clean Natural in rats was considered to be 1,000 mg/kg/day.

Four-Week Repeated Oral Toxicity Study of AIP1, a Water-soluble Carbohydrate Fraction from Artemisia iwayomogi in Mice

  • Ryu, Sung-Ha;Jo, Hae-Ran;Kim, Ji-Won;Youn, Hyun-Joo;Kim, Kyu-Bong
    • Toxicological Research
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    • v.27 no.4
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    • pp.261-267
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    • 2011
  • Artemisia iwayomogi, a member of the Compositae, is a perennial herb easily found in Korea and used as a traditional medicine to treat liver disease. AIP1, a water-soluble carbohydrate fraction from Artemisia iwayomogi, showed anti-tumor and immuno-modulating activities in animal studies. A subacute toxicological evaluation of AIP1 was performed for 4 weeks in ICR mice. After administration of AIP1 (0, 20, 100, 500 mg/kg/day), the clinical signs, mortalities, body weight changes, hematology, blood clinical biochemistry, urinalysis, organ histopathology, organ weights and gross finding were examined. The results showed that there were no significant differences in body weight changes, food intakes, water consumptions, or organ weights among different dose groups. Also we observed no death and abnormal clinical signs during the experimental period. Between the groups orally treated with AIP1 and the control group, there was no statistical significance in hematological test or serum biochemical values. Histopathological examination showed no abnormal changes in AIP1 groups. These results suggest that no observed adverse effect level (NOAEL) of the oral administration of AIP1 for 4 weeks was considered to be more than 500 mg/kg/day in mice under the condition investigated in current study.

Thirteen-Week Repeated Oral Toxicity Study of Paecilomyces sinclairii in Sprague-Dawely Rats (랫드에서 매미눈꽃동충하초, Paecilomyces sinclairii의 13주 반복투여 독성에 관한 연구)

  • Ahn Mi Young;Jee Sang Duk;Kim Ji Young;Han Jea Woong;Lee Yang Ki;Lee Yang Woo;Ryu Kang Sun;Lee Byung Mu;Jung Na Jin;Kim Sung Nam
    • Toxicological Research
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    • v.20 no.4
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    • pp.339-348
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    • 2004
  • Paecilomyces sinclairii was administered ad libitum feeding at percentage levels of 0, 1.25, 2.5, 5 and 10 percentage (calculated about 8 g/kg)/feeder for a period of 3 months. There was no observed clinical signs or deaths related to treatment in all groups tested. Therefore, the approximate lethal dose of P. sinclairii was considered to be higher than 8 g/kg in rats. Mild decreases in body weight gain were observed dose-dependently in P. sinclairii treated groups in dose response manner after 2 weeks. Interestingly, the weight of abdominal adipose tissues surrounding epididymides were greatly reduced by this Dongchunghacho, in parallel with the mild increase in body weight gain. However, the absolute weight change of other organs was not observed. There were not significantly different from the control group in urinalysis, ocular examination, hematological, serum biochemical value and histopathological examination. From these results, it is concluded that the no-observed-adverse-effect level (NOAEL) of P. sinclairii is less than 1.25% (1 g/kg) in rats in the present study.

Effect of Oral Administration of Processed Sulphur on Hepatotoxicity (법제 유황 경구투여가 간독성에 미치는 영향)

  • Song, In-Sun;Youn, Dae-Hwan;Yoo, Hwa-Seung
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.21 no.4
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    • pp.898-906
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    • 2007
  • This study was to evaluate the effects of oral administration of Processed Sulphur on Hepatotoxicity. Processed Sulphur was administered orally to rats for 28 days. We measured the body and liver weight index, heamtological and biomedical parameters. We also observed the histopathological changes of liver in rats. No significant differences in body weight, liver weight index, heamtological and biomedical parameters and histopathological changes of hepatocyte between control and Processed Sulphur fed group were found. Our data indicate that hepatotoxicity was not caused by oral medication of Processed Sulphur up to 60mg/200g/day for 28 days in rats. Therefore, Processed Sulphur appears to be safe and non-toxic in these studies and a no-observed adverse effect level (NOAEL) in rats is established at 60mg/200g/day. The data could provide satisfactory preclinical evidence of safety to launch clinical trial on standardized formulation of mineral extracts.

Valid Assessment for Copper Standard Establishment in Drinking Water (먹는물에서 구리기준 설정 타당성)

  • Yu, Soon-Ju;Jeong, Dong-Hwan;Kim, Jun-Hwan
    • Journal of Environmental Impact Assessment
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    • v.17 no.2
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    • pp.143-151
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    • 2008
  • As the NOAFL of copper based on liver toxicity in the human body is set and the TDI of copper is lower, it is necessary to strengthen the drinking water standard of copper according to toxic effects and the TDI of copper in humans. It is difficult to calculate the accurate drinking water standard because of the part of uncertainty for chronic effects of acute human with Wilson's disease and baby in the current studies. In order to improve the drinking water standard of copper considering of liver toxicity, it is desired to set the drinking water standard with concerning of the revising tendency in the foreign countries such as US, EC and WHO.

작업환경을 위한 TLV의 근거 - PERFLUOROBUTYL ETHYLENE(1)

  • Kim, Chi-Nyeon
    • 월간산업보건
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    • s.276
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    • pp.27-31
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    • 2011
  • Perfluorobutyl ethylene(PFBE)은 유기용제 혼합물에 주로 사용되는 산업화학물질로 동물에게 경구, 피부, 눈 그리고 흡입 노출되는 경우 급성 독성이 매우 낮다. Perfluorobutyl ethylene을 흰쥐에게 하루 6시간, 일주일에 5일씩 2주간을 0, 500 ppm, 5,000 ppm, 50,000 ppm을 흡입 노출시킨 연구에서 최대무작용량(no-observed-adverse effect level, NOAEL)으로 500 ppm이 결정되었으며 5,000 pm에서는 단핵 백혈구가 약간 증가하였다. 50,000 ppm에서도 병리학적 변화는 없었다. 그 후의 흡입연구는 하루 6시간, 28일간 연속적으로 흰쥐 암수에게 400 ppm, 2,000 pm, 10,000 ppm의 농도로 perfluorobutyl ethylene 증기를 노출시켰다. 최종 노출 후 흰쥐를 희생시켜 관찰한 결과, 체내 기관 무게변화를 포함한 어떠한 변화도 관찰되지 않았다. 그러나 10,000 ppm에 노출된 수컷 흰쥐 5마리 중 4마리는 작은 다중간세포질 액포가 발견되었다. Perfluorobutyl ethylene 증기 10,000 ppm에 노출된 수컷 흰쥐는 부분적으로 평균 혈액응고 촉진 시간이 감소하였다. 이 연구에서는 최대무작용량을 2,000 ppm으로 결정하였다. Perfluorobutyl ethylene의 TLV-TWA 100 ppm은 노출 후 악영향을 최소화하는데 충분한 농도이며 "피부흡수(Skin)", "감작제(SEN)" 그리고 발암성에 대한 경고주석을 설정하기에는 유용한 연구가 충분하지 않다.

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Reproductive Toxicity Study of Aspalatone, A New Antithrombetic Agent: Teratogenicity Study in Rats (항혈전제 아스파라톤의 생식독성연구:랫드 최기헝성시험)

  • 정문구;이상준;김종춘;송시환
    • Biomolecules & Therapeutics
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    • v.6 no.2
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    • pp.151-158
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    • 1998
  • Aspalatone, a new antithrombotic agent, was administered orally to pregnant Sprague-Dawley rats during the organogenetic period at dose levels of 0, 20, 100 and 500 mg/kg/day. All dams were subjected to caesarean section on day 20 of pregnancy. Effects of test substance on dams and embryonic development of F1 fetuses were examined There were treatment-related decreases in body weight and food consumption in the 500 mg/kg group. There was a increase in the spleen weight in the 100 and 500 mg/kg groups. Develo-pmental toxicity was evident as decreased fetal body weights and increased fetal malformations in the 500 mg/ kg group. External and skeletal malformations of fetuses occurred at an incidence of 1 and 8.2%, respectively. In addition, there was a delay in ossification of sternebrae and sacrocaudal vertebrae in the 500 mg/kg group. The results show that the no observed adverse effect dose level (NOAEL) for maternal toxicity was 20 mg/kg/ day and for developmental toxicity was 100 mg/kg/day.

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Four-week Oral Toxicity Study of DA-9601, an Antiulcer Agent of Artemisia spp. Extract, in Rats (애엽추출물 항궤양제 DA-9601의 랫드에 대한 4주 경구 반복투여 독성연구)

  • 김옥진;강경구;김동환;백남기;안병옥;김원배;양중익
    • Biomolecules & Therapeutics
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    • v.4 no.4
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    • pp.354-363
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    • 1996
  • This study was conducted to investigate the repeated dose toxicity of DA-9601, an antiulcer agent of Artemisia app. extract, in rats. DA-9601 was administered orally once a day for 4 weeks to 10 males and 10 females per group at doses of 0(vehicle control), 125, 500 or 2000 mg/kg/day. Throughout the study, no treatment-related deaths and clinical signs were observed. In female rats receiving 125 mg/kg of DA-9601, water consumption increased slightly on day 4, 11 and 25. Hematological examination showed a decrease of MCV and an increase of PLT in male rats at the doses of 500 and 2000 mg/kg groups. Blood biochemistry revealed slight decreases of cholesterol, BUN and Na in male rats and decreases of total bilirubin and creatinine and slight increases of globulin and Cl in female rats. The organ weights at the end of 4 weeks showed slight changes in some organs of treated groups. But, all these changes were not considered to be of toxicological importance, because they did not show dose-response relationship and relevance to gross and microscopic findings. Histopathologically, abnormal treatment-related changes were not observed in any organ and target organs were not detected. On the basis of these results, the NOAEL(no-observed-adverse-effect level) of DA-9601 was estimated to be more than 2000 mg/kg/day under the conditions tested.

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Inhalation toxicity assesment of C.I.No. Reactive Red 195 in Rats (아조계 반응성염료 C.I.No. Reactive Red 195의 흡입독성평가)

  • Chung, Yong Hyun;Han, Jeong Hee;Song, Kyung Seuk;Kim, Hyeon Yeong;Lee, Sung Bae;Yu, Il Je
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.11 no.3
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    • pp.198-205
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    • 2001
  • Many reactive dyes have been used in occupational settings without knowing their toxicity and health hazard information. To investigate the toxicity of reactive dye, C.I.No. Reactive Red 195 was exposed to male and female Sprague Dawley rats by inhalation for 28 days. The rats were exposed C.I.No. Reactive Red 195 for 6 hrs per day and 5days per week. The concentrations for the inhalation exposure were 0, 10, 40 and $160mg/m^3$. After 4 weeks of exposure, rats were examined for exposure related changes through pathology, blood biochemistry and hematology. There were no dose related changes including clinical signs, body weight and relative organ weight changes, hematological and biochemical and histopathological findings. The results indicate that no observed adverse effect level (NOAEL) of 28 days inhalatrion toxicity test for C.I.No. Reactive Red 195 was $160mg/m^3$.

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