• Title/Summary/Keyword: No-observed adverse effect level

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Performances of Anaerobic Sequencing Batch Reactor for Digestion of Municipal Sludge at the Conditions of Critical Solid-liquid Separation (혐기성 연속 회분식 공정에 의한 도시하수슬러지 소화시 고액분리 특성에 따른 처리효율평가)

  • Hur, Joon-Moo;Park, Jong-An
    • Journal of Environmental Health Sciences
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    • v.28 no.5
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    • pp.77-85
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    • 2002
  • The objective of this study was to evaluate the performances of the ASBR under critical conditions of solid-liquid separation, caused by extremely high solids concentration, for wider application of the ASBR to various wastes. The ASBRs and completely-mixed daily-fed control runs were operated using a municipal mixed sludge at 35$^{\circ}C$ and 55$^{\circ}C$. Conversion of completely-mixed daily-fed reactor to sequencing batch mode and changes in HRT of all ASBRs were easily achieved without adverse effect, regardless of digestion temperature. Solids accumulation was remarkable in the ASBRs, and directly affected by settleable solids concentration of the feed sludge. Noticeable difference in solids-liquid separation was that flotation thickening occurred in the mesophilic ASBRs, while gravity thickening was a predominant solid-liquid separation process in the thermophilic ASBRS. Solids profiles at the end of thickening step dramatically changed at solid-liquid interface, and slight difference in solids concentrations was observed within thickened sludge bed. Organics removals based on subnatant or supernatant after thickening always exceeded 80% in all reactors. Thickened sludge volume and gas production of the ASBRs affected mutually. Gas production increased as thickened sludge accumulated, and continuous gas evolution during thickening could cause thickened sludge to expand or resuspend. Thickened sludge volume exceeding a predetermined withdrawal level resulted in loss of organic solids as well as biomass during withdrawal step, leading to decrease in gas production ind SRT. Such an adverse mutual effect was significant in gravity thickening, while it was not sensitive in flotation thickening. Changes in organic loading had no significant effect on organic removals and gas production after build-up of solids in the ASBRs.

Pre- and postnatal development study of amitraz in rats (랫드에서 amitraz의 출생 전후 발생 시험)

  • Kim, Sung-Hwan;Lim, Jeong-Hyeon;Park, Na-Hyeong;Moon, Changjong;Park, Soo-Hyun;Kang, Seong-Soo;Bae, Chun-Sik;Kim, Sung-Ho;Shin, Dong-Ho;Kim, Jong-Choon
    • Korean Journal of Veterinary Research
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    • v.50 no.2
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    • pp.93-103
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    • 2010
  • This study investigated the potential effects of amitraz on the pre- and postnatal development, behavior, and reproductive performance of offspring of parent rats given amitraz during pre-mating, gestation, and lactation. The test chemical was administered via the drinking water containing 0, 40, 120, and 360 ppm to male rats from 2 weeks before mating to the end of 14-day mating period and to females from 2 weeks before mating, throughout mating, gestation and lactation up to weaning. Based on fluid consumption, the male rats received an average of $0,\;5.7{\pm}1.33,\;13.2{\pm}2.08,$ and $35.8{\pm}3.42$ mg/kg/day amitraz, and the female rats received an average of $0,8.7{\pm}4.42,\;20.1{\pm}9.60,\;and\;47.6{\pm}22.38$ mg/kg/day amitraz, respectively. At 360 ppm, an increase in the incidence of abnormal clinical signs, a suppression in the body weight gain, a decrease in the food consumption and litter size, an increase in the post-implantation loss, and a decrease in the seminal vesicle weight were observed in the parent animals. In addition, a suppression in the body weight gain, a decrease in the grip strength, a delay in the negative geotaxis, an increase in the pre- and post-implantation loss, and a decrease in the number of live embryos were observed in the offspring. At 120 ppm, suppressed body weight gain and reduced food consumption were observed in the parent rats. Suppressed body weight gain and decreased grip strength were also observed in the offspring. There were no signs of either reproductive or developmental toxicity at 40 ppm. Under these experimental conditions, the no-observed-adverse-effect level of amitraz for parent rats and their offspring was estimated to be 40 ppm in rats.

A 13-Week Repeated Oral Dose Toxicity Test and a 4-Week Recovery Test of Standardized Cornus officinalis and Psoralea corylifolia L . in Sprague-Dawley Rats (산수유(山茱萸)와 보골지(補骨脂) 복합추출물의 Sprague-Dawley 랫드를 이용한 13 주 반복경구투여 독성시험 및 4 주 회복시험)

  • Sim, Seo-Ah;Kang, Sung-Chul;Jin, Bo-Ram;Kim, Min-jeong;Yeo, Sujung;Park, In-hwa;Jerng, Ui Min;Cha, Yun-yeop;Ahn, Ji-Hye;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.36 no.6
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    • pp.27-37
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    • 2021
  • Objectives : In the current study, we performed the 13-week repeated oral dose toxicity test and a 4-week recovery test of standardized Cornus officinalis Sieb. et Zucc. and Psoralea corylifolia L. 30 % ethanol extract (SCP) in Sprague-Dawley (SD) rats owing to aims for verifying no observed adverse effect level (NOAEL). Methods : The animal study was performed according to OECD guidelines for the testing of chemicals section 4 health effects test No.408 repeated dose 90-day oral toxicity study in rodents (03 October 2008). In the repeated dose toxicity study, SCP was orally administered to female and male rats at dose levels of 1,000, 2,000, and 4,000 mg/kg/day for 13-week. The control group and high dose (4,000 mg/kg/day) group were then monitored for 4 extra weeks to determine recovery time after the study period. 1) Results : Compared with the control group, there were no treatment-related adverse effects in clinical signs, body weight, hematology, serum biochemistry (Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, 𝛾-Glutamyl transpeptidase, Blood urea nitrogen, Creatinine, Glucose, Total cholesterol, Total protein, Creatine phosphokinase, Albumin, Total bilirubin, Triglyceride, Inorganic phosphorus, Albumin/Globulin ratio, Calcium ion, Sodium ion, Potassium ion, Chloride ion), necropsy findings and organ weight (Ovary, Adrenal gland, Pituitary, Thymus, Prostate, Testis, Epididymis, Spleen, Kidney, Heart, Lung, Brain, Liver) at any dose tested. Conclusions : Taken together, these results suggest that the NOAEL of SCP in both genders was considered as over 4,000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

Recommendation of an Occupational Exposure Limit and Legal Control Following an Acute Hepatotoxicity Incident from HCFC-123 (HCFC-123의 급성 독성간질환 발생 사례에 따른 노출기준 및 법 관리 필요성 권고)

  • Lee, Kwon Seob;Jo, Ji hoon;Choi, Bo Kyung;Lee, Hye Lim;Byeon, Sang Hoon
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.28 no.1
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    • pp.80-90
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    • 2018
  • Objectives: This study was performed to propose a domestic occupational exposure limit(OEL) following a health hazard assessment, calculation of a non-carcinogenicity reference concentration worker($RfC_{worker}$) value, and examination of international agencies' exposure limits. It also recommends legal management within the Occupational Safety and Health Act for HCFC-123, which caused an acute hepatotoxicity incident. Methods: An acute hepatotoxicity incident due to the fire extinguishing agent HCFC-123 was investigated. Toxicological hazard and health hazard classifications were examined and a non-carcinogenicity $RfC_{worker}$ value was calculated for HCFC-123. An OEL and the necessity of legal management were recommended as well. Results and Conclusions: An OEL for HCFC-123 of 10 ppm($62.5mg/m^3$), which considered the $RfC_{worker}$ value, 5.56 ppm, produced in dose-response assessment and the exposure level of 19.1-20.9 ppm measured as an eight-hour TWA(time-weighted average) in the incident place, is recommended. HCFC-123 is urged to be included as a chemical requiring legal management in the Occupational Safety and Health Regulations. In addition, it is recommended that a peak exposure of ACGIH be adopted in the Notice of the Ministry of Employment and Labor.

Risk Assessment of Ethylhexyl Dimethyl PABA in Cosmetics

  • Sung, Chi Rim;Kim, Kyu-Bong;Lee, Joo Young;Lee, Byung-Mu;Kwack, Seung Jun
    • Toxicological Research
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    • v.35 no.2
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    • pp.131-136
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    • 2019
  • Ethylhexyl dimethyl para-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl dimethyl PABA is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5-2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that ethylhexyl dimethyl PABA is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that ethylhexyl dimethyl PABA inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of ethylhexyl dimethyl PABA following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of ethylhexyl dimethyl PABA in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% ethylhexyl dimethyl PABA, which is the maximum level allowed by the relevant domestic authorities.

The Effect of Hyeonggaeyeongyotang Extract on the Fertility, Early Embryonic Development in Wistar rats by Oral Gavage Administration (형개련교탕(荊芥連翹湯) 추출물의 경구투여(經口投與)가 rat의 수태능(受胎能) 및 초기(初期) 배발생(胚發生)에 미치는 영향(影響))

  • Kim, Eun-Hee;Hwang, Sun-Yi;Kim, Sang-Chan;Jee, Seon-Young
    • Herbal Formula Science
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    • v.16 no.1
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    • pp.65-78
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    • 2008
  • Objectives : this study was to access the effect of Hyeonggaeyeongyotang water extracts, a polyherbal formula has been used as folk medicine, on the fertility and early embryonic development of male and female Wistar rats when administered by oral gavage. Methods : In male rats, Hyeonggaeyeongyotang extract were dosed 4 weeks before pairing and 2 weeks after mating including the mating periods up to termination after necropsy of the majority of the females. In female rats, they were dosed 2 weeks before pairing, and from Day 0 to Day 7 of gestation. This study was conducted in accordance with the recommendations of the KFDA Guideline [2005-60] for Detection of Toxicity to Reproduction for Medicinal Products. Results: 1. No Hyeonggaeyeongyotang extract treatment-related changes on the clinical signs and mortalities, the Food consumptions, the Body weights and gains were demonstrated in all dosed levels tested in this study except for 500ml/kg-dosing male group in which a significant(p<0.05) increase of body gains was detected during day 0-7 after dosing. 2. No Hyeonggaeyeongyotang extract treatment-related changes on the pre-coital intervals, the estrus cycles, the mating index, conception rate and fertility index were demonstrated in all dosed levels tested in this study. 3. No Hyeonggaeyeongyotang extract treatment-related gross findings on reproductive organs, the weights of reproductive organs, histopathological findings on reproductive organs, the corpora lutea number, implantation site number, live fetus number, number of resorpted embryo and pre-and post-implatation loss were demonstrated in all dosed levels tested in this study. Conclusions : Base on the results, it is considered that the NOAEL (No-Observed-Adverse-Effect Level) for fertility and early embryonic development toxicity of Hyeonggaeyeongyotang extract was under 2000ml/kg/day in Wistar male and female rats because there no treatment-related changes on the fertility and early embryonic developmental index were demonstrated in all dosed levels tested.

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A 90-day repeated-dose oral toxicity study on Flos lonicerae extract in Fischer 344/N rats (금은화(Flos lonicerae) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험)

  • Han, Zhong-Ze;Zhang, Hu-Song;Kang, Sang-Chul;Gil, Ki-Hyun;Kong, Kwang-Han;Kim, Do-Hyung;Ahn, Tae-Hwan;Bae, Jin-Sook;Go, Hyeon-Kyu;Han, Myoung-Kyu;Kim, Hak-Soo;Heo, Hyun-Suk;Park, Eun-Mi;Song, Si-Whan;Kim, Kap-Ho;Park, Chan-Koo;Lee, Hyun-Kul
    • Korean Journal of Veterinary Research
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    • v.48 no.4
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    • pp.401-411
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    • 2008
  • This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

Thirteen-Week Repeated Oral Toxicity Study of Leaf Folder (Cnaphalocrocis medinalis) Resistant Rice (Nakdongbyeb) in Sparague-Dawely Rats (SD 랫드에서 혹명나방 저항성 유전자 변형 낙동벼의 13주 경구 반복투여 독성에 관한 연구)

  • Seo, Dong-Seok;Kwon, Min;Sung, Ha-Jung;Park, Cheol-Beom
    • The Korean Journal of Pesticide Science
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    • v.15 no.2
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    • pp.104-113
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    • 2011
  • We investigated the systemic effects of leaf folder (Cnaphalocrocis medinalis) resistant rice (transgenic rice, Nakdongbyeb) in Sprague-Dawley rats for 13 weeks. Leaf folder resistant rice was added to the diet at percentage levels of 0, 5 and 20 percentage/feeder and was administered for 13 weeks. The results did not show any changes in food and water intake. There were also no biologically significant changes in both body and organ weights, hematological and blood biochemical parameters, autopsy and histopathology between the treatment and control groups. Based on these results, no observed adverse effect level (NOAEL) of transgenic rice was considered to be more than 10,000 mg/kg b.w. under the conditions of the present study.

A 90-day repeated-dose oral toxicity study on Chelidonium majus extract in Fischer 344/N rats (백굴채(Chelidonium majus) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험)

  • Kim, Do-Hyung;Zhang, Hu-Song;Kim, Kwang-Ho;Kang, Sang-Chul;Kim, Hak-Soo;Gil, Ki-Hyun;Kong, Kwang-Han;Ahn, Tae-Hwan;Bae, Jin-Sook;Go, Hyeon-Kyu;Kim, Kap-Ho;Park, Chan-Koo;Lee, Hyun-Kul;Song, Si-Whan;Han, Zhong-Ze
    • Korean Journal of Veterinary Research
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    • v.49 no.1
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    • pp.23-34
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    • 2009
  • This study was performed to evaluate repeated-dose oral toxicities of Chelidonium majus extract in Fischer 344/N rats. Chelidonium majus extract was administered orally to rats at dose levels of 0, 25, 74, 222, 666 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Chelidonium majus extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, There were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Chelidonium majus extract. These results suggest that the oral no observed adverse-effect level of the test item, Chelidonium majus extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

Recommendation of Occupational Exposure Limit through occupational hazard assessment of PHMG-Phosphate (PHMG-Phosphate의 직업적 유해성평가를 통한 노출기준 제안 연구)

  • Lee, Hye Lim;Byeon, Sang Hoon;Lee, Kwon Seob
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.29 no.1
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    • pp.13-20
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    • 2019
  • Objective: This study was performed to propose a domestic occupational exposure limit(OEL) following a health hazard assessment, calculation of a non-carcinogenicity reference concentration worker($RfC_{worker}$) value, and examination of international agencies' exposure limits. It also recommends legal management within the Occupational Safety and Health Act for PHMG-Phosphate(CAS No. 89697-78-9), It is a humidifier disinfectant that generated many lung injuries. Methods: We have investigated the recommendation or guidelines of foreign OEL for PHMG-Phosphate and the actual state of legal management in Korea. To examine the procedures and methods for recommendation OEL. Toxicological hazard and health hazard classifications were examined and a non-carcinogenicity $RfC_{worker}$ value was calculated for PHMG-Phosphate. An OEL and the necessity of legal management were recommended as well. Results and Conclusions: The OEL for PHMG-Phosphate is recommended to be $0.01mg/m^3$. The recommended OEL is close to 10 times the RfCworker value of $0.000833mg/m^3$ calculated from the chemical dose-response hazard assessment, which is a 2017 study. The CMIT/MIT(3:1) mixture, which was a social issue as a humidifier disinfectant substance, was also exposed to the same ratio in March 2018, establish the OEL. It is recommended to establish OEL for PHMG-Phosphate to prevent worker health hazards and for chemical safety management.