• Title/Summary/Keyword: single oral toxicity

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Single Oral Dose Toxicity Studies of Polycan, β-Glucan Originated from Aureobasidium in Mice

  • Lee, Hyeung-Sik;Yang, Kun-Ju;Shin, Hyun-Dong;Park, Bok-Ryeon;Son, Chang-Woo;Jang, Hee-Jeong;Park, Dong-Chan;Jung, Young-Mi;Ku, Sae-Kwang
    • Toxicological Research
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    • v.21 no.4
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    • pp.361-365
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    • 2005
  • This study was conducted to obtain the acute information of the oral dose toxicity of Polycan - originated from Aureobasidium pullulans SM-2001 (half of the dry material is -1,3/1,6-glucans), a UV induced mutant of A. pullulans, having various pharmacological effects, in male and female mice. In order to calculate $50\%$ lethal dose $(LD_{50})$, approximate LD and target organs, test article was administered twice by oral gavage to male and female ICR mice at total 1000, 500 and 250mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings. The results obtained in this study suggest that the Polycan is non-toxic in mice and is therefore likely to be safe for clinical use. The L050 and approximate $(LD_{50})$ in mice after single oral dose of Polycan were considered over 1000 mg/kg, respectively.

Toxicity Evaluation of Asarum Sieboldii Extract for Human's Safety (인체안전성을 위한 족두리풀 천연추출물의 독성평가)

  • Kim, Young Hee;Jo, Chang Wook;Hong, Jin Young;Lee, Jeung Min;Kim, Soo Ji;Jeong, So Young
    • Journal of Conservation Science
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    • v.33 no.4
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    • pp.255-266
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    • 2017
  • Chemically derived pesticides have been used to prevent biological damage to domestic cultural property. However, their use is gradually being restricted due to the harmful effects on the human body and environment. Therefore, there is a growing interest in the search for new antifungal biopharmaceuticals whose safety has been confirmed by toxicity evaluation through animal experiments. This paper presents methods of toxicity evaluation of natural biocides using Sprague-Dawley rats and New Zealand White (NZW) rabbits. Safety of the natural biocide extract of Asarum sieboldii was evaluated using single-dose oral and dermal toxicity tests in Sprague-Dawley rats, and eye and skin irritation tests in NZW rabbits. The extract has proven antimicrobial and insecticidal activities against wood-rotting fungi and termites. After single oral administration to rats, the $LD_{50}$ values were determined to be over 4,000 and 2,000 mg/kg for males and females, respectively. After single dermal administration to rats, the $LD_{50}$ values exceeded 10,000 mg/kg for both males and females. The extract was identified to be non-irritant to the rabbit eye, and only slightly irritant to the rabbit skin. In this study, we confirmed the safety of the A sieboldii extract through animal testing. Due to the harmfulness of humidifier disinfectants, focus is on the safety of chemical pesticides, and toxicity evaluation is suggested as the basic method for hazard evaluation.

Study on the Anti-allergic Effect of Armeniacae Semen Herbal Acupuncture Solution (행인약침(杏仁藥鍼)이 항알레르기에 미치는 영향)

  • Kim, Yu-Seung;Song, Choon-Ho
    • Korean Journal of Acupuncture
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    • v.24 no.4
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    • pp.151-162
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    • 2007
  • Objectives : The purpose of this study was to examine the anti-allergic effect in vivo, and to observe single toxicity in mice of Armeniacae Semen herbal acupuncture solution (ASHA). Methods : We investigated anti DNP IgE-mediated passive cutaneous anaphylaxis in rodents and compound 48/80-induced active systemic anaphylatic shock in mice after treatment at both BL13 with ASHA of 25 ${\mu}{\ell}$(mice) or 50 ${\mu}{\ell}$(rats) 3 times for 5 days. To ascertain safety and toxicity of ASHA, we examined single toxicity test. In single test, three groups were treated with different dosages of ASHA (ASHA250, ASHA500 and ASHA1000) according to on Korean Food and Drug Administration, respectively. We observed attentively motality, abnormal clinical sign, body weight change, and organ weight of mice after ASHA treatment. Results : ASHA inhibited passive cutaneous anaphylaxis and active systemic anaphylatic shock by oral administration. During toxicity experiment period, there was no difference in body weight change, and organ weight among different dose groups. Death were not found in single test i.p. group. (ASHA250, ASHA500 and ASHA1000). Several individuals of single test i.p. group were observed yellow brown discharge around anus in early period after administration. Conclusions : These results indicate that ASHA have inhibition effects on passive cutaneous anaphylaxis and active systemic anaphylatic shock, and suggest that has some toxicity in high dosage.

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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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    • v.11 no.6
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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.

Single Dose Toxicity Study of Seonpyejeongcheon-tang in Sprague-Dawley Rats (Sprague-Dawley 랫드를 이용한 선폐정천탕의 단회투여독성시험)

  • Lee, Eung-Seok;Han, Jong-Min;Yang, Su-Young;Kim, Min-Hee;Kim, Seung-Hyung;NamGung, Uk;Park, Yang-Chun
    • The Journal of Internal Korean Medicine
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    • v.33 no.1
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    • pp.62-68
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    • 2012
  • Objectives : This study aimed to evaluate the single oral dose toxicity of Seonpyejeongcheon-tang (SJT) in male and female Sprague-Dawley rats. Methods : In this single oral toxicity study, rats were orally administrated in a single dose of 0 or 5,000 mg/kg SJT. There were 7 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological findings were observed for 14 days. Organ weight, clinical chemistry and hematology were tested after 14 days. Results : There was no mortality or other clinical signs for 14 days. There were also no significant differences in body weight, organ weights, hematological and serum chemical parameters between the SJT and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of SJT is over 5,000 mg/kg, so this finding can be expected to provide scientific evidence for the safety of SJT.

Single-Dose Toxicity and Four Week Repeated-Dose Toxicity Study on Tensolin-F® (3,9-diferuloyl-6-oxopterocarpen) (Tensolin-F® (3,9-diferuloyl-6-oxopterocarpen)의 단회 독성시험 및 4주 반복투여 독성시험)

  • Kim, Keun-Su;Park, Sung-Min;Lee, Nam-Jin;Pyo, Hyeong-Bae;Chai, Hee-Yul;Jung, Yu-Ri;Lin, Chun-Mai;Kim, Sun-Hee;Lee, Hye-Young;Kang, Jong-Koo
    • Toxicological Research
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    • v.23 no.4
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    • pp.405-413
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    • 2007
  • This study was to investigate single and repeated-dose toxicities of Tensolin-$F^{(R)}$, an anti-wrinkle agent, in Sprague-Dawley (SD) rats or ICR mice. In single-dose oral toxicity study, the test materials were administered once by gavage to male and female SD rats at dose levels of 0 and 2,000 mg/kg. No dead animals and abnormal necropsy findings were found in control and Tensolin-$F^{(R)}$ treated group. Therefore, the approximate lethal dose of Tensolin-$F^{(R)}$ was considered to be higher than 2,000 mg/kg in rats. In the 4-week repeated oral toxicity study, the test material was administered once daily by gavage to male and female ICR mice at dose levels of 0, 25, 50 and 100 mg/kg/day for 4-weeks. In the results, no abnormality was observed in mortality, clinical findings, body weight changes, food and water consumptions, opthalmoscopic findings, necropsy findings, histopathological findings. In hematological analysis, there was a trend of increase in reticulocyte at male 25 mg/kg, although such changes were in normal ranges. On the other hand, there was a trend of decrease in hemoglobin at female 50, 100 mg/kg, such changes were in normal ranges. In addition, serum biochemical parameters including sodium, BUN and chloride increased at 25, 50 and 100 mg/kg. Relative organ weights of right testis, brain, lung and left epididymis were increased in 100 mg/kg groups of male rats in contrast to not change in female groups. However, these changes of relative organ weights, hematological and serum biochemical parameters were not accompanied with related signs such as histopathological changes or clinical findings. In conclusion, 4-week repeated oral dose of Tensolin-$F^{(R)}$ to ICR mice did not cause apparent toxicological change at the dose of 25, 50, 100 mg/kg body weight. Consequently the no-observed-adverse-effect level (NOAEL) for Tensolin-$F^{(R)}$ in ICR mice following gavage for at least 4-week is higher than 100 mg/kg/day.

Single Oral Dose Toxicity Test of Water Extracts of Radix Araliae Cordatae in ICR Mice

  • Leem, Moon-Jeong;Ryu, Jei-Man;Ku, Sae-Kwang
    • Biomolecules & Therapeutics
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    • v.15 no.2
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    • pp.127-132
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    • 2007
  • The object of this study was to evaluate the acute toxicity of lyophilized water extract of Radix Araliae Cordatae (RA) in male and female mice. The extract was administered to female and male ICR mice as an oral dose of 2000 mg/kg (body wt.) according to the recommendation of KFDA Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy, organ weight and histopathology of 12 principle organs were examined. As results, we could not find any mortality, clinical signs, changes in the body weight and gross findings except for increases of hypertrophy of lymph nodes in male RA extracts-dosing group. In addition, no RA extracts-treatment related abnormal changes in the organ weight and histopathology of principle organs except for some sporadic accidental findings. The results obtained in this study suggest that the RA extracts does not cause any toxicological signs. The LD$_{50}$ and approximate LD of RA extracts in both female and male mice were considered as over 2000 mg/kg.

Acute and Subacute Toxicity of l-Muscone in Beagle Dogs (비글개에서 l-muscone의 급성독성 및 아급성독성시험 연구)

  • 유아선;권오경;성하정;곽형일;방명주;박대규;정규혁;윤효인;조명행
    • Toxicological Research
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    • v.13 no.4
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    • pp.449-460
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    • 1997
  • Single and 4 weeks oral administration of l-muscone, a major active ingredient of musk, to beagle dogs of both sexes were performed to investigate both acute and subacute toxicity. Beagle dogs(3 males and 3 females) in acute experiments were administered orally with single dosage of 2,000 mg/kg and groups of 9 male and 9 female beagle dogs in subacute experiments were given daily different dosage of l-muscone, 0.2 mg/kg/day(low dosage group), 2 mg/kg/day(middle dosage group), or 20 mg/kg/day(high dosage group) once a day for 4 weeks by oral route according to the Established Regulation of Korean Food and Drug Administration(1996.4.16). $LD_{50}$ value for beagle dogs was more than 2,000 mg/kg on oral route for both male and females. In animals administered with l-muscone, there were neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical signs, urinalysis, eye examination, hematology, serum chemistry, organ weight and other findings. No histolopathological lesions were observed in both control and treatment groups. Above data strongly suggest that l-muscone in beagle dogs is considered to be safe.

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Acute toxicity study of 77 herbal formulas according to GLP guidelines in rats (흰쥐에서 GLP 기준에 의한 한약처방 77종의 단회 투여 급성 독성 연구)

  • Hyeun-kyoo Shin;Woo-Young Jeon;Chang-Seob Seo;Mee-Young Lee
    • The Journal of Korean Medicine
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    • v.44 no.3
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    • pp.29-38
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    • 2023
  • Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

Acute Oral Toxicity and Pathogenicity of a Potential Probiotic Bacillus sp. A9184 Isolated from Soybean Paste

  • Lim, Jong-Hwan;Park, Byung-Kwon;Kim, Myoung-Seok;Rhee, Man-Hee;Park, Seung-Chun;Yun, Hyo-In
    • Toxicological Research
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    • v.20 no.4
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    • pp.359-363
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    • 2004
  • This study provides more information about the potential toxicological risk of Bacillus sp. A9184 isolated from soybean paste. The evaluation was based on the guidelines of acute oral toxicity/pathogenicity for microbial pesticide and was to get more comprehensive understanding on the acute toxicity of the potential probiotic in Sprgue-Dawley rats. No dead animal was observed in rats after single oral administration with bacteria ($10^8$ CFU per animal). There were neither no treatment-related changes in clinical signs, nor changes in body weight and body temperature as com-pared with the untreated group. All tested animal showed the increase in body weight with time. The results obtained in this study suggest that the potential probiotic, Bacillus sp. A9184, is non-toxic for rat.