• Title/Summary/Keyword: 4-Week subacute toxicity

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Toxicity Study of AS6, a Triterpenoid Derivative: 4-Week Repeated Oral Administration in Rats

  • Lee, Michael;Cha, Shin-Woo;Im, Doo-Hyun;Yang, Byung-Chul;Lim, Kwang-Hyeon;Cha, Kyung-Hoi;Kim, Jong-Choon;Chung, Moon-Koo;Han, Jung-Hee
    • Biomolecules & Therapeutics
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    • v.11 no.1
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    • pp.72-79
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    • 2003
  • The present study was conducted to investigate the potential subacute toxicity of AS6, [(3$\beta$, 4$\alpha$)-3,23-dihydroxyurs-12-en-28-oic acid], by a 4-week repeated oral administration in Sprague-Dawley rats. To test the subacute toxicity, AS6 was administered once daily by gavage to rats at dose levels of 0, 250, 500, and 1000 mg/kg/day for 4 weeks. There were no treatment-related effects on mortality, clinical signs, body weight, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathology in any treatment group. In the condition of this study, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day for both male and female rats.

Subacute Inhalation Toxicity of 3-Methylpentane

  • Chung, Yong Hyun;Shin, Seo-Ho;Han, Jeong Hee;Lee, Yong-Hoon
    • Toxicological Research
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    • v.32 no.3
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    • pp.245-250
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    • 2016
  • 3-Methylpentane ($C_6H_{14}$, CAS No. 96-14-0), isomer of hexane, is a colorless liquid originating naturally from petroleum or natural gas liquids. 3-Methylpentane has been used as a solvent in organic synthesis, as a lubricant, and as a raw material for producing carbon black. There is limited information available on the inhalation toxicity of 3-methylpentane, and the aim of this study was to determine its subacute inhalation toxicity. According to OECD Test Guideline 412 (subacute inhalation toxicity: 28-day study), Sprague Dawley rats were exposed to 0, 284, 1,135, and 4,540 ppm of 3-methylpentane for 6 hr/day, 5 days/week for 4 weeks via whole-body inhalation. Mortality, clinical signs, body weights, food consumption, hematology, serum chemistry, organ weights, and gross and histopathological findings were compared between control and all exposure groups. No mortality or remarkable clinical signs were observed during the study. No gross or histopathological lesions, or adverse effects on body weight, food consumption, hematology, serum chemistry, and organ weights were observed in any male or female rats in all exposure groups, although some statistically significant changes were observed in food consumption, serum chemistry, and organ weights. In conclusion, the results of this study indicate that no observable adverse effect level (NOAEL) for 3-methylpentane above 4,540 ppm/6 hr/day, 5 days/week for rats.

STUDIES ON THE SUBACUTE TOXICITY AND TOXICOKINETICS OF DW-224a, AFTER SINGLE AND 4-WEEK REPEATED ORAL ADMINISTRATION IN DOGS

  • Junghee Han;Cha, Shin-Woo;Chung, Moon-Koo;Han, Sang-Seop
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2002.11b
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    • pp.193-193
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    • 2002
  • The subacute toxicities and toxicokinetics of a new fluoroquinolone antibiotics, DW-224a, were evaluated after single (at the 1st day) and 4-week (at the 28th day) oral administration of the drug, in doses of 0 (to serve as a control), 10, 30 and 90 mg/kg/day, to male and female dogs (n = 3 for male and female dogs for each dose).(omitted)

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Subacute Inhalation Toxicity of Cyclohexanone in B6C3F1 Mice

  • Lee, Yong-Hoon;Chung, Yong Hyun;Kim, Hyeon-Yeong;Shin, Seo Ho;Lee, Sang Bae
    • Toxicological Research
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    • v.34 no.1
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    • pp.49-53
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    • 2018
  • Cyclohexanone ($C_6H_{10}O$, CAS No. 108-94-1) is a colorless oily liquid obtained through the oxidation of cyclohexane or dehydrogenation of phenol. It is used in the manufacture of adhesives, sealant chemicals, agricultural chemicals, paint and coating additives, solvent, electrical and electronic products, paints and coatings, photographic supplies, film, photochemicals, and as an intermediate in nylon production. Owing to the lack of information on repeated inhalation toxicity of cyclohexaone, in this study, we aimed to characterize the subacute inhalation toxicity. B6C3F1 mice were exposed to 0, 50, 150, and 250 ppm of cyclohexanone for 6 hr/day, 5 days/week for 4 weeks via whole-body inhalation in accordance with the OECD Test Guideline 412 (subacute inhalation toxicity: 28-day study). Mortality, clinical signs, body weights, food consumption, hematology, serum biochemistry, organ weights, as well as gross and histopathological findings were evaluated between the control and exposure groups. No mortality or remarkable clinical signs were observed during the study. No adverse effects on body weight, food consumption, hematology, serum biochemistry, and organ weights, gross or histopathological lesions were observed in any male or female mice in any of the exposure groups, although some statistically significant changes were observed in organ weights. We concluded that no observable adverse effect level (NOAEL) is above 250 ppm in mice exposed to cyclohexanone for 6 hr/day for 5 days/week.

Subacute toxicities and toxicokinetics of CJ-10882, a type IV phosphodiesterase inhibitor, after 4-week repeated oral administration in dogs

  • Junghee Han;Cha, Shin-Woo;Im, Doo-Hyun;Chung, Moon-Koo
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.05a
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    • pp.43-44
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    • 2003
  • The subacute toxicity and toxicokinetics of a type IV phosphodiesterase inhibitor, CJ-10882, were evaluated after single (on the 1st day) and 4-week (on the 27th day) oral administration of the drug, in doses of 0 (to serve as a control), 2, 10 and 50 mg/kg/d, to male and female dogs (n = 3 for male and female dogs for each dose). During the test period, clinical signs, mortality, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross findings, organ weight and histopathology were examined.(omitted)

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A 4-week Repeated Oral Dose Toxicity Study of CJ-10882 in Dogs

  • Cha, Shin-Woo;Kim, Jong-Choon;Kim, Dal-Hyun;Chung, Moon-Koo;Junghee Han
    • Toxicological Research
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    • v.18 no.3
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    • pp.241-248
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    • 2002
  • The present study was conducted to investigate the potential subacute toxicity of CJ-10882 by a 4-week repeated oral dose in dogs. The test article was administered once dally by gavage to dogs at dose levels of 0, 2, 10, and 50 mg/kg/day for 4 weeks. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross finding, organ weight, and histopathology were evaluated. Several clinical sign were observed in treated dogs at 50 mg/kg, including salivation and vomiting. Increase in the serum level of ALT and albumin observed in the female 50 mg/kg group was considered as a toxic effect related to the test article since the histopathological change in Liver was accompanied. There were no treatment-related effects on mortality, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings and organ weights in any treatment group. Based on these results, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was 10 mg/kg/day and the absolute toxic dose was 50 mg/kg for both male and female dogs.

Four-Week Oral Toxicity Study of CJ-50002 (Vibrio Vaccine) in Rats (CJ-50002(비브리오백신)의 랫드에 대한 4주간 경구 반복투여 독성연구)

  • 윤병일;정수연;김달현;이영수;김대용
    • Toxicological Research
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    • v.15 no.1
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    • pp.9-17
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    • 1999
  • This study was performed to evaluate the subacute toxicity of CJ-50002 (Vibrio Vaccine) in SPF Spraqur-Dawley (SD) rats. Vibrio vaccine was administered orally at a dose level of high (167mg/kg/day), medium (16.7mg/kg/day), and low (16.7mg/kg/day) once a day and repeated fro 4 weeks. Ten males and female rats were assigned to each group. After 4 week administration, no significant dose-dependent changes in body weight, water and food consumption rate or organ weight were noted dependent changes in body weight, water and food consumption rate or organ weight were noted among 4 groups. Urinanalysis, hematology, and serum chemistry, also fail to detect any dose-related change among 4 groups tested. During necropsy and histopathological examination, no specific toxicity related to treated material was found. The result of this study demonstrated that vibrio vaccine when administered orally for 4 weeks at a high dose of 167mg/kg/day, no dose-related toxicity was found in treated make and female rats.

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SINGLE OR FOUR-WEEK REPEATED INTRAVENOUS TOXICITY STUDIES OF A NEW CEPHALOSPORIN ANTffiIOTIC AGENT, IDC-7181 IN RATS

  • Zhang, Hu-Song;Huang, Zai-Zhi;Jung, Eun-Yong;Jung, Seong-Eui;Lim, Kwang-Hyun;In, Chang-Hoon;Kim, Dae-Joong;Nam, Sang-Yoon;Kang, Jong-Koo
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2001.10a
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    • pp.169-169
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    • 2001
  • This study was designed to evaluate an acute and subacute intravenous dose toxicity of a new cephalosporin antibiotic agent, IDC-7181 in 7-week-old Sprague-Dawley rats. IDC-7181 was intravenously injected to rats at dose levels of 0, 3.2, 16, 80, 400 and 2, 000 mg/kg/day for single dose toxicity study and at dose levels of 0, 10, 50 and 250 mg/kg/day for 4 week-repeated dose toxicity study. All rats survived throughout the study periods.(omitted)

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Single and Four-week Intravenous Toxicity Studies of DA-3585, a Recombinant Human Erythropoietin, in Rats (재조합 사람 적혈구 조혈인자 DA-3585의 랫드에 대한 단회 및 4주반복 정맥투여 독성시험)

  • Kim, Dong-Hwan;Cho, Hyeon;Kang, Kyung-Koo;Baik, Nam-Gi;Kim, Won-Bae
    • Biomolecules & Therapeutics
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    • v.6 no.2
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    • pp.182-190
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    • 1998
  • DA-3585 is a recombinant human erythropoietin produced by Dong-A pharmaceutical Co. Ltd. using recombinant DNA technique. Recently, recombinant human erythropoietin (rHu-EPO) has been used to treat various types of anemia. In this study, we examined acute and subacute toxicity of DA-3585 in rats. DA-3585 was intravenously administered to rats at dose levels of 0, 6,250, 12,500 and 25,000 lU/kg for single dose toxicity study and at dose levels of 0,100,500 and 2,500IU/kg daily for 4 week-repeated dose toxicity study. In the single dose toxicity study, there were no death, clinical signs and changes in body weight gain related to the treatment. Necropsy revealed no evidence of toxicity related to DA-3585, In the repeated dose toxicity study, all the rats survived throughout the study. There were no treatment-related changes in clinical signs, food and water intake, and body weight. Hematological examination showed increases in the number of erythrocytes, hemoglobin concentration, hematocrit value and mean corpuscular volume, and decrease in the number of platelet in 500 and 2,500 lU/kg dosed groups. Extramedullary hematopoiesis in the spleen and erythroid hyperplasia in the bone marrow were noted as treatment-related histological changes. Toxicologically significant changes were not observed in blood biochemistry, urinalysis, organ weights and in any other examinations. The treatment-related changes observed in this study were hematological or histological changes associated with pharmacological effects of DA-3585. On the basis of the results of this study, LD5n value of DA-3585 was above 25,000 lU/kg and the no-observed-adverse-effect-level was estimated to be 100 lU/kg.

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