• 대한한의학방제학회지
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• 제15권2호
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• pp.113-117
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• 2007

Objectives: Samul-tang(Siwu-tang) has been traditionally prescribed a medicine as a restorative. Methods: In this study, we investigated the acute toxicity about water-extracted Samul-tang(Siwu-tang). Twenty-five mice completed 14 days of oral Samul-tang(Siwu-tang) at the respective doses of 0(control group), 2560, 3200, 4000 and 5000mg/kg. Results: We observed survival rates, general toxicity, change of body weight, and autopsy. Conclusions: Compared with the control group, we could not find any toxic alteration in all treated groups (2560, 3200, 4000 and 5000mg/kg). $LD_{50}$ of Samul-tang(Siwu-tang) was over 5000mg/kg and it is very safe to ICR mice.

• Asian Pacific Journal of Cancer Prevention
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• 제16권16호
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• pp.7331-7335
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• 2015

Background: Concurrent chemoradiation with three weekly high dose cisplatin is the non-surgical standard of care for the treatment of locally advanced head and neck cancers. Although this treatment regime is efficacious, it has high acute toxicity, which leads not only to increased treatment cost, but also to increased overall treatment time. Hence, the current study was undertaken to evaluate the acute toxicity and tumor response in head and neck cancer patients treated with concurrent chemoradiation using $40mg/m^2$ weekly cisplatin, which has been our institutional practice. Materials and Methods: This single institution retrospective study included data for 287 head and neck cancer patients treated with concurrent chemoradiation from 2012 to 2014. Results: The mean age of the patients was 48.8 years. The most common site of involvement was oral cavity. Most of the study patients presented with advanced stage disease. The mean overall treatment time was 56.9 days. Some 67.2% had overall complete response to treatment as documented till 90 days from the start of treatment. According to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria, mucositis was seen in 95.1% of the patients. Dermatitis and emesis were observed in 81.9% and 98.6%, respectively. Regarding haematological toxicity, 48.8% and 29.6% suffered from anaemia and leukopenia, respectively, during treatment. Acute kidney injury was assessed using the Common Terminology Criteria for Adverse Events (CTCAE), and was found in 18.8% of the patients. Conclusions: Concurrent chemoradiotherapy with weekly cisplatin is an effective treatment regime for head and neck cancers with reasonable toxicity which can be used in developing countries, where cost of treatment is so important.

• Biomolecules & Therapeutics
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• 제7권2호
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• pp.185-190
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• 1999

The current study was performed to determine the acute oral toxicity of P55A, a crude extract of 1 : 1 mixture of Phellodendron amurense cortex and Aralia elata cortex, in SD rats and beagle dogs. 5 rats of each sex were treated with a single dose of P55A orally at doses of 0 and 5,000 mg/kg respectively. Also 2 dogs of each sex were treated with a single dose of P55A orally at doses of 0 and 2,000 mgAg, respectively. After the treatment, clinical signs, and body weight change were observed for 14 days. All rats survived during the study and did not show any clinical sign. Body weight gain showed no significant difference between the control and treated rats. Grossly, no lesion was observed in the rats. All dogs survived during the study. In clinical signs, dark stool was observed in the 2,000 mg/kg treated dogs at day 1 after administration. The animals recovered from general signs at day 2 after administration. Body weight gain showed no significant difference between the control and treated dogs. Grossly, no lesion was observed in the dogs. It is suggested that the LD$_{50}$ of P55A by oral administration was estimated to be over 5,000 mg/kg in both sexes of rats and 2,000 mg/kg in both sexes of beagle dogs.s.

• 셀메드
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• 제11권3호
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• pp.13.1-13.9
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• 2021

Background and Objective: Nux-vomica based traditional Unani formulation, Habb-e-Azaraqi (HAZ) is an important drug used by Unani physicians since several decades. It possesses Muqawwi-i-A'sab (nervine tonic), Muharrik-i-A'sab (nervine stimulant) properties and is an effective treatment option for diseases like Laqwa (facial palsy), Falij (paralysis), Niqris (gout) and Waja'al-Mafasil (arthritis) etc. The aim of the study is to access and provide information of HAZ for its TLC, HPTLC Fingerprinting defining its clear qualitative perspective and acute oral toxicity evaluation for its safety assessment which was not done earlier, thus contributing in the field of research. Materials and Methods: The chief ingredient, nux-vomica was detoxified as per method mentioned in Unani Pharmacopeia before its use in formulation. TLC and HPTLC was developed under four detection system i.e., UV 366nm, UV 254nm, exposure to iodine vapours and after derivatization with anisaldehyde sulphuric acid. Acute toxicity studies were performed as per OECD Guidelines 425 at a limit dose of 2000 mg/kg. Observations were done for signs of toxicity, body weight, and feed consumption at regular intervals followed by haematological and biochemistry evaluation. Results: The generated data proved the authenticity and established the TLC and HPTLC profile of the formulation. Acute toxicity revealed no significant differences in HAZ-treated animals with respect to body weight gain, feed consumption, haematology, clinical biochemistry evaluation. No significant gross pathological observation was noticed in necropsy. Conclusion: Data of the present study is substantial and scientific proof of HAZ in terms of standardization and toxicity study that can be utilize in future research activities.

• Biomolecules & Therapeutics
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• 제9권3호
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• pp.231-235
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• 2001

The single oral toxicity of JG-381 was studied in Sprague-Dawley rats of both sexes. In this study, rats were administrated orally with dosages of 267, 400, 600, 900 and 1350 mg/kg of JG-381. We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days after JG-381 administration. When we administered different doses of 267, 400, 600, 900 and 1350 mg/kg, we found 1, 4, 4, 5 and 5 male rats died and 3, 5, 4, 5 and 5 female rats died within 1 day after administration, respectively. Some clinical signs (decrease locomotor activity, salivation, soft stool, prone position, lacrimation, crouching position, convulsion, ataxic gait, incontinence of urine) were also observed during the experimental period. Our findings suggest that oral L $D_{50s}$ (95% confidence limit) for male and female rats are 327 mg/kg (270~396 mg/kg) and 250 mg/kg (256~264 mg/kg), respectively.y.

• Asian Pacific Journal of Cancer Prevention
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• 제15권15호
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• pp.5999-6003
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• 2014

Pesticides used in Korea are grouped by four classes of hazard (extremely, highly, moderately and slightly hazardous) based on acute oral and dermal toxicity in the rat. However, there is little information of carcinogenic effects. The aim of this study was to evaluate potential carcinogenicity for active ingredients of pesticides used in Korea. A total of 1,283 pesticide items were registered under the Pesticide Control Act of which 987 were commercially available. Of these 987 items, 360 active ingredients not duplicated were evaluated for carcinogenicity using the carcinogen list established by the US Environmental Protection Agency (EPA). Some 25 out of 360 ingredients were classified as likely to be carcinogenic (probable) to humans and 52 had suggestive evidence of carcinogenic potential (suspected) based on the US EPA classification. Some 31% of 987 items contained probable or suspected human carcinogenic ingredients. Carcinogenic pesticides accounted for 24% (5,856/24,795 tons) of the total volume of consumption in Korea. Interestingly, pesticides with lower acute toxicity were found to have higher carcinogenic potential. Based on these findings, the study suggests that it is important to provide information on long-term toxicity to farmers, in addition to acute toxicity data.

• Toxicological Research
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• 제22권4호
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• pp.439-443
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• 2006

This study was conducted to investigate the potential acute toxicity of Aralia elata by a single oral dose in ICR mice. Thirty mice of each sex were randomly assigned to three groups of 10 mice each. The test articles were administered once by the gavage to mice at dose levels of 0, 2,500 and 5,000 mg/kg body weight. The mortality and changes on body weight and clinical signs of gross observation were monitored for 14 days after dosing. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. There were no dead animal and adverse effects on clinical signs, the body weight and the gross finding. As the results, we could not find any toxic effect at the dose levels of 2,500 or 5,000 mg/kg in mice and the minimal lethal dose was considered to be over 5,000 mg/kg body weight in mice.

• Toxicological Research
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• 제14권4호
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• pp.501-505
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• 1998

The acute toxicity study of combined antibiotic (Cefatrizine / Clavulanic Acid), a formulation consisting of cafatrizine and clavulanic acid in a ratio of 2 : 1, was evaluated in rats. The antibiotic was orally administered with single dose in dose levels up to 5 g/kg (0, 1.25, 2.5, 5 g/kg). Treatment-related effects were limited to soft stool excretion and caecal dilatation, but histologically no morphological changes could be detected in caecum. In hematology, serum-chemistry parameters and histopathology, no drug-related changes were found. The results of the present study indicate that cefatrizine / clavulanic acid has a low toxic potential and the oral $LD_{50}$values exceed 5 g / kg in rats

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1996년도 춘계학술대회
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• pp.251-251
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• 1996

-Acute oral and subcutaneous toxicity of Aloewhite(30% aloesine) were carried out in ICR mice. In this study, we daily examined number of deaths, clinical signs, body weights, and pathological examinations for 14 days after single oral and subcutaneous administration of Aloewhite with different dose levels. Aloewhite did not show any remarkable toxic effect in mice. These results suggest that oral and subcutaneous LD$\sub$50/ values in mice were over 6.8g/kg and 10g/kg, respectively.

• 대한본초학회지
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• 제35권4호
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• pp.45-50
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• 2020

Objective : This study was performed to evaluate the toxicity after a single oral administration of black raspberry extract to male and female Sprague-Dawley (SD) rats and to determine the approximate lethal dose (ALD). Methods : We previously showed that the black raspberry extract repressed the simvastatin-mediated expression of Proprotein convertase subtilisin/kexin type 9 (PCSK9) and improved Low-Density Lipoprotein cholesterol (LDL-C) uptake by hepatocytes through the induction of the Low-Density Lipoprotein Receptor expression in hepatocytes. The groups consisted of black raspberry extract groups, as an oral dose of 2,000 mg/kg and a control group. 5 weeks SD rats were randomly assigned to 4 groups of 5 rats. Each male and female SD rats were administered orally once. For 14 days after the administration, mortality, clinical signs, changes in body weight, and necropsy findings were observed according to the "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity- Fixed Dose Procedure" of OECD Test Guideline. Results : There were no cases of mortality in the group administered with 2,000 mg/kg of male and female, and no abnormalities in body weight change and clinical signs. Also, no gross abnormalities were observed at the autopsy. Conclusions : As a result of a single oral administration of the black raspberry extract to SD rats, the ALD was determined to exceed 2,000 mg/kg for both male and female SD rats.