Single and 90-day repeated oral dose toxicity studies of fermented Rhus verniciflua stem bark extract in Sprague–Dawley rats

Shin, Sera; Koo, Kyo-Hwan; Bae, Jong‐Sup; Cha, Seung-Bum; Kang, Insoo; Kang, Minsoo; Kim, Hak‐Soo; Heo, Hyun-Suk; Park, Minsu; Gil, Gi-Hyun; Lee, Jooyoung; Kim, Kap-Ho; Li, Yinghua; Lee, Hyun-Kul; Song, Si-Whan; Choi, Han‐Seok; Kang, Boo-Hyon; Kim, Jong-Choon

doi:10.1016/j.fct.2013.01.043

Cited by 39 publications

(22 citation statements)

References 41 publications

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“…In general, the decrease in BUN level is not a critical factor in toxicity studies [ 34 ]. Moreover, these changes were not regarded as adverse effects because they remained within normal ranges [ 36 , 37 ]. Hematological examinations revealed reductions in red blood cell volume distribution width (RDW) in the male group given 1,000 mg/kg/day.…”

Section: Discussionmentioning

confidence: 99%

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

Shin

Won²,

Ha³

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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The root of Polygala tenuifolia Willdenow has been used for the treatment of insomnia, depression, and amnesia. However, the toxicological properties of the herb have been overlooked, because it has been used for a long time for various purposes. In this study, we evaluated the preclinical safety of the root extract in rats and beagle dogs. First, the acute oral toxicity was tested in both rats and dogs. In the rats, only one female of 2 g/kg died, but no treatment-related death or clinical and gross findings were observed after the administration. No toxicological changes or mortalities related to the test substance were also observed after the administration in the dogs. Although vomiting, discoloration, or hemorrhage was found in some dogs, there were no serious abnormalities. Second, the subchronic toxicity was investigated in the rats. Two animals were found dead in the female group of 1,000 mg/kg/day, but there were no abnormal findings associated with the test substance. There also were no adverse effects on the clinical signs, body weight, and hematological and biochemical findings. Therefore, our results showed that the acute or subchronic toxicity of the root extract of Polygala tenuifolia might not be toxic to rats and dogs.

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Section: Discussionmentioning

confidence: 99%

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

Shin

Won²,

Ha³

et al. 2014

Evidence-Based Complementary and Alternative Medicine

View full text Add to dashboard Cite

show abstract

“…Since traditional medicines are often perceived as "natural" and therefore free from side effects (Markman, 2002;Shin et al, 2013), a comprehensive analysis of safety issues for the majority of herbal medicine has not been fully established although we recently found that various beneficial herbs have toxic side effects (Che et al, 2014(Che et al, , 2015Yun et al, 2015a). It has been reported that C. racemosa induced the acute liver injury (Enbom et al, 2014;Muqeet Adnan et al, 2014;NIDDK, 2015).…”

Section: Introductionmentioning

confidence: 96%

Pre-clinical in vitro and in vivo safety evaluation of Cimicifuga heracleifolia

Yun

You

Kim

et al. 2015

Regulatory Toxicology and Pharmacology

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“…Plant-derived natural products are attracting significant attention around the world due to the perception that they are safe ‘natural’ drugs for promoting health without showing side effects. In addition, it is easy to obtain them from many grocery stores without having a prescription [ 14 – 20 ]. However, it has been demonstrated that many traditional beneficial herbs have genotoxic or systemic (liver and kidney) toxicity [ 21 – 25 ].…”

Section: Introductionmentioning

confidence: 99%

Assessment of acute, 14-day, and 13-week repeated oral dose toxicity of Tiglium seed extract in rats

Yun

Kwon

Kim

et al. 2018

BMC Complement Altern Med

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BackgroundSeed of mature Croton tiglium Linne, also known as Tiglium seed (TS), has been widely used as a natural product due to its several health beneficial properties including anti-tumor and antifungal activities. Despite its ethnomedicinal beneficial properties, toxicological information regarding TS extract, especially its long-term toxicity, is currently limited. Therefore, the objective of the present study was to evaluate acute and subchronic toxicity of TS extract in rats after oral administration following test guidelines of the Organization for Economic Cooperation and Development (OECD).MethodsToxicological properties of TS extract were evaluated by toxicity assays to determine its single-dose acute toxicity (125, 250, 500, 1000, or 2000 mg/kg), 14-day repeated-dose toxicity (125, 250, 500, 1000, or 2000 mg/kg) and 13-week repeated-dose toxicity (31.25, 62.5, 125, 250, and 500 mg/kg) in Sprague-Dawley rats and F344 rats. Hematological, serum biochemical, and histopathological parameters were analyzed to determine its median lethal dose (LD50) and no-observed-adverse-effect-level (NOAEL).ResultsOral single dose up to 2000 mg/kg of TS extract resulted in no mortalities or abnormal clinical signs. In 13-week toxicity study, TS extract exhibited no dose-related changes (mortality, body weight, food/water consumption, hematology, clinical biochemistry, organ weight, or histopathology) at dose up to 500 mg/kg, the highest dosage level suggested based on 14-day repeat-dose oral toxicity study.ConclusionAcute oral LD50 of TS extract in rats was estimated to be greater than 2000 mg/kg. NOAEL of TS extract administered orally was determined to be 500 mg/kg/day in both male and female rats. Results from these acute and subchronic toxicity assessments of TS extract under Good Laboratory Practice regulations indicate that TS extract appears to be safe for human consumption.Electronic supplementary materialThe online version of this article (10.1186/s12906-018-2315-5) contains supplementary material, which is available to authorized users.

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Single and 90-day repeated oral dose toxicity studies of fermented Rhus verniciflua stem bark extract in Sprague–Dawley rats

Cited by 39 publications

References 41 publications

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

Pre-clinical in vitro and in vivo safety evaluation of Cimicifuga heracleifolia

Assessment of acute, 14-day, and 13-week repeated oral dose toxicity of Tiglium seed extract in rats

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