Oral dose-ranging developmental toxicity study of an herbal supplement (NT) and gallic acid in rats

Booth, A. D.; Amen, Ronald J.; Scott, Michael L.; Greenway, Frank L.

doi:10.1007/s12325-010-0021-x

Cited by 18 publications

(16 citation statements)

References 8 publications

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“…On the 21 st day of the study a caesarean section is performed and felaser with haemorrhagic bullae, limb malformations, exencephally, cleft palates, open eyelids, detail deformities, mortality and the number of live and dead animals are noted. Embryo toxicity assays such as embryonic stems cell test, micromass embryotoxicity assay and whole rat embryotoxicity assays can be done (Kimm-Brinson & Ramsdell, 2001;Hofmann et al, 2002;Booth et al, 2010). During generation reproduction toxicity study, genetic toxicity testing can be carried out to identify gene mutations, chromosomal changes and alterations on the DNA sequency.…”

Section: Two Generation Reproduction Toxicity Studiesmentioning

confidence: 99%

Toxicity studies of drugs and chemicals in animals: an overview

Saganuwan¹

2017

BJVM

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SummarySaganuwan, S. A., 2017. Toxicity studies of drugs and chemicals in animals: An overview. Bulg. J. Vet. Med., 20, No 4, Toxicity study is the investigation of either short or long-term toxic effects of a drug or chemical on animals. The toxicity is dose-dependent as asserted by Paracelsus over 500 years ago. However, short-term toxic effect is determined using median lethal dose (LD 50 ) first introduced by Trevan in 1927 and revised many times. Presently there is a growing preponderance of rejection of scientific papers on acute toxicity study, simply because of the belief that in the current hazard and safety assessment of drugs and chemicals, LD 50 values are no longer used. In view of this, literature search was carried out with a view to investigating the relevance of LD 50 in development and assessment of drugs and chemicals. The findings revealed that in the past, many animals had been used for LD 50 determination. OECD has reduced the number of test animals to 5-15 and presently it is further reduced to 2-6. Acute toxicity study is being carried out in medicinal plants research and in the study of patent medicine. Although the application of LD 50 has been drastically reduced, it is still applied and accepted in some parts of the world. Moreover, animals on which LD 50 tests are conducted, should be allowed to die to see the end effect of the test drug or chemical because euthanisia of test animals may mask some toxicity signs of the test agents. Therefore, toxicity study of drugs and chemicals is a scientific process necessary for discovery and development of drugs as well as identification of potential toxicants.

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Section: Two Generation Reproduction Toxicity Studiesmentioning

confidence: 99%

Toxicity studies of drugs and chemicals in animals: an overview

Saganuwan¹

2017

BJVM

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“…Embryotoxicity studies can be performed using in vitro methods such as the embryonic stem cell test (EST) for embryotoxicity, micromass embryotoxicity assay, and whole rat embryo embryotoxicity assay. [29–31]…”

Section: Sources Of Toxic Substancesmentioning

confidence: 99%

Toxicological screening

Parasuraman¹

2011

Journal of Pharmacology and Pharmacotherapeutics

423

219

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Toxicity testing of new compounds is essential for drug development process. The preclinical toxicity testing on various biological systems reveals the species-, organ- and dose- specific toxic effects of an investigational product. The toxicity of substances can be observed by (a) studying the accidental exposures to a substance (b) in vitro studies using cells/ cell lines (c) in vivo exposure on experimental animals. This review mainly focuses on the various experimental animal models and methods used for toxicity testing of substances. The pre-clinical toxicity testing helps to calculate “No Observed Adverse Effect Level” which is needed to initiate the clinical evaluation of investigational products.

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“…The authors tested gallic acid, another food component absorbed in rodents, and was found to cause weight loss. 31 The authors found no evidence of any reproductive toxicity at 430 mg/kg per day, or less, giving further reassurance of the safety of angiogenic inhibitors that are components of food, and anticipate a similar experience with platycodin D. 32 …”

Section: Discussionmentioning

confidence: 84%

Pharmacokinetic pilot study of the antiangiogenic activity of standardized platycodi radix

et al. 2011

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Introduction Platycodi radix is a radish used in food, such as Korean kimchi, and has been shown to cause weight loss in rodents. Platycodin D is considered its active ingredient and has been shown to inhibit lipases. The authors hypothesized that platycodi radix and the platycodin D it contains inhibit angiogenesis; another mechanism for weight loss. Methods This study tested platycodi radix extract, platycodin D, and an extract of platycodi radix standardized to platycodin D for their ability to inhibit angiogenesis in a human adipose tissue assay. This study treated five healthy volunteers, orally, with platycodi radix extract standardized to 414 mg of platycodin D. Three volunteers were treated under fasting conditions, one volunteer with a 400 kcal meal, and one volunteer treated with a placebo. Blood was drawn over 5 hours to compare serum inhibition of the human adipose tissue angiogenesis. Results Platycodin radix extract, platycodin D, and platycodi radix extract standardized to platycodin D all inhibited angiogenesis. The three volunteers who consumed platycodi radix extract standardized to 414 mg of platycodin D had a 25.76% reduction in angiogenesis from baseline at 60 minutes (P<0.002), and had a statistically significant reduction in angiogenesis from 30 to 240 minutes (P<0.05 to P<0.002). The placebo decreased angiogenesis by 5.6% between 30 and 240 minutes, compared with 17.8% by the extract. The meal delayed absorption by approximately 3.5 hours. Conclusion Platycodi radix extract standardized to platycodin D inhibited angiogenesis in human volunteers, and paves the way for a dose-response study and a human clinical obesity trial.

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Oral dose-ranging developmental toxicity study of an herbal supplement (NT) and gallic acid in rats

Abstract: The combination of NT and gallic acid gave no evidence of reproductive toxicity at 430 mg/kg per day or below, which is reassuring should this combination be used in the future as a dietary herbal supplement for the treatment of obesity.

Cited by 18 publications

References 8 publications

Toxicity studies of drugs and chemicals in animals: an overview

Toxicity studies of drugs and chemicals in animals: an overview

Toxicological screening

Pharmacokinetic pilot study of the antiangiogenic activity of standardized platycodi radix

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