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Acute and sub-acute oral toxicity of Dracaena cinnabari resin methanol extract in rats

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      Abstract

      Background

      Dracaena cinnabari (DC) is a perennial tree that located on the Southern coast of Yemen native to the Socotra Island. This tree produces a deep red resin known as the Dragon’s blood, the Twobrother’s Blood or Damm Alakhwain. The current study performed to evaluate the safety of the DC resin methanol extract after a single or 28 consecutive daily oral administrations.

      Methods

      In assessing the safety of DC resin methanol extract, acute and sub-acute oral toxicity tests performed following OECD guidelines 423 and 407, respectively, with slight modifications. In acute oral toxicity test, DC resin methanol extract administered to female Sprague Dawley rats by oral gavage at a single dose of 300 and 2000 mg/kg body weight. Rats observed for toxic signs for 14 days. In sub-acute oral toxicity test, DC resin methanol extract administered to the rats by oral gavage at 500, 1000, and 1500 mg/kg body weight daily up to 28 days to male and female Spradgue Dawley rats. The control and high dose in satellite groups were also maintained and handled as the previous groups to determine the late onset toxicity of DC resin methanol extract. At the end of each test, hematological and biochemical analysis of the collected blood were performed as well as gross and microscopic pathology.

      Results

      In acute oral toxicity, no treatment-related death or toxic signs were observed. It revealed that the DC resin methanol extract could be well tolerated up to the dose 2000 mg/kg body weight and could be classified as Category 5. The sub-acute test observations indicated that there are no treatment-related changes up to the high dose level compared to the control. Food consumption, body weight, organ weight, hematological parameters, biochemical parameters and histopathological examination (liver, kidney, heart, spleen and lung) revealed no abnormalities. Water intake was significantly higher in the DC resin methanol extract treated groups compared to the control.

      Conclusion

      This study demonstrates tolerability of DC resin methanol extract administered daily for 28 days up to 1500 mg/kg dose.

      Electronic supplementary material

      The online version of this article (10.1186/s12906-018-2110-3) contains supplementary material, which is available to authorized users.

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      Most cited references 39

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      Concordance of the toxicity of pharmaceuticals in humans and in animals.

      This report summarizes the results of a multinational pharmaceutical company survey and the outcome of an International Life Sciences Institute (ILSI) Workshop (April 1999), which served to better understand concordance of the toxicity of pharmaceuticals observed in humans with that observed in experimental animals. The Workshop included representatives from academia, the multinational pharmaceutical industry, and international regulatory scientists. The main aim of this project was to examine the strengths and weaknesses of animal studies to predict human toxicity (HT). The database was developed from a survey which covered only those compounds where HTs were identified during clinical development of new pharmaceuticals, determining whether animal toxicity studies identified concordant target organ toxicities in humans. Data collected included codified compounds, therapeutic category, the HT organ system affected, and the species and duration of studies in which the corresponding HT was either first identified or not observed. This survey includes input from 12 pharmaceutical companies with data compiled from 150 compounds with 221 HT events reported. Multiple HTs were reported in 47 cases. The results showed the true positive HT concordance rate of 71% for rodent and nonrodent species, with nonrodents alone being predictive for 63% of HTs and rodents alone for 43%. The highest incidence of overall concordance was seen in hematological, gastrointestinal, and cardiovascular HTs, and the least was seen in cutaneous HT. Where animal models, in one or more species, identified concordant HT, 94% were first observed in studies of 1 month or less in duration. These survey results support the value of in vivo toxicology studies to predict for many significant HTs associated with pharmaceuticals and have helped to identify HT categories that may benefit from improved methods. Copyright 2000 Academic Press.
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        Administration of substances to laboratory animals: routes of administration and factors to consider.

        Administration of substances to laboratory animals requires careful consideration and planning to optimize delivery of the agent to the animal while minimizing potential adverse experiences from the procedure. For all species, many different routes are available for administration of substances. The research team and IACUC members should be aware of reasons for selecting specific routes and of training and competency necessary for personnel to use these routes effectively. Once a route is selected, issues such as volume of administration, site of delivery, pH of the substance, and other factors must be considered to refine the technique. Inadequate training or inattention to detail during this aspect of a study may result in unintentional adverse effects on experimental animals and confounded results.
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          Dragon's blood: botany, chemistry and therapeutic uses.

          Dragon's blood is one of the renowned traditional medicines used in different cultures of world. It has got several therapeutic uses: haemostatic, antidiarrhetic, antiulcer, antimicrobial, antiviral, wound healing, antitumor, anti-inflammatory, antioxidant, etc. Besides these medicinal applications, it is used as a coloring material, varnish and also has got applications in folk magic. These red saps and resins are derived from a number of disparate taxa. Despite its wide uses, little research has been done to know about its true source, quality control and clinical applications. In this review, we have tried to overview different sources of Dragon's blood, its source wise chemical constituents and therapeutic uses. As well as, a little attempt has been done to review the techniques used for its quality control and safety.
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            Author and article information

            Affiliations
            [1 ]ISNI 0000 0001 2308 5949, GRID grid.10347.31, Department of Oral and Craniofacial Sciences, Faculty of Dentistry, , University of Malaya, ; 50603 Kuala Lumpur, Malaysia
            [2 ]ISNI 0000 0004 0366 8575, GRID grid.459705.a, Department of Oral Biology and Biomedical Sciences, Faculty of Dentistry, , MAHSA University, ; 42610 Jenjarom, Selangor Malaysia
            [3 ]ISNI 0000 0001 2308 5949, GRID grid.10347.31, Department of Oral & Maxillofacial Clinical Sciences, Faculty of Dentistry, , University of Malaya, ; Kuala Lumpur, 50603 Malaysia
            [4 ]ISNI 0000 0001 2308 5949, GRID grid.10347.31, Oral Cancer Research and Coordinating Centre, Faculty of Dentistry, , University of Malaya, ; Kuala Lumpur, 50603 Malaysia
            Contributors
            dr_nash1@yahoo.com
            aied_absi@yahoo.com
            marinab@um.edu.my
            drranand@um.edu.my
            Journal
            BMC Complement Altern Med
            BMC Complement Altern Med
            BMC Complementary and Alternative Medicine
            BioMed Central (London )
            1472-6882
            5 February 2018
            5 February 2018
            2018
            : 18
            29402248 5800047 2110 10.1186/s12906-018-2110-3
            © The Author(s). 2018

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

            Funding
            Funded by: FundRef http://dx.doi.org/10.13039/501100004386, Universiti Malaya;
            Award ID: RG422/12HTM
            Funded by: Ministry of Higher Education, Malaysia (MY)
            Award ID: UM.C/625/1/HIR/MoE/DENT /24
            Categories
            Research Article
            Custom metadata
            © The Author(s) 2018

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