REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF EURYCOMA LONGIFOLIA AQUEOUS EXTRACT (PHYSTA®) IN WISTAR RATS
Keywords:
Reproductive toxicity, Eurycoma longifolia, Developmental toxicity, PHYSTAAbstract
Objective: Reproductive and developmental toxicities of Eurycoma longifolia aqueous extract (PHYSTA®) in male and female wistar rats were examined concerning its effect on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition.
Methods: Eurycoma longifolia aqueous extract at a dose of 250, 500 and 1000 mg/kg b. w. was administered daily by oral gavage during 14 day premating and 14 days mating period in both male and female, during gestation period and up to post natal day 3 in females. Animals were observed for clinical signs, morbidity, mortality, body weight development, food consumption and pub observation (number of live pups/litter, live birth index, implant sites, fetal resorption etc.). Male and females were sacrificed on day 29 and post natal day (PND) 4 respectively; then subjected to necropsy.
Results: The result indicated non-significant predominant clinical signs, no mortality, and no toxicological relevance effect on body weight. In addition increased food consumption with no treatment related effect on litters, precoital interval and duration of gestation was observed. Pre and post natal data (Corpora lutea, implant sites, live pups, pre and post percent pre-implantation loss) remain unaffected. All pregnancies resulted in normal birth and delivery index remain unaffected. Survival of pups from PND 0 to PND 4 remained unaffected along with no treatment related gross external findings. No gross pathology findings and no statistically significant absolute and relative organ weight was observed. The histopathological evaluation does not revealed any lesions considered to be treatment related.
Conclusion: In conclusion, the repeated dose administration of Eurycoma longifolia aqueous extract (PHYSTA®) to male Wistar rats for 28-29 days and female Wistar rats up to 54 days at dosages of 250, 500 and 1000 mg/kg b.w. revealed no major toxicological findings. As per the present investigation the non-observed-adverse event level (NOAEL) for Eurycoma longifolia aqueous extract (PHYSTA®) is believed to be 1000 mg/kg body weight for reproductive and developmental toxicity.
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References
Fisher P, Ward A. Medicine in europe. Complementary medicine in Europe. J Br Med 1994;309:107–11.
Eisenberg DM, Davis RB, Ettner SL. Trends in alternative medicine use in the United States. 1990-1997. Results of a follow-up national survey. Am J Med Assoc 1998;280:1569–75.
Kuo PC, Shi LH, Damu AG, Su CR, Huang CH, Ke CH, et al. Cytotoxic and antimalarial β-carboline alkaloids from the roots of Eurycoma longifolia. J Nat Prod 2003;66:1324-7.
Ang HH, Hitotsuyanagi Y, Fukaya H, Takeya K. Quassinoids from Eurycoma longifolia. Phytochem 2002;59(8):833-7.
Hadiah TJ. Eurycoma longifolia Jack. Eksplorasi 1996;2:6.
Ismail SB. Randomized clinical trial on the use of physta freeze-driedwater extract of Eurycoma longifolia for the improvement of quality of life and sexual well-being in men. Evidence-Based Complementary Altern Med 2012. doi.org/10.1155/ 2012/ 429268. [Article in Press]
Satyavivad J, Noppamas S, Aimon S, Yodhathai T. Toxicological and antimalarial activity of eurycomalactone and Eurycoma longifolia Jack extracts in mice. Thai J Phytopharm 1998;5:14-27.
Choudhary YK. Acute, subacute and subchronic 90-days toxicity of Eurycoma longifolia aqueous extract (Physta®) in wistar rats. Int J Pharm Pharm Sci 2012;4:232-8.
OECD (Organization for Economic Co-operation and Development) Guideline No.421. Testing of Chemicals, Reproductive/Development Toxicity Screening Test; 1995.