Esievo et al Journal of Drug Delivery & Therapeutics. 2023; 13(10):11-27 ISSN: 2250-1177 [11] CODEN (USA): JDDTAO Available online on 15.10.2023 at http://jddtonline.info Journal of Drug Delivery and Therapeutics Open Access to Pharmaceutical and Medical Research Copyright © 2023 The Author(s): This is an open-access article distributed under the terms of the CC BY-NC 4.0 which permits unrestricted use, distribution, and reproduction in any medium for non-commercial use provided the original author and source are credited Open Access Full Text Article Research Article Acute and Delayed Oral Toxicity Studies and Observations on Pregnancy, Gestation and Reproductive Performance of Wistar Rats Administered Limit Dose of Purified Extract from Stem Bark of Antidiabetic Anogeissus leiocarpus (African Birch Tree) King Akpofure Nelson Esievo 1,2,3+ , Lauretta Oghenekevwe Esievo 4,5 , Dahiru Sani 6 , Kingsley Oghenerukevwe Esievo 7 , Edith Monica Esievo 8,9 , Emmanuel Oluwadare Balogun 10,11 , John Wassagwa 10 #, Peter Ibrahim Rekwot 4,12 , Lushaikyaa Allam 4,13 and Edward Oniovosa Uyobisere 14 1. Lecturer/Resource Person, College of Veterinary Surgeons, Nigeria, Pathology Faculty, Samaru, Zaria Study Centre, Faculty of Veterinary Medicine, Ahmadu Bello University, Zaria, Nigeria. 2. Department of Veterinary Pathology, College of Veterinary Medicine, Federal University of Agriculture, Zuru, Nigeria. 3. Consultant, Research and Diagnosis Unit, Kanesco Global Services Limited (RC 829505), Hayin Mallam, Samaru Zaria, Nigeria. 4. Department of Theriogenology and Production, Faculty of Veterinary Medicine, Ahmadu Bello University, Zaria, Nigeria. 5. Department of Theriogenology, College of Veterinary Medicine, Federal University of Agriculture, Zuru, Nigeria. 6. Department of Veterinary Pharmacology and Toxicology, Faculty of Veterinary Medicine, Ahmadu Bello University, Zaria, Nigeria. 7. Department of Agronomy, Faculty of Agriculture, Ahmadu Bello University, Zaria, Nigeria. 8. Department of Veterinary Surgery, College of Veterinary Medicine, Federal University of Agriculture, Zuru, Nigeria. 9. Royal Veterinary College, University of London, Royal College Street, London NW1 0TU, United Kingdom. 10. Department of Biochemistry, Faculty of Life Sciences, Ahmadu Bello University, Zaria, Nigeria. 11. African Centre of Excellence for Neglected Tropical Diseases and Forensic Biotechnology (ACENTDFB), Ahmadu Bello University, Zaria, Nigeria. 12. Artificial Insemination Unit, National Animal Production Research Institute, Ahmadu Bello University, Shika, Zaria, Nigeria. 13. Veterinary Teaching Hospital, Ahmadu Bello University, Zaria, Nigeria. 14. Department of Soil Science, Faculty of Agriculture, Ahmadu Bello University, Zaria, Nigeria #UNESCO International Centre for Biotechnology, University of Nigeria, Nsukka, Nigeria Article Info: _____________________________________________ Article History: Received 26 July 2023 Reviewed 02 Sep 2023 Accepted 10 Sep 2023 Published 15 Oct 2023 _____________________________________________ Cite this article as: Esievo KAN, Esievo LO, Sani D, Esievo KO, Esievo EM, Balogun EO, Wassagwa J, Rekwot PI, Allam L, Uyobisere EO, Acute and Delayed Oral Toxicity Studies and Observations on Pregnancy, Gestation and Reproductive Performance of Wistar Rats Administered Limit Dose of Purified Extract from Stem Bark of Antidiabetic Anogeissus leiocarpus (African Birch Tree), Journal of Drug Delivery and Therapeutics. 2023; 13(10):11-27 DOI: http://dx.doi.org/10.22270/jddt.v13i10.5965 _____________________________________________ *Address for Correspondence: King Akpofure Nelson Esievo, Department of Veterinary Pathology, College of Veterinary Medicine, Federal University of Agriculture, Zuru, Nigeria. Abstract _____________________________________________________________________________________________________________________ Objectives: The maximum purification of the extracts of antidiabetic Anogeissus leiocarpus stem bark led to a quest for its lethal dose (LD50) and effects on pregnancy, gestation, pups (kitten) and reproductive performance of Wistar rats. Design: Extracts of A. leiocarpus were subjected to column and thin layer chromatography until final purification. Five (5) each of adult male and female rats were used for the study. The revised limit test dose of 2000mg/kg.bd.wt. was used to evaluate the acute oral toxicity and effects on reproductive characteristics of the purified extracts on Wistar rats. The rats were monitored for instant death and 24hours later, 3 each of male and female rats were humanely sacrificed. On day 0 and 24hours later biomarkers of liver damage, AST, ALT, and ALP and that of kidney, urea, were assayed. The remaining 4 rats (2 males and 2 females) were monitored for additional 14days and thereafter for any effect of the limit dose on reproductive activities. Results: The limit dose caused no death within the first 24hours and no hepato-renal damages. Pregnancy, gestation, parturition, pups (kitten) and reproductive performance were normal. The median lethal Dose (LD50) is > 2000mg/kg./bd.wt. Conclusion: Animal experimentation, using Wistar rats showed that purified extracts of A. leiocarpus stem bark as a non-conventional drug for diabetes mellitus, has no effects on pregnancy and reproductive performance. There was no teratogenic effect on pups. The compound has a wide range of safety value. Keywords: Oral Toxicity, Pregnancy, Gestation, Reproductive Performance, Wistar Rats, Anogeissus leiocarpus, Purified Extract