Homeopathy 2024; 113(02): 086-097
DOI: 10.1055/s-0043-1770338
Original Research Article

Acute and Sub-acute Oral Toxicity Assessment of Ferrum phosphoricum in Rats

Mahima Sharma
1   Department of Pharmacology, Drug Standardisation, Dr D P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
,
Sangita Behera
1   Department of Pharmacology, Drug Standardisation, Dr D P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
,
Raj Kumar Regar
1   Department of Pharmacology, Drug Standardisation, Dr D P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
,
Deepika Tripathi
1   Department of Pharmacology, Drug Standardisation, Dr D P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
,
Satvinder Singh
2   Department of Biochemistry, Dr D P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
,
Narasimha G.V. Kumar
3   Department of Pharmacology, Drug Standardisation, Dr Anjali Chatterji Regional Research Institute for Homeopathy, Kolkata, West Bengal, India
,
1   Department of Pharmacology, Drug Standardisation, Dr D P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
› Author Affiliations
Funding None.

Abstract

BackgroundFerrum phosphoricum (FP) has been used by traditional medicine practitioners for various ailments since ancient times. However, scientific evidence on the safety of FP is still unavailable. Thus, the current study aimed to investigate the acute and sub-acute oral toxicity of homeopathic FP in experimental rats.

Methods In an acute toxicity investigation, a single dose of 2,000 µL/kg of FP 6c, 30c and 200c was administered to female Wistar rats, which were monitored for up to 14 days according to the Organization for Economic Cooperation and Development (OECD) guideline 423. For a sub-acute toxicity study, FP 6c, 30c and 200c (200 µL/kg) were administered to male and female rats for 28 days as per the OECD guideline 407. All the animals were observed for mortality, clinical signs and body weight during the study. At the end of the experiment, hematological, biochemical and histopathological assessments were performed.

Results During the acute toxicity study, no mortality was observed in rats administered with FP, and thus the median lethal dose (LD50) was identified as >2,000 µL/kg. In the sub-acute study, no mortality or adverse clinical signs were noticed with FP treatment. Moreover, weekly body weight gain was normal. Hematological and biochemical investigations revealed no abnormalities. Furthermore, histological analysis of FP-treated rats' vital organs revealed no pathological changes.

Conclusion Overall, our findings imply that FP 6c, 30c and 200c potencies are safe and do not cause toxicity when given orally to Wistar albino rats for an extended period at a dose of 200 µL/kg.



Publication History

Received: 21 January 2023

Accepted: 11 April 2023

Article published online:
21 August 2023

© 2023. Faculty of Homeopathy. This article is published by Thieme.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Ha AW, Kang HJ, Kim SL, Kim MH, Kim WK. Acute and sub-acute toxicity evaluation of corn silk extract. Prev Nutr Food Sci 2018; 23: 70-76
  • 2 Vickers A, Zollman C. ABC of complementary medicine: homoeopathy. BMJ 1999; 319: 1115-1118
  • 3 Briggs CJ, Norrie O. Regulation of herbal and homeopathic medicines. Pharm Dev Regul 2003; 1: 245-259
  • 4 World Health Organization. Safety Issues in the Preparation of Homeopathic Medicines. World Health Organization; 2009
  • 5 Singh S, Karwasra R, Sharma D. et al. Assessment of acute and 28-days repeated dose sub-acute toxicity study of selected ultra-diluted preparations in Wistar rats. J Forensic Chemistry Toxicol 2019; 5: 115-124
  • 6 Habs M, Koller M. Material risks of homeopathic medicinal products: regulatory frameworks, results of preclinical toxicology, and clinical meta-analyses and their implications. Complement Med Res 2021; 28: 64-84
  • 7 Manchanda RK. Popularity, safety and quality of homeopathic medicines. Indian J Res Homeopathy 2018; 12: 191
  • 8 Boericke W. Materia Medica with Repertory. 9th ed. Santa Rosa: Boericke and Tafel; 1927: 328-331
  • 9 Clarke JH. A Dictionary of Practical Materia Medica. Homeopathic Publishing Company; 1902
  • 10 Tasinov O, Kiselova-Kaneva Y, Ivanova D, Pasheva M, Vankova D, Ivanova D. Ferrum phosphoricum D12 treatment affects J774 A.1 and 3T3–L1 cells proliferation and gene expression of inflammation, oxidative stress and iron metabolism-related proteins. Homeopathy 2020; 109: A025
  • 11 Tasinov O, Kiselova-Kaneva Y, Ivanova D, Pasheva M, Vankova D, Ivanova D. Ferrum phosphoricum D12 treatment affects J774A.1 cell proliferation, transcription levels of iron metabolism, antioxidant defense, and inflammation-related genes. Homeopathy 2022; 111: 113-120
  • 12 Poitevin B, Aubin M, Royer JF. Effet de belladonna et ferrum phosphoricum sur la chemiluminescence des polynucleaires neutrophiles humains. An Homeopath Fr 1983; 25: 5-12
  • 13 Organization for Economic Co-operation and Development. . Test No. 423: Acute Oral Toxicity—Acute Toxic Class Method; 2002. Accessed April 24, 2023 at: https://www.oecd-ilibrary.org/environment/test-no-423-acute-oral-toxicity-acute-toxic-class-method_9789264071001-en
  • 14 Organization for Economic Co-operation and Development. . Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents; 2008 https://doi.org/10.1787/9789264070684-en
  • 15 Olfert E, Bhasin J, Latt R, McCutcheon K, Rainnie D, Schunk M. CCAC Guidelines on: Choosing an Appropriate Endpoint in Experiments Using Animals for Research, Teaching and Testing. Canadian Council on Animal Care; 1998
  • 16 Chitra B, Ramaswamy RS, Suba V. Toxicity evaluation of Pũrṇa Cantirotaya Centũram, a Siddha Medicine in Wistar Rats. Int Sch Res Notices 2015; 2015: 473296
  • 17 Wren AF, Cleary M, Frantz C, Melton S, Norris L. 90-day oral toxicity study of a grape seed extract (IH636) in rats. J Agric Food Chem 2002; 50: 2180-2192
  • 18 Rao JV. Toxic effects of novel organophosphorus insecticide (RPR-V) on certain biochemical parameters of euryhaline fish, Oreochromis mossambicus. Pestic Biochem Physiol 2006; 86: 78-84
  • 19 Li X, Luo Y, Wang L. et al. Acute and sub-acute toxicity of ethanol extracts from Salvia przewalskii Maxim in rodents. J Ethnopharmacol 2010; 131: 110-115
  • 20 Anderson N, Borlak J. Molecular mechanisms and therapeutic targets in steatosis and steatohepatitis. Pharmacol Rev 2008; 60: 311-357
  • 21 Schalm's Veterinary Hematology WorldCat.org. ( n.d. ). Accessed December 23, 2022 at: https://www.worldcat.org/title/schalmsveterinaryhematology/oclc/751369443?referer=di&ht=edition
  • 22 El Hilaly J, Israili ZH, Lyoussi B. Acute and chronic toxicological studies of Ajuga iva in experimental animals. J Ethnopharmacol 2004; 91: 43-50
  • 23 Olorunnisola O, Bradley G, Afolayan A. Acute and sub-chronic toxicity studies of methanolic extract of Tulbaghia violacea rhizomes in Wistar rats. Afr J Biotechnol 2012; 11: 14934-14940
  • 24 Loge JP, Lange RD, Moore CV. Characterization of the anemia associated with chronic renal insufficiency. Am J Med 1958; 24: 4-18
  • 25 Rubin E, Gottlieb C, Vogel P. Syndrome of hepatitis and aplastic anemia. Am J Med 1968; 45: 88-97
  • 26 Vítek L. The role of bilirubin in diabetes, metabolic syndrome, and cardiovascular diseases. Front Pharmacol 2012; 3: 55
  • 27 Wallig MA, Bolon B, Haschek WM, Rousseaux CG. Fundamentals of Toxicologic Pathology. Academic Press; 2017
  • 28 Nigatu TA, Afework M, Urga K, Ergete W, Makonnen E. Toxicological investigation of acute and chronic treatment with Gnidia stenophylla Gilg root extract on some blood parameters and histopathology of spleen, liver and kidney in mice. BMC Res Notes 2017; 10: 625
  • 29 Michael B, Yano B, Sellers RS. et al. Evaluation of organ weights for rodent and non-rodent toxicity studies: a review of regulatory guidelines and a survey of current practices. Toxicol Pathol 2007; 35: 742-750