Romanian Society of Pharmaceutical Sciences

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UNVEILING ACUTE AND 28-DAY ORAL TOXICITIES OF CHEMICALLY CHARACTERISED AQUEOUS EXTRACT OF RUBUS FRUTICOSUS L. IN MICE

YAHYA EL-MERNISSI 1,2*, NAOUAL EL MENYIY 2, AZIZ ZOUHRI 3, AMINA LABHAR 1, RAFIK EL-MERNISSI 3, RABIE KACHKOUL 4,5, M’HAMED AHARI 1, AMIN SALHI 1, MOHAMMED BOURHIA 6, AMIRA METOUEKEL 6, GAMAL A. SHAZLY 7, LHOUSSAIN HAJJI 3, HASSAN AMHAMDI 1

1Applied chemistry team, Faculty of Sciences and Techniques, Abdelmalek Essaadi University, 32 003 Al Hoceima, Morocco
2 Laboratory of Pharmacology, National Agency of Medicinal and Aromatic Plants, Taounate 34025, Morocco
3 Bioactives and Environmental Health Laboratory, Faculty of Sciences, Moulay Ismail University, Meknes B.P. 11201, Morocco
4 Higher Institute of Nursing Professions and Health Techniques of Fez, Ministry of Health and Social Protection, EL Ghassani Hospital, Fez 30000, Morocco
5 Laboratory of Biotechnology and Natural Resources Valorisation, Faculty of Sciences, Ibn Zohr University, 80060, Agadir, Morocco
6 University of Technology of Compiègne, EA 4297 TIMR, 60205 Compiègne Cedex, France
7 Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia

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Rubus fruticosus L. (Rosaceae) is traditionally used in the treatment of diarrhoea, inflammation, ulcers, anaemia, cardiovascular disease and diabetes. This study aimed to evaluate the safety profile of R. fruticosus L., a plant widely used in phytotherapy for its medicinal properties. Acute and repeated 28-day oral toxicity assessments were performed in mice. In the acute toxicity study, no treatment-related mortality or significant alterations in body weight were observed in mice administered single doses of 1000 and 2000 mg/kg body weight of the aqueous leaf extract of R. fruticosus L. Similarly, in the repeated 28-day oral toxicity study, no significant differences in body weight, clinical signs, or organ weights were noted between the groups receiving 250, 500 and 1000 mg/kg per day of the extract compared to the control group. Histopathological evaluations of the liver and kidneys revealed normal findings. In addition, GC-MS analyses revealed 12 compounds in the aqueous extract, with the most abundant being nonanoic acid, octanoic acid, n-decanoic acid and methyl palmitate. Thus, the present study demonstrates that aqueous leaf extract of R. fruticosus L., at doses up to 1000 mg/kg per day, is non-toxic and does not induce adverse effects after 28 days of administration, indicating its potential safety for use in phytotherapy.