28. Evaluation of acute and subchronic toxicity of EATWELLB in experimental animals
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Abstract
The present study investigated the oral acute and subchronic toxicities of the EATWELLB solution in experimental animals. The acute toxicity was conducted using Swiss mice through oral administration, and LD50 was determined by the Litchfield-Wilcoxon method. The subchronic toxicity was studied based on the guidance of the World Health Organization using Wistar rats. EATWELLB was administered orally at 1.8 mL/kg per day and 5.4 mL/kg per day over four weeks. Regarding acute toxicity, EATWELLB did not express acute toxicity in mice at the highest dose used (75 ml/kg). Our findings showed that the maximum tolerated dose was 20.8 times higher than the expected human dose without symptoms of acute toxicity. LD50 of EATWELLB could not be determined in mice. In terms of the subchronic toxicity, EATWELLB caused no significant change in general status, haematological examination, renal and hepatic function tests; in addition, it did not cause any change in the histology of the liver and kidney of experimental rats. Based on aforementionned results, we suggest that EATWELLB at 1.8 mL/kg per day and 5.4 mL/kg per day did not cause subchronic toxicity in experimental animals.
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Keywords
EATWELLB, acute toxicity, subchronic toxicity, experimental animals
References
2. Cloetens L, Ulmius M, Johansson-Persson A, et al. Role of dietary beta-glucans in the prevention of the metabolic syndrome. Nutrition Reviews. 2012;70(8):444-458.
3. Nagaraj S. Loss of Appetite in Adult Patients: Effectiveness and Safety of an Appetite Stimulating Medication in an Open-Label, Investigator-Initiated Study in India. Journal of Nutrition and Metabolism. 2022;2022:2661912.
4. Dorato MA, Buckley LA. Toxicology testing in drug discovery and development. Current Protocols in Toxicology 2007; Chapter 19:Unit19.1.
5. OECD. Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation, acute oral toxicity. Environmental Health and Safety Monograph Series on Testing and Assesment. 2001;19.
6. Litchfield JT, Wilcoxon F. A simplified method of evaluating dose-effect experiments. Journal of Pharmacology and Experimental Therapeutics. 1949;96(2):99-113.
7. World Health Organization. General Guidelines for Methodologies on Research and Evaluation. WHO; Geneva, Switzerland 2000;35.
8. Nseabasi Etim. Haematological Parameters and Factors Affecting Their Values. Agricultural Science. 2014;2(1):37-47.
9. Kohn DF, Clifford CB. Biology and Diseases of Rats. Laboratory Animal Medicine. 2012;121-165.
10. Tsubuku S, Mochizuki M, Mawatari K, et al. Thirteen-week oral toxicity study of L-lysine hydrochloride in rats. International journal of toxicology. 2004;23(2):113-118.
11. Chen SN, Nan FH, Chen S, et al. Safety assessment of mushroom β-glucan: subchronic toxicity in rodents and mutagenicity studies. Food and Chemical Toxicology. 2011;49(11):2890-2898.
12. Majeed M, Majeed S, Nagabhushanam K, et al. Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study. Journal of Medicinal Food. 2018;21(11): 1120-1128.