Nonclinical Safety Assessment of Morus alba L. Fruits: Study of 90-D Toxicity in Sprague Dawley Rats and Genotoxicity in Salmonella

• Published in: Journal of food science Vol. 81; no. 5; pp. T1328 - T1335
• Main Authors: Chang, Bo Yoon, Kim, Seon Beom, Lee, Mi Kyeong, Park, Hyun, Kim, Sung Yeon
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.05.2016; Wiley Subscription Services, Inc
• Subjects: Administration, Oral; Animals; Assessments; DNA Damage; Female; Fruit; Fruits; Genotoxicity; herbal safety; Male; Morus; Morus alba; Morus alba L. fruit; Mutagenicity Tests; No-Observed-Adverse-Effect Level; Organ Size - drug effects; Plant Extracts - pharmacology; Plant Extracts - toxicity; Rats; Rats, Sprague-Dawley; Rodents; Safety; Salmonella; Salmonella typhimurium; Salmonella typhimurium - drug effects; Salmonella typhimurium - genetics; SD rat; Strain; subchronic toxicity; Toxicity; Toxicity Tests, Subchronic; genotoxicity; subchronic toxicity; herbal safety; SD rat; Morus alba L. fruit
• ISSN: 0022-1147; 1750-3841
• DOI: 10.1111/1750-3841.13285

Morus alba L. is a traditional herb with a long history of consumption, both as an edible fruit and as medicine. However, its safety evaluation has not yet been established. The objective of this study was to evaluate subchronic oral toxicity and genotoxicity of M. alba L. fruits (MFE). The subchronic toxicity after daily oral administration of MFE at 0, 40, 200, and 1000 mg/kg for 90 d was examined in Sprague Dawley (SD) rats. MFE administration did not lead to death, adverse effects, change in food and water consumption, and body weight gain. Significant toxic effects were not found within the parameters of organ weight, biochemical values, and hematological and urine analysis between the control and the MFE group. The genotoxicity of MFE was assayed by Ames test in Salmonella typhimurium strains TA98, TA102, and TA1535. No genotoxicity was found in all the tested strains. Thus in this study, a no‐observed‐adverse‐effect level for MFE in 90 d repeated oral toxicity study in rats was determined to be greater than 1000 mg/kg regardless of gender. The results also suggested that MFE does not have a genotoxicity potential.