Evaluation of acute, repeated dose 28-day and 13-week oral toxicity and genotoxicity of a standardized fraction (HemoHIM) from .

HemoHIM is a functional food ingredient comprising a triple herbal combination of extracts from Nakai, Makino, and Pallas. It was developed to aid the recovery of impaired immune function. Although it is widely used to treat various immune disorders in Korea, its potential toxicity has not been extensively investigated. Therefore, a comprehensive study was conducted to assess the safety of HemoHIM, including acute oral dose toxicity, 28-day and 13-week repeated-dose toxicity, and genotoxicity. To evaluate its safety profile, the dose was increased to 2,000 mg/kg/day, which corresponds to the dose limit for acute toxicity as per the Organization for Economic Cooperation and Development Test Guideline 423. No abnormal findings were observed at the higher doses. For the 28-day and 13-week repeated-dose toxicity studies, HemoHIM was administered at doses of 500, 1,000, and 2,000 mg/kg/day to examine subchronic toxicity in male and female rats. No test item-related clinical signs or mortality was observed at any of the tested doses. Gross pathology, hematology, blood chemistry, and histopathology evaluations further supported the safety of HemoHIM. Therefore, the NOAEL of HemoHIM was considered to be at 2,000 mg/kg/day for both sexes of rats. Bacterial reverse mutation tests, a chromosome aberration test in human peripheral blood lymphocytes, and a mouse micronucleus test were conducted to determine the genotoxicity of HemoHIM, which revealed that HemoHIM was non-mutagenic and non-clastogenic. Collectively, these findings provide valuable evidence to support the safe use of HemoHIM as a functional food ingredient.