Acute toxicity and genotoxicity evaluation of irradiated ophiopogonis radix at 25 kGy with electron beam

Abstract

As concerned about the potential risks of irradiated Ophiopogonis Radix (IOR) at a high radiation level (25 kGy) by high-energy electron beam irradiation, this study evaluated oral acute toxicity and genotoxicity of IOR. Moisture, total ash, water-soluble extracts, and ruscogenin content in IOR meet the requirement of Ophiopogonis Radix described in the Chinese Pharmacopoeia. When the mice received by oral 21.5 g/kg BW administration of IOR in the acute toxicity test, neither mortality nor any other abnormal general clinical signs were found within 14 days, except that 10% of mice suffered from diarrhea on day 1, which disappeared and returned to normal on day 4. The acute toxicity test indicated the LD50 of IOR was higher than 21.5 g/kg BW. Ames test showed no dose-dependent increase in TA97a, TA98, TA100, TA102, and TA1535 strains with or without rat liver microsomal enzyme mixture (S9) metabolic activation, at a quantity range of 50–5000 μg IOR. Mouse micronucleus test of bone marrow cells demonstrated no significant increase in the frequencies of micronucleated polychromatic erythrocytes (MN PCEs) among each IOR dose. Mouse sperm abnormality test showed that there was no evidence of the potential to induce sperm malformation with oral administration at doses of 2.5, 5.0, and 10.0 g/kg BW. Overall, the acute toxicity or genotoxicity of IOR were not observed, indicating that IOR at 25 kGy with a high-energy electron beam is toxicologically safe.