Experimental Study On Toxicological Safety Evaluation Of Anti-fatigue Health Product TPSH

Object: To evaluate the toxicological safety of anti-fatigue healthproduct TPSH.Methods:In the acute toxicity test, mice were orally treated with TPSH at21500, 10000, 4640, 2150mg/kg·bw to observe the death or changes inbehavior of TPSH-treated mice for 14 days.Ames tests, reverse mutation assays of Salmonella typhimuriumstrains TA97, TA98, TA100 and TA102, were used for evaluating themutagenesis of TPSH. The number of revertant colonies was recordedafter treating Salmonellar strains with TPSH for 48 hours. Mice wereorally treated with TPSH twice in 24 hours at the doses of 4630, 2315,1158mg/kg.bw for detecting the micronucleus rates of bone marrow cells.Sperm shape abnormality test was also carried out in mice treated withTPSH at the same doses.A 30 days feeding test was conducted in rats to assess the effects ofTPSH on behaviour, body-weight gain, food intake, food utilization rateand haematology parameters, blood biochemistries and organ weights,and the changes of histological pathology.Results:In the acute toxicity test, the death rates of animals in the groups at21500 and 10000 mg/kg·bw of TPSH were 100％and 60％respectively.No animals in the groups at 4640 and 2150mg/kg-bw of TPSH died. TheLD50 of TPSH was 9260mg/kg.bw.The mutagenicity of TPSH was not found in three mutation tests. The numbers of revertant colonies in TPSH-treated groups were less thantwice of the number in normal group(spontaneously revertant colonies) inAmes test. There was no significant differences in the micronucleus ratesof bone marrow cells in mice between the negative control andTPSH-treated groups. Sperm shape abnormality in mice treated withTPSH was not observed.Abnormal symptoms and deaths of animals were not observed in 30days feeding test. No significant difference had been found in bodyweight, food consumption, food availability, haematology parameters,blood biochemistries, organ/body weight ratio, and histological pathologyin rats between control and TPSH-treated groups (P＞0.05).Conclusions: The results showed that the anti-fatigue health productTPSH had no toxicity, and it can not cause mutation or heredity toxicity.These suggest that it is safe to use TPSH in clinic.