| Object:In order to further develop the application of Aquilaria sinensisleaves, According to "Procedures and methods for toxicological assessment of food safety(GB15193-2003), to evaluate the acute and subchronic toxicity, genotoxicity and teratogenicity of Aquilaria sinensis leave extract, so as to assure the safety of Aquilaria sinensis leaves as a new resources food for human health.Methods:1. Acute toxicity test:20healthy KM mice (half male and half female) were orally treated with Aquilaria sinensis leave extract at30.00g/kg·bw (maximum tolerated dose, MTD) as a single dose, and the death and changes in behaviors of all animals were observed for14days.2.Ames test:Ames test was conducted with Salmonella typhimurium tester strains TA97, TA98, TA100and TA102respectively. The rat liver microsomal enzymes (S-9) induced by polychlorinated biphenyls (PCB) were used in vitro metabolic activation system. The number of revertant colonies was counted by visual observation in these strains at the levels of different exposure (5000μg/plate,1000μg/plate,200μg/plate,40μg/plate and8μg/plate) respectively. These tests were repeated once under the same experimental conditions.3. Bone marrow micronucleus test:50healthy KM mice (half male and half female) were orally administered with Aquilaria sinensis leave extract by24-hour intervals method at the doses of10.00g/kg-bw,5.00g/kg-bw and2.50g/kg-bw respectively. The micronucleus rate was counted by microscopic examination for1000polychromatic erythrocytes in every animal and the ratio of polychromatic erythrocytes to normochromatic erythrocyte (PCE/NCE).4. Sperm abnormality test:25healthy male KM mice were gavaged once a day with Aquilaria sinensis leave extract at the doses of10.00g/kg·bw,5.00g/kg-bw and2.50g/kg·bw respectively for5days. All the animals were sacrificed at the thirtieth day after the last administration to calculate sperm malformation rates.5. Teratogenic test:120healthy SD female rats were free to mate with60SD male rats as the ratio of1:1respectively. Pregnant rats were orally treated once a day with Aquilaria sinensis leave extract at three doses of5.00g/kg·bw,10.00g/kg·bw and15.00g/kg·bw respectively during pregnant7th～16th days。All female animals were sacrificed at the pregnant20th day. The embryo toxicity index of pregnant rats and the growth index of fetal rats were anatomically observated respectively.6.90-day feeding test:80healthy SD rats (half male and half female) were divided into four groups and were gavaged with Aquilaria sinensis leave extract at different doses of0.00g/kg·bw,5.00g/kg·bw,10.00g/kg·bw and15.00g/kg-bw respectively once a day for90days. At the end of the test, all the animals were sacrificed. The body weight, food consumption and organ weight of all animals were recorded, and their organ coefficients and food utilization were counted. The routine blood and biochemical indexs of all animals were measured by automated hematology analyzer and biochemical analyzer respectively. The changes of gross anatomy and histopathology were observed by visual and microscope observation in rats.Results:1. The maximum tolerated dose of mice treated with Aquilaria sinensis leaves was more than30.00g/kg-bw, Aquilaria sinensis leave extract was practically non-toxic.2. Genetic toxicity of Aquilaria sinensis leave extract was not observed in Ames test, mouse bone marrow micronucleus test and sperm abnormality test.3. The body growth, the numbers of corpus luteum and embryo implantation, and the weights of ovary, placenta and uterus-placenta of pregnant rats, as well as body weight and length, tail length, the incidence of stillbirth and absorptive embryo, and appearance, bones and internal organs development of fetal rats in all groups treated with Aquilaria sinensis leave extract were not significantly different, compare to control group(P>0.05). 4. Significant alternations were not found in body weight, food utilization, routine blood and blood biochemical parameters, organ weight and organ coeffients in rats treated with Aquilaria sinensis leave extract (P>0.05), compared to the control group. Gross anatomy and histopathology examination also revealed no obvious abnormality.Conclusions:The acute and subchronic toxicity, genotoxicity and teratogenicity of Aquilaria sinensis leave extract were not observed. It is safe for human health and can be used as a new resources food. |
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