Full
Outline
To assess the safety of a taurine-zinc-selenium fortified walnut milk.
The fortified walnut milk was lyophilized into a powder prior to toxicological evaluation. Its safety was assessed via an acute oral toxicity test and a 28 d repeated-dose oral toxicity study. For the acute toxicity test, specific pathogen free(SPF) Kunming mice (n=20, half male and half female) were administered the test substance at the maximum feasible dose, which was determined by its maximum solubility and gavage volume. The dose was administered in 2 equal portions 6 h apart, followed by a 14 d observation period for clinical signs and mortality. For the 28-day study, a total of 80 SPF Sprague-Dawley rats were randomly allocated to 4 groups and the test substance was administered by gavage at doses of 0 (control), 1.8 (low), 3.6 (medium) or 7.2 g/(kg·bw)/day (high). These dosages corresponded to 4, 8, and 16 times the recommended human intake, respectively. Throughout the study, monitored clinical manifestations, body weight, food consumption and food utilization efficiency. At termination, blood and urine samples were collected for hematological, serum biochemical and urinalysis assessments. Major organs were weighed, and histopathological examinations were performed.
In the acute oral toxicity test, no mortality or treatment-related clinical signs of toxicity were observed. Gross necropsy revealed no organ abnormalities. The median lethal dose (LD₅₀) was therefore determined to be greater than 18.0 g/(kg·bw), classifying the substance as practically non-toxic. In the 28 d oral toxicity study, all animals remained in good health, and there were no statistically significant differences in body weight gain, food consumption, food utilization efficiency,hematological, serum biochemical parameters and organ coefficient between the treatment groups and the control group (P>0.05). All urinalysis parameters were unremarkable. No treatment-related histopathological lesions or cellular damage were found in any major organs.
The taurine-zinc-selenium fortified walnut milk demonstrates a high degree of safety under the conditions of this study. It does not induce acute or subacute toxicity at doses up to 7.2 g/(kg·bw)/day in rats. Based on these findings, the no-observed-adverse-effect level (NOAEL) is established at 7.2 g/(kg·bw)/day, the highest dose tested.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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