2- Safety of AHCC
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For thousands of years and all over the world, various Basidiomycetes mushrooms have been used as a food and for traditional folk medicine, especially in Asia and Europe. Among these mushrooms is Shiitake, a well-known edible mushroom. AHCC’s primary ingredients consist of these various types of edible Basidiomycetes mushrooms, thus it would be logical that AHCC’s consumption is safe when consumed orally. Moreover, during its 15 years of use, AHCC has demonstrated to be safe as a nutrition supplement. There are currently hundreds of thousands of people taking AHCC and no side effects have been reported.
Although there have not been any toxicological problems or side effect with AHCC to date, acute and subacute toxicological studies were conducted in animals at The Safety Research Institute for Chemical Compounds Co., LTD. All the toxicological studies were done in correspondence with GLP standards and guidelines for toxicological experiments. Acute toxicology studies of rats show the LD50 of AHCC taken orally to be over 12 g/kg, and over 8.5 g/kg while given intraperitoneally.
Date： Jun. 10.1996 ～ Sep. 12.1996
1) Oral single dose toxicity study of AHCC FD in rats
Animals: ＳＰＦ male SD rats (5 weeks old), and female SD rats (6 weeks old).
Dose: The maximum dose was 12,500mg/kg for AHCC FD. Thus the single dose toxicity for orally administered AHCC FD was at a dose of 0 for the control or 12,500mg/kg for the experimental group. Each male and female group consisted of 10 rats.
Results: No death occurred during the observation period of the control group or 12,500mg/kg AHCC group. The LD50 was more than 12,500mg/kg for oral single dose toxicity of AHCC FD. It was concluded that oral administration of AHCC FD had little acute toxicity potential.
2) Intraperitoneal single dose toxicity study of AHCC FD in rats
Animals: ＳＰＦ male SD rats (5 weeks old), and female SD rats (6 weeks old).
Dose: In this study, rats were administered AHCC FD intraperitoneally at a dose of 0 for the control, and 6,250, 7,430, 7,870, 8,340, 8,840, 9,370, 10,500, or 12,500 mg/kg body weight. Each male and female group consisted of 5 rats.
Histopathological findings：Organs and tissues of male rats died within 24 hr in the 12,500mg/kg group and those of the female rat died within 48 hr in the 8,840mg/kg group. These organs and tissues were examined histopathologically.
Results: LD50 was 8,490 mg/kg in male rats and 9,849 mg/kg in female rats. The minimum lethal dose of AHCC FD was 7,430mg/kg in male rats and 8,340mg/kg in female rats.
Conclusion: The minimal lethal dose of intraperitoneally administered AHCC was lower in the male rats than in the female rats, at 7,430mg/kg and 8,340mg/kg respectively.
3) Oral subchronic toxicological study of AHCC
This study was conducted at the Biochemistry Department of Amino Up Chemical, Co., Ltd.
Animals: 24 male and 24 female SD rats (7 weeks old) were used for this study.
Administration of AHCC: AHCC was incorporated into SE-2 standard powder diet in the proportion of 1% and 5%. The experimental groups, which consisted of 8 male and 8 female rats, received this AHCC diet for 16 weeks. The control group was fed the standard powder diet without AHCC.
Methods: The rats in the experimental groups were weighed every 2 days and body measurements were taken every week. After 16 weeks, the rats were executed, and their blood cell count was taken. Assays on liver function were performed, as were histopathologies of the liver, kidney, spleen and heart.
Results: There were no overt signs of toxicity in either male and female rats in the two AHCC-treated groups. Food consumption was not affected by the incorporation of AHCC into diet. The daily consumption of AHCC was 0.61g/kg body weight in 1% AHCC-treated group and 2.95 g/kg in 5% AHCC-treated group.
§ Weight - No significant changes in weight gain were noticed in the three groups (as shown in Fig. Left). The weights of their livers, hearts, and kidneys are shown in Fig. Right. Although there were no significant differences, the weight of the kidneys in the 5% AHCC-treated rats was higher than those of control group and the 1% AHCC-treated group.
§ Blood Cells - The numbers of red blood cells in the AHCC-treated groups were more than that of the control group, but the number of white blood cells was same in three groups. The sGTP, sGOP, albumin, and globulin levels were not significantly different in the three groups.
§
Conclusion: The administration of AHCC to rats in the doses of 0.61 and 2.95 g/kg/day for 16 weeks caused no significant changes in body weight, organ weight, blood cell count, or organ pathology between either AHCC-treated groups and the control group. Furthermore, no toxicity was seen as measured by physiological, biochemical and histopathological indexes. Therefore, AHCC should be safe when administered orally under a daily dose of 2.95 g/kg.
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