INTOX Private Limited, Pune, MS, 412108, India.
Toxicol Mech Methods. 2008;18(5):433-42. doi: 10.1080/15376510802084030.
ABSTRACT (-)-Hydroxycitric acid (HCA), a natural plant extract from the dried fruit rind of Garcinia cambogia, has been reported to inhibit fat synthesis and reduce food intake. The objective of this study was to evaluate the effects of a novel calcium/potassium salt of (-)-hydroxycitric acid (HCA-SX) on the reproductive systems of male and female rats, the postnatal maturation and reproductive capacity of their offspring, and possible cumulative effects through multiple generations. Sprague-Dawley rats (30/sex/group) were maintained on feed containing HCA-SX at dose levels of 0, 1000, 3000, or 10,000 ppm for 10 weeks prior to mating, during mating, and, for females, through gestation and lactation, across two generations. During the period of study, animals were examined daily for signs of clinical toxicity and their body weight and feed consumption were recorded twice a week. For the parents (F(0) and F(1)) and the offspring (F(1) and F(2a)), reproductive parameters such as fertility and mating, gestation, parturition, litters, lactation, sexual maturity, and development of offspring were assessed. At termination, necropsy and histopathological examinations were performed on all animals. Dietary exposure of HCA-SX to parental male and female rats of both (F(0) and F(1)) the generations during the premating and mating periods, for both sexes, and during gestation and lactation in case of female rats, did not reveal any remarkable incidence of mortality or abnormal clinical signs. Compared to respective controls, HCA-SX exposure did not affect feed consumption or body weight at any of the exposure levels. HCA-SX exposure did not affect reproductive performance as evaluated by sexual maturity, fertility and mating, gestation, parturition, litter properties, lactation, and development of the offspring. Based on the results of this study, the parental as well as the offspring no-observed-adverse-effect level for HCA-SX was determined to be greater than 10,000 ppm in diet or equivalent to 1018 and 1524 mg/kg body weight/day in male and female rats, respectively.
（-）-羟基柠檬酸（HCA）是一种从藤黄果实干果皮中提取的天然植物提取物，已被报道可抑制脂肪合成和减少食物摄入。本研究旨在评估新型钙/钾盐（-）-羟基柠檬酸（HCA-SX）对雄性和雌性大鼠生殖系统的影响、其后代的产后成熟和生殖能力，以及通过多代可能产生的累积效应。30 只/性别/组的 Sprague-Dawley 大鼠在交配前、交配期间和雌性大鼠妊娠和哺乳期，用含 HCA-SX 的饲料喂养，剂量分别为 0、1000、3000 或 10000ppm，跨越两代。在研究期间，每天观察动物的临床毒性迹象，并记录其体重和饲料摄入量，每周记录两次。对于父母代（F(0)和 F(1)）和子代（F(1)和 F(2a)），评估了生育力和交配、妊娠、分娩、产仔数、哺乳期、性成熟和子代发育等生殖参数。在研究结束时，对所有动物进行了尸检和组织病理学检查。在交配前和交配期间，以及雌性大鼠妊娠和哺乳期，HCA-SX 对雄性和雌性父母代大鼠的饮食暴露，在两个世代中，都没有发现任何显著的死亡率或异常临床症状。与各自的对照组相比，HCA-SX 暴露在任何暴露水平下都不影响饲料消耗或体重。HCA-SX 暴露不影响生殖性能，如性成熟、生育力和交配、妊娠、分娩、产仔数、哺乳期和子代发育。基于这项研究的结果，HCA-SX 的母体和子代未观察到不良效应水平（NOAEL）被确定为大于 10000ppm 的饮食或相当于雄性和雌性大鼠分别为 1018 和 1524mg/kg 体重/天。
