Toxicity assessment of the alcoholic leaves extract of Reinwardtia indica

The present study aimed to evaluate the safety of the alcoholic leaves extract of Reinwardtia indica in Charles foster rats through an acute and sub-acute oral administration.For assessment of acute oral toxicity test, ratswere orally treated with single dose of the alcoholic leaves extract of Reinwardtia indica at the doses of 50, 250, 500, 1000 2000 and 5000 mg/kg. In sub-acute toxicity study, using the OECD guidelines no. 407, the extract was administered at the doses of 50, 250, 500, 1000, 2000 mg/kg/day for 28 consecutive days and at the dose of 2000 mg/kg satellite group also used for 6 weeks.In acute toxicity above mentioned doses neither showed mortality nor exterior signs of toxicity. In sub-acute, study no significant changes found in haematological and biochemical level ofthe treated rat after 14 days and 28 days in comparison to control. The histopathology of rat brain, kidney, liver, and heart also showed the no cellular changes after extract treated rat.The alcoholic leaves extract of Reinwardtia indica was found non-toxic in single drug dose administration up to 5000 mg/kg (acute study) and in sub-acute administration up to 2000 mg/kg.本研究旨在通过急性与亚急性经口染毒方式，评估印度蕊木（Reinwardtia indica）叶乙醇提取物对Charles Foster大鼠的安全性。在急性经口毒性试验中，大鼠单次经口给予该叶乙醇提取物，给药剂量分别为50、250、500、1000、2000及5000 mg/kg。亚急性毒性试验参照经济合作与发展组织（OECD）第407号指南开展，以50、250、500、1000、2000 mg/kg/天的剂量连续给药28天；另设置2000 mg/kg剂量的卫星组，给药周期为6周。急性毒性试验中，上述各剂量组均未出现大鼠死亡，亦未观察到外在毒性征象。亚急性毒性试验中，给药14天及28天后，与对照组相比，给药大鼠的血液学及生化指标均未出现显著变化。对大鼠脑、肾、肝及心脏进行组织病理学检查，结果显示提取物给药组大鼠的组织均未出现细胞形态学改变。综上，印度蕊木叶乙醇提取物在单次给药最高剂量达5000 mg/kg（急性毒性试验）及亚急性给药最高剂量达2000 mg/kg时，均未表现出毒性。