作 者：
高峄涵;严大为;郑赛晶;盛云华;周慧明;沈轶
单 位：
上海市食品药品检验所;上海新型烟草制品研究院
关键词：
电子烟;气溶胶;吸入;丙二醇;毒性;大鼠
摘 要：
[目的]研究电子烟雾化剂1,2-丙二醇(PG)的大鼠90天吸入毒性,为长期吸食电子烟的安全性评价提供试验依据.[方法]成年Wistar大鼠按其体重随机分为阴性对照组和PG暴露的低、中、高3个剂量组(剂量分别为100 mg/kg、500 mg/kg和1500 mg/kg),每组16只大鼠,雌雄各半.试验分为90天暴露期和停止暴露后1个月恢复期.试验期间观察动物体重和耗食量变化;分别在暴露期和恢复期结束后,每组各取一半动物进行血生化、血液学和尿液等指标检测,并对动物脏器进行组织病理学检查.[结果]与阴性对照组相比,①雌性大鼠体重仅低剂量组第8周有显著降低(P<0.05),其它组别试验期间未出现显著性差异;雄性大鼠低、中剂量组的体重试验期间未出现显著性差异,但高剂量组雄性大鼠在暴露后4周后的体重显著降低(P<0.05或P<0.01),直至恢复期结束;②低、高剂量组动物在4周的恢复期内耗食量下降幅度显著,雌性和雄性动物降幅范围分别达到12.7%~40.8% 和13.9%~35.9%,其它组别和试验期间摄食量波动较小;③低、中、高剂量组的部分生化指标钠离子、氯离子和钾离子等水平发生变化,恢复期结束后恢复正常水平;④中、高剂量组雄性大鼠的红细胞数显著降低(P<0.05或P<0.01),且低、中、高剂量组有量效关系,恢复期后该指标恢复正常,其它血液学指标未见显著异常;⑤暴露期和恢复期各剂量组尿液指标均未见显著异常(P>0.05);⑥各剂量组脏器重量和脏器系数均未见显著差异(P>0.05),仅恢复期结束后中剂量组雌性大鼠胸腺重量增大,胸腺的脏脑比系数显著升高(P<0.05).[结论]大鼠90天吸入PG的NOEL值为100 mg/kg,长期吸入较低剂量PG无显著毒性作用.
译 名：
Inhalation toxicity testing on Wistar rats exposed to atomized propylene glycol in ninety days
作 者：
GAO Yihan;YAN Dawei;ZHENG Saijing;SHENG Yunhua;ZHOU Huiming;SHEN Yi;Shanghai New Tobacco Product Research Institute;Shanghai Institute for Food and Drug Control;
关键词：
electronic cigarette;;aerosol;;inhalation;;propylene glycol;;toxicity;;rat
摘 要：
Objective: To provide experimental gist for safety evaluation of long-term using of e-cigarettes, 90 days nose-only inhalation study of aerosolized propylene glycol in rats has been conducted. Method: Adult Wistar rats were randomly divided into control group and experimental groups with low, medium and high-dose PG exposure according to their body weight(the inhalation doses were 100 mg/kg,500 mg/kg and1500 mg/kg respectively) with 16 rats in each group(half male and female). The experiment was carried out with 90-day exposure period and one-month recovery period. Changes of body weight and food intake were observed during the experiment. By the end of exposure period and recovery period, half of the rats in each group were taken for blood biochemistry, hematology, urine and other indicators detection, and histopathological examination of the rats were performed. Results: Compared with the negative control group, ① Only in low-dose group, the weight of female rats got significantly lower at the 8 th week(P<0.05), and there was no significant difference for the other groups. No significant differences were observed during weight test of the low-and middle dose groups of male rats, while male rats in the high-dose group showed a noteworthy decrease in body weight after 4 weeks of exposure(P<0.05 or P<0.01) until the end of recovery period. ② In low-and high-dose groups, animals' food intake decreased significantly in the recovery period of 4 weeks, with a decrease range of 12.7%-40.8% for female animals and 13.9%-35.9% for male animals, and no significant difference was observed in other groups or during the experimental period. ③ Biochemical indicators such as sodium ion, chloride ion and potassium ion concentrations for the experimental groups get changed, and returned to normal levels after the recovery period. ④ Erythrocyte counts in male rats of medium-and high-dose groups were significantly decreased(P<0.05 or P<0.01), and low-, medium-and high-dose groups have a doseeffect relationship. This indicator returned to normal level after the recovery period. No other abnormal changes in hematological indexes were found. ⑤Urine analysis showed no obvious abnormalities during exposure period and recovery period. ⑥There was no significant difference in organ weight and organ coefficient for all experimental groups(P>0.05), while thymus weight of the female rats in middledose group were increased and ratio coefficient of viscera to brain for thymus were significantly enhanced(P<0.05). Conclusion: NOEL(No-observed-effect-level) value of 90-day inhaled PG in rats is 100 mg/kg, and long-term inhalation of PG at low dose has no obvious toxic effect.
