医用乙醇消毒液的毒性试验观察

OBSERVATION ON TOXICITY TEST FOR MEDICAL ETHANOL DISINFECTION SOLUTION

目的了解乙醇消毒液的毒性,评价其使用的安全性。方法采用动物试验法对其急性毒性、亚急性毒性和皮肤刺激性进行了观察。结果含体积分数75%乙醇消毒液对大、小鼠急性经口LD50均大于5000mg/kg(体重)。各剂量诱导的PCE微核率与阴性对照组比较无显著性差异。该乙醇消毒液原液对家兔完整皮肤无刺激性。亚急性毒性试验各剂量组动物生长发育良好;对大鼠的体重、血常规及血液生化等指标与阴性对照组比较无显著性影响。病理检查发现,高剂量组个别动物肝脏、肾脏和肺脏切片可观察到少数组织轻度改变,但无组间特异性分布,同样的变化在对照组动物中也能观察到,其它脏器均无异常变化。结论该乙醇消毒液属实际无毒,无致微核作用,对家兔完整皮肤无刺激性,亚急性毒性试验未发现明显异常。

Objective To know the toxicity of ethanol disinfection solution and to evatuate its safety for use. Methods Animal test method was used to observe its acute toxicity, subacute toxicity and skin irritation. Results Both rat and mouse acute oral LD50 of 75% （v/v） ethanol disinfection solution was 〉 5000 mg/kg （bw）. The PCE micronucleus rate induced by various dosages was not significantly different from that of the negative control group. The stock solution of ethanol disinfection solution did not irritate the intact rabbit skin. Subacute toxicity test showed that the development and growth of animals of various dosage groups were good and the body weight, blood routine and blood biochemical indexes of the rats were not significantly influenced as compared with the negative control group. Pathological examination found sfight changes of a few tissues in liver, kidney and lung sections of a few animals in high dosage group but no specific distribution between different groups. Same changes also could be seen in animals of control group. Other organs hand no abnormal change. Conclusion The ethanol disinfection solution is practically non- toxic, h did not induce micronucleus formation and was non -irritating to rabbit intact skin. Subacute toxicity test did not find obvious abnormality.