Acute Toxicity,Short-Term Toxicity and Hemolysis Test of 1,2-Propanediol
Objective To provide toxicological evidence for the clinical application of 1,2-propanediol(PG).Methods A total of 60 ICR mice were randomly divided into the control group(equal volume of Sodium Chloride Injection)and PG dose groups(8 750,9 475,10 250,11 100,and 12 000 mg/kg),the corresponding drugs were injected into the tail vein once,and toxic reactions and mortality were observed.The LD50 was calculated.Eighty Wistar rats were divided into the control group(equal volume of Sodium Chloride Injection),high-,medium-,and low-dose groups(6 666,3 333,1 666 mg/kg of PG),and they were continuously injected with the corresponding drugs intraperitoneally for 16 d.The general condition of the rats was observed and their body mass was measured.After the end of the experiment,the blood routine and biochemical indicators were detected,organ coefficients were calculated,and histopathological examination was performed.The in vitro hemolysis of PG was investigated by visual observation and spectrophotometry,and the hemolysis rate was calculated.Results After the administration,the toxic reactions in mice mainly manifested as convulsions,limb rigidity,difficulty breathing,and urinary incontinence,with more pronounced reactions at higher doses.The LD50 of PG for mice was 10 483 mg/kg.Compared with those in the control group,the serum alanine aminotransferase and creatinine of female rats,and serum uric acid of male rats in the high-dose group increased significantly(P<0 05),the liver and lung coefficients of female rats in the high-dose group increased significantly(P<0.05),while the stomach coefficient of female rats in the high-dose group decreased significantly(P<0.05).The histopathological examination results showed no significant histological changes in the liver and kidneys of rats in the high-dose group.No hemolysis was observed in the 25%PG solution tube,while the upper layer of the 50%,75%,and 100%PG solution tubes was slightly red.The longer the incubation time,the higher the concentration,and the darker the color.The hemolysis rate was all higher than 5%.Conclusion PG has a high LD50 value in mice and does not have a significant toxic effect on rats,indicating a high safe dose of PG.However,there is a certain risk of hemolysis in PG,and it is necessary to control the clinical medication speed and time to ensure the safety of medication.
1,2-propanediolacute toxicity testshort-term toxicity testhemolysis test