Abstract
Systemic toxicity caused by repeated exposure to both polar and nonpolar leachables of di(2-ethylhexyl)-1,2-cyclohexane plasticized polyvinyl chloride (PVC) was evaluated with dual routes of parenteral administration method on rats in the study. Experimental group and control group were designed by researchers. Tail intravenous injection with 0.9% sodium chloride injection extracts and intraperitoneal injection with corn oil extracts were conducted to the experimental rats while tail intravenous injection with 0.9% sodium chloride Injection and intraperitoneal injection with corn oil were conducted to the control rats. After 14 days, blood specimens were collected for clinical pathology (hematology and clinical chemistry) analysis. Selected organs were weighed and a histopathological examination was conducted. As a result, compared with the control animals, there were no toxicity-related changes on the parameters above. The results show that the rats do not show obvious systemic toxicity reaction caused by repeated exposure with dual routes of parenteral administration method on rats after administration with both polar and nonpolar exacts of di(2-ethylhexyl)-1,2-cyclohexane plasticized PVC simultaneously up for 14 days.
Highlights
Polyvinyl chloride (PVC) with good physical properties and good biocompatibility to tissues including blood is widely used in many medical devices such as blood transfusion apparatus, intravascular catheter, blood circuit, heart oxygenator, chest or abdominal drain tube and so on [1]
Dual routes of parenteral administration method were used in this study to fully evaluate the potential systemic toxicity risk of DEHCH plasticized PVC
According to the characteristics of PVC materials plasticized by DEHCH, we pioneered the use of polar and nonpolar vehicles and injected into test rats in the dual administration routes, which simulates the effects of clinically applicable water-soluble and fat-soluble drugs on PVC plasticized by DEHCH
Summary
Polyvinyl chloride (PVC) with good physical properties and good biocompatibility to tissues including blood is widely used in many medical devices such as blood transfusion apparatus, intravascular catheter, blood circuit, heart oxygenator, chest or abdominal drain tube and so on [1]. According to the ISO10993-11:2009 requirements, the research on repeated contacting body systemic toxicity test was performed on DEHCH plasticized PVC material to verify the safety of using this material continuously [6]. For devices with a direct or indirect fluid-path or blood contact environment, extraction using polar extraction vehicle (such as physiological saline) and tests for systemic toxicity by the intravenous route may be appropriate. Repeated exposure to fat-soluble vehicle may cause the risk of systemic toxicity, only repeated administration of polar extraction could not fully evaluate the risk of chemical leaching due to the contacting plasma and liquid drug and plasma. Dual routes of parenteral administration method were used in this study to fully evaluate the potential systemic toxicity risk of DEHCH plasticized PVC.
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