Assessment of the teratogenic potential of plasma-soluble extracts of diethylhexyl phthalate plasticized polyvinyl chloride plastics in rats

It is concluded that plasma extracts of PL-130 and PL-146 were not teratogenic when administered iv to pregnant rats during the critical period of organogenesis.

Abstract

Plasma extracts of two polyvinyl chloride (PVC) plastics (designated PL-130 and PL-146) containing diethylhexyl phthalate (DEHP) as a plasticizer and used in the manufacture of parenteral fluid storage bags were administered iv to pregnant rats daily from the sixth through fifteenth day of gestation. Two groups of rats received PL-130 extracts in doses equivalent to 1.3 and 4.7 mg DEHP/kg per day, and two groups received PL-146 extracts in doses equivalent to 1.4 and 5.3 mg DEHP/kg per day. The higher doses are similar to those predicted to be received by a 60-kg human undergoing an exchange transfusion of 21-day-old blood. A control group of rats received the plasma vehicle only. No differences were seen in the growth rates or behavior of the control and treated groups. There were no significant effects on fetal weights, or on crown-rump and transumbilical distances in offspring. The number of live and resorbed fetuses was not significantly different in control and treated groups. The incidence of gross external, skeletal, and visceral defects among offspring was similar in all groups, and there was no statistically significant difference between control and treated groups. It is concluded that plasma extracts of PL-130 and PL-146 were not teratogenic when administered iv to pregnant rats during the critical period of organogenesis.