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PEDIATRICS Vol. 111 No. 6 June 2003, pp. 1467-1474

TECHNICAL REPORT

Pediatric Exposure and Potential Toxicity of Phthalate Plasticizers

ABSTRACT

Phthalates are plasticizers that are added to polyvinyl chloride (PVC) products to impart flexibility and durability. They are produced in high volume and generate extensive though poorly defined human exposures and unique childhood exposures. Phthalates are animal carcinogens and can cause fetal death, malformations, and reproductive toxicity in laboratory animals. Toxicity profiles and potency vary by specific phthalate. The extent of these toxicities and their applicability to humans remains incompletely characterized and controversial. Two phthalates, diethylhexyl phthalate (DEHP) and diisononyl phthalate (DINP), have received considerable attention recently because of specific concerns about pediatric exposures. Like all phthalates, DEHP and DINP are ubiquitous contaminants in food, indoor air, soils, and sediments. DEHP is used in toys and medical devices. DINP is a major plasticizer used in children’s toys.

Scientific panels, advocacy groups, and industry groups have analyzed the literature on DEHP and DINP and have come to different conclusions about their safety. The controversy exists because risk to humans must be extrapolated from animal data that demonstrate differences in toxicity by species, route of exposure, and age at exposure and because of persistent uncertainties in human exposure data. This report addresses sensitive endpoints of reproductive and developmental toxicity and the unique aspects of pediatric exposures to phthalates that generate concern. DEHP and DINP are used as specific examples to illustrate the controversy.

Abbreviations: PVC, polyvinyl chloride • DEHP, diethylhexyl phthalate • DINP, diisononyl phthalate • MEHP, monoethylhexyl phthalate • ECMO, extracorporeal membrane oxygenation • NOAEL, no observable adverse effect level • LOAEL, lowest observable adverse effect level • CERHR, Center for the Evaluation of Reproductive Risks to Humans • DBP, dibutyl phthalate

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