Aggregate Exposures to Phthalates in Humans July 2002

Reviewers HCWH thanks the following individuals for reviewing an earlier draft of this report. Their comments and suggestions were invaluable and substantially improved the manuscript. We are grateful for their contribution. Their review, however, does not constitute endorsement of the report or its conclusions. Two additional reviewers chose to remain anonymous. A g g r e g a t e E x p o s u r e s t o P h t h a l a t e s i n H u m a n s 1 Executive Summary Phthalates are a family of chemicals that are produced in the millions of tons annually worldwide, and are a principal component of many diverse products that consumers come into contact with at home, at work, and in hospitals. They include products made of flexible polyvinyl chloride plastic (PVC), cosmetics and other personal care goods, pesticides , building materials, lubricants, adhesives, and film, among other items. Phthalates are released into the environment by manufacturers and escape from consumer products in which they are used. Worldwide ecosystem contamination and direct contact with phthalate-containing products result in virtually ubiquitous human exposures. Health effects that may be caused by exposure to phthalates differ among the various individual compounds and depend on the timing and the size of the dose. Young, developing organisms are more vulnerable to exposure to phthalates than adults. In particular , the developing male reproductive tract appears to be the most sensitive endpoint, although effects on the liver, kidneys, lungs, and blood clotting are also of concern. In animal tests considered relevant to humans, several of the phthalates, including di-(2-ethylhexyl) phthalate (DEHP), di-butyl phthalate (DBP), benzyl butyl phthalate (BBP), and perhaps di-isononyl phthalate (DINP), interfere with male reproductive tract development and are toxic to cells in the testes responsible for assuring normal sperm and hormone production. Human exposure to DEHP from PVC medical devices used in patient care has been known for some time. Expert panels of the US National Toxicology Program (NTP) and Health Canada, as well as the US Food and Drug Administration (FDA), however, have recently reviewed the toxicology of DEHP and considered exposures to patients that may result from the use of DEHP-containing equipment. Each review concluded that some patients are likely to be exposed to potentially unsafe amounts of DEHP while receiving medical care. Testing by the US Centers for Disease Control and Prevention …