NTP-CERHR monograph on the potential human reproductive and developmental effects of di (2-ethylhexyl) phthalate (DEHP).

The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) conducted an updated evaluation of the potential for DEHP to cause adverse effects on reproduction and development in humans. The first CERHR expert panel evaluation of DEHP was completed in 2000 by the Phthalates Expert Panel. CERHR selected DEHP for an updated evaluation because of: (1) widespread human exposure, (2) public and government interest in adverse health effects, (3) recently available human exposure studies, and (4) the large number of relevant toxicity papers published since the earlier evaluation. DEHP (CAS RN: 117-81-7) is a high production volume chemical used as a plasticizer of polyvinyl chloride in the manufacture of a wide variety of consumer goods, such as building products, car products, clothing, food packaging, children's products (but not in toys intended for mouthing), and in medical devices made of polyvinyl chloride. The public can be exposed to DEHP by ingesting food, drink or dust that has been in contact with DEHP-containing materials, by inhaling contaminated air or dust, or by undergoing a medical procedure that uses polyvinyl chloride medical tubing or storage bags. It is estimated that the general population of the United States is exposed to DEHP levels ranging from 1 to 30 microg/kg bw/day (micrograms per kilogram body weight per day). The results of this DEHP update evaluation are published in an NTP-CERHR monograph that includes: (1) the NTP Brief, (2) the Expert Panel Update on the Reproductive and Developmental Toxicity of DEHP, and (3) public comments on the expert panel report. The NTP reached the following conclusions on the possible effects of exposure to DEHP on human development and reproduction. Note that the possible levels of concern, from lowest to highest, are negligible concern, minimal concern, some concern, concern, and serious concern. There is serious concern that certain intensive medical treatments of male infants may result in DEHP exposure levels that adversely affect development of the male reproductive tract. DEHP exposure from medical procedures in infants was estimated to be as high as 6000 microg/kg bw/day. There is concern for adverse effects on development of the reproductive tract in male offspring of pregnant and breast feeding women undergoing certain medical procedures that may result in exposure to high levels of DEHP. There is concern for effects of DEHP exposure on development of the male reproductive tract for infants less than one year old. Diet, mouthing of DEHP-containing objects, and certain medical treatments may lead to DEHP exposures that are higher than those experienced by the general population. There is some concern for effects of DEHP exposure on development of the reproductive tract of male children older than one year. As in infants, exposures of children to DEHP may be higher than in the general population. There is some concern for adverse effects of DEHP exposure on development of the male reproductive tract in male offspring of pregnant women not medically exposed to DEHP. Although DEHP exposures are assumed to be the same as for the general population, the developing male reproductive tract is sensitive to the adverse effects of DEHP. There is minimal concern for reproductive toxicity in adults exposed to DEHP at 1 - 30 microg/kg bw/day. This level of concern is not altered for adults medically exposed to DEHP. NTP will transmit the NTP-CERHR Monograph on DEHP to federal and state agencies, interested parties, and the public and it will be available in electronic PDF format on the CERHR web site http://cerhr.niehs.nih.gov and in printed text or CD-ROM from the CERHR.