Potential adverse effects of phthalic acid esters on human health: a review of recent studies on reproduction.

Various phthalic acid esters (PAEs) have been used for a wide range of products. PAEs and their metabolites produce reproductive and developmental toxicities in laboratory animals. These findings have raised concern about the possibility of PAEs as contributors to reproductive and developmental adverse effects in humans. This paper focuses on PAE exposure and health effects in human populations and summarizes recent studies. The exposure data in human populations indicate that the current methodology of estimation of PAE exposure is inconsistent. It is therefore important to obtain improved data on human PAE exposure and better understanding of the toxicokinetics of PAEs in each subpopulation. Studies on health effects of PAEs in humans have remained controversial due to limitations of the study designs. Some of findings in human populations are consistent with animal data suggesting that PAEs and their metabolites produce toxic effects in the reproductive system. However, it is not yet possible to conclude whether phthalate exposure is harmful for human reproduction. Studies in human populations reviewed in this paper are useful for showing the strength of the association. It is sometimes claimed that the use of animal data for estimating human risk does not provide strong scientific support. However, because it is difficult to find alternative methods to examine the direct toxic effects of chemicals, animal studies remain necessary for risk assessment of chemicals including PAEs.