The carcinogenicity of di(2-ethylhexyl) phthalate (DEHP) in perspective.

The commonly used plasticizer di(2-ethylhexyl) phthalate (DEHP) was recently tested for chronic toxic potential by incorporation into the diet of rats and mice for approximately 2 yr. Upon reviewing the test results, the sponsoring organization concluded that DEHP was carcinogenic to the rats and mice, as indicated by increased occurrences of liver tumors in the DEHP-exposed animals in comparison to controls. Another group has disagreed with this conclusion, however, citing perceived methodological deficiencies and improper interpretations in the study, and has also suggested that rodents may not be adequate models of human response to DEHP. This communication compares the conduct of the DEHP bioassay favorably with state-of-the-art procedures in animal carcinogenicity testing and documents approval of the study interpretations by several independent peer review groups. The carcinogenic potential of DEHP is placed in perspective by evaluating the evidence for DEHP-induced tumors in rodent species in light of dose response relationships, other biochemical and toxicological effects of DEHP, and its comparative metabolism and disposition in rodent and primate species. A composite analysis of the currently available information indicates that DEHP has been shown to be carcinogenic to rodents in a valid chronic test, indicating that it should be considered as a potential carcinogen in humans, as well. Further experimental inquiry will be required, however, to accurately assess the potential health risks posed to humans by exposure to small amounts of this plasticizer.