Toxicology and carcinogenesis studies of di(2-ethylhexyl) phthalate administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats.

Abstract

Di(2-ethylhexyl) phthalate (DEHP) is a member of the phthalate ester chemical class that occurs commonly in the environment and to which humans are widely exposed. Lifetime exposure to DEHP is likely to occur, including during the in utero and early postnatal windows of development. To date, no carcinogenicity assessments of DEHP have used a lifetime exposure paradigm that includes the perinatal period (gestation and lactation). The National Toxicology Program (NTP) tested the hypothesis that exposure during the perinatal period would alter the DEHP carcinogenic response quantitatively (more neoplasms) or qualitatively (different neoplasm types). Two chronic carcinogenicity assessments of DEHP were conducted in which Sprague Dawley (Hsd:Sprague Dawley SD) rats were exposed to dosed feed containing 0, 300, 1,000, 3,000, or 10,000 ppm DEHP for 2 years using different exposure paradigms. In Study 1, groups of 45 F0 time-mated females were provided dosed feed beginning on gestation day (GD) 6 through lactation. On postnatal day (PND) 21, groups of 50 F1 rats per sex continued on the study and were provided dosed feed containing the same DEHP concentration as their respective dam for 2 years. In Study 2, groups of 50 rats per sex, aged 6 to 7 weeks at study start, were provided dosed feed containing DEHP for 2 years. (Abstract Abridged).