7 Final Report on the Safety Assessment of Dibutyl Phthalate, Dimethyl Phthalate, and Diethyl Phthalate

Abstract

Dibutyl Phthalate (DBP), Dimethyl Phthalate (DMP), and Diethyl Phthalate (DEP) are dialkyl phthalates used primarily in cosmetics at concentrations of less than 10 percent as plasticizers, solvents, and perfume fixatives. These phthalates are rapidly absorbed, metabolized, and excreted. Acute animal feeding studies indicate that these ingredients are nontoxic. The results of most subchronic and chronic tests indicate that these ingredients are relatively nontoxic to rats. The oral administration of DBP produced testicular atrophy in various test rodents. The available data are not adequate to prove that these ingredients are teratogenic agents to experimental animals. This was not observed after the administration of DMP and DEP. Undiluted DBP, DMP, and DEP produced only minimal irritation to eyes of rabbits. The mutagenic activity of DBP, DMP, and DEP toward Salmonella typhimurium mutants is essentially negative, but some assays reported positive findings. Carcinogenesis was not observed in DBP feeding studies. Limited clinical data on DBP, DMP, and DEP indicate that these ingredients are not human skin irritants, sensitizers, or phototoxic agents. On the basis of the available data, it is concluded that these compounds are safe for topical application in the present practices of use and concentration in cosmetics.