3 Final Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, and Butylparaben

Abstract

The Parabens are esters of p-hydroxybenzoic acid (PHBA) and are the most commonly used as preservatives in cosmetic formulations. Data obtained from chronic administration studies indicate that Parabens are rapidly absorbed, metabolized, and excreted. Acute chronic and subchronic toxicity studies in animals indicate that Parabens are practically nontoxic by various routes of administration. Methylparaben and Ethylparaben at 100 percent concentration were slightly irritating when instilled into the eyes of rabbits. Numerous in vitro mutagenicity studies indicate that the Parabens are non-mutagenic. Methylparaben was noncarcinogenic when injected in rodents or when administered intravaginally in rats. Cocarcinogenesis studies on Propyl- and Methylparaben were negative. Teratogenic studies on Methyl- and Ethylparaben were also negative. Parabens are practically nonirritating and nonsensitizing in the human population with normal skin. Paraben sensitization has been reported when Paraben-containing medicaments have been applied to damaged or broken skin. Photo-contact sensitization and phototoxicity tests on product formations of Methyl-, Propyl-, and/or Butylparaben gave no evidence of significant photoreactivity. It is concluded that Methylparaben, Ethylparaben, Propylparaben, and Butylparaben are safe as cosmetic ingredients in the present practices of use.