title: Evidence of Absence: Estrogenicity Assessment of a New Food-Contact Coating and the Bisphenol Used in Its Synthesis.
abstract: Consumer concerns about exposure to substances found in food contact materials with estrogenic activity (EA) have created substantial demand for alternatives. We assessed the potential EA of both a new bisphenol monomer used to synthesize polymeric coatings for metal food-contact applications and the nonintentionally added substances (NIAS) that may migrate into food. We evaluated tetramethyl bisphenol F (TMBPF) using in vitro and in vivo assays. We extracted the polymeric coating using food simulants ethanol (50% v/v) and acetic acid (3% w/v) and measured migration using tandem liquid chromatography (LC)/mass spectrometry (MS) and LC time-of-flight MS for TMBPF and NIAS, respectively. We also tested migrants for EA using the E-SCREEN assay. TMBPF did not show estrogenic activity in the uterotrophic assay and did not alter puberty in male and female rats or mammary gland development in female rats. Neither TMBPF nor the migrants from the final polymeric coating increased proliferation of estrogen-sensitive MCF7 cells. TMBPF did not show estrogen-agonist or antagonist activity in the estrogen receptor-transactivation assay. TMBPF migration was below the 0.2 parts per billion detection limit. Our findings provide compelling evidence for the absence of EA by TMBPF and the polymeric coating derived from it and that human exposure to TMBPF would be negligible.
authors.affiliation: Department of Integrative Physiology and Pathobiology, Tufts University School of Medicine , Boston, Massachusetts 02111, United States.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Soto
authors.affiliation: Department of Integrative Physiology and Pathobiology, Tufts University School of Medicine , Boston, Massachusetts 02111, United States.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Schaeberle
authors.affiliation: The Valspar Corporation , Packaging Division, Sewickley, Pennsylvania 15143, United States.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Maier
authors.affiliation: Department of Integrative Physiology and Pathobiology, Tufts University School of Medicine , Boston, Massachusetts 02111, United States.
authors.forename: Carlos
authors.initials: C
authors.lastname: Sonnenschein
authors.affiliation: Independent Consultant, Germantown, Maryland 20874, United States.
authors.forename: Maricel V
authors.identifier: 0000-0002-3853-9461
authors.initials: MV
authors.lastname: Maffini
mesh_terms: D000818:Animals; D004967:Estrogens; D005502:Food; D005506:Food Contamination; D018857:Food Packaging; D006801:Humans; D051381:Rats; D012741:Sexual Maturation
chemical_list: D004967:Estrogens