title: Oral dietary developmental toxicity study with polyvinyl acetate phthalate (PVAP) in the rat.
abstract: Polyvinyl acetate phthalate (PVAP) was evaluated in a developmental toxicity study with Crl:CD(SD) rats. Female rats were provided continual access to the formulated diets on days 6 through 20 of presumed gestation (DGs 6 through 20) at concentrations of 0%, 0.75%, 1.5% and 3%. All surviving rats were sacrificed and Caesarean-sectioned on DG 21. The following parameters were evaluated: viability, clinical observations, body weights, feed consumption, necropsy observations, Caesarean-sectioning and litter observations, including gravid uterine weights, fetal body weights and sex, and fetal gross external, soft tissue and skeletal alterations. There were no treatment-related adverse effects reported in the developmental toxicity study. The maternal and developmental no-observable-adverse-effect level (NOAEL) of PVAP was the highest concentration administered, i.e., 3.0% (equivalent to 2324mgPVAP/kg/day).
authors.affiliation: Colorcon, Inc., 275 Ruth Road, Harleysville, PA 19438, USA. Electronic address: cdemerlis@colorcon.com.
authors.forename: C C
authors.initials: CC
authors.lastname: DeMerlis
authors.affiliation: Colorcon, Inc., 275 Ruth Road, Harleysville, PA 19438, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Schoneker
authors.affiliation: School of Medicine, Virginia Commonwealth University, Richmond, VA 23229, USA.
authors.forename: J F
authors.initials: JF
authors.lastname: Borzelleca
mesh_terms: D000818:Animals; D004305:Dose-Response Relationship, Drug; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D018811:Maternal Exposure / Q000009:adverse effects*; D019055:No-Observed-Adverse-Effect Level; D011145:Polyvinyls / Q000008:administration & dosage / Q000633:toxicity*; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D011145:Polyvinyls; C036125:polyvinylacetate phthalate polymer
keywords: Developmental study; Enteric coating; Enteric polymer; Modified release coating; PVAP; PVAP-T; Pharmaceutical excipient; Polyvinyl acetate phthalate; Polyvinyl acetate phthalate and titanium dioxide