title: Developmental toxicity of polyethylene glycol-g-polyvinyl alcohol grafted copolymer in rats and rabbits.
abstract: Polyethylene glycol-g-polyvinyl alcohol (PEG-PVA) grafted copolymer was evaluated in developmental toxicity studies with Wistar rats and Himalayan rabbits. Pregnant Wistar rats were gavaged with 0 (vehicle control), 100, 300, or 1000 mg PEG-PVA grafted copolymer/kg bw/day from gestation day (GD) 6-15. Pregnant Himalayan rabbits received the same treatment from GD 6 to 19. On GD 20 and 29 for rats and rabbits, respectively, the animals were euthanized and were examined grossly. For each dam, corpora lutea were counted and number and distribution of implantation sites were determined. The fetuses were removed, sexed, weighed, and evaluated for any external, soft tissue, and skeletal findings. No significant findings were found that could be attributed to administration of PEG-PVA grafted copolymer. Under the conditions of these studies, the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity in both species was the highest dose tested of 1000 mg/kg bw/day.
authors.affiliation: Product Safety Department, BASF SE, Ludwigshafen, Germany.
authors.forename: Franziska F
authors.initials: FF
authors.lastname: Heuschmid
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.forename: Paul
authors.initials: P
authors.lastname: Schuster
authors.forename: Birthe
authors.initials: B
authors.lastname: Lauer
authors.forename: Bennard
authors.initials: B
authors.lastname: van Ravenzwaay
mesh_terms: D000014:Abnormalities, Drug-Induced; D000818:Animals; D004305:Dose-Response Relationship, Drug; D005079:Excipients / Q000737:chemistry / Q000633:toxicity*; D005260:Female; D005333:Fetus / Q000187:drug effects; D011145:Polyvinyls / Q000008:administration & dosage / Q000633:toxicity*; D011247:Pregnancy; D011817:Rabbits; D011897:Random Allocation; D051381:Rats
chemical_list: D005079:Excipients; C519734:Kollicoat IR; D011145:Polyvinyls
keywords: Developmental; Excipient; Film coating polymer; GD; Kollicoat® IR; PEG; PEG–PVA; PVA; Polyethylene glycol-g-polyvinyl alcohol grafted copolymer; Prenatal; gestation day; polyethylene glycol; polyethylene glycol-g-polyvinyl alcohol; polyvinyl alcohol