title: Polyethylene glycol-g-polyvinyl alcohol grafted copolymer: reproductive toxicity study in Wistar rats.
abstract: Polyethylene glycol-g-polyvinyl alcohol (PEG-PVA) grafted copolymer was administered by gavage to groups of 25 male and 25 female young Wistar rats at doses of 0 (vehicle control), 100, 300, or 1000 mg/kg bw/day for one generation (F0). The study followed the treated F0 generation through mating, gestation, lactation, and weaning of the F1 generation. F1 animals were mated and followed to gestation day (GD) 15-17 at which time F2 implants were evaluated. There were no indications from the various clinical and gross pathological examinations that the oral administration of PEG-PVA grafted copolymer to the F0-parental rats produced any signs of general, reproductive, or developmental toxicity in the F0 or F1 animals or F2 implants. Based on the lack of any dose-related or biologically relevant effects on fertility, reproduction, development, and overall health of rats gavaged with PEG-PVA grafted copolymer and their progeny, the no-observed-adverse effect level (NOAEL) was determined to be the highest dose tested of 1000 mg/kg bw/day.
authors.affiliation: Product Safety Department, BASF SE, Ludwigshafen.
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: D000818:Animals; D030762:Estrous Cycle / Q000187:drug effects; D005260:Female; D008098:Litter Size; D008297:Male; D011145:Polyvinyls / Q000008:administration & dosage / Q000633:toxicity*; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects; D011897:Random Allocation; D051381:Rats; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects*; D012741:Sexual Maturation / Q000187:drug effects; D013737:Testis / Q000187:drug effects / Q000473:pathology
chemical_list: C519734:Kollicoat IR; D011145:Polyvinyls
keywords: Excipient; Fertility; Film coating polymer; GD; Kollicoat® IR; PEG; PEG–PVA; PVA; Polyethylene glycol-g-polyvinyl alcohol grafted copolymer; Postnatal; gestation day; polyethylene glycol; polyethylene glycol-g-polyvinyl alcohol; polyvinyl alcohol