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Oral dietary developmental toxicity study with polyvinyl acetate phthalate (PVAP) in the rat

DOI: 10.1016/j.yrtph.2014.07.021
Title: Oral dietary developmental toxicity study with polyvinyl acetate phthalate (PVAP) in the rat
Journal Title: Regulatory Toxicology and Pharmacology
Volume: 70
Issue: 1
Publication Date: October 2014
Start Page: 325
End Page: 332
Published online: online 30 July 2014
ISSN: 0273-2300
Affiliations:

  • a Colorcon, Inc., 275 Ruth Road, Harleysville, PA 19438, USA

  • b School of Medicine, Virginia Commonwealth University, Richmond, VA 23229, USA
  • Abstract: l 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 2324 mg PVAP/kg/day).
    Received: 17 February 2014
    Corresponding information:
    Email: cdemerlis@colorcon.com

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