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

C C DeMerlis1, D R Schoneker1, J F Borzelleca2

  • 1Colorcon, Inc., 275 Ruth Road, Harleysville, PA 19438, USA.

Regulatory Toxicology and Pharmacology : RTP
|August 2, 2014
PubMed

Insights

Polyvinyl acetate phthalate (PVAP) showed no adverse effects in a rat developmental toxicity study. The highest dose tested, 3.0%, was determined to be the no-observable-adverse-effect level (NOAEL).

Area of Science:

  • Toxicology
  • Reproductive Toxicology
  • Pharmacology

Background:

  • Polyvinyl acetate phthalate (PVAP) is a substance requiring toxicological evaluation.
  • Assessing developmental toxicity is crucial for understanding potential risks to offspring.
  • Regulatory safety assessments necessitate comprehensive toxicity studies.

Purpose of the Study:

  • To evaluate the developmental toxicity of Polyvinyl acetate phthalate (PVAP) in rats.
  • To determine the maternal and developmental no-observable-adverse-effect level (NOAEL) of PVAP.

Main Methods:

  • A developmental toxicity study was conducted using Crl:CD(SD) rats.
  • Female rats received diets containing 0%, 0.75%, 1.5%, or 3.0% PVAP from gestation days 6 through 20.
  • Maternal and fetal parameters, including viability, body weight, and external/skeletal alterations, were assessed on gestation day 21.

Main Results:

  • No treatment-related adverse effects were observed in dams or fetuses across all evaluated parameters.
  • All measured endpoints, including viability, clinical observations, and fetal development, were unaffected by PVAP exposure.
  • The highest dose tested (3.0% PVAP) did not elicit any adverse effects.

Conclusions:

  • Polyvinyl acetate phthalate (PVAP) demonstrated a lack of maternal and developmental toxicity in the tested rat model.
  • The no-observable-adverse-effect level (NOAEL) for both maternal and developmental endpoints was determined to be the highest concentration administered (3.0% PVAP).
  • These findings suggest a favorable safety profile for PVAP concerning developmental toxicity under the study conditions.

Keywords:
Developmental studyEnteric coatingEnteric polymerModified release coatingPVAPPVAP-TPharmaceutical excipientPolyvinyl acetate phthalatePolyvinyl acetate phthalate and titanium dioxide

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