Preclinical acute toxicology study of surfactant-stabilized ultrasound contrast agents in adult rats

Int J Toxicol. 2010 Jan-Feb;29(1):32-9. doi: 10.1177/1091581809354342. Epub 2009 Dec 14.

Abstract

Gas-filled microbubbles are used as contrast agents in diagnostic ultrasound imaging. A preclinical, acute toxicity study of 2 surfactant-stabilized ultrasound contrast agents (ST68 and ST44) was conducted. Subjects were 104 Sprague-Dawley rats (experimental doses, 0.1, 0.2, 0.8, and 1.0 mL/kg; control, 1.0 mL/kg saline) that were studied for 14 days after contrast; clinical signs, weight, blood, and urine were evaluated. Histopathology was performed following euthanasia. Of the 40 animals receiving ST44, 4 died prematurely and a dose dependency was demonstrated (P = .011), whereas in the ST68 groups only 1 death occurred (no dose dependency; P = .48). Only the weight of rats injected with ST44 varied significantly (P = .0003). This dependency was also found for 3 of 5 urine parameters and 4 of 36 blood parameters (P < .05). For ST68, only 1 urine parameter showed significance (P < .0001). Giant cell infiltration in the lungs was significantly higher than controls in the ST44 0.1 mL/kg and the ST68 0.8-1.0 mL/kg groups (P < .01). It is concluded that the prudent choice for future nonrodent, toxicology studies and potentially for human clinical trials is ST68 (given the deaths in the ST44 groups).

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Animals
  • Body Weight / drug effects
  • Contrast Media / toxicity*
  • Dose-Response Relationship, Drug
  • Female
  • Hexoses / toxicity*
  • Longevity / drug effects
  • Male
  • Microbubbles
  • Polysorbates / toxicity*
  • Rats
  • Rats, Sprague-Dawley
  • Surface-Active Agents* / toxicity
  • Toxicity Tests, Acute
  • Ultrasonography

Substances

  • Contrast Media
  • Hexoses
  • Polysorbates
  • ST68
  • Surface-Active Agents