Final Report on the Developmental Toxicity of Polyoxyethylene SorbitanMonolaurate (CAS NO 9005-64-5) in Sprague-Dawley (CD (Trade Name)) Rats on Gestational Days 6 through 15. Laboratory Supplement. Sections 1-7A

摘要

The Sprague-Dawley rat (CD) is the species and strain of choice for thedevelopmental toxicity studies of Polysorbate 20 (polyoxyethylene sorbitan monolaurate). Treatment will be administered by gavage from gestational days 6 through 15. Maternal toxicity assessment will include organ weights (liver, heart and kidney) and optional histopathology since focal necrosis and organ congestion have been associated with exposure to Tween 80 (Nityanand and Kapoor, 1979). The dose levels for each test agent will be control (0), 500, and 5000 mg/kg/day in a volume of 5 ml/kg. RTI Protocol No. 398 pertains specifically to the developmental toxicity evaluation of polyoxyethylene sorbitan monolaurate (TW20) in the rat. The document is a supplement to the final report. It contains a summary of the methodology used in the protocol.