Dimethylpolysiloxane Fluid-c14 (Dow Corning 360 Medical Fluid-c14) Distribution and Disposition in Rats Following Subcutaneous Injection with Cover Letter dated 04/20/94

摘要

Dimethylsiloxanes and silicones (CAS No. 63148-62-9) was evaluated in a subchronic study to determine the distribution following subcutaneous injection. Four groups of 2 male Sprague-Dawley rats were subcutaneously injected with 475 to 559 mg radiolabeled PDMS fluid/kg and placed in metabolism cages to collect expired air, urine, and feces. The animals were observed throughout the study period for signs of toxicity and changes in food consumption and body weight. The groups were sacrificed 8, 30, 60, and 90 days post-injection, gross necropsy was performed, and the tissues were assayed for radioactivity. No signs of toxicity were observed, no changes in body weight or food consumption were reported, and there were no abnormal findings at necropsy. The animals were found to excrete 0.00104 to 0.00849% of the injected dose in expired air, 0.002 to 0.09% in urine and 0.016 to 6.57% in feces (although contamination was suspected for 3 rats having the highest fecal elimination). Overall, 0.15% of the injected dose migrated from the injection site and was distributed to all tissues, concentrating primarily in the axillary lymph nodes.