REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES OF SILICONE ELASTOMERQ7-2423 Q7-2551 IN RATS AND RABBITS

The purpose of these studies was to assess the potential adverse effec ts of silicone breast implant envelope elastomer on general reproducti on and fetal development in rats and rabbits. One control and one trea tment group of 30 male and 30 female Charles River CD rats and 25 inse minated New Zealand white rabbits per group were used in the one-gener ation reproductive and developmental toxicity studies, respectively. T wo 1.2-cm discs of silicone elastomer were subcutaneously implanted in one site in the left flank and one site in the right-flank of the tre ated group of rats, while four 2.5-cm discs were implanted in two site s in the left flank and two sites in the right flank of the treated gr oup of rabbits. The size of the elastomer implants was chosen to appro ximate the expected body burden of women with breast implants. The con trol animals in both studies received subcutaneous implantation of eit her 1.2- or 2.5-cm discs of polyethylene of the same number in the sam e locations. The control and test articles were implanted in the male and female rats at 61 and 47 days, respectively, prior to mating (in t he rat reproduction study) and approximately 42 days prior to insemina tion of female rabbits (in the rabbit developmental toxicity study). S ubcutaneously implanted discs of silicone breast implant envelope elas tomer did not induce maternal or developmental toxicity before or duri ng pregnancy or during lactation, did not cause any adverse effects on the parents or neonates, and did not impair reproductive performance in the rat reproduction study. No maternal toxicity or adverse develop mental effects, including teratogenicity, were observed in the treated groups in the rabbit developmental toxicity study. (C) 1994 Society o f Toxicology.