REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES OF SILICONE GEL Q7-2159A IN RATS AND RABBITS

Studies reported here assessed the potential adverse effects of silico ne gel, Dow Coming Q7-2159A, on general reproduction and fetal develop ment in male and female Charles River CD rats and New Zealand white ra bbits. Two control and three treatment groups of 30 male and 30 female rats and 25 female rabbits per group were used in the one-generation reproduction and developmental toxicity studies, respectively. The sil icone gel was implanted subcutaneously in two flank sites at dosage le vels of 3, 10, and 30 ml/kg. The highest dose was selected on the basi s of likely human body burden. Control groups received either sterile saline or carboxymethylcellulose solution in two flank implantation si tes. The control and test articles were implanted in male and female r ats 61 and 47 days, respectively, prior to mating (in the rat reproduc tion study) and approximately 42 days prior to insemination of female rabbits (in the rabbit developmental toxicity study). There were no tr eatment-related effects on F-0 parental general conditions and reprodu ctive performance, F-1 neonatal viability, or growth in the rat reprod uction study. No maternal nor developmental effects, including teratog enicity, were observed in rabbits in the groups implanted with Q7-2159 A gel in the developmental toxicity study. (C) 1994 Society of Toxicol ogy.