Three-generation reproduction study with dioctyl sodium sulfosuccinate in rats.

Groups of 30 male and 30 female rats (F0) were fed diets containing 0, 0.1, 0.5, or 1.0% dioctyl sodium sulfosuccinate (DSS) for 10 and 2 weeks, respectively. The F0 animals were then mated to produce an F1 litter. Groups of 30 male and 30 female F1 animals were fed the same dose levels for at least 10 weeks postweaning, and the breeding program was repeated to produce F2 animals. F3 animals were produced from F2 animals by the same procedure. The study was terminated with the F3 weanlings. Test diets were fed continuously throughout the study. All F0, F1, and F2 adults and F3 weanlings (one/sex/litter) were necropsied and given a macroscopic examination. There were no effects on reproductive function for parental animals of either sex during any of the three generations in this study. At the highest dose level (1.0% DSS), body weights were lower than those of controls during the premating phase for males in all three generations and for F1 and F2 females. Body weights for F1 and F2 males and females in the 0.5% dose group were also low during the premating phase. Pup weights on Lactation Day 0 were significantly lower than those of controls only for the high-dose group during the third generation. However, lower pup weight gains in the mid- and high-dose groups resulted in significantly lower pup weights on Day 21 for all three generations. Perinatal pup survival across three generations ranged from 96 to 100% for the control and treated groups. Pup survival ranged from 95 to 100% for controls, from 98 to 100% for low- and mid-dose groups, and from 91 to 99% for the high-dose group. There were no treatment-related mortality and antemortem or macroscopic observations. In summary, DSS administered in the diet to three successive generations of rats at levels of 0.5 and 1.0% caused a reduction in body weights for parental males in all generations and for F1 and F2 females. Pup weights at the 0.5 and 1.0% dose levels were also lower than those of the control in all three generations. However, the reduced body weights did not interfere with development of normal reproductive performance. DSS at levels up to 1.0% had no effects on the reproductive function of either sex in any generation and produced no treatment-related antemortem or macroscopic observations.