How should reproductive or developmental toxicity data be evaluated for possible TSCA §8(e) submission if maternal toxicity is also present?
A.18. Statistically or biologically significant increases in reproductive or developmental toxicity should be reported under TSCA §8(e) regardless of the level of maternal toxicity observed in the study. Data indicating maternal toxicity without accompanying developmental toxicity in such studies should also be considered for TSCA §8(e) reporting. Q.19. What criteria should be used to determine which reproductive or developmental effects observed in animal tests are reportable under TSCA §8(e)? For example, should reversible developmental effects, such as reduced birth weight and/or incomplete ossification, trigger TSCA §8(e) reporting? A.19. In addition to teratogenic effects, all adverse developmental and reproductive effects regardless of reversibility should be considered for reporting under TSCA §8(e). This includes any effect on the developing organism that is observed prenatally or postnatally, and any effect on the male or female reproductive system. Q.20. When evaluating repea
