Developmental and reproduction toxicity studies of glycolipids from Dacryopinax spathularia

The developmental and reproduction toxicity potential of jelly mushroom glycolipids from Dacryopinax spathularia was studied in Crl:CD (SD) rats by daily oral gavage administration at doses of 150, 500 or 1000 mg/kg/day. Pregnant female rats in the developmental study received the test article from Gestation Days 6-19. F0 and F1 parental animals in the 2-generation reproduction toxicity study were dosed for a minimum of 70 days prior to mating and throughout mating, gestation, and lactation, until the day prior to euthanasia (following weaning of litters on postnatal day 21). The offspring of the F0 and F1 generations were potentially exposed to the test article in utero and via the milk while nursing. In the developmental study, there were no adverse effects on intrauterine growth and survival, or fetal morphology. In the 2-generation reproduction toxicity study, there were no adverse effects on observed parameters including macroscopic or microscopic findings, or organ weights for F0 or F1 animals, no effects on reproductive performance, and no test article-related effects on F1 and F2 postnatal survival, development, or growth. Therefore, the no-observed-adverse-effect level (NOAEL) for parental systemic toxicity, parental reproductive toxicity, and developmental/neonatal toxicity, was considered to be 1000 mg/kg/day, the highest dosage tested.