Final Study Report on the Developmental Toxicity Evaluation of Emodin (CAS No. 518-82-1) Administered in the Feed to Sprague Dawley (CD (Trade Name)) Rats on Gestational Days 6 to 20

摘要

Emodin is a naturally occurring and pharmacologically active anthroquinone found in the roots and bark of certain plant species. Other anthroquinones have been shown to be mutagenic, where as allied synthetic compounds, i.e., anthracyclines, have been shown to be teratogenic. The wide availability of emodin in herbal preparations, coupled with the potential for mutagenic and/or teratogenic activity, suggested that ingestion of emodin by pregnant women might have adverse developmental effects. Estimated maximum human exposure to emodin is 3 mg/kg/day in a 70 kg person. In the present study, timed mated Sprague-Dawley rats (25/group) were exposed to emodin a nominal concentration of 0, 425, 850, and 1700 ppm in NIH-07 ground rodent diet from gestational day (gd) 6 to 20. Average daily intake was 0, 31, and 57 mg emodin/kg of body weight/day for the control, low- and mid-dose groups. Average daily intake for the 1700 ppm group was 80-144 mg emodin/kg of body weight/day, but could not be estimated more accurately due to scattering of the feed by the animals. Nominal concentrations of emodin (ppm in feed) and calculated intake of emodin (mg/kg/day) are expressed as the bulk test article (96.2% purity).