Developmental and Reproductive Effects of SE5-OH: An Equol-Rich Soy-Based Ingredient

Table 2

Isolated embryo-fetal effects noted during necropsy observations/examinations in the developmental toxicity study in rats.

Effect	Occurrence
Fusion of placentae	Occurred in one dam in the 200 mg/kg dose group. No other placental abnormalities identified in any group.
Rudimentary tail	Occurred in one fetus of the 1000 mg/kg dose group. No other external fetal abnormalities identified in any group.
Visceral anomaly: ventricular septal defect	Occurred in one control group fetus and one 2000 mg/kg group fetus. No other anomalies identified in any group.
Visceral variants: thymic neck remnant, supernumerary coronary ostium, left umbilical artery, and renal pelvis dilation	Occurred with equal incidence in the control and 2000 mg/kg groups.
Skeletal anomalies/malformations: wavy and nodulated ribs	Occurred in one 2000 mg/kg group fetus. No other anomalies identified in any group.
Skeletal variants: foramen hypoglossi double, closure of transverse foramen of one or more cervical vertebral arches, transverse foramen opening in 7th cervical arch, splitting of ossification centers in thoracic vertebral bodies, hemicentric thoracic centrum, dumbbell ossification of thoracic centrum, lumbarization, cervical ribs, short supernumerary 14th rib, reduced 13th ribs, splitting of sternebrae	Incidence of dumbbell ossification of thoracic centrum was significantly low in the 2000 mg/kg dosing group but was judged incidental with no toxicological significance.