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.