Registration Dossier
Registration Dossier
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EC number: 619-079-3 | CAS number: 949109-75-5
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
A series of studies were conducted to examine the uterotrophic potential of the dietary sterols, in rats by oral gavage. The endpoint determined was the wet weight of the uterus. Phytosterols, phytosterol esters,cholesterol and cholesteryl palmitate were all found to be negative in this assay system at doses of up to 500 mg/kg/day (bw) for three days. Positive controls coumestrol and beta-estradiol both gave positive responses (increased uterine weights) at doses of 20 and 0.4 mg/kg (bw) respectively.
Additional information
In addition two in vitro studies (rel 4) on the oestrogenic potential of phytosterols wihich investigated both the binding to rat uterine cytosol oestrogen receptors and binding to and activation of human oestrogen receptor cells in yeast cells. Both studies with phytosterols at up to 2 micromoles gave no evidence of binding. These data confirm the findings in the in vivo study.
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