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Zeranol--a 'nature-identical' oestrogen?

D G Lindsay

    Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
    |August 1, 1985
    PubMed
    Summary
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    Zeranol, a growth promoter, and myco-oestrogens have low estrogenic activity. Their combined dietary exposure is safe, with a safety margin over 500-fold compared to the no-observed-effect level.

    Area of Science:

    • Food safety
    • Toxicology
    • Endocrinology

    Background:

    • Zeranol is an anabolic growth promoter used in food animals, resulting in low tissue residues.
    • Myco-oestrogens, like zearalenone, are common cereal contaminants with greater residues than zeranol.
    • Zeranol, myco-oestrogens, and their metabolites share chemical and biological similarities.

    Purpose of the Study:

    • To compare the biological effects of zeranol and myco-oestrogens.
    • To assess the toxicological profiles, including oestrogenicity, teratogenicity, genotoxicity, and carcinogenicity.
    • To determine the safety margin for dietary exposure to these compounds.

    Main Methods:

    • Comparative analysis of chemical, steric, and biological properties.
    • Evaluation of toxicological data related to oestrogenic activity.

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  • Calculation of safety margins based on expected dietary exposure and no-observed-effect levels (NOELs).

    • Main Results:

    • Zeranol and related myco-oestrogens exhibit significantly lower hormonal activity (100-1000 times less) than oestradiol.
    • No toxicological effects were observed that were not attributable to their oestrogenic properties.
    • A likely no-observed-effect level (NOEL) was estimated between 0.05-0.1 mg/kg body weight/day.

    Conclusions:

    • Zeranol and myco-oestrogens are considered safe at expected dietary exposure levels.
    • A substantial safety margin (greater than 500-fold) exists for combined exposure.
    • Exposure to zeranol alone provides an even larger safety margin (over 35,000-fold).