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Long-term toxicity study quillaia extract in rats

J J Drake, K R Butterworth, I F Gaunt

    Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
    |February 1, 1982
    PubMed
    Summary
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    Quillaia extract showed no carcinogenic effects in rats over a 2-year study. The highest dietary level of 3.0% was determined as the no-untoward-effect level.

    Area of Science:

    • Toxicology
    • Natural Product Research

    Background:

    • Quillaia extract is derived from the soapbark tree (Quillaja saponaria Molina).
    • Its safety profile for long-term dietary consumption requires thorough toxicological evaluation.

    Purpose of the Study:

    • To assess the chronic toxicity and carcinogenicity of quillaia extract in a rodent model.
    • To establish a no-untoward-effect level (NOEL) for dietary quillaia extract.

    Main Methods:

    • A 2-year dietary study involving 48 male and 48 female rats per group.
    • Administration of quillaia extract at dietary levels of 0%, 0.3%, 1.0%, and 3.0%.

    Main Results:

    • No adverse effects on mortality, clinical chemistry, hematology, or histopathology were observed.

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  • A 3% dietary level in males showed reduced body weight, kidney lesions, and organ weights, attributed to decreased food intake.
  • No evidence of carcinogenicity was found at any tested dose.
  • Conclusions:

    • Quillaia extract is not carcinogenic in rats at dietary levels up to 3.0%.
    • The no-untoward-effect level was established at 3.0% in the diet, approximately 1.5 g/kg/day.