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Oral toxicity of a tocotrienol preparation in rats.

  1. Oral toxicity of a tocotrienol preparation in rats.
    Nakamura H, Furukawa F, Nishikawa A, Miyauchi M, Son HY, Imazawa T, Hirose M.
    Division of Pathology, National Institute of Health Sciences, 1-18-1 Kamiyoga,
    Setagaya-ku, 158-8501, Tokyo, Japan.

    "Tocotrienols are added as antioxidants to food. As there have been no reports of 
    toxicological evaluation, a 13-week oral toxicity study was performed in Fischer 
    344 rats of both sexes at dose levels of 0 (group 1), 0.19 (group 2), 0.75 (group
    3) and 3% (group 4) of a preparation in powdered diet. Suppression of body weight
    gain was observed in group 4 males. On hematological examination, significant
    decrease in mean corpuscular volume (MCV) was observed in all treated males.
    Platelets were significantly reduced in group 3 and 4 males. Hemoglobin
    concentration, MCV, mean corpuscular hemoglobin and mean corpuscular hemoglobin
    concentration were significantly decreased in group 3 and 4 females and
    hematocrit in group 4 females. On serum biochemical examination, increase in the 
    albumin/globulin ratio (A/G) and alkaline phosphatase in all treated males,
    elevated alanine transaminase in group 4 of both sexes and increases in
    asparagine transaminase and gamma-glutamyl transaminase in group 4 females were
    observed. With regard to relative organ weights, liver weights in group 4 of both
    sexes and adrenal weights in all treated males demonstrated an increase, and
    ovary and uterus weights in group 4 females were reduced. Histopathologically,
    slight hepatocellular hypertrophy in group 3 and 4 males, and reduction of
    cytoplasmic vacuolation in the adrenal cortical region in group 4 males were
    observed. Because of pathological changes in male liver and hematological changes
    in females, the no-observed-adverse-effect level (NOAEL) was concluded to be
    0.19% in the diet (120 mg/kg body weight/day for male rats and 130 mg/kg body
    weight/day for female rats). As a decrease in MCV, an increase in the A/G,
    elevation of alkaline phosphatase and increase in adrenal weight were observed in
    all treated males, a no-observed-effect level (NOEL) could not be determined in
    this examination


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