ACUTE TOXICITY

PURPOSE:

  • To determine the median lethal dose (LD50) and to provide observations for subsequent studies.
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    • ANIMALS:

  • At least two species, rats and mice are the most common.

    At least 10 animals, 5 per sex,

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    • DOSAGE:

  • Single administration by gavage or capsule or multiple administration over a 24 hour period

    At least 3 dose levels bracketing the range from 10 to 90 % mortality.

    Controls generally not required.

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    • OBSERVATIONS:

  • Animals observed twice daily for 14 days.

    Observations recorded individually for each animal; should include time of onset, duration, and intensity of toxicological and pharmacological signs. complete gross necropsy on all dead animals.

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    • INFORMATION:

  • LD50

    Guide lines for doses to be used in sub-acute testing

    Nature of potential toxicity

    Target organs

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