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Chronic Toxicity Study

  • To determine the life-long "safe" dose of non-carcinogenic chemicals, NOEL = No Observable Effect Level.
  • Usually 2 years in length for rodent studies.
  • Doses usually set at the MTD, 1/4 MTD, and 1/8 MTD.
    50 rats/sex/group
  • Used for setting safety factors such as ADI (Allowable Daily Intake)
    ADI = NOEL/100
    10-fold for species difference
    10-fold for individual variation