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TABLE 3-6 Relative Spectrum of Concern: Guidelines for Types of Evidence from Animal Studiesa

Increasing Concern

At least one acceptable, quality study showing effects of Category A at Dose > 1,000× Human Intake

At least one acceptable, quality study showing effects of Category A at Dose > 100 to < 1,000× Human Intake

At least one acceptable, quality study showing effects of Category A at Dose < 100× Human Intake

OR

OR

OR

At least one acceptable, quality study showing effects of Category B at Dose > 100× Human Intake

At least one acceptable, quality study showing effects of Category B at Dose > 10 to < 100× Human Intake

At least one acceptable, quality study showing effects of Category B at Dose < 10× Human Intake

OR

OR

OR

At least one acceptable, quality study showing effects of Category C at Dose > 10× Human Intake

OR

Studies showing adverse effects, but which cannot be interpreted because of deficiencies in design, conduct, or reporting

OR

Acceptable, quality non-oral studies indicating adverse effect from Category A, B, or C

At least one acceptable, quality study showing effects of Category C at Dose > 1 to < 10× Human Intake

At least one acceptable, quality study showing effects of Category C at Dose ≤ 1× Human Intake

a Categories A, B, and C refer to relative seriousness of a variety of adverse effects identified in animal studies, ranging from reproductive failure (A) to reduced food consumption (C). See Box 3-4 for further examples.

Information About Related Substances

Information about substances related to the dietary supplement ingredient of interest may be useful when predicting risk to human health. Such substances may be related to dietary supplement ingredients in one of several ways, such as:

  • Chemical relatedness—the ingredient or constituent of an ingredient is similar to known toxic chemicals, or is known to contain chemicals similar in structure to known toxicophores;8

8  

Chemical structures associated with potential adverse effects.



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