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Data Selection

The data evaluation process results in the selection of the most appropriate or critical data sets for deriving the UL. Selecting the critical data set includes the following considerations:

  • Human data are preferable to animal data.

  • In the absence of appropriate human data, information from an animal species with biological responses most like those of humans is most valuable.

  • If it is not possible to identify such a species or to select such data, data from the most sensitive animal species, strain, and gender combination are given the greatest emphasis.

  • The route of exposure that most resembles the route of expected human intake is preferable. This includes considering the digestive state (e.g., fed or fasted) of the subjects or experimental animals. Where this is not possible, the differences in route of exposure are noted as a source of uncertainty.

  • The critical data set defines a dose-response relationship between intake and the extent of the toxic response known to be most relevant to humans. Data on bioavailability are considered and adjustments in expressions of dose-response are made to determine whether any apparent differences in response can be explained.

  • The critical data set documents the route of exposure and the magnitude and duration of the intake. Furthermore, the critical data set documents the intake that does not produce adverse effects (the NOAEL), as well as the intake producing toxicity.

Identification of NOAEL (or LOAEL) and Critical Endpoint

A nutrient can produce more than one toxic effect (or endpoint), even within the same species or in studies using the same or different exposure durations. The NOAELs (and LOAELs) for these effects will differ. The critical endpoint used in this report is the adverse biological effect exhibiting the lowest NOAEL (e.g., the most sensitive indicator of a nutrient’s toxicity). The derivation of a UL based on the most sensitive endpoint will ensure protection against all other adverse effects.

For some nutrients there may be inadequate data on which to develop a UL. The lack of reports of adverse effects after excess intake of a nutrient does not mean that adverse effects do not occur. As the intake of any nutrient increases, a point (see Figure 3-2) is reached at which intake begins to pose a risk. Above this point,



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