Cover Image

HARDBACK
$59.95



View/Hide Left Panel

TABLE 3-8 Relative Spectrum of Concern for In Vitro Data

Increasing Concern

Standardizeda subcellular and cellular assays validated for the purpose of establishing in vivo toxic effect

Standardized subcellular and cellular assays validated for the purpose of establishing in vivo toxic effect

Standardized subcellular and cellular assays validated for the purpose of establishing in vivo toxic effect

AND

AND

AND

Multiple different assays suggesting the same pathological condition or endpoint

Multiple different assays suggesting the same pathological condition or endpoint

Multiple different assays suggesting the same pathological condition or endpoint

AND

AND

AND

Poor consistency/reproducibility in response

AND

No knowledge about concentration of toxicant in blood or tissue

Consistency in response

AND

No knowledge about concentration of toxicant in blood or tissue

Knowledge of presence of toxicant in blood or tissue enhanced by knowledge of concentrations comparable with those causing toxicity in vitro

OR

OR

OR

Standardized assays validated for the purpose of establishing organ toxicity

Standardized assays validated for the purpose of establishing organ toxicity

Standardized assays validated for the purpose of establishing organ toxicity

AND

AND

AND

Multiple different assays suggesting the same pathological condition or endpoint

Multiple different assays suggesting the same pathological condition or endpoint

Multiple different assays suggesting the same pathological condition or endpoint

Vulnerable subpopulations can be defined as groups of individuals who are more likely to experience an adverse event related to the use of a particular dietary supplement ingredient or individuals in whom the specific adverse effects identified are more likely to be serious in comparison with the general population. Characteristics that contribute to such vulnerability may be physiological (including genetic predisposition) and include age, developmental stage (e.g., pregnancy or fetal period), presence of other diseases, or concurrent use of medications or other therapeutic practices.

When evaluating risk and reviewing data, it is important to ask if ingredients are more likely to cause harmful effects to particular subgroups of the population, especially if those subgroups are known to consume the particular ingredient of concern. Vulnerability of a population subgroup is



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement