Determination of acceptable exposure levels for humans for endocrine
active substances: Use of animal models
P. A. Fenner-Crisp
ILSI Risk Science Institute, One Thomas Circle, NW,
Ninth Floor, Washington, DC 20005-5802, USA
Abstract: Regulatory authorities and other scientific organizations
around the world have developed hazard/risk assessment practices that
involve the derivation of numerical values said to represent "acceptable"
or "safe" levels of human exposure to individual chemical substances.
Human data would be preferable for this purpose since interspecies extrapolation
would not be necessary. In most cases, however, these data are not available
or are inadequate for this purpose. Therefore, results from studies
conducted in non-human mammalian species are used as the principal or
sole basis for hazard/risk assessment. Existing risk assessment frameworks
developed for the evaluation of endpoints of toxicity for chemical substances
are sufficiently flexible to incorporate knowledge concerning the mode(s)/mechanism(s)
of action by which these endpoints occur, including those involving
disturbance of normal endocrine status ("endocrine disruption"). Background
on nomenclature, traditional practices using non-human animal models,
and the nature and adequacy of data sets for deriving acceptable human
exposures for chemicals, including endocrine active substances, are
described, as is how/why the existing frameworks are adequate for the
purpose of deriving numerical values for endocrine active substances.
Projections on how assessment practices for these substances may evolve
further in the future also are offered.
*Report from a SCOPE/IUPAC project: Implication of
Endocrine Active Substances for Human and Wildlife (J. Miyamoto and
J.Burger, editors). Other reports are published in this issue,
pp. 1617-2615.
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