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The Skeleton pp 385-413 | Cite as

Experimental Skeletal Dysmorphology

Risk Assessment Issues
  • Rochelle W. Tyl
  • Melissa C. Marr
  • Christina B. Myers
Chapter

Abstract

The two components of formal risk assessment are hazard identification and risk assessment. Hazard can be defined as the intrinsic capacity of an agent to do harm. Risk can be defined as the assessment of whether an agent will produce adverse outcomes to the species of interest under relevant exposure conditions. The critical aspect of risk is relevant exposure, by a relevant route, at relevant doses or concentrations, during sensitive life stages (i.e., timing of exposure), and for appropriate durations. Laboratory animal studies are critical for the risk component. The doses for the animal studies at which effects are observed or not observed are then compared with the exposures from all sources (e.g., feed, water, air) as measured, calculated, or modeled of the species of interest, to calculate a margin of exposure (MOE). The larger the MOE, the less concern. The species of interest is usually, but not always, humans (e.g., increasing attention to environmental risk assessments).

Keywords

Developmental Toxicity Skeletal Malformation Skeletal Variation Fetal Body Weight Historical Incidence 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 2004

Authors and Affiliations

  • Rochelle W. Tyl
  • Melissa C. Marr
  • Christina B. Myers

There are no affiliations available

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