When Is a Teratology Study Not an Evaluation of Teratogenicity?

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Abstract
The most widely used developmental toxicity safety evaluation is the Segment II protocol executed in rats and rabbits. It has come to be called the “teratology” study, even though it is not designed to produce terata and is not the optimal means for producing such, even if this should be the goal. To comply with the misstated letter of the Toxic Substances Control Act yet honor its intent to protect the conceptus from toxic insult, toxicologists are faced with terminology, definitions, and interpretations that result in unnecessary contention between the regulator and the regulated. When the developmental toxicology and teratology of the Segment II protocol are viewed in the appropriate context, the experiments provide not only a means for preventing embryo damage but also a means by which substances can be ranked according to their developmental hazard potential.