Problems in Developmental Toxicology Caused by Incorrectly Used Terminology

Abstract

Communication problems caused by the use of imprecise or incorrect terminology and poor translations have historically plagued the field of “developmental toxicology,” the study of embryo-fetal toxicity/teratogenicity. The recent international efforts towards standardizing protocols identified how severe these problems can become and how they can be the underlying cause of incorrect interpretation of data; unnecessary replication of studies; delays in reaching market; lawsuits; and elective abortions. The incorrect incorporation of the word “teratology” into the FDA 1966 Guidelines, and many subsequent guidelines, to identify a study in which the conceptus is exposed during the period of major embryogenesis was the basis for many other problems. For example, other potential outcomes of exposure are often not given the same level of concern as malformation, the interrelationship of the maternal animal and the developing conceptus is sometimes excluded from evaluation, and agents are often categorized as “teratogens,” regardless of dose-dependent observations and relative exposures of the dam and conceptus. The proliferation of terms to modify the severity and relevance of fetal morphologic observations to human risk assessment has increased the difficulties in data interpretation. Many professional societies and regulatory groups have pleaded for the development and use of common terms, and some heroic attempts have been made. However, there is no currently internationally acceptable glossary or terminology.