PROBLEMS IN DEVELOPMENTAL TOXICOLOGY CAUSED BY INCORRECTLY USED TERMINOLOGY

Communication problems caused by the use of imprecise or incorrect ter minology and poor translations have historically plagued the field of ''developmental toxicology,'' the study of embryo-fetal toxicity/terat ogenicity. The recent international efforts towards standardizing prot ocols identified how severe these problems can become and how they can be the underlying cause of incorrect interpretation of data; unnecess ary replication of studies; delays in reaching market; lawsuits; and e lective abortions. The incorrect incorporation of the word ''teratolog y'' into the FDA 1966 Guidelines, and many subsequent guidelines, to i dentify a study in which the conceptus is exposed during the period of major embryogenesis was the basis for many other problems. For exampl e, other potential outcomes of exposure are often not given the same l evel of concern as malformation, the interrelationship of the maternal animal and the developing conceptus is sometimes excluded from evalua tion, and agents are often categorized as ''teratogens,'' regardless o f dose-dependent observations and relative exposures of the dam and co nceptus. The proliferation of terms to modify the severity and relevan ce of fetal morphologic observations to human risk assessment has incr eased the difficulties in data interpretation. Many professional socie ties 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.