BEHAVIORAL-EVALUATIONS IN DEVELOPMENTAL TOXICITY TESTING - MARTA SURVEY RESULTS

During 1991, the Middle Atlantic Reproduction and Teratology Association (MARTA) conducted a survey of laboratories performing behavioral evaluations as part of GLP developmental toxicity studies. This survey was conducted to determine the extent to which an ''industry standard'' had evolved for behavioral test batteries. The most commonly used developmental parameters were eye opening, pinna unfolding, and sexual maturation (physical landmarks); surface righting, pupil constriction, and nonautomated acoustic startle (reflexive landmarks). Locomotor activity was used by 80% of the laboratories. The majority (76%) of laboratories conducted at least one learning and/or retention evaluation; nearly one-fourth of the laboratories routinely performed two. The most common learning tests were watermaze (primarily a simple two-choice discrimination task) and passive avoidance. Automated startle paradigms (habituation, prepulse modification, and/or startle elicitation) were evaluated by 28% of the laboratories. This survey showed a remarkable similarity in methodology across laboratories and a progressive increase in the number of GLP studies that included behavioral assessments. The results indicate that behavioral tests have become a common component of developmental toxicity assessments of pharmaceuticals.