US EPA

Developmental toxicity testing over the last three decades has provided considerable data that have been used by regulatory agencies to set standards and to regulate exposures. s part of a larger guidelines effort, the Environmental Protection Agency (EPA) published guidelines for developmental toxicity risk assessment, first in 1986 and again in 1991. his was the first guideline developed to describe a consistent approach for noncancer and nonmutagenic risk assessment. this chapter focuses on the risk assessment process used for developmental toxicity by EPA, although the guidelines represent a consensus document within the field of developmental toxicology. hree major components are discussed: hazard identification/dose-response evaluation, exposure assessment, and risk characterization. he basic default assumptions are discussed, as is characterization of the data base, dose-response modeling and application of the benchmark dose (BMD) approach, and the components important to developmental toxicity in the estimation of human exposure. he Chapter also discusses research needs that have been identified through the development of the risk assessment guidelines.

Kimmel, C. AND G. Kimmel. PRINCIPLES OF DEVELOPMENTAL TOXICITY RISK ASSESSMENT. U.S. Environmental Protection Agency, Washington, D.C., EPA/600/A-95/110 (NTIS PB95274221), 1995.

Book Chapter: andbook of Developmental Toxicology, CRC Press