National Institute of Environmental Health Sciences, Contracts and Procurement Management Branch, OM, P.O. Box 12874, Research Triangle Park, NC 27709

A -- DEVELOPMENTAL TOXICITY TESTING AND RESEARCH SOL NIH-ES-96-21 DUE 042996 POC Connie C. Riley, Contract Specialist, 919/541-0398 The purpose of this contract is to conduct developmental toxicity testing and research.This proposed contract is an extension of an effort in developmental toxicity that arose in thelate 1970's. One of the primary goals is to determine the developmental toxicity of chemicalsto which a wide segment of the population is exposed. In this case, that population consists ofwomen of childbearing age, primarily pregnant women. Since it is difficult to assess exposureto potential developmental toxicants and outcome of exposure within this group, wellcontrolled animal studies must provide a basis for human risk assessment. For this purpose,most studies will be designed to determine a dose-response relationship in addition to thedetection of a potential for developmental toxicity. In most cases, term fetuses will beassessed for developmental toxicity after exposure to the chemical during embryogenesis. Task 1 is a developmental toxicity screening study. This range-finding study serves toidentify chemicals and dosages that result in developmental toxicity. Estimated 3-5 studies peryear, 10-12 animals per group and 6 animal dose groups. After this study, the chemical mayenter a Task 2 study. These studies are conventional (20 animals per group and 4 animal dosegroups) and modified (approximately 16 animals per group and 6 animal dose groups)developmental toxicity studies (FDA Segment II studies). It is estimated 3-4 of these studiesper year. The approximate level of effort anticipated for each year of the contract is 7,950hours. In order to optimize animal usage and to gain preliminary information about the effect ofcertain chemicals on development, a section of this developmental toxicology contract effort(Task 3) will be gross developmental assessment of term fetuses from other studies performedunder contract, such as the Reproductive Assessment by Continuous Breeding (RACB) studies.Results from these studies would not be definitive, but would provide further informationabout the chemical and aid in determining whether this chemical should enter thedevelopmental toxicology protocol (Task 1 or Task 2 studies). All responsible sources may submit an offer which shall be considered. (0057)

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