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Work Plan to do list:. a table merging work plan dates and mission clarification table timelines for the individual assays a diagram of the Endocrine Disruptor Program activities and validation process. Inutero Lactational Assay. Prevalidation Study
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Work Plan to do list: • a table merging work plan dates and mission clarification table • timelines for the individual assays • a diagram of the Endocrine Disruptor Program activities and validation process
Inutero Lactational Assay • Prevalidation Study • EPA will develop a prevalidation study plan based on protocol C in the DRP • The study plan will identify several chemicals and recommended dose levels with justification for choices made • EPA will e-mail the study plan to the EDMVS for a 2-week review and schedule a conference call to discuss comments
IUL Assay (cont) • DRP • The EDMVS will submit comments for incorporation into the final DRP • A table listing the endpoints of interest and predicted responses to agents of known modes of action (a qualitative prediction model) will be included • A chart comparing protocols A,B, and C will be included.
Consider standardizing • vehicle • diet • water • dose-setting • light cycle • definitions and techniques • VO and PPS, including how measurements are to be made • training video for techniques of concern
Multi-dose study • Add weak thyroid chemical if possible
Multi-chemical study • Include small organ weights • add/substitute chemicals as discussed
Other studies to consider • strain differences in onset of puberty • strain differences in sensitivity (e.g., adding Long-Evans rats to multi-dose study) • … but don’t get too caught up in strain issues (see recommendation)
Check literature for • PND of formation of blood/testis barrier in rats
Other items (not specific to pubertals) • Update table of chemicals used in EDSP studies with • ER/AR binding study chemicals • adult male chemicals • corrections • Choose a core set of chemicals to include across assays • Provide EDMVS with rationale for doses when presenting studies
Other items (continued) • Include systemic toxicants that are expected to be non-endocrine-active, if possible, in assays. • Find a more humane way for sacrifice of culls, if possible • Code chemicals in prevalidation studies if possible