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Technical Questions/Answers about the Assays
The Agency has issued clarifications about technical aspects of the conduct of Tier 1 assays for the Endocrine Disruptor Screening Program in response to questions raised by Test Order recipients and others. In some cases, these questions pointed out simple but
significant errors in test guidelines (e.g., incorrect references to tables and misplaced decimal points). In other cases, questions pointed out ambiguous language that required clarification; and in yet other cases, questions were raised about whether alternative techniques had been considered by the Agency and rejected, or whether they might be acceptable to use. Access the documents below to review the Agency's response to questions.
- Clarifications on Technical Aspects of the EDSP Tier 1 Assays (PDF) (37 pp, 622K, About PDF)
- Responses to EDSP Tier 1 Technical Questions Received from CeeTox Contract Laboratory - Generic Technical Questions Regarding the Conduct of in vitro EDSP Tier 1 Assays (PDF) (4 pp, 61K, About PDF)
- Responses to EDSP Tier 1 Technical Questions Received from Integrated Laboratory Systems - Conducting in vivo Mammalian Studies (PDF) (4 pp, 53K, About PDF)
- Responses to EDSP Tier 1 Technical Questions Received from Huntingdon Life Sciences - Conducting the EDSP Aromatase Assay Using Guideline 890.1200 (PDF) (4 pp, 56K, About PDF)
- Responses to EDSP Tier 1 Technical Questions Received from Huntingdon Life Sciences - Regarding the Estrogen Receptor Binding Assay (PDF) (4 pp, 103K, About PDF)
- Responses to EDSP Tier 1 Technical Questions Received from CeeTox Contract Laboratory - Assessing False Positives in the Estrogen Receptor Transcriptional Activation (ERTA) Assay (PDF) (4 pp, 58K, About PDF)