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Peer Review Evaluation Report: Oral Up-and-Down Procedure

An independent scientific peer review meeting was held in July 2000 to evaluate the usefulness and validation status of the revised up-and-down procedure (UDP). NICEATM assembled available data on the revised UDP into a background review document, which was used by the Peer Review Panel to assess the method.

The Peer Review Panel met again for additional discussions via a public teleconference in August 2000.

The Revised Up-and-Down Procedure: A Test Method for Determining the Acute Oral Toxicity of Chemicals
(NIH Publication No. 02-4501 - November 2001)

Complete Report

Volume 1 (Main Body and Appendices A through E)
Volume 2 (Appendices F through Q)

Main Report Body

Appendix A: ICCVAM Test Method Recommendations

Appendix B: Final Revised UDP Test Guideline (U.S. EPA 10/31/2001)

Appendix C: August 2001 Peer Panel Meeting Review Materials

  1. Acute Oral Toxicity: Revised UDP Test Guideline, 07/12/2001
  2. A Proposed Procedure for Calculating Confidence Intervals
  3. Description of the Acute Oral Toxicity Software Program
  4. Evaluation Guidance to the Panel for the Revised UDP

Appendix D: Federal Register Notices for the UDP

  1. Vol. 65, No. 34, February 18, 2000, Request for Data and Nomination of Expert Scientists
  2. Vol. 65, No. 106, June 1, 2000, Notice of Peer Review Panel Meeting and Request for Comments
  3. Vol. 66, No. 121, June 22, 2001, Notice of Availability and Request for Comments
  4. Vol. 66, No. 133, July 21, 2001, Notice of Peer Review Panel Meeting

Appendix E: Summary Minutes and Public Comments from the UDP Meetings

  1. Minutes and Public Comments of the Peer Review Panel Meeting, 07/25/2000 Crystal City, Arlington, VA
  2. Minutes of the Peer Review Panel Meeting, 08/21/2001, Research Triangle Park, NC
  3. Submitted Public Comment for the 08/21/2001 Meeting

Appendix F: Revised Background Review Document on the UDP (9/01) 

Appendix G: Acute Oral Toxicity: Modified UDP (U.S. EPA Revised Test Guideline 425N, 04/2000)

Appendix H: Acute Oral Toxicity: UDP (OECD Test Guideline 425, adopted 21 September 1998)

Appendix I: Acute Oral Toxicity (OECD Test Guideline 401, adopted 24 February 1987)

Appendix J: Development of OECD 425

  1. UDP: Is there a Need for Further Validation?
  2. Rationale for the UDP as Submitted to OECD
  3. Presentation for Test Guideline 425 - UDP

Appendix K: UDP Primary Test: Proposed Revision of the Guideline 425

  • "Primary Procedure' for Point Estimation of the LD50

Appendix L: UDP Primary Test: Comparison of Stopping Rules and LD50 Estimators

Appendix M: The UDP Limit Test: Accuracy of In Vivo Limit Dose Tests 

Appendix N: Proposed UDP Supplemental Procedure to Estimate Slope and Confidence Interval

  1. Considerations for Supplemental Procedure
  2. Supplemental Procedure to Determine Slope and Confidence Interval
  3. Summary Tables
  4. Simulation Tables and Legends
  5. Additional Simulations: Supplemental Procedures to Determine Slope

Appendix O: The Basis for Revising the UDP

  1. Statistical Basis for Estimating Acute Oral Toxicity
  2. Comparison of Classification Probabilities
  3. Brief Statistical Description of the Method

Appendix P: Selection of the Appropriate Animal Gender for the UDP

  1. Gender Sensitivity of Xenobiotics
  2. Comparison of Male and Female Rat Oral and Dermal LD50 Values
  3. Toxicological Evaluation of Pesticide Hazard to Avian Wildlife
  4. Sex Dependent Metabolism of Xenobiotics

Appendix Q: U.S. Federal Regulations on Acute Toxicity

  1. CPSC Regulations, Administration and Enforcement
  2. OSHA Regulations, Hazard Communication
  3. U.S. EPA Regulations, Pesticide Registration
  4. U.S. EPA Regulations, Pesticide Labeling
  5. U.S. EPA Regulations, Data Requirements
  6. U.S. EPA Regulations, New Uses
  7. U.S. DOT Regulations, Shipping Requirements