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SACATM: Background Meeting Materials October 2004

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  1. Introductory Materials

  • SACATM Charter [PDF]
  • SACATM Roster [PDF])
  • ICCVAM Agency Representatives [PDF]
  • Summary Minutes for the March 10-11, 2004 SACATM meeting [PDF]
  1. Update on Activities of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of alternative Methods (ICCVAM) [Opening Remarks by the ICCVAM Chair Presentation] [NICEATM-ICCVAM Update Presentation]

Background Materials:

Federal Register Notices

  • Notice of the Availability of Agency Responses to ICCVAM Test Recommendations for the Revised Up-and-Down Procedure for Determining Acute Oral Toxicity and In Vitro Methods for Assessing Acute Systemic Toxicity [March 10, 2004 (Vol. 69, No. 47) pages 1148-1149] [PDF or HTML]
  • Request for Public Comment on the Nomination for Ocular Toxicity Test Methods and Related Activities and Request for Data on Chemicals Evaluated by In Vitro or In Vivo Ocular Irritancy Test Methods [March 24, 2004 (Vol. 69, No. 57) pages 13859-13861] [PDF or HTML]
  • In Vitro Endocrine Disruptor Test Methods: Request for Comments and Nominations [April 21, 2004 (Vol. 69, No. 77) page 21564] [PDF or HTML]
  • Request for Nominations of Scientific Experts for Independent Expert Panel Evaluations and/or other Reviews of In Vitro Testing Methods for Identifying Potential Ocular Irritants [April 21, 2004 (Vol. 69, No. 77) page 21565] [PDF or HTML]
  • Notice of Availability of Recommended Performance Standards for In Vitro Test Methods for Skin Corrosion (NIH Publication No: 04-4510, May 2004) [May 28, 2004 (Vol. 69, No. 104) pages 30693-30694] [PDF or HTML]

Other

  • ICCVAM-NICEATM Recommended Performance Standards for In Vitro Test Methods for Skin Corrosions (May 2004, NIH Publication No. 04-4510) [PDF (5.6 MB) or HTML]
  • 5th World Congess on Alternatives and Animal Use in the Life Sciences August 21-25, 2005 Meeting Announcement (Berlin, Germany) [PDF of brochure or World Congress HTML]
  • OECD Announcement of New Draft Test Guideline 435 "In Vitro Membrane Barrier Test Method for Skin Corrosion" [pdf]
  • OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline: 435 "In Vivo Membrane Barrier test method for Skin Corrosion [pdf]
  1. Update on ECVAM Workshop Recommendations and Validation Studies [Presentation]

Background Materials:

Newsletters

Workshop Reports

  • Blood-Brain Barrier In Vitro models and their Application in Toxicology. The ECVAM Workshop Report 49. Prieto et al. (2004). ATLA 32, 37-50
  1. Evaluation of the Under-Prediction Rate for the In Vivo Rabbit Dermal Irritation Test [Presentation]

Background Materials:

  • Memorandum from Director, NICEATM [September 17, 2004] [PDF]
  • Poster: Estimate of Underprediction Rates for the In Vivo Rabbit Dermal Irritation Assay. Society of Toxicology Meeting, Baltimore, MD, March 24, 2004 [PDF]
  • Dr. Haseman's analysis: Estimation of the Underprediction Rates for the In Vivo Rabbit Dermal Irritation Assay [May 2003] [PDF]
  1. Preliminary Evaluation of the Under-Prediction Rate for the In Vivo Rabbit Ocular Irritation Test [Presentation]

Background Materials:

  • Memorandum from Director, NICEATM [September 17, 2004] [PDF]
  • NICEATM Analysis of the In Vivo Database Using the GHS Classification System [PDF]
  • ALLTOX Database [PDF]
  • Request for Existing Dermal and Ocular Irritancy Chemical Test Data from Animal and Human Studies using Standardized Testing Methods [July 16, 2003 (Vol. 68, No. 136) pages 42067-42068] [PDF or HTML]
  1. ICCVAM Nominations [Presentation]

Background Materials:

  • EPA Letter to NICEATM, RE: Skin and Eye Irritation Potential and Labeling Requirements for Antimicrobial Cleaning Product Formulations [June 21, 2004] [PDF]
  1. NTP Roadmap [Presentation]

Background Materials:

  1. ICCVAM Perspectives on Proposed OECD Draft guidance Document on the Validation and International Acceptance of New or Updated Test methods for Hazard Assessment (Guidance Document 34) [Presentation]

Background Materials:

  • ICCVAM Comments on the Revised (October 2003) Draft Guidance Document No. 34 on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment (February 4, 2004) [PDF]
  • ICCVAM Comments on the Draft Guidance Document on the Development, Validation, and Regulatory Acceptance of New and Updated Internationally Acceptable Test Methods for Hazard Assessment (November 30, 2001)[PDF]
  • OECD Environment, Health and Safety Publications Series on Testing and Assessment No. 34: Draft Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment [October 2003] [PDF]
  • OECD Report of the Stockholm Conference on Validation and Regulatory Acceptance of New and Updated Methods in Hazard Assessment [September 30, 2002] [PDF]