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Acute Oral Toxicity - Workshop on Acute Chemical Safety Testing

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Workshop Presentations

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Session #1: Current Acute Systemic Toxicity Injury and Toxicity Assessments

Session #2: Key Pathways and Biomarkers for Acute Systemic Toxicity

Session #3: Humane Endpoints

Session #4: State of the Science: Using In Vitro Methods to Predict Acute Systemic Toxicity

Opening Plenary Session: Welcome and Introduction To Presentations

  • William Stokes, Director, NICEATM [PDF]
  • Marilyn Wind, Chair, ICCVAM
  • Thomas Hartung, Director, ECVAM
  • Hajime Kojima, Director, JaCVAM

Session #1: Current Acute Systemic Toxicity Injury and Toxicity Assessments

Co-Chairs: William Stokes, D.V.M., DACLAM (NIEHS) and Marilyn Wind, Ph.D. (CPSC)

This session examined poisoning as a public health issue and the impact that regulatory requirements for acute systemic toxicity testing have had on public health. It also reviewed the type of data collected during testing and how this information is used for classification and labeling of chemicals and risk management.

  • Public Health Perspective of Acute Poisoning [PDF]
    Daniel Cobaugh, PharmD., DABAT, Director of Research and Program Development, American Society of Health-System Pharmacists (ASHP) Research and Education Foundation

  • Regulatory Needs and Uses for Acute Systemic Toxicity Data [PDF]
    Deborah McCall, Office of Pesticide Programs, EPA

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Session #2: Key Pathways and Biomarkers for Acute Systemic Toxicity
Co-Chairs: Deborah McCall (EPA) and Thomas Hartung, M.D., Ph.D. (ECVAM)

This session reviewed current understanding of the key pathways of acute systemic toxicity, as well as covering measurements and observations that could be included in the current acute systemic toxicity tests to elucidate key toxicity pathways.

  • Data Currently Collected During Acute Systemic Toxicity Tests [PDF]
    Gary Wnorowski, B.A., M.B.A., LAT, President, Product Safety Laboratories

  • Quantifying Evident Toxicity for the Fixed Dose Procedure [PDF]
    Robert Guest, B.Sc., Head of Alternative and Acute Toxicology, Safepharm Laboratories

  • Clinical Biomarkers used to Diagnose and Treat Acute Poisoning in Humans [PDF]
    Frank Paloucek, Pharm.D. DABAT, FASHP, Director of Residency Programs, College of Pharmacy, University of Illinois at Chicago

  • Clinical Biomarkers Used to Diagnose and Treat Acute Poisoning in Animals [PDF]
    Steven Hansen, D.V.M., DABT, DABVT, Senior Vice President, ASPCA Animal Poison Control Center, University of Illinois at Urbana-Champaign

  • Methodologies for Collecting Clinical Biomarker Data in Laboratory Animals [PDF]
    Karen Steinmetz, Ph.D., DABT, Director, Mammalian Toxicology Dept., Biosciences Division, SRI International

  • Non-Invasive and Minimally Invasive Techniques for Measuring Physiological Parameters in Laboratory Rodents [PDF]
    Kathleen Murray, D.V.M., M.S., DACLAM, Senior Director, Animal Program Management, Charles River Laboratories

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Session #3: Humane Endpoints
Co-Chairs: Masih Hashim, Ph.D. (EPA) and Cassandra Prioleau, Ph.D. (CPSC)

This session discussed the humane endpoints used for acute toxicity testing, and the potential for new information obtained on key toxicity pathways to yield earlier, more humane endpoints for acute toxicity testing.

  • The Concept of Humane Endpoints and Their Identification: Application for Acute Systemic Toxicity Testing [PDF]
    William Stokes, D.V.M., DACLAM, NIEHS, Director, NICEATM

  • Opportunities for Detecting Pain and Distress Associated with Acute Systemic Toxicity [PDF]
    Steven Niemi, D.V.M., DACLAM, Director, Center for Comparative Medicine, Massachusetts General Hospital

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Session #4: State of the Science: Using In Vitro Methods to Predict Acute Systemic Toxicity
Co-Chairs: Steve Reynolds, Ph.D. (NIOSH) and Hajime Kojima, Ph.D. (JaCVAM)

This session summarized previous workshops, including major conclusions, recommendations, and initiatives, and noted the current status of any ongoing activities resulting from these workshops.

  • The Future of Toxicology as a Predictive Science [PDF]
    Melvin Andersen, Ph.D., DABT, Director, Division of Computational Biology, The Hamner Institutes for Health Sciences

  • Recommendations from an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity [PDF]
    A. Wallace Hayes, Ph.D., DABT, FATS, Flbiol, Science Advisor and Visiting Scientist, Harvard School of Public Health

  • Current ICCVAM Recommendations for the Use of In Vitro Test Methods to Estimate Acute Systemic Toxicity [PDF]
    Marilyn Wind, Ph.D., Deputy Associate Executive Director for Health Sciences, CPSC; Chair, ICCVAM and ATWG

  • The ACuteTox Project: Optimization and Prevalidation of an In Vitro Test Strategy for Predicting Human Toxicity [PDF]
    Thomas Hartung, M.D., Ph.D., Director, European Centre for the Validation of Alternative Methods (ECVAM)

  • Using High Throughput Screening (HTS) to Identify Predictive In Vitro Biomarkers for Acute Systemic Toxicity [PDF]
    Raymond Tice, Ph.D., Deputy Director, NICEATM, NIEHS


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