Predictive Models for Acute Oral Systemic Toxicity
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Owner/Developer: Interagency coordination committee on the validation of alternative methods and National Toxicology Program (ICCVAM)
United States of America
11 April 2018
United States of America
|Description:||The development of test methods that reduce or replace animal use for acute toxicity tests required by regulatory authorities is one of ICCVAM’s high priority activities. To this end, the ICCVAM Acute Toxicity Workgroup, with support from NICEATM, sponsored a global project to develop in silico models of acute oral systemic toxicity that predict five specific endpoints identified by member regulatory agencies. These endpoints included identification of “very toxic” chemicals (LD50 less than 50 mg/kg), “nontoxic” chemicals (LD50 greater than or equal to 2000 mg/kg), point estimates for LD50s, and categorization of toxicity hazard using the U.S. Environmental Protection Agency and United Nations Globally Harmonized System of Classification and Labelling classification schemes. NICEATM invited scientists to develop and submit in silico models that predict any or all of these endpoints. This workshop provided an opportunity for project participants to present their submitted models. Workshop participants also discussed developing a consensus model that integrates the submitted models to predict acute oral toxicity, as well as next steps needed to encourage appropriate use of these models in regulatory contexts.|
Optional / Voluntary
Researchers, Regulators and policy-makers, Teachers and educators, Managers, Scientific officers / Project managers
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), Consulting, SMEs
Continuing Professional Development
Legislative aspects, Computational methods
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
1.Implementation of Non-Animal Approaches for Acute Systemic Toxicity
2.Amended TSCA: EPA’s Strategic Plan to Promote the Development and
Implementation of Alternative Test Methods
3.Regulatory Needs and Decision Contexts for Acute Oral Systemic Toxicity Data
4.Rat Oral Acute Toxicity Database and Variability
5.Collaborative Modeling Efforts for the Acute Oral Systemic Toxicity Endpoints
6.In Silico Approaches for Acute Oral Toxicity
Platform Presentations and Panel Discussion 1
7.In Silico Approaches for Acute Oral Toxicity
Platform Presentations and Panel Discussion 2
8. End User Applications – Short Presentations, Case Studies, and Panel Discussion
9.Charges to Breakout Groups
10.Group A&B: Practical Applications
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