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HSL Training: Derivation of a Derived No-Effect Level Using PBPK and Benchmark Dose Response Modelling

Start date: 15 Jun. 2010

End date: 16 Jun. 2010

Health & Safety Laboratory
Training Unit
Buxton, Derbyshire

Introduction

The risk to humans from exposure to chemicals is considered controlled if the level of exposure does not exceed an appropriate health based value such as, the derived no-effect level (DNEL) under REACH and guidance values under the Biocides Directive and Plant Protection Products Directive. However, several quite different health based values may be determined from the same animal toxicology data. This can lead to disputes between industry and regulator.

This course is designed to introduce participants to the application of user-friendly tools for quantitative, data-informed chemical risk assessment, which have the potential to reduce the uncertainties associated with inter-species extrapolation and the use of in vitro data. The participants will use {cms_selflink page=’pbpk’ text=’physiologically based pharmacokinetic (PBPK) modelling ‘}to convert administered doses to organ and tissue concentrations, benchmark dose response modelling and apply inter- and intra-species assessment factors to derive a DNEL.

The course will cover:

– Tools for use in quantitative, data-informed chemical risk assessment.
– An approach for the derivation of a DNEL for a chemical with a demonstrable threshold.
– The fundamental concepts underlying PBPK modelling.
– The rapid construction of PBPK models using a user-friendly model equation generator and visualizing model output using the software, Berkeley Madonna®.

Presenters include:

– Dr.George Loizou a biochemical toxicologist with over 22 years experience in quantitative, mechanistic toxicology.
– Keynote speaker – M.E. (Bette) Meek, Associate Director, Chemical Risk Assessment McLaughlin Institute for Population Health Risk Assessment University of Ottawa.

Who should attend?

– Industrial professionals responsible for conducting or evaluating risk assessments on consumer, environmental and occupational exposure to chemicals.
– Occupational health and safety professionals.
– Scientists interested in physiologically based pharmacokinetic modelling.

For more information and registration, please visit http://www.hsl.gov.uk/training/courses/pbpk_bench.html

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