Development of a New Tool for Modelling Potential Risks from Food ...

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Probabilistic Non-cancer Risk Assessment • Concept first raised in the early 1990s • Groups that have published in this area – RIVM, TNO, FoBiG, and BAuG – U.S. EPA – Harvard Center for Risk Analysis • Cited in ECHA guidance for REACH • Benefits – Allows the investigation of the impact of making multiple conservative assumptions for each component – The approach gives: • A single value (lower 5 th percentile) • Complete distribution to provide a context to the standard 10
Why Perform a Probabilistic Analysis? • The use of the Cramer classes/Munro et al. approach for a single chemical gives a conservative assumption of toxicity • Applying the same approach to multiple chemicals can result in an over-estimation – It is unlikely that all chemicals in a mixture will be as toxic as the 5 th percentile • The conservative adjustment factors have a similar problem 11
Page 1 and 2: Development of a New Tool for Model
Page 3 and 4: Challenges Posed by Mixtures • Co
Page 5 and 6: Limitations to the Tool • Does no
Page 7 and 8: Models for Mixture Toxicity (Cont.)
Page 9: The Cramer Class Approach Class II
Page 13 and 14: Probabilistic Additive Model of Mix
Page 15 and 16: Residue Data Compound Concentration
Page 17 and 18: Results 0.05 Safe Dose mg/kg/d 0.04
Page 19 and 20: Estimates of Safe Doses in Bottled
Page 21: Questions 21

Development of a New Tool for Modelling Potential Risks from Food ...

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