Refined hazard characterization of 3‐MCPD using benchmark dose modeling

Abstract

Abstract3‐Monochloropropane‐1,2‐diol (3‐MCPD)‐esters represent a newly identified class of food‐borne process contaminants of possible health concern. Due to hydrolysis 3‐MCPD esters constitute a potentially significant source of free 3‐MCPD exposure and their preliminary risk assessment was based on toxicological data on free 3‐MCPD. 3‐MCPD is a non‐genotoxic carcinogen and a (provisional maximum) tolerable daily intake ((PM)TDI) of 2 µg/kg bodyweight per day was established by the Scientific Committee on Food and the Joint FAO/WHO Expert Committee on Food Additives. Both committees derived the TDI from a lowest observed adverse effect level, not a no observed adverse effect level, for renal tubular hyperplasia, using an uncertainty factor of 500. When using the Benchmark Dose (BMD) approach and a BMDL10 value as point of departure, part of this uncertainty factor of 500 would no longer be needed. The present study presents a BMD analysis of the currently available chronic data on 3‐MCPD mediated induction of tubular hyperplasia in rats as the most sensitive endpoint. The results indicate a (model‐averaged) BMDL10 value of 0.72 mg/kg bw/day. The TDI that would be derived based on this BMDL10 value will depend on the uncertainty factor chosen. Using the default uncertainty factor of 100 for inter‐ and intraspecies extrapolation would result in a TDI of 7 µg/kg bw/day.See commentary by Abraham et al. [p. 1225–1226]