Probabilistic risk assessment of exposure to leucomalachite green residues from fish products

Abstract

To assess the potential risk of human exposure to carcinogenic leucomalachite green (LMG) due to fish consumption, the probabilistic risk assessment was conducted for adolescent, adult and senior adult consumers in Taiwan. The residues of LMG with the mean concentration of 13.378±20.56 μg kg(-1) (BFDA, 2009) in fish was converted into dose, considering fish intake reported for three consumer groups by NAHSIT (1993-1996) and body weight of an average individual of the group. The lifetime average and high 95th percentile dietary intakes of LMG from fish consumption for Taiwanese consumers were estimated at up to 0.0135 and 0.0451 μg kg-bw(-1) day(-1), respectively. Human equivalent dose (HED) of 2.875 mg kg-bw(-1) day(-1) obtained from a lower-bound benchmark dose (BMDL10) in mice by interspecies extrapolation was linearly extrapolated to oral cancer slope factor (CSF) of 0.035 (mgkg-bw(-1)day(-1))(-1) for humans. Although, the assumptions and methods are different, the results of lifetime cancer risk varying from 3×10(-7) to 1.6×10(-6) were comparable to those of margin of exposures (MOEs) varying from 410,000 to 4,800,000. In conclusions, Taiwanese fish consumers with the 95th percentile LADD of LMG have greater risk of liver cancer and need to an action of risk management in Taiwan.

Keywords: AIC; Akaike information criterion; BFDA; BMD; BMDL(10); BMR; Bureau of Food and Drug Analysis; CSF; Cancer slope factor; DNA; EFSA; European Food Safety Authority; Fish consumption; HED; IPCS; International Programme on Chemical Safety; JECFA; Joint FAO/WHO Expert Committee on Food Additives; LADD; LMG; Leucomalachite green; Lifetime cancer risk; MC; MG; MOA; MOEs; Margin of exposure; Monte Carlo; NAHSIT; NTP; National Toxicology Program; Nutrition and Health Survey in Taiwan; PDFs; POD; Probabilistic assessment; US Environmental Protection Agency; USEPA; benchmark dose; benchmark response; cancer slope factor; deoxyribonucleic acid; human equivalent dose; leucomalachite green; lifetime average daily dose; lower-bound benchmark dose; malachite green; margins of exposure; mode of action; point of departure; probability density functions.