AFLATOXIN M1
Overview
Functional Class
Food Contaminant
MYCOTOXIN
MYCOTOXIN
Evaluations
Evaluation year: 2002
Comments:
Using worst-case assumptions, the additional risks for liver cancer predicted with use of proposed maximum levels of aflatoxin M1 of 0.05 and 0.5 µg/kg are very small. The potency of aflatoxin M1 appears to be so low in HBsAg- individuals that a carcinogenic effect of M1 intake in those who consume large quantities of milk and milk products in comparison with non-consumers of these products would be impossible to demonstrate.
Intake:
0.11, 0.25, or 2.5 ng/kg bw/d, based on proposed maximum levels of aflatoxin M1 contamination in milk of 0.05 & 0.5 µg/kg and weighted mean of 0.023 µg/kg for the GEMS/Food European-type diet.
Tolerable Intake:
genotoxic carcinogen, none established
Meeting:
56
Report:
Tox Monograph:
Toxicological study
Pivotal Study:
2 year study in Fischer rats (Cullen et al., 1987). Male Fischer rats (n=62-63/group) were fed aflatoxin M1 in the diet at levels of 0, 0.5, 5, or 50 ppm by weight, corresponding to total intake values over a 21-month span of 0, 0.01, 0.1, or 1 mg of aflatoxin, with a separate group fed 50 ppm by weight of aflatoxin B1, resulting in a total intake of 0.8 mg of aflatoxin B1 by the 17-month point. Rats in all treatment groups except the aflatoxin B1 group were sacrificed at 3, 6, 10, 16, 17, 19, or 21 months. The aflatoxin B1 group was sacrificed at 17 months. Significant increases in the incidences of hepatocellular carcinomas and hepatic neoplastic nodules were noted in the high-dose aflatoxin M1 group at 21 months. Increased incidences of hepatocellular carcinomas were noted in the aflatoxin B1 group at 17 months.
Animal Specie:
Fischer rats
Effect:
Carcinogenicity
NOEL:
0.1 mg total intake over 21 months
Point of departure:
Carcinogenic potency for aflatoxin M1 was calculated to be 10% of the carcinogenic potency for aflatoxin B1, based on induction of hepatocellular carcinomas in aflatoxin B1-treated rats versus aflatoxin M1-treated rats