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Laboratory studies have described the carcinogenicity of fumonisin B₁ (FB₁) in rodents and epidemiological evidence suggests an association between FB₁ (a mycotoxin produced by Fusarium moniliforme) and cancer in humans. This study was designed to reveal in rainbow trout, a species with very low spontaneous tumor incidence, if FB₁ was (i) a complete carcinogen, in the absence of an initiator; (ii) a promoter of liver tumors in fish initiated as fry with aflatoxin B₁ (AFB₁); and (iii) a promoter of liver, kidney, stomach, or swim bladder tumors in fish initiated as fry with N-methyl-N′-nitro-nitrosoguanidine (MNNG). FB₁ was not a complete carcinogen in trout. No tumors were observed in any tissue of fish fed diets containing 0, 3.2, 23, or 104 ppm FB₁ for a total of 34 weeks (4 weeks FB₁ exposure, 2 weeks outgrowth on control diet, followed by 30 weeks FB₁ diet) in the absence of a known initiator. FB₁ promoted …