For definition of Groups, see Preamble Evaluation.
VOL.: 56 (1993) (p. 489)
Chem. Abstr. Name: L-Phenylalanine, N-[(5-chloro-3,4-dihydro-8-hydroxy-3-methyl-1-
Ochratoxin A is produced by Aspergillus ochraceus and Penicillium verrucosum. Human exposure occurs mainly through consumption of contaminated grain and pork products, as confirmed by detection of ochratoxin A in human blood and milk.
A number of descriptive studies have suggested a correlation between exposure to ochratoxin A and Balkan endemic nephropathy and have found a correlation between the geographical distribution of Balkan endemic nephropathy and a high incidence of and mortality from urothelial urinary tract tumours. In the only study in which ochratoxin A was measured, levels were higher in the blood of patients with Balkan endemic nephropathy and/or urothelial urinary tract tumours than in unaffected people; no distinction was made between the two diseases.
Ochratoxin A was tested for carcinogenicity by oral administration in mice and rats. It increased the incidence of hepatocellular tumours in mice of each sex and produced renal-cell adenomas and carcinomas in male mice and in rats of each sex.
Ochratoxin A caused renal toxicity, nephropathy and immunosuppression in several animal species.
No adequate data were available on the genetic and related effects of ochratoxin A in humans. It induces DNA damage in rodents in vivo and in rodent cells in vitro.
There is inadequate evidence in humans for the carcinogenicity of ochratoxin A.
There is sufficient evidence in experimental animals for the carcinogenicity of ochratoxin A.
Ochratoxin A is possibly carcinogenic to humans (Group 2B).
For definition of the italicized terms, see Preamble Evaluation.
Previous evaluation: Suppl. 7 (1987) (p. 271)
See Also: Toxicological Abbreviations Ochratoxin A (JECFA Food Additives Series 47) Ochratoxin A (WHO Food Additives Series 28) OCHRATOXIN A (JECFA Evaluation)