International Agency for Research on Cancer (IARC) - Summaries & Evaluations

(Group 2B)

For definition of Groups, see Preamble Evaluation.

VOL.: 56 (1993) (p. 489)
CAS No.: 303-47-9
Chem. Abstr. Name: L-Phenylalanine, N-[(5-chloro-3,4-dihydro-8-hydroxy-3-methyl-1-
oxo-1H-2-benzopyran-7-yl)-carbonyl]-, (R)-

5. Summary of Data Reported and Evaluation

5.1 Exposure data

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.

5.2 Human carcinogenicity data

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.

5.3 Animal carcinogenicity data

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.

5.4 Other relevant data

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.

5.5 Evaluation

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.

Overall evaluation

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)


Last updated 08/21/1997

    See Also:
       Toxicological Abbreviations
       Ochratoxin A (JECFA Food Additives Series 47)
       Ochratoxin A (WHO Food Additives Series 28)
       OCHRATOXIN A (JECFA Evaluation)