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

(Group 3)

For definition of Groups, see Preamble Evaluation.

VOL.: 56 (1993) (p. 397)

CAS No.: 17924-92-4
Chem. Abstr. Name: 1H-2-Benzoxacyclotetradecin-1,7(8H)dione, 3,4,5,6,9,10-hexahydro-14,16-dihydroxy-3-methyl, [S-(E)]-

CAS No.: 51481-10-8
Chem. Abstr. Name: Trichothec-9-en-8-one, 12,13-epoxy-3,7,15-trihydroxy(3a,7a)-

CAS No.: 23282-20-4
Chem. Abstr. Name: Trichothec-9-en-8-one, 12,13-epoxy-3,4,7,15-tetrahydroxy(3a,4b,7a)-

Fusarenone X
CAS No.: 23255-69-8
Chem. Abstr. Name: Trichothec-9-en-8-one, 4-(acetyloxy)-12,13-epoxy-3,7,15-trihydroxy(3a,4b,7a)-

5. Summary of Data Reported and Evaluation

5.1 Exposure data

The mycotoxins considered are produced by Fusarium species that occur primarily on wheat, barley and maize. The toxins occur whenever these cereals are grown under humid conditions. Exposure occurs through dietary consumption of contaminated cereals. Deoxynivalenol has been held responsible for large-scale human poisonings this century in China and India. Chronic exposures to deoxynivalenol, zearalenone and nivalenol occur in several parts of the world; humans are rarely exposed to fusarenone X.

5.2 Human carcinogenicity data

A few ecological studies that considered F. graminearum suggested no correlation with the incidence of oesophageal cancer.

5.3 Animal carcinogenicity data

Zearalenone was tested for carcinogenicity by administration in the diet in one experiment in mice and in two experiments in rats. An increased incidence of hepatocellular adenomas was observed in female mice and of pituitary adenomas in mice each sex. No increase in the incidence of tumours was observed in rats.

No data were available to the Working Group on the carcinogenicity in experimental animals of deoxynivalenol.

Nivalenol was tested for carcinogenicity in one experiment in female mice by oral administration in the diet. No increase in tumour incidence was observed.

Fusarenone X was tested for carcinogenicity in two studies in male rats by oral administration and in male mice and male rats by subcutaneous injection. The studies were inadequate for evaluation.

5.4 Other relevant data

In episodes of food poisoning in humans caused by deoxynivalenol, severe gastrointestinal involvement was the primary sign.

Zearalenone has oestrogenic effects in domestic pigs and experimental animals. Deoxynivalenol causes outbreaks of feed refusal and vomiting in domestic pigs. Deoxynivalenol and fusarenone X cause immunosuppression in mice. Nivalenol causes bone-marrow toxicity in experimental animals.

No data were available on the genetic and related effects of zearalenone, deoxynivalenol, nivalenol or fusarenone X in humans.

Zearalenone induces chromosomal anomalies in cultured rodent cells. It does not induce recombination in yeast or gene mutation or DNA damage in bacteria.

Deoxynivalenol induces cell transformation, chromosomal aberrations and inhibition of gap-junctional intercellular communication in cultured mammalian cells. It does not induce unscheduled DNA synthesis or mutation in cultured mammalian cells and does not induce mutation in bacteria.

Nivalenol and fusarenone X have not been studied adequately for genetic effects.

5.5 Evaluation

There is inadequate evidence in humans for the carcinogenicity of toxins derived from
Fusarium graminearum.

No data were available on the carcinogenicity to humans of toxins derived from
F. crookwellense and F. culmorum.

There is limited evidence in experimental animals for the carcinogenicity of zearalenone.

There is inadequate evidence in experimental animals for the carcinogenicity of

There is inadequate evidence in experimental animals for the carcinogenicity of nivalenol.

There is inadequate evidence in experimental animals for the carcinogenicity of fusarenone X.

Overall evaluation

Toxins derived from Fusarium graminearum, F. culmorum and F. crookwellense are not classifiable as to their carcinogenicity to humans (Group 3).

For definition of the italicized terms, see Preamble Evaluation.

Previous evaluation: Suppl. 7 (1987) (pp. 64, 74)

Synonyms for 1H-2-Benzoxacyclotetradecin-1,7(8H)-dione, 3,4,5,6,9,10-hexahydro-
14,16-dihydroxy-3-methyl, [S-(E)]-

Synonyms for Trichothec-9-en-8-one, 12,13-epoxy-3,7,15-trihydroxy-(3a,7a)- Synonyms for Trichothec-9-en-8-one, 12,13-epoxy-3,4,7,15-tetrahydroxy-,
Synonyms for Trichothec-9-en-8-one, 4-(acetyloxy)-12,13-epoxy-3,7,15-

Last updated 08/21/1997

    See Also:
       Toxicological Abbreviations
       Aflatoxins (WHO Food Additives Series 40)
       Aflatoxins (IARC Summary & Evaluation, Volume 56, 1993)
       Aflatoxins (IARC Summary & Evaluation, Volume 82, 2002)