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

DIETHYLSTILBOESTROL (STILBOESTROL)

VOL.: 6 (1974) (p. 55)

5. Summary of Data Reported and Evaluation

(N.B.: This section should be read in conjunction with the section 'General Conclusions on Hormones'.)

5.1 Animal carcinogenicity data

Diethylstilboestrol (DES) was tested in mice by oral administration, local application and subcutaneous injection, in mice, rats, hamsters and squirrel monkeys by subcutaneous implantation and in hamsters by subcutaneous injection. Its administration to mice resulted in an increased incidence of mammary and lymphoid tumours in both males and females, and of interstitial-cell tumours of the testis in males and cervical and vaginal tumours in females, including those exposed only on the first day of life. In rats, increased incidences of pituitary, mammary and bladder tumours were observed. In hamsters, a high incidence of renal tumours was observed in castrated males and females and in intact males, but not in intact females. In squirrel monkeys, malignant mesotheliomas of the uterine serosa were observed.

DES treatment in most cases increased the incidence of mammary tumours in strains of mice having a spontaneous incidence of these tumours, which may be related to the presence of a virus; testicular tumours occurred in strains having a particular genetic susceptibility to such tumours. No evidence of a possible role of a virus has been shown in rats. Bladder tumours occurred only in rats in which bladder calculi were present.

In most cases, an accurate assessment of the effective carcinogenic dose in implantation studies is not possible. However, in oral administration studies, the lowest statistically significant dose (p < 0.01) producing mammary carcinomas in mice was about 0.15 mg/day (6 mg/kg bw/day). This dose is similar to that used in humans in the control of menopausal symptoms by DES (10 mg/kg bw/day) and 30 times less than the dose given for the control of mammary or prostatic cancer (300 mg/kg bw/day).

5.2 Human carcinogenicity data

The administration of diethylstilboestrol to women during pregnancy is associated with an increased risk of vaginal or cervical adenocarcinoma in their exposed female offspring. There may also be an increased risk of endometrial carcinoma in women with gonadal dysgenesis treated with this drug. It is possible that the administration of the drug therapeutically to men with carcinoma of the prostate increases the risk of breast cancer.

Subsequent evaluations: Vol. 21 (1979); Suppl. 7 (1987)


Last updated: 17 March 1998






















    See Also:
       Toxicological Abbreviations
       DIETHYLSTILBOESTROL (JECFA Evaluation)