Androsta-1,4-diene-3,17-dione

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: published data, FDA assessment

Data source

Reference

Reference Type:

review article or handbook

Title:

FDA White Paper, Health Effects of Androstendione

Author:

FDA

Year:

2004

Bibliographic source:

Available from: .

Report date:

2004

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Androst-4-ene-3,17-dione

EC Number:

200-554-5

EC Name:

Androst-4-ene-3,17-dione

Cas Number:

63-05-8

Molecular formula:

C19H26O2

IUPAC Name:

androst-4-ene-3,17-dione

Results and discussion

Any other information on results incl. tables

An assessment of Health Effects of Androstendione is provided by FDA.

Summary: "Androstenedione and related molecules, if given in sufficient quantities and for sufficient duration, are likely to cause androgenic (and thus anabolic) or estrogenic effects in humans. Although these compounds possess at most weak intrinsic androgenic activity, they are prohormones for both androgens (testosterone) and estrogens. The biochemical evidence supporting the effect of androstenedione to raise circulating levels of testosterone and estrogens is strong. This, in conjunction with the known potential for site-of-action direct conversion of androstenedione to testosterone, leads to a conclusion of a direct relationship between risk of androgenic or estrogenic effects of treatment and dose and duration of treatment. In particular, androstenedione and related molecules consumed in sufficient quantities to have any anabolic effects will confer androgenic and estrogenic risks, although risks may also be present with consumption that is not sufficient to produce obvious anabolic effects.

Children and adolescents are particularly vulnerable to irreversible effects of androstenedione via its conversion to active sex steroids. These effects include disruption of normal sexual development, specifically virilization in girls associated with severe acne, excessive body and facial hair, deepening of the voice, permanent enlargement of the clitoris, disruption of the menstrual cycle, and infertility. The conversion to estrogens can cause feminization of boys, with breast enlargement and testicular atrophy. In girls, exposure to excess estrogens may confer long-term increased risk for breast and uterine cancer. Finally, in boys and girls, the combined effects of excessive androgens and estrogens can induce premature puberty, early closure of the growth plates of long bones, resulting in significant compromise of adult stature."