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Key value for chemical safety assessment

Justification for classification or non-classification

Use of therapeutically effective doses of spironolactone can lead to reversible fertility disturbances in humans of both sexes. In so far as such effects are the expression of an anti-androgenic partial effect, corresponding disturbances to sexual function should fundamentally also be taken into consideration following intake of aldona. As a matter of precaution, the risk of a feminizing effect in male offspring should also be assumed if women are burdened with aldona during the sensitive phase of fetal sexual differentiation (from day 45 after conception onwards). After spironolactone, feminizing effects were observed on the external genital organs of male offspring of rats exposed to daily doses of ca. 160 mg/kg body weight during gestation. Animal experiments produced no indication that spironolactone may possess a teratogenic potential beyond this. For humans there is too little experience concerning the safety of using spironolactone during pregnancy. In analogy to spironolactone, exposure of nursing women is fundamentally to be avoided as neither the entry of aldona and/or possible metabolites into the mother's milk nor an inhibition of the milk production can as yet be excluded. A potential risk to the development of the infant has thus to be assumed.

According to the Directive 67/548/EEC, aldona is classified:

Category 2; R60- May impair fertility.

Category 2; R61 - Possible risk of harm to the unborn child.

Classified as Category 1B according to Regulation (EC) 1272/2008 (CLP).

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