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Key value for chemical safety assessment

Justification for classification or non-classification

There are no data available on aldonaethylenolether or the pharmacological active metabolite aldona.

Use of therapeutically effective doses of the aldosterone antagonist 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 (which also showed an anti-aldosterone effect and is structurally similar to spironolacton) and aldonaethylenolether, which will be metabolized in vivo to the pharmacological active aldona. As a matter of precaution, the risk of a feminizing effect in male offspring should also be assumed if women are burdened with aldonaethylenolether during the sensitive phase of fetal sexual differentiation (from day 45 after conception onwards) since after spironolactone administration 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 aldonaethylenolether and/or possible metabolites into the mother's milk nor an inhibition of the milk production can yet be excluded. A potential risk to the development of the infant has thus to be assumed.

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

Repr. Category 2; R60 - May impair fertility.

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

R64 - May cause harm to breast-fed babies

Aldonaethylenolether is classified as Repr. Category 1B; H360 FD and Lact.; H362 according to Regulation (EC) 1272/2008 (CLP).

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