Registration Dossier
Registration Dossier
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EC number: 220-165-4 | CAS number: 2649-76-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
There are no data available on aldonaethylenolether or the pharmacological active metabolite aldona.
Following treatment with the aldosterone antagonist spironolactone side effects such as gynecomastia and impotence were observed in men and disturbances to cycle (intracyclic menstrual bleeding, amennorhea) and - although seemingly contradictory - hirsutism in women. These effects are dose-dependent and probably arise from a reduction of the 17-hydroxylase activity and an anti-androgenic partial effect. Since aldona, the pharmacological active metabolite of aldonaethylenolether, also develops antiandrogenic properties in animal experiments, similar effects on the endocrine system should be taken into consideration in case of repeated intake of aldona and therefore also aldonaethylenolether. Since no experimental data are available concerning the relative efficacy of aldonaethylenolether in this respect, it is not possible to make an assessment of the potentially effective dose range in humans. Other generalside-effects of spironolactone during therapeutic use in adults (dose range: 50 - 400 mg/day, oral) include disturbances of the gastrointestinal tract (e.g. nausea, vomiting and cramps), changes to the metabolism (e.g. disturbance of the electrolyte metabolism, increase in the uric acid level) and liver function disturbances (cholestasis). Depending on their extent, such electrolyte changes (hyperkalemia, hyponatremia) may lead to disturbances in cardiac rhythm. In the case of existing hypotonia spironolactone can also lead to a further decrease in blood pressure. Due to the anti-aldosterone effect of aldona demonstrated in animal experiments and the structural similarity to spironolactone, exposure to aldona can be expected to lead to the same effects. Therefore, also exposure to aldonaethylenolether, which will be metabolized in vivo to the pharmacological active metabolite aldona, can be expected to lead to the same effects as spironolactone.
Due to the described potential effects classification with Xn, R 48/20/21/22 according to 67/548/EEC and STOT RE Cat 2, H373 according to Regulation (EC) No. 1272/2008 (CLP) is required.
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