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EC number: 220-165-4
CAS number: 2649-76-5
There are no data
available on aldonaethylenolether or the pharmacological active
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
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
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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