Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-707-0 | CAS number: 85390-93-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Justification for classification or non-classification
There are no data available on 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one or the stereoisomer 3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one.
Since 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one is a derivative of the steroid hormone prasteron with a high structural similarity similar effects can be expected. Prasteron was shown in animal experiments to have the ability to inhibit fertility in rodents in high doses. Such disturbances to sexual function should fundamentally also be taken into consideration following intake of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one. Moreover, reproduction toxicity data in rats indicate that prasteron has a virilizing potential in female fetuses. This finding is explicable either by the moderate androgenic activity of prasteron itself or by the metabolism of the compound to endogenous androgens such as testosterone or dihydrotestosterone. As a matter of precaution, the risk of a virilizing effect in female offspring should also be assumed if women are burdened with 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one during the sensitive phase of fetal sexual differentiation. Animal experiments produced no indication that prasteron may possess a teratogenic potential beyond this. In analogy to prasteron, exposure of nursing women is fundamentally to be avoided as neither the entry of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one 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, 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one 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.
According to Regulation (EC) 1272/2008 (CLP) 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one is classified:
Repr. Category 1B; H360 FD
Lact.; H362 .
Additional information
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.
