Tibolone is a synthetic steroid hormone indicated for the prevention of postmenopausal osteoporosis and for the treatment of estrogen deficiency symptoms. Tibolone acts as an agonist primarily at estrogen receptors (ER) with a preference for ERα. It also possesses androgenic and progestogenic properties. The metabolites of tibolone are responsible for the effects in various tissues. Metabolites 3α- and 3β-hydroxy-tibolone both have estrogenic effects and the δ(4)-metabolite has progestogenic and androgenic effects. The specific tissue-selective effects of tibolone occur due to the metabolism, regulation of enzymes, and receptor activation that vary at different tissues. The bone-conserving effects are due to estradiol receptor activation and does not involve the progesterone and androgen receptors. In the uterus, the progestogenic activity of the δ(4)-metabolite and the effect on estrogen-inactivating enzymes prevent estrogenic stimulation.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).


CAS Registry Number:
Trade names:
Tibella®, Livial®
$679 USD


Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL monograph for Tibolone, just click the ADD TO CART button.


If you're wondering about HBEL, we have something for you.

Search OEL Fastrac

Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.

Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing