Please note, this OEL/ADE monograph also applies to Clemizole hydrochloride (CAS RN 1163-36-6), and Clemizole sulfate (CAS RN 17162-20-8). Clemizole is a member of the class of benzimidazoles that is a 1H-benzimidazole substituted by a pyrrolidin-1-ylmethyl and a 4-chlorobenzyl groups at positions 2 and 1, respectively. Clemizole hydrochloride is a sedating antihistamine. Clemizole was widely used during the 1950s and 1960s for the symptomatic relief of allergic conditions, in pruritic skin disorders, and in combination preparations for the treatment of symptoms of the common cold. Clemizole has also been applied topically as the hexachlorophene, the sodium sulfate, and the undecylate derivatives in topical and rectal preparations combined with corticosteroids and local anesthetics. Clemizole is under investigation via oral administration for the treatment of hepatitis C virus (HCV) infection, of hepatocellular carcinoma, and as an anti-seizure medication.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.


CAS Registry Number:
$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. Over 20 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.

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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.
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