Anthralin

Please note, this OEL/ADE monograph also applies to Anthralin monoacetate (CAS RN 51794-03-7) and Anthralin triacetate (CAS RN 16203-97-7). Anthralin (1,8-dihydroxy-9anthrone, dithranol) is an older anti-psoriatic agent that was first synthesized as a derivative of chrysarobin, obtained from the araroba tree in Brazil over 100 years ago. Various forms of the drug are available, including solutions, foams and shampoos. Anthralin is also used for the treatment of alopecia. The anti-proliferative effects of anthralin appear to result from both an inhibition of DNA synthesis, as well as from its strong reducing properties. Recently, anthralin’s effectiveness as an anti-psoriatic agent has also been, in part, attributed to its abilities to induce lipid peroxidation and reduce levels of endothelial adhesion molecules which are markedly elevated in psoriatic patients. Unlike retinoids and PUVA, anthralin does not inhibit liver microsomal enzyme activity; consequently, the likelihood of adverse drug interactions is greatly reduced when other agents are administered concomitantly with anthralin.

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.

Anthralin

CAS Registry Number:
1143-38-0
Trade names:
Zithranol-RR®, Dritho-creme®, Zithranol®, Antraforte Ointment®, Anthranol Cream®, Anthrascalp Lotion®, Micanol Cream®
Cost:
$679 USD

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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

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  • K. Rosenthal
  • Director of Manufacturing