Pyrithione

Please note, this OEL/ADE monograph also applies to Pyrithione zinc (CAS RN 13463-41-7), Pyrithione sodium (CAS RN 3811-73-2), Pyrithione zirconium (CAS RN 12390-74-8), Pyrithione cadmium (CAS RN 18897-36-4), Pyrithione titanium (CAS RN 12570-37-5), and Pyrithione barium (CAS RN 25142-21-6). Pyrithione is a fungistatic and antimicrobial derivative of aspergillic acid. It is Indicated for the treatment of dandruff and seborrheic dermatitis. Inhibition of fungal growth by pyrithione zinc is linked to increased copper uptake and cellular levels of copper, which is demonstrated by decreased CTR1-lacZ expression and slightly increased CUP1-lacZ expression in affected microorganisms. The coordination complex of pyrithione zinc dissociates, and pyrithione ligand forms a copper pyrithione (CuPT) complex from available extracellular copper in the target organism. Pyrithione acts as an ionophore, interacting nonspecifically with the plasma membrane to shuttle copper into the cell, and facilitates copper transport across intracellular membranes. Copper may be shuttled into the mitochondria. Copper inactivates iron-sulfur (Fe-S) cluster-containing proteins via a mechanism similar to that described for copper-induced growth inhibition in bacteria. Decreased activity of Fe-S proteins leads to inhibition of fungal metabolism and fungal growth. Pyrithione zinc has been shown to slightly increase the levels of zinc.

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.

Pyrithione

CAS Registry Number:
1121-30-8
Trade names:
2-in-1 Anti-Dandruff, Aveeno
Cost:
$639 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

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
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To order an OEL/ADE monograph for Pyrithione, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing