Ethylenediaminetetraacetic Acid

Please note, this OEL/ADE monograph also applies to Ethylenediaminetetraacetic acid (CAS RN 60-00-4), Edetate sodium (CAS RN 64-02-8, 70699-53-5), EDTA Monosodium salt (CAS RN 17421-79-3, 7379-28-4), Edetate disodium anhydrous (CAS RN 139-33-3), Edetate disodium dihydrate (CAS RN 6381-92-6), Edetate trisodium (CAS RN 150-38-9), Edetate trisodium monohydrate (CAS RN 10378-22-0; 85715-60-2), Edetate tetrasodium tetrahydrate (CAS RN 13235-36-4), Edetate calcium disodium anhydrous (CAS RN 23411-34-9, 62-33-9), Edetate calcium disodium monohydrate (CAS RN 304695-78-1), Edetate calcium disodium dihydrate (CAS RN 6766-87-6), Edetate calcium disodium trihydrate (CAS RN Not Available), Triethylammonium EDTA (CAS RN 60816-63-9), Sodium federate (CAS RN 15708-41-5), EDTA tripotassium salt dihydrate (CAS RN 65501-24-8), Disodium manganese EDTA (CAS RN 15375-84-5), Disodium zinc EDTA (CAS RN 14025-21-9, 73513-47-0), Magnesium disodium EDTA (CAS RN 14402-88-1), EDTA Calcium sodium (CAS RN 76353-66-7), Zinc EDTA (CAS RN 55448-21-0, 12519-36-7), Monoferric edetate (CAS RN 17099-81-9), Edetate dipotassium anhydrous (CAS RN 2001-94-7), Dipotassium EDTA dihydrate (CAS RN 25102-12-9), EDTA Monopotassium salt (CAS RN 53404-51-6), EDTA Chromium (CAS RN 24669-13-4), Edetate tetrapotassium (CAS RN 7379-27-3, 5964-35-2), Dicobalt edetate (CAS RN 36499-65-7). Ethylenediaminetetraacetic acid (EDTA), also known as edetic acid, is a chelating agent that sequesters a variety of polyvalent cations. It is used in pharmaceutical manufacturing and as a food additive (4). Ethylenediaminetetraacetic acid (EDTA) is used to treat mercury and lead toxicity, to reduce blood cholesterol, and to treat some blood transfusion-dependent anemias. Ethylenediaminetetraacetic acid (EDTA) and its salts are also used in cosmetics.

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 and the Permitted Daily Exposure (PDE) value.

Ethylenediaminetetraacetic Acid

CAS Registry Number:
60-00-4
Synonym:
edetic acid
Trade names:
Endrate®, Chelatran®, Limclair®
Cost:
$989 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