OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to ethylenediamine dihydrochloride (CAS RN 333-18-6), diethylenetetramine (CAS RN 1336-49-8), ethylenediamine monohydrate (CAS RN 6780-13-8), ethylenediamine hydrochloride (CAS RN 15467-15-9), ethylenediamine sulfate (CAS RN 22029-36-3), ethylenediamine tartrate (CAS RN 22719-15-9), and ethylenediamine succinate (CAS RN 57213-61-3). Ethylenediamine (EDA), also known as 1,2-diaminoethane, is an organic compound that is used as a building block for the production of many other chemical products. Ethylenediamine is a chemical intermediate used in the manufacture of dyes, fungicides, waxes, insecticides, resins, casein, lacquer, and shellac. It is also used in many industrial processes. Ethylenediamine is used as a stabilizer, emulsifier, and preservative in topical fungicides, antibiotic creams, eye drops, and nose drops. It forms a stable mixture with theophylline to produce aminophylline or aminophylline hydrate. It is an ingredient of some topical creams. Ethylenediamine is a component of soldering flux used in the electronics industry. Mycolog II® cream no longer contains ethylenediamine however, many generic versions still use the older formulation which utilizes ethylenediamine as a stabilizer. Ethylenediamine has been used in veterinary medicine as a urinary acidifier. Finally, ethylenediamine is approved for use within allergenic epicutaneous patch tests which are indicated for use as an aid in the diagnosis of allergic contact dermatitis (ACD) in persons 6 years of age and older.

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.

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.

How to order

To order an OEL/ADE monograph for Ethylenediamine, just click the ADD TO CART button.

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