OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Sodium benzoate (CAS RN 532-32-1), magnesium dibenzoate (CAS RN 553-70-8), zinc benzoate (CAS RN 553-72-0), potassium benzoate (CAS RN 582-25-2), potassium benzoate trihydrate (CAS RN 6100-02-3), penzyl alcohol (CAS RN 100-51-6), ammonium benzoate (CAS RN 1863-63-4), calcium benzoate (CAS RN 2090-05-3), and benzaldehyde (CAS RN 100-52-7). Benzoates are fungistatic and antibacterial compounds that are widely used as food preservatives, pharmaceutical preservatives, and cosmetic preservatives. Benzoic acid 6% with salicylic acid 3% has a long history of use as an antifungal (3). This has been used to treat tinea capitis and tinea pedis infections. Benzoic acid has also been used in desloughing preparations and has been given as a urinary antiseptic. Sodium benzoate is used as part of the treatment of hyperammonemia that occurs in inborn errors of the urea cycle. It has also been reported to be effective in reducing plasma-glycine concentrations in nonketotic hyperglycinemia, although it may not be effective in preventing mental retardation. Sodium benzoate is a common ingredient in cough medicine preparations. Benzaldehyde is an aromatic aldehyde primarily used as a flavoring and fragrance agent, providing the characteristic almond scent in foods, beverages, cosmetics, and scented products. It also used as denaturant in cosmetics, as an industrial intermediate in the synthesis of various organic compounds including plastics, dyes, pharmaceuticals, and benzoic or cinnamic acids. Additionally, it functions as a bee repellent, a component in cosmetics and personal care products, a solvent for oils and resins, and as an additive with antibacterial and antifungal properties. Its widespread application is mainly due to its strong and pleasant almond-like aroma. Benzoic acid is available as injection for intravenous (IV) solution, as suspension, tincture, lozenge, tablets, and syrup for oral administration, as solution for rectal administration, as paste and liquid for dental administration, and as cloth, lotion, patch, solution, liquid, ointment, and cream for topical administration.

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 Benzoic Acid, just click the ADD TO CART button.

HBEL

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