OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to additional CAS RNs 129813-58-7, 68442-69-3, 129813-59-8, 129813-60-1, Benzene, C10-13- alkyl derivatives (CAS RN 67774-74-7), dodecylbenzene (CAS RN 123-01-3, 29986-57-0), and undecylbenzene (CAS RN 6742-54-7, 29463-63-6). Benzene, C10-C16 alkyl derivatives can be classified as a linear alkylbenzene (LAB) compound. Linear alkylbenzene (LAB) is a mixture of substances composed of a benzene ring attached to a single chain of carbon atoms. Various isomers are possible since the benzene ring may be positioned at all carbons of the alkyl chain except the terminal carbon. In commercially available benzene, C10-C16 alkyl derivatives, the number of carbons per alkyl chain ranges for any given product from ten to sixteen. The production of linear alkylbenzene sulfonate (LAS), a detergent surfactant, consumes > 98% of all LABs. Benzene, C10-C16 alkyl derivatives are not used for therapeutic indications.

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.

Inquiries on monograph availability

The OEL/ADE monograph for Benzene,C10-C16 Alkyl Derivatives is under development.

You can contact us and let us know if you'd like to be notified when this document becomes available.

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