OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alternate CAS RNs 464-48-2/464-49-3/8008-51-3/21368-68-3. Camphor, also known as bornan-2-one, is a bicyclic monoterpene ketone found widely in plants. Camphor is a constituent of a variety of foods. Typical sources are herbs, such as basil, coriander, marjoram, rosemary and sage. Both enantiomers are naturally occurring. The essential oil from the camphor tree (Cinnamomum camphora) contains up to 84% dcamphor. Essential oils from herbs are characterized by typical ratios of the enantiomers. For example, a 72-75% excess of the l-camphor enantiomer is characteristic of coriander oil (Coriandrum sativum L.), whereas, an excess of the d-camphor enantiomer characterizes the essential oils of sage and basil. As a pharmaceutical ingredient, camphor oil has anti-inflammatory and analgesic properties and is used for its aromatic properties, as an insect repellant, in embalming fluids, and in various topical skin preparations. Additionally, camphor taken internally in small amounts (toxic in large doses) acts as a carminative, a reflex expectorant, and reflex stimulant of the heart, circulation and respiration. Camphor has also been used as a sedative and nervous system depressant in convulsions, hysteria, epilepsy, and chorea.

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

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HBEL

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