OEL Fastrac Catalog

Anise oil is the common name for the essential oil obtained from the dried ripe fruits of the plant Pimpinella anisum L, which belongs to the Apiaceae (Umbelliferae) botanical family. The material of interest for medicinal use is the fruit (the whole cremocarp), generally entire, having an odor reminiscent of anethole. A small fragment of the thin, rigid, slightly curved pedicel is frequently attached. This herbal substance is administered in liquid or, after crushing, in solid dosage forms. Pimpinella anisum L., fructus (aniseed) is characterized by a content of essential oil (anise oil) not lower than 20 mL per kg anhydrous fruit and its medicinal properties are mainly attributed to its content of essential oil. Other constituents include flavonol glycosides, phenolic acid, a phenolic glycoside, furocoumarins, (mainly bergapten), hydroxycoumarins, (mainly umbelliferone) and fixed oil and lipids, (mainly constituted of petroselinic acid). Twelve new and 5 known glycosides of phenylpropanoids, including 4 stereoisomers of anethole glycol 2’-O-beta-D-glucopyranoside and 4 stereoisomers of 1’-(4-hydroxyphenyl)propane-1’,2’-diol 2’-O-beta-glucopyranoside were extracted from the water-soluble portion of the methanolic extract of aniseed, together with anethole glycols and guaiacyl glycerol. The isolation and characterization of eight 2-Cmethyl- D-erythritol glycosides and of twelve phenylpropanoid glycosides from the watersoluble portion of aniseed have been carried out.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

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 Anise, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.