Calcium Undecylenate
What Is It?
Undecylenic Acid, a fatty acidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides., occurs as a pale liquid. Undecylenic Acid as well as some of its salts (Calcium, Zinc) are used in the formulation of topical antifungal products. In the United States, topical antifungal products are regulated as Over-the-Counter (OTC) drugs by the Food and Drug Administration.
Why Is It Used?
Undecylenic Acid inhibits the growth and reproduction of fungal cells and decrease the number of fungi present. In the United States, antifungal agents are regulated as over-the-counter (OTC) drug ingredients. Undecylenic Acid and its Calcium and Zinc salts also help to cleanse the skin or to prevent odor by destroying or inhibiting the growth of microorganisms and prevent powdered or granular substances from forming clumps. These ingredients also clean skin and hair by helping water to mix with oil and dirt so that they can be rinsed away, and help to form emulsions by reducing the surface tension of the substances to be emulsified.
Scientific Facts
Undecylenic Acid is an organic unsaturated fatty acid derived from natural Castor oil (ricinoleic acid). It is the common name of the 10-undecenoic acid and is used in the manufacture of pharmaceuticals and cosmetics and personal care products. Undecylenic acid is produced by cracking of castor oil under pressure.
Safety Information
The Food and Drug Administration (FDA) reviewed the safety of Undecylenic Acid and its Calcium and Zinc salts and approved these ingredients for use in Over-The-Counter (OTC) antifungal drug products. Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) has deferred evaluation of these ingredients because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
In the United States, OTC antifungal products may contain Undecylenic Acid, Calcium Undecylenate or Zinc Undecylenate, individually or in any ratio that provides a total undecylenate concentration of 10 to 25%.
Link to FDA Code of Federal Regulations for Undecylenic Acid
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Undecylenic Acid and its salts may be used as preservatives in cosmetics and personal care products marketed in Europe according to the Cosmetics Directive of the European Union (see Annex VI).
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
10-Undecenoic Acid is another name for Undecylenic Acid. It is a fatty acid. Fatty acids are the carboxylic acids obtained by hydrolysisDecomposition of a chemical compound into smaller constituents by reaction with water. of fats and oils. Carboxylic acids having alkyl chains shorter than about seven carbon atoms are not commonly considered fatty acids. Natural fatty acids may be saturated or unsaturated and generally contain an even number of carbon atoms.
Resources
Find out more about the regulation of Over-the-Counter drugs by the Food and Drug Administration
OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…
Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/