What is 5-hydroxyundecanoic Acid Lactone?
5-hydroxyundecanoic acid lactone (CAS Number: 710-04-3) is an organic compound belonging to the lactone family of chemicals. Lactones are cyclic esters formed when a hydroxyl group and a carboxylic acid group on the same molecule react to create a ring structure. This particular compound is an 11-carbon chain lactone with a hydroxyl functional group, giving it distinctive aromatic properties that contribute fruity, creamy, and coconut-like flavor notes.
Common Uses
This flavoring agent is primarily used in the food and beverage industry to enhance flavor profiles. It appears in applications such as dairy products, beverages, confectionery, and baked goods. The compound's natural-like sensory characteristics make it valuable for manufacturers seeking to create or enhance fruity and creamy taste experiences. As with other synthetic flavor compounds, it is typically used in very small quantities to achieve the desired sensory effect.
Safety Assessment
According to FDA records, 5-hydroxyundecanoic acid lactone has generated zero reported adverse events and zero recalls. The compound has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA, which means it does not have official status confirming safety for its intended use. However, the absence of GRAS status does not indicate a safety concern; rather, it reflects the regulatory pathway taken by manufacturers. Some food additives operate under food additive regulations requiring pre-market approval rather than through the GRAS notification process.
The lack of adverse event reports and recalls suggests no documented safety incidents have been associated with this compound in commercial food use. However, comprehensive toxicological studies specific to this compound appear limited in publicly available scientific literature.
Regulatory Status
In the United States, 5-hydroxyundecanoic acid lactone is permitted as a flavoring agent under FDA regulations governing synthetic flavoring substances (21 CFR § 182.60). Its use is subject to current good manufacturing practice regulations, which specify that additives must be of appropriate purity and used only in quantities necessary to achieve their intended effect.
The European Food Safety Authority (EFSA) maintains its own Flavourings Working Group, and approval status may differ between U.S. and EU jurisdictions. Manufacturers using this compound in different markets must ensure compliance with each region's specific food additive regulations.
The compound is classified as a synthetic flavor substance rather than a natural flavoring, though some lactones do occur naturally in foods. The synthetic designation reflects its manufacturing method rather than any inherent safety distinction.
Key Studies
Published scientific literature specifically examining 5-hydroxyundecanoic acid lactone remains limited. Most data supporting its safety profile comes from industry submissions and regulatory dossiers rather than independent peer-reviewed toxicological studies. The lactone chemical class generally has established safety data, as many lactone-based flavoring compounds have been studied and used in food applications for decades.
Similar lactone compounds have undergone safety evaluations by both the FDA and EFSA, providing a broader safety context for this chemical class. The absence of reported adverse events, combined with its long history of use in commercial products, suggests an acceptable safety profile, though direct comparative studies with other flavoring agents are not readily available in public databases.