4-acetyl-6-tert-butyl-1,1-dimethylindane

4-acetyl-6-tert-butyl-1,1-dimethylindane is a synthetic flavoring compound belonging to the class of aromatic chemicals. With CAS number 13171-00-1, it consists of an indane backbone (a bicyclic aromatic hydrocarbon) with several substituents: an acetyl group at the 4-position, a tert-butyl group at the 6-position, and two methyl groups on the 1-position. This specific molecular structure creates aromatic properties that make it useful in the flavor industry.

This compound is classified as a flavoring agent or flavor adjuvant, meaning it is added to food and beverage products to provide or enhance flavor characteristics. Such synthetic aromatics are typically used in small quantities in processed foods, beverages, confectionery, and other flavored products. The specific flavor profile this compound provides—likely woody, aromatic, or similar complex sensory characteristics—makes it suitable for particular formulation needs in the food industry.

According to FDA records available through AdditiveFacts.com, there are zero recorded adverse events associated with this additive and zero product recalls linked to its use. This absence of reported safety incidents provides a baseline indicator that the compound has not generated observable public health concerns in its current applications.

However, it is important to note that this additive has not received GRAS (Generally Recognized As Safe) status from the FDA. GRAS status means the FDA has determined a substance is safe for its intended use based on either extensive prior approval or consensus among qualified experts. The lack of GRAS designation suggests that either formal safety evaluations have not been completed through FDA channels, or that the evidence submitted did not meet the criteria for this determination.

The toxicological profile of similar synthetic flavor compounds has been extensively studied, and many such compounds are in common use in food products. These evaluations typically examine acute and chronic toxicity, potential allergenicity, metabolism, and genetic toxicity (mutagenicity) endpoints.

In the United States, this compound does not hold FDA GRAS status. This means it may be regulated under different provisions depending on its use and market status. Some synthetic flavor compounds may be marketed under the Federal Food, Drug, and Cosmetic Act without explicit FDA pre-approval if they are considered food additives with an established safety history.

International regulatory approaches vary. In the European Union, flavoring substances are evaluated through EFSA (European Food Safety Authority) processes, though specific information about this particular compound's EU regulatory status is not detailed in available FDA records.

Manufacturers and importers of products containing this additive would be responsible for ensuring compliance with applicable food additive regulations in their respective markets.

Detailed peer-reviewed toxicological studies specific to 4-acetyl-6-tert-butyl-1,1-dimethylindane are not extensively documented in publicly available FDA databases. The compound represents a niche flavoring chemical with limited widespread use compared to more common flavor ingredients.

For safety evaluation of such compounds, the flavor industry typically relies on structure-activity relationship (SAR) assessments, which predict safety profiles based on the chemical structure and comparison to related compounds with known safety data. Formal toxicology studies may have been conducted by manufacturers but are not always publicly disclosed unless required for regulatory submissions.

The International Organization of the Flavoring Industry (IOFI) and similar bodies maintain databases of flavor ingredient safety assessments, though this information is proprietary in many cases.