# 2-hexyl-4,5-dimethyl-1,3-dioxolane

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**Safety rating:** UNKNOWN
**CAS number:** 6454-22-4
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

2-hexyl-4,5-dimethyl-1,3-dioxolane is a synthetic flavoring compound belonging to the dioxolane chemical family. It is used in food manufacturing to provide specific aromatic notes and flavor enhancement in various processed food products.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | not_evaluated |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is 2-hexyl-4,5-dimethyl-1,3-dioxolane?

2-hexyl-4,5-dimethyl-1,3-dioxolane (CAS Number: 6454-22-4) is a synthetic organic compound classified as a flavoring agent. It belongs to the dioxolane family of chemicals, which are five-membered heterocyclic rings containing two oxygen atoms. The compound's chemical structure includes a hexyl side chain and two methyl substituents on the dioxolane ring, contributing to its distinctive sensory properties.

## Common Uses

This flavoring compound is used in the food industry as a flavoring agent or flavor adjuvant. Flavoring agents of this type are typically employed in small quantities to enhance or create specific taste and aroma profiles in processed foods and beverages. The specific applications may include dairy products, baked goods, confectionery, and other food categories where complex flavor profiles are desired. The actual concentrations used in food products are generally very low, typically measured in parts per million (ppm).

## Safety Assessment

According to FDA records, there have been no reported adverse events associated with 2-hexyl-4,5-dimethyl-1,3-dioxolane, and no food recalls have been attributed to this substance. The absence of adverse event reports and recalls suggests that the compound has not generated safety concerns in the food supply based on available FDA data.

Like many synthetic flavoring compounds, safety evaluation of this additive would typically consider factors such as acute and chronic toxicity, genotoxicity, and potential metabolic effects. Synthetic flavorings are generally used at very low exposure levels, which contributes to their safety profile. However, comprehensive toxicological data on this specific compound may be limited in the public domain.

## Regulatory Status

2-hexyl-4,5-dimethyl-1,3-dioxolane is not listed as Generally Recognized as Safe (GRAS) by the FDA. This means it has not undergone the FDA's formal GRAS determination process. However, the lack of GRAS status does not automatically indicate a safety concern; rather, it reflects the regulatory pathway and approval status for the compound. Some flavoring agents are approved for use through other regulatory mechanisms or prior sanction provisions.

The regulatory classification and approval status of this flavoring agent may vary in different countries and regulatory jurisdictions. Food manufacturers using this ingredient must comply with the specific regulations of the regions where their products are distributed.

## Key Studies

Publicly available peer-reviewed literature specifically focused on 2-hexyl-4,5-dimethyl-1,3-dioxolane appears to be limited. Safety assessments of synthetic flavoring compounds typically follow established toxicological testing protocols and guidelines established by regulatory agencies such as the FDA and EFSA (European Food Safety Authority). These evaluations generally include consideration of the compound's chemical structure, intended use levels, and potential metabolic pathways.

For synthetic flavoring agents, the Flavor and Extract Manufacturers Association (FEMA) maintains the GRAS list of flavoring substances, though this particular compound's inclusion status would need to be verified against current databases. Additional information regarding specific toxicological or safety studies on this compound may be available through direct inquiry with regulatory agencies or manufacturers.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "2-hexyl-4,5-dimethyl-1,3-dioxolane — Safety, regulation, and evidence." https://additivefacts.com/additives/2-hexyl-4-5-dimethyl-1-3-dioxolane. Accessed 2026-05-19.