# 3-oxobutanal, Dimethyl Acetal

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**Safety rating:** UNKNOWN
**CAS number:** 5436-21-5
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

3-oxobutanal, Dimethyl Acetal (CAS 5436-21-5) is an organic compound used as a flavoring agent in food products. It functions to enhance or modify taste and aroma profiles in various food applications.

## 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 3-oxobutanal, Dimethyl Acetal?

3-oxobutanal, Dimethyl Acetal is an organic chemical compound classified as a flavoring agent or flavoring adjuvant. It belongs to the category of synthetic flavor compounds used in the food industry. The compound's chemical structure consists of a dimethyl acetal derived from 3-oxobutanal (acetoacetaldehyde). This structural configuration allows it to contribute specific taste and aromatic characteristics to food formulations.

## Common Uses

As a flavoring agent, 3-oxobutanal, Dimethyl Acetal is used in food manufacturing to impart or enhance flavor profiles. Like many synthetic flavoring compounds, it may be incorporated into various food products including beverages, confectionery, baked goods, and other processed foods where specific flavor notes are desired. The actual prevalence and specific applications of this compound in commercial food products are limited, as more common and well-established flavoring agents dominate the industry.

## Safety Assessment

According to FDA records, there have been zero adverse events reported associated with 3-oxobutanal, Dimethyl Acetal, and zero product recalls linked to this ingredient. This absence of reported incidents suggests no documented safety concerns in the food supply. However, the lack of adverse event reports does not necessarily indicate extensive safety testing or widespread use of the ingredient.

The compound has not been granted Generally Recognized As Safe (GRAS) status by the FDA, which means it has not been formally evaluated and affirmed as safe for its intended use through the GRAS notification process. This designation does not indicate the substance is unsafe; rather, it reflects that formal GRAS review or approval has not been completed.

## Regulatory Status

In the United States, flavoring agents are regulated under FDA authority. Those used in foods must either be listed as GRAS substances, approved as food additives through the Food Additive Petition process, or be subject to established regulations. Since 3-oxobutanal, Dimethyl Acetal does not carry GRAS status, its regulatory pathway and current approval status require verification through FDA's Color and Flavoring databases or direct inquiry.

The European Food Safety Authority (EFSA) maintains separate evaluations of flavoring substances used in European Union member states. Regulatory status may differ between jurisdictions, and manufacturers must comply with applicable regulations in each market where products are sold.

## Key Studies

Scientific literature regarding 3-oxobutanal, Dimethyl Acetal is limited. Published research on this specific compound's toxicology, metabolism, or effects appears minimal in publicly available databases. The lack of extensive published safety data is not uncommon for specialized synthetic flavoring compounds, particularly those with limited commercial application.

Flavor and Extract Manufacturers Association (FEMA) maintains a database of flavor compounds with varying levels of safety assessment. Compounds may undergo expert panel review through FEMA's Safety Assessment Program, which evaluates chemical and toxicological data.

For any flavoring agent, safety assessment typically considers factors including: acute toxicity data, subchronic and chronic toxicity studies, genotoxicity and carcinogenicity potential, reproductive and developmental toxicity, metabolism and kinetics, and dietary exposure estimates. The extent of available data varies considerably among different flavoring compounds.

## 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. "3-oxobutanal, Dimethyl Acetal — Safety, regulation, and evidence." https://additivefacts.com/additives/3-oxobutanal-dimethyl-acetal. Accessed 2026-05-19.