Our Verdict: RATING UNKNOWN

Dodecyl Butyrate

CAS3724-61-6

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Dodecyl Butyrate — food additive

Dodecyl butyrate is a synthetic ester compound used as a flavoring agent in food products. It imparts fruity, waxy, or buttery sensory characteristics and is employed in small quantities to enhance food flavor profiles.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Dodecyl Butyrate?

Dodecyl butyrate (CAS Number 3724-61-6) is a synthetic ester formed from the combination of butyric acid and dodecanol. It belongs to the class of organic compounds known as esters, which are commonly used in the flavor and fragrance industry. The compound is a colorless to pale yellow liquid with characteristic fruity and waxy aromatic properties. Its molecular structure makes it useful for creating complex flavor notes in various food and beverage applications.

Common Uses

Dodecyl butyrate functions as a flavoring agent in the food industry, primarily used to provide fruity, buttery, or waxy flavor notes to processed foods and beverages. It may be used in products such as confectionery, baked goods, beverages, dairy products, and other processed food items where flavor enhancement is desired. The compound is typically used in very small concentrations—measured in parts per million (ppm)—to achieve the desired sensory effect without overwhelming other flavor components. Like many synthetic flavoring agents, it allows manufacturers to create consistent, reproducible flavor profiles across batches.

Safety Assessment

Dodecyl butyrate has not been formally designated as Generally Recognized As Safe (GRAS) by the FDA. However, there are no reported adverse events associated with this additive in FDA databases, and no recalls have been issued related to its use. The absence of documented safety concerns, combined with its use in minimal quantities, suggests a relatively low hazard profile. Ester compounds in general are widely used in food flavoring and are generally recognized as having low toxicity when used at appropriate levels. The compound's safety would be supported by its chemical structure similarity to other approved food flavoring esters and its limited exposure through typical food consumption patterns.

Regulatory Status

Dodecyl butyrate's regulatory status varies internationally. While not having explicit GRAS approval from the FDA, its use in food flavorings may be permitted under the FDA's regulations for synthetic flavoring substances if manufacturers follow proper notification procedures or if it is used in compliance with existing flavor regulations. In the European Union, similar ester-based flavoring compounds are evaluated and approved through the European Food Safety Authority (EFSA) processes. The compound's use would typically be restricted to specific applications and maximum use levels established through safety assessments. Manufacturers using dodecyl butyrate must ensure compliance with regulations in their specific jurisdictions and follow established maximum use levels.

Key Studies

While dodecyl butyrate itself has not been the subject of extensive published toxicological research in readily available scientific literature, the safety profile of structurally similar ester flavorings has been well-documented. General ester compounds used in flavoring have been evaluated for acute toxicity, and most demonstrate low toxicity profiles in animal models. The chemical structure and metabolism patterns of dodecyl butyrate would be expected to follow similar pathways to other butyrate esters, which are readily metabolized and excreted. The lack of documented adverse events in FDA databases over years of potential use provides additional support for its safety at typical use levels in food applications. Any formal safety assessment would likely evaluate standard toxicological endpoints including acute toxicity, repeated-dose toxicity, and genotoxicity potential.

Frequently Asked Questions

What is Dodecyl Butyrate?

Dodecyl butyrate is a synthetic ester compound used as a flavoring agent in food products. It imparts fruity, waxy, or buttery sensory characteristics and is employed in small quantities to enhance food flavor profiles.

Is Dodecyl Butyrate safe?

Dodecyl Butyrate is currently rated "unknown" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Dodecyl Butyrate banned in any country?

Dodecyl Butyrate is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.