Our Verdict: RATING UNKNOWN

Diethyl Sebacate

CAS110-40-7

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

Diethyl Sebacate โ€” food additive

Diethyl sebacate (CAS 110-40-7) is an ester compound used as a flavoring agent and adjuvant in food products. It is not currently approved as a Generally Recognized as Safe (GRAS) ingredient by the FDA, though it has no reported adverse events or recalls in the FDA database.

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 Diethyl Sebacate?

Diethyl sebacate is an organic ester compound formed from sebacic acid (a ten-carbon dicarboxylic acid) and ethanol. Its chemical formula is Cโ‚โ‚„Hโ‚‚โ‚†Oโ‚„, with CAS number 110-40-7. As an ester, it combines the properties of both its parent compounds and is classified as a flavoring agent or flavoring adjuvant in food applications. The compound exists as a colorless to pale yellow oily liquid at room temperature.

Common Uses

Diethyl sebacate is employed in the food industry primarily as a flavoring agent and flavoring adjuvant. Adjuvant flavoring compounds are used in very small quantities to enhance, modify, or round out the flavor profiles of foods and beverages. The compound is particularly valued in applications where its ester properties contribute to sensory characteristics. While specific commercial food products using this ingredient are limited in published literature, its classification indicates potential use in flavored foods, beverages, and food flavorings where minute quantities would provide functional benefit.

Safety Assessment

According to FDA records, diethyl sebacate has zero reported adverse events and zero recalls associated with its use in food. This absence of negative safety reports suggests a favorable safety profile in practical food applications. However, the lack of GRAS status indicates that comprehensive safety dossiers meeting FDA's stringent approval criteria have not been formally submitted or accepted.

Limited toxicological data is publicly available for this specific compound. Similar esters of sebacic acid and short-chain alcohols have generally demonstrated low toxicity in animal studies, with primary concerns typically related to gastrointestinal effects at high dosesโ€”conditions unlikely to occur from food additive exposure. The compound's chemical structure, as an ester of a naturally-occurring fatty acid and ethanol, suggests a relatively low inherent hazard profile.

Dermal and inhalation exposure during manufacturing would be the primary occupational health concern rather than dietary exposure. For consumers, the flavoring adjuvant application would involve extremely small quantities, further reducing potential exposure risk.

Regulatory Status

Diethyl sebacate is not currently on the FDA's GRAS list, meaning it has not been formally recognized as safe for its intended use in the United States. Despite this non-GRAS status, the compound has not been prohibited or banned by the FDA. The lack of GRAS designation may reflect limited commercial use, minimal regulatory attention, or simply the absence of a formal safety petition rather than identified safety concerns.

International regulatory status varies. Some countries may permit this compound under different regulatory frameworks or general provisions for flavoring agents. The European Food Safety Authority (EFSA) maintains its own approved flavoring substances list, and diethyl sebacate's status would need to be verified through their specific databases.

Manufacturers seeking to use diethyl sebacate in food products would typically need to either secure GRAS status through a formal petition process or operate under applicable exemptions in their respective jurisdictions.

Key Studies

Published scientific literature specifically addressing diethyl sebacate's safety or efficacy in food applications is limited. Most available information derives from its use in industrial applications (plasticizers, cosmetics) rather than food use. The absence of peer-reviewed food safety studies may contribute to the lack of GRAS status.

General toxicology research on sebacate esters indicates that these compounds are typically metabolized readily and excreted, with low bioaccumulation potential. The chemical structure suggests it would undergo hydrolysis to sebacic acid and ethanol, both of which are naturally encountered compounds.

Frequently Asked Questions

What is Diethyl Sebacate?

Diethyl sebacate (CAS 110-40-7) is an ester compound used as a flavoring agent and adjuvant in food products. It is not currently approved as a Generally Recognized as Safe (GRAS) ingredient by the FDA, though it has no reported adverse events or recalls in the FDA database.

Is Diethyl Sebacate safe?

Diethyl Sebacate 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 Diethyl Sebacate banned in any country?

Diethyl Sebacate 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.