Our Verdict: RATING UNKNOWN

3-oxododecanoic Acid Glyceride

CAS128362-26-5

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

3-oxododecanoic Acid Glyceride — food additive

3-oxododecanoic Acid Glyceride is a synthetic flavoring agent derived from a 12-carbon fatty acid structure. It is used in food products to provide or enhance specific flavor profiles, though it is not currently recognized as Generally Recognized as Safe (GRAS) by the FDA.

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 3-oxododecanoic Acid Glyceride?

3-oxododecanoic Acid Glyceride (CAS Number: 128362-26-5) is a synthetic organic compound that functions as a flavoring agent in food products. The compound is a glyceride derivative—a type of molecule formed when glycerol combines with fatty acids—based on a 12-carbon chain with a ketone functional group at the third carbon position. This chemical structure allows it to contribute specific aromatic and taste properties to food formulations.

As a synthetic flavoring substance, this additive belongs to a broader category of chemicals engineered to enhance or provide distinct flavor notes in processed foods, beverages, and other food applications.

Common Uses

3-oxododecanoic Acid Glyceride is used as a flavoring agent or flavor adjuvant in food manufacturing. Flavor adjuvants are substances that modify or enhance the perception of flavor in food products without necessarily providing flavor themselves. This compound would typically be used in very small quantities, as is standard practice with most synthetic flavoring agents.

While specific commercial applications for this particular compound are limited in publicly available literature, synthetic flavoring agents in this chemical class are generally employed in:

- Processed snack foods

- Beverages

- Dairy products

- Bakery items

- Confectionery products

The specific flavor profile and applications depend on the compound's organoleptic properties and how manufacturers incorporate it into food formulations.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 3-oxododecanoic Acid Glyceride and zero product recalls linked to this substance. This absence of reported incidents suggests that any exposure through food has not generated safety concerns significant enough to trigger regulatory action or consumer complaints documented by the FDA.

However, the lack of adverse event reports does not necessarily indicate comprehensive safety data. The FDA maintains that additives should undergo appropriate toxicological testing to establish their safety at intended use levels. The compound's non-GRAS status means it has not been formally determined by the FDA to be generally recognized as safe based on either scientific procedures or common use in food before 1958.

Limited published toxicological data is available in scientific literature for this specific compound. Safety assessment would ideally include:

- Acute toxicity studies

- Subchronic and chronic toxicity testing

- Genotoxicity assessment

- Reproductive and developmental toxicity evaluation

- Metabolic fate and absorption studies

Regulatory Status

3-oxododecanoic Acid Glyceride is not listed on the FDA's GRAS (Generally Recognized as Safe) inventory. This designation means the compound has not undergone the formal GRAS determination process, which requires either substantial scientific consensus or a history of safe use in food before 1958.

For use in food products in the United States, this additive would require either:

1. A successful GRAS petition submission and acceptance by the FDA, or

2. FDA approval through the food additive petition process, which involves submission of safety data

The regulatory status in other regions, such as the European Union under EFSA (European Food Safety Authority), may differ. Some synthetic flavoring agents permitted in one jurisdiction may be restricted or require additional documentation in others.

Key Studies

Publicly available peer-reviewed research specifically investigating 3-oxododecanoic Acid Glyceride is extremely limited. Most scientific information about this compound comes from chemical databases, industry formulation records, and regulatory submissions rather than published toxicological literature.

General research on related glyceride-based flavoring compounds and synthetic flavor agents provides context for understanding this category of additives, though compound-specific data would be necessary for comprehensive safety assessment.

Manufacturers or researchers seeking to establish GRAS status or food additive approval for this compound would need to generate or compile appropriate safety data according to FDA guidelines outlined in 21 CFR Part 570 for indirect food additives or relevant sections for direct additives.

Frequently Asked Questions

What is 3-oxododecanoic Acid Glyceride?

3-oxododecanoic Acid Glyceride is a synthetic flavoring agent derived from a 12-carbon fatty acid structure. It is used in food products to provide or enhance specific flavor profiles, though it is not currently recognized as Generally Recognized as Safe (GRAS) by the FDA.

Is 3-oxododecanoic Acid Glyceride safe?

3-oxododecanoic Acid Glyceride 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 3-oxododecanoic Acid Glyceride banned in any country?

3-oxododecanoic Acid Glyceride 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.