Our Verdict: RATING UNKNOWN

11-dodecenoic Acid

CAS65423-25-8

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

11-dodecenoic Acid — food additive

11-dodecenoic acid is a fatty acid derivative used as a flavoring agent in food products. It contributes to the sensory profile of various foods and is chemically classified as an unsaturated fatty acid with a 12-carbon chain.

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 11-dodecenoic Acid?

11-dodecenoic acid, identified by CAS number 65423-25-8, is an unsaturated fatty acid containing 12 carbon atoms with a single double bond at the 11th position. It belongs to the family of aliphatic carboxylic acids and is structurally related to naturally occurring fatty acids found in various plant and animal sources. The compound exists as a colorless to pale yellow liquid at room temperature and is used in the food industry primarily as a flavoring agent or flavoring adjuvant.

Common Uses

As a flavoring agent, 11-dodecenoic acid is utilized in food manufacturing to enhance or modify the sensory characteristics of products. Its applications are typically found in processed foods where flavor complexity or enhancement is desired. The compound may contribute subtle flavor notes derived from its fatty acid chemistry. Due to its classification as a flavoring substance, it is used in relatively small quantities to achieve the desired organoleptic effects. Specific food categories using this ingredient vary by manufacturer and regional formulation practices.

Safety Assessment

11-dodecenoic acid has demonstrated a favorable safety profile based on available data. The FDA has recorded zero adverse events associated with this additive, indicating no reported health complaints or safety incidents in the agency's surveillance systems. Additionally, no product recalls involving 11-dodecenoic acid have been documented by the FDA, suggesting consistent safety in commercial applications.

As a fatty acid derivative, the compound would be expected to have low acute toxicity. The gastrointestinal tract can metabolize fatty acids through normal digestive processes. However, comprehensive long-term toxicity or carcinogenicity studies specific to this compound are not prominently documented in public databases, which is not uncommon for minor food ingredients used in very small quantities.

Regulatory Status

11-dodecenoic acid does not currently hold GRAS (Generally Recognized as Safe) status with the FDA. This designation does not necessarily indicate safety concerns; rather, it reflects that a formal GRAS determination has not been submitted or approved through FDA procedures. The absence of GRAS status may indicate limited commercial use or that manufacturers have not pursued this regulatory pathway. The compound may still be permitted in food products under other regulatory frameworks or through different authorization mechanisms depending on jurisdiction and intended use levels.

In the European Union, regulatory oversight of flavoring substances is governed by EFSA (European Food Safety Authority) evaluations. Flavoring substances must comply with EU regulations regarding purity criteria and safety assessments before approval for use.

Key Studies

Publicly available peer-reviewed research specifically targeting 11-dodecenoic acid's safety or toxicology appears limited in the scientific literature. This is typical for minor food additives used at low concentrations. Broader research on medium-chain and long-chain fatty acids demonstrates that these compounds are generally well-tolerated by human metabolism. The chemical structure of 11-dodecenoic acid suggests it would undergo beta-oxidation, the normal metabolic pathway for fatty acid breakdown in the body.

Data on structurally similar fatty acid derivatives, combined with the absence of adverse events in FDA databases, supports the conclusion that this additive has not generated safety concerns in practical food applications. However, manufacturers and regulatory bodies rely on the principle that food ingredients should be used at levels that represent minimal dietary exposure relative to the total diet.

Frequently Asked Questions

What is 11-dodecenoic Acid?

11-dodecenoic acid is a fatty acid derivative used as a flavoring agent in food products. It contributes to the sensory profile of various foods and is chemically classified as an unsaturated fatty acid with a 12-carbon chain.

Is 11-dodecenoic Acid safe?

11-dodecenoic Acid 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 11-dodecenoic Acid banned in any country?

11-dodecenoic Acid 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.