Our Verdict: RATING UNKNOWN

Glyceryl 5-hydroxydodecanoate

CAS26446-32-2

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

Glyceryl 5-hydroxydodecanoate — food additive

Glyceryl 5-hydroxydodecanoate is a synthetic flavoring compound derived from glycerol and a hydroxylated fatty acid. It functions as a flavoring agent or adjuvant in food products, contributing to taste and aroma 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 Glyceryl 5-hydroxydodecanoate?

Glycerol 5-hydroxydodecanoate (CAS Number: 26446-32-2) is a synthetic organic compound classified as a flavoring agent. It is derived from the esterification of glycerol with 5-hydroxydodecanoic acid, a modified fatty acid with 12 carbon atoms and a hydroxyl functional group. This compound belongs to the broader category of fatty acid esters commonly used in food applications to enhance or modify flavor characteristics.

Common Uses

Glycerol 5-hydroxydodecanoate is used as a flavoring agent or flavoring adjuvant in the food industry. Like other synthetic flavor compounds, it may be incorporated into processed foods, beverages, seasonings, and other food products where its specific sensory properties are desired. The specific flavor profile and sensory contribution of this compound make it useful in formulations where subtle or complex taste notes are required. However, detailed information about its prevalence in specific food categories remains limited in public databases.

Safety Assessment

According to FDA records, there have been zero reported adverse events and zero recalls associated with glyceryl 5-hydroxydodecanoate. The compound has not been formally approved under the FDA's Generally Recognized as Safe (GRAS) program, which means it has not undergone the standard GRAS notification review process that establishes a consensus of expert opinion regarding its safety.

The absence of reported adverse events and recalls suggests that the compound has not generated significant safety concerns in its current food applications. However, the lack of GRAS status indicates that formal safety dossiers or peer-reviewed toxicological studies may not have been submitted to the FDA for evaluation, or such evaluations may not be publicly accessible.

As a synthetic ester derived from glycerol and a fatty acid derivative, the compound shares structural similarities with other food-grade fatty acid esters that have established safety profiles. Glycerol is a generally recognized safe compound, and fatty acid esters are widely used in food processing. However, each specific compound warrants individual evaluation.

Regulatory Status

In the United States, glyceryl 5-hydroxydodecanoate is permitted for use as a flavoring agent under FDA regulations, specifically 21 CFR Part 182 and related sections governing flavor ingredients. However, its non-GRAS status means it operates under different regulatory provisions than GRAS-affirmed compounds.

The European Union's approach to flavoring compounds involves the EFSA (European Food Safety Authority) and comprehensive evaluation processes. Status within the EU flavor database should be verified for specific regulatory requirements in European markets.

The compound is not listed among FDA-prohibited or recalled substances, indicating it meets basic regulatory requirements for food use in jurisdictions where it is permitted.

Key Studies

Publicly available peer-reviewed literature specifically addressing the safety or toxicology of glyceryl 5-hydroxydodecanoate appears limited. Most information regarding this compound derives from FDA flavor ingredient databases and regulatory filings rather than published academic research.

For compounds in this class, safety evaluations typically consider absorption, distribution, metabolism, and excretion (ADME) properties. As an ester of glycerol and a fatty acid, metabolic pathways would likely involve hydrolysis to component fatty acids and glycerol, both of which are normal constituents of dietary fat.

Comprehensive toxicological data for this specific compound would be contained in regulatory submissions to the FDA or other authorities, though such detailed information may not be publicly accessible unless specifically disclosed in regulatory documents.

Frequently Asked Questions

What is Glyceryl 5-hydroxydodecanoate?

Glyceryl 5-hydroxydodecanoate is a synthetic flavoring compound derived from glycerol and a hydroxylated fatty acid. It functions as a flavoring agent or adjuvant in food products, contributing to taste and aroma profiles.

Is Glyceryl 5-hydroxydodecanoate safe?

Glyceryl 5-hydroxydodecanoate 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 Glyceryl 5-hydroxydodecanoate banned in any country?

Glyceryl 5-hydroxydodecanoate 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.