Our Verdict: RATING UNKNOWN

Propyleneglycol Dioctanoate

CAS7384-98-7

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

Propyleneglycol Dioctanoate — food additive

Propyleneglycol Dioctanoate (CAS 7384-98-7) is a synthetic ester compound used as a flavoring agent and adjuvant in food products. It functions to enhance, modify, or carry flavors in various food and beverage formulations.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Propyleneglycol Dioctanoate?

Propyleneglycol Dioctanoate is a synthetic ester derived from propylene glycol and octanoic acid (caprylic acid). It is a clear, colorless to pale yellow liquid with a mild fatty odor. The compound belongs to the class of polyol esters commonly used in food technology as flavor carriers and solubilizing agents. Its chemical structure allows it to dissolve both hydrophilic and lipophilic flavor compounds, making it useful in complex flavor formulations.

Common Uses

Propyleneglycol Dioctanoate is employed primarily as a flavoring agent and adjuvant in the food industry. It serves multiple functions:

- **Flavor carrier**: Dissolves and stabilizes flavor compounds that would otherwise be poorly soluble

- **Flavor adjuvant**: Enhances or modifies the perception of flavors in finished products

- **Solubilizer**: Helps incorporate hydrophobic flavor oils into aqueous systems

Typical applications include flavored beverages, confectionery, baked goods, and dairy products. The compound allows manufacturers to create more stable and uniform flavor distributions in products where traditional approaches might prove ineffective.

Safety Assessment

Propyleneglycol Dioctanoate has not been established as Generally Recognized As Safe (GRAS) by the FDA. However, the absence of GRAS status does not indicate the substance is unsafe; rather, it indicates that formal GRAS notification or petition has not been submitted or approved through FDA channels.

The FDA adverse events database contains zero reported adverse events associated with this additive. Similarly, no product recalls linked to propyleneglycol dioctanoate have been documented in FDA records. This absence of reported safety incidents, combined with its chemical similarity to propylene glycol (which is widely approved and used) and caprylic acid (a naturally occurring fatty acid), suggests a reasonable safety profile.

The compound's use in food is permitted in some jurisdictions under specific conditions, indicating regulatory bodies have assessed it as acceptable for food applications at approved levels. The European Union's regulatory approach to food additives and the varying approval statuses across different countries suggest that safety evaluations have been conducted, though approval pathways differ internationally.

Regulatory Status

In the United States, propyleneglycol dioctanoate does not have FDA GRAS status, meaning it cannot be used as an additive in foods intended for the U.S. market without specific FDA authorization or a successful GRAS petition. This distinction is important: GRAS status is one pathway to food additive approval, but not the only pathway.

The regulatory status may vary internationally. Some countries' food additive regulations permit its use as a flavoring agent, while others may require additional approvals or documentation. Food manufacturers intending to use this additive must verify compliance with regulations in their target markets.

Under FDA regulations, any food additive not recognized as GRAS or approved through the food additive petition process cannot be legally used in foods sold in the United States. This represents a significant regulatory limitation rather than a safety determination.

Key Studies

Limited published peer-reviewed literature specifically addresses propyleneglycol dioctanoate. Much of the safety assessment for this class of compounds relies on:

- **Chemical analogy**: Safety data on propylene glycol and caprylic acid, both well-established food ingredients

- **Structural similarity**: Comparison to other approved polyol esters used as food additives

- **Toxicology databases**: Reference to general toxicological properties of the ester class

The compound's components (propylene glycol and octanoic acid) have extensive safety histories in food applications, which provides a foundation for assessing the ester derivative. Propylene glycol is approved as a food additive in numerous countries and has been extensively studied. Caprylic acid occurs naturally in coconut oil and other fats, with established safety in food use.

MoreComplete safety assessment would require access to any proprietary studies submitted to regulatory agencies or published toxicological evaluations specific to this ester combination.

Frequently Asked Questions

What is Propyleneglycol Dioctanoate?

Propyleneglycol Dioctanoate (CAS 7384-98-7) is a synthetic ester compound used as a flavoring agent and adjuvant in food products. It functions to enhance, modify, or carry flavors in various food and beverage formulations.

Is Propyleneglycol Dioctanoate safe?

Propyleneglycol Dioctanoate 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 Propyleneglycol Dioctanoate banned in any country?

Propyleneglycol Dioctanoate 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.