Our Verdict: RATING UNKNOWN

P-tolyl Octanoate

CAS59558-23-5

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

P-tolyl Octanoate โ€” food additive

P-tolyl octanoate (CAS 59558-23-5) is an organic ester compound used as a flavoring agent in food products. It functions to provide or enhance flavors in various food applications where its aroma and taste properties are desired.

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 P-tolyl Octanoate?

P-tolyl octanoate is an organic ester compound composed of p-cresol (4-methylphenol) and octanoic acid. This synthetic flavoring ingredient belongs to the family of aromatic esters, which are commonly used in the food industry to impart specific flavor and aroma characteristics to food and beverage products. The compound has the CAS registry number 59558-23-5, which uniquely identifies it in chemical databases.

Common Uses

P-tolyl octanoate functions primarily as a flavoring agent or flavor adjuvant in food manufacturing. Like other ester-based flavorings, it is used in relatively small quantities to provide or enhance specific taste and aroma profiles in finished food products. The compound's organoleptic properties make it useful in applications where fruity, woody, or other characteristic notes are desired. Typical applications may include beverages, confectionery, baked goods, and other processed food categories, though specific commercial uses would depend on regulatory approvals in individual jurisdictions.

Safety Assessment

According to the FDA's adverse event reporting system, there have been zero reported adverse events associated with P-tolyl octanoate. Additionally, the FDA database shows zero recalls involving this substance. These data suggest no documented safety concerns have been identified through post-market surveillance in the United States.

However, it is important to note that the absence of reported adverse events does not necessarily indicate comprehensive toxicological evaluation. The compound has not received a Generally Recognized as Safe (GRAS) determination from the FDA, which means it has not undergone the formal GRAS review process that some food additives pursue. GRAS status requires either extensive history of safe use or submission of a GRAS notice with supporting scientific data demonstrating safety at intended levels of use.

The safety profile of food-grade esters generally is well-established, as this class of compounds is widely used in flavoring applications across the food industry. P-tolyl octanoate, as an ester, would be expected to follow typical metabolic pathways for similar compounds, though specific pharmacokinetic data for this particular substance may be limited in publicly available literature.

Regulatory Status

P-tolyl octanoate does not have FDA GRAS status. Its regulatory status in the United States is not explicitly listed as approved or prohibited for food use in the CFR (Code of Federal Regulations). This classification means it operates in a regulatory gray areaโ€”it is not affirmatively approved for food use through the GRAS process or food additive petition route, but neither is it prohibited.

In the European Union, this ingredient may be subject to different regulatory frameworks. The EFSA (European Food Safety Authority) maintains separate lists of approved food additives, and approval status may differ from FDA determinations.

For manufacturers wishing to use P-tolyl octanoate legally in food products, jurisdiction-specific regulatory requirements should be carefully reviewed. The lack of GRAS status means some manufacturers may pursue formal food additive petitions or GRAS notices to establish a clear legal pathway for its use.

Key Studies

Publicly available peer-reviewed studies specifically focused on P-tolyl octanoate appear limited. Broader research on structurally similar esters used in flavor applications demonstrates that these compounds are typically metabolized rapidly through standard ester hydrolysis pathways. General toxicological data on related octanoate esters and p-cresol derivatives would be relevant to understanding the potential safety profile of this substance.

The absence of specific toxicological studies in the public domain, combined with zero FDA adverse event reports, suggests either limited use volume or good safety margins at typical use levels. Manufacturers considering use of this ingredient in food products may wish to review any proprietary safety data or consult with regulatory specialists familiar with flavor additive submissions.

Frequently Asked Questions

What is P-tolyl Octanoate?

P-tolyl octanoate (CAS 59558-23-5) is an organic ester compound used as a flavoring agent in food products. It functions to provide or enhance flavors in various food applications where its aroma and taste properties are desired.

Is P-tolyl Octanoate safe?

P-tolyl Octanoate 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 P-tolyl Octanoate banned in any country?

P-tolyl Octanoate 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.