Our Verdict: RATING UNKNOWN

(+/-)-4-ethyloctanal

CAS58475-04-0

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

(+/-)-4-ethyloctanal — food additive

(+/-)-4-ethyloctanal is a synthetic flavoring compound used to impart fruity and fatty notes in food products. It is not currently FDA GRAS-listed but has been used in flavoring applications with no reported adverse events or recalls.

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 (+/-)-4-ethyloctanal?

(+/-)-4-ethyloctanal, identified by CAS Number 58475-04-0, is a synthetic organic compound belonging to the aldehyde chemical class. The compound consists of an eight-carbon chain with an ethyl substituent at the fourth position and an aldehyde functional group. The (+/-) designation indicates it exists as a racemic mixture, meaning it contains equal proportions of both left-handed and right-handed molecular forms. This compound is colorless to pale yellow and is used primarily in the flavor and fragrance industry.

Common Uses

(+/-)-4-ethyloctanal is employed as a flavoring agent or flavoring adjuvant in various food and beverage applications. Its sensory profile typically contributes fruity, fatty, and slightly mushroom-like notes to formulations. It is found in compositions designed for beverages, dairy products, baked goods, and confectionery items. Like many synthetic flavor compounds, it is used in very small quantities—typically parts per million—to achieve desired sensory characteristics without significantly impacting nutritional composition.

Safety Assessment

The safety profile of (+/-)-4-ethyloctanal is characterized by an absence of reported adverse events in the FDA database and zero associated recalls. This lack of reported incidents suggests a reasonable margin of safety in its current applications at typical use levels. However, comprehensive toxicological data on this specific compound appears limited in publicly available scientific literature.

The compound's safety would be governed by general principles applied to synthetic flavoring agents, which typically undergo assessment for acute toxicity, chronic effects, and potential allergenicity. Aldehyde-class compounds generally demonstrate low acute toxicity when ingested, though individual compounds within this class can vary in their toxicological profiles.

As with all flavor compounds, safety depends significantly on use level. Food flavoring agents are typically added at concentrations far below those that would produce toxic effects based on animal studies. The lack of adverse events or recalls associated with this ingredient suggests it has been used responsibly within appropriate concentration ranges.

Regulatory Status

(+/-)-4-ethyloctanal has not been designated as Generally Recognized as Safe (GRAS) by the FDA. This means the compound does not benefit from the regulatory status that allows some flavoring agents to be used without pre-market approval, provided they meet specific GRAS conditions.

Despite lacking GRAS status, the ingredient may still be used under FDA regulations if it complies with the Food and Drug Administration's regulations for food additives. It may also be subject to self-affirmed GRAS status if a manufacturer or supplier has conducted an appropriate safety assessment and maintains documentation supporting its safe use.

The European Commission's Flavor Regulation system (1334/2008) provides another regulatory framework that may apply to this compound depending on its production and use location.

Key Studies

Publicly available peer-reviewed studies specifically examining (+/-)-4-ethyloctanal appear limited. Most information regarding this compound derives from flavor industry databases, chemical suppliers' specifications, and regulatory submissions rather than independent published research.

To understand the safety of this compound more thoroughly, relevant considerations include data on structurally similar aldehydes, general toxicology principles for this chemical class, and industry-standard flavor safety assessment methodologies. Organizations such as the Flavor and Extract Manufacturers Association (FEMA) have historically evaluated similar compounds through their Expert Panel process.

Any manufacturer or distributor using this ingredient would typically have access to safety data sheets and technical documentation outlining its properties, stability, and appropriate handling procedures. The continued absence of adverse event reports despite apparent use in commercial applications suggests adequate safety margins at current consumption levels.

Frequently Asked Questions

What is (+/-)-4-ethyloctanal?

(+/-)-4-ethyloctanal is a synthetic flavoring compound used to impart fruity and fatty notes in food products. It is not currently FDA GRAS-listed but has been used in flavoring applications with no reported adverse events or recalls.

Is (+/-)-4-ethyloctanal safe?

(+/-)-4-ethyloctanal 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 (+/-)-4-ethyloctanal banned in any country?

(+/-)-4-ethyloctanal 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.