Our Verdict: RATING UNKNOWN

4-(p-tolyl)-2-butanone

CAS7774-79-0

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-(p-tolyl)-2-butanone — food additive

4-(p-tolyl)-2-butanone (CAS 7774-79-0) is an organic compound used as a flavoring agent in food products. It is not currently recognized as Generally Recognized as Safe (GRAS) by the FDA and has limited regulatory approval for food use.

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 4-(p-tolyl)-2-butanone?

4-(p-tolyl)-2-butanone is an organic ketone compound with the molecular formula C₁₁H₁₄O. It is also known by its systematic name 4-(4-methylphenyl)-2-butanone. The compound contains a tolyl group (derived from toluene) attached to a butanone backbone, giving it specific aromatic characteristics relevant to its application in flavoring.

Common Uses

This compound is used as a flavoring agent in the food industry, typically in applications requiring aromatic or fruity flavor profiles. Like many synthetic flavoring compounds, it would be employed in relatively small quantities to achieve desired sensory characteristics in beverages, confectionery, baked goods, and other processed food products. The specific organoleptic properties of this compound make it suitable for particular flavor formulations in commercial food manufacturing.

Safety Assessment

As of the available data, there have been zero adverse events reported to the FDA associated with this additive, and no recalls have been issued. However, the absence of reported adverse events does not indicate widespread approval or extensive safety assessment. The lack of FDA GRAS status indicates that the compound has not undergone the rigorous safety review process required for that designation.

Limited toxicological data appears to be available in published scientific literature regarding this specific compound's safety profile. Most flavoring agents undergo assessment through in vitro and in vivo studies to evaluate potential toxicity, metabolic fate, and potential for bioaccumulation. However, detailed information about such studies for this particular compound is not readily available in public databases.

The chemical structure suggests it would undergo typical metabolic pathways for similar aromatic ketone compounds, though specific metabolism studies would be necessary to confirm this. As with all food additives, any safety assessment would need to consider factors such as typical consumption levels, cumulative exposure, and potential interactions with other dietary components.

Regulatory Status

4-(p-tolyl)-2-butanone is not listed as GRAS by the FDA, which represents a significant regulatory limitation in the United States market. This means it cannot be used in food products without specific regulatory approval through the food additive petition process or other authorized pathways. Different regulatory jurisdictions may have varying approval statuses; for example, the European Food Safety Authority (EFSA) and other international food safety bodies may have different classifications.

The compound's regulatory status may limit its use primarily to markets or applications where it has received specific approval. Food manufacturers seeking to use this additive would need to ensure compliance with regulations in their target markets and potentially obtain regulatory clearance before commercial use.

Key Studies

Published scientific literature specific to the safety or organoleptic properties of 4-(p-tolyl)-2-butanone is limited. Most safety assessments of flavoring compounds follow standardized testing protocols established by organizations such as the Flavor and Extract Manufacturers Association (FEMA) and evaluated through their Expert Panel process.

The absence of significant published research on this compound, combined with its lack of GRAS status, suggests that comprehensive safety data may not be publicly available or that the compound has not been extensively studied within regulatory frameworks. Any organization considering use of this compound would likely need to commission additional safety studies or review existing proprietary data to support regulatory submissions.

Frequently Asked Questions

What is 4-(p-tolyl)-2-butanone?

4-(p-tolyl)-2-butanone (CAS 7774-79-0) is an organic compound used as a flavoring agent in food products. It is not currently recognized as Generally Recognized as Safe (GRAS) by the FDA and has limited regulatory approval for food use.

Is 4-(p-tolyl)-2-butanone safe?

4-(p-tolyl)-2-butanone 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-(p-tolyl)-2-butanone banned in any country?

4-(p-tolyl)-2-butanone 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.