Our Verdict: RATING UNKNOWN

2-keto-4-butanethiol

CAS34619-12-0

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

2-keto-4-butanethiol — food additive

2-keto-4-butanethiol is a sulfur-containing organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS (Generally Recognized As Safe) substance by the FDA but has not been associated with documented 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 2-keto-4-butanethiol?

2-keto-4-butanethiol (CAS Number: 34619-12-0) is a synthetic organic chemical belonging to the class of sulfur-containing flavor compounds. It is characterized by the presence of both a ketone functional group (2-keto) and a thiol group (-SH), which is a reactive sulfur compound. The molecular formula indicates a four-carbon chain structure with these functional groups positioned along the backbone. This compound is manufactured through synthetic chemical processes rather than derived from natural sources.

Common Uses

This compound functions as a flavoring agent or flavoring adjuvant in food applications. Flavoring agents in this chemical class are typically used to impart specific taste and aroma characteristics to food and beverage products. Sulfur-containing compounds like 2-keto-4-butanethiol are often employed to create savory, meaty, or complex flavor profiles in processed foods. The specific applications may include seasonings, processed meat products, soups, sauces, and other savory food formulations where such flavor notes are desired.

Safety Assessment

As of the available regulatory data, there have been zero documented adverse events reported to the FDA associated with 2-keto-4-butanethiol, and no product recalls have been issued. This suggests that any food products containing this additive have not generated consumer safety complaints or regulatory concerns serious enough to warrant enforcement action. However, the absence of adverse event reports does not automatically indicate comprehensive safety testing or approval. The lack of GRAS status means this compound has not undergone the formal FDA review process that would establish it as generally recognized as safe by qualified experts based on scientific procedures.

Regulatory Status

2-keto-4-butanethiol is not listed on the FDA's GRAS inventory, meaning it does not have the regulatory status that would allow unrestricted use in food products in the United States without further approval or notification. The FDA maintains a GRAS notification program through which manufacturers can petition for approval of new food additives. Without GRAS status, use of this compound in food would typically require approval through the FDA's food additive petition process (FAP), which involves submission of safety data and toxicological studies for agency review.

International regulatory frameworks may treat this compound differently. The European Food Safety Authority (EFSA) and other regulatory bodies maintain their own lists of approved food flavorings with different approval processes and standards. The regulatory status in individual countries should be verified before any commercial food application.

Key Studies

Publicly available scientific literature on 2-keto-4-butanethiol appears limited. Most of the information regarding this compound is contained within proprietary flavor company databases and regulatory submission records. The chemical's properties, including its sensory characteristics and intended flavor applications, are typically documented in industry technical literature rather than peer-reviewed publications. Comprehensive toxicological studies, including acute toxicity, subchronic toxicity, and potential genotoxicity assessments, would be necessary components of any FDA food additive petition. The absence of GRAS status suggests such comprehensive testing and submission may not yet have been completed, or the petition process may still be ongoing. For current researchers or manufacturers interested in this compound's safety profile, direct consultation with the FDA or review of specific food additive petition documents (if filed) would be necessary to access detailed study results.

Frequently Asked Questions

What is 2-keto-4-butanethiol?

2-keto-4-butanethiol is a sulfur-containing organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS (Generally Recognized As Safe) substance by the FDA but has not been associated with documented adverse events or recalls.

Is 2-keto-4-butanethiol safe?

2-keto-4-butanethiol 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 2-keto-4-butanethiol banned in any country?

2-keto-4-butanethiol 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.