Our Verdict: RATING UNKNOWN

1-(3-hydroxy-5-methyl-2-thienyl)ethanone

CAS133860-42-1

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

1-(3-hydroxy-5-methyl-2-thienyl)ethanone — food additive

1-(3-hydroxy-5-methyl-2-thienyl)ethanone is a synthetic flavoring compound with a thiophene ring structure used to create specific taste and aroma profiles in food products. This substance functions as a flavoring agent or adjuvant in the food industry.

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 1-(3-hydroxy-5-methyl-2-thienyl)ethanone?

1-(3-hydroxy-5-methyl-2-thienyl)ethanone (CAS Number: 133860-42-1) is a synthetic organic compound belonging to the thiophene chemical class. The molecule features a five-membered thiophene ring with a hydroxyl group at the 3-position, a methyl group at the 5-position, and an ethanone substituent at the 1-position. This specific structural arrangement contributes to its sensory properties as a flavoring ingredient.

Thiophene-based compounds have been explored in flavor chemistry for their ability to impart subtle, complex taste and aroma characteristics. The hydroxyl functional group in this particular molecule provides additional opportunities for flavor interactions and intensity modulation.

Common Uses

This compound is employed as a flavoring agent or flavoring adjuvant in the food industry. Flavoring adjuvants are substances that enhance, modify, or support primary flavorings without necessarily providing flavor themselves. Such compounds may be used in beverages, confectionery, baked goods, and other processed foods where specific taste profiles are desired.

The specific sensory characteristics of this thiophene derivative would determine its particular applications, though detailed commercial uses remain proprietary to flavor manufacturers. The quantity used in food products would typically be minimal, consistent with standard flavoring industry practices where such compounds are employed at very low concentrations (often parts per million).

Safety Assessment

According to FDA records, there are zero reported adverse events associated with this substance, and no FDA recalls have involved this additive. This absence of safety incidents provides a baseline indication that the substance has not generated acute safety concerns in the food supply.

It is important to note that the absence of adverse event reports does not constitute formal approval or comprehensive safety clearance. Rather, it indicates that no serious health incidents have been formally documented and linked to this additive by the FDA.

The substance has not received GRAS (Generally Recognized As Safe) status from the FDA. GRAS designation typically requires either substantial scientific consensus from qualified experts or an approved food additive petition demonstrating safety through comprehensive toxicological studies. The lack of GRAS status does not necessarily indicate the substance is unsafe; instead, it reflects that formal safety documentation through FDA procedures has not been completed or submitted.

Regulatory Status

This compound operates in a regulatory gray area common to many specialty flavoring ingredients. In the United States, flavoring substances may be used under the assumption of prior sanction or under FDA regulations for food additives, depending on their history and supporting documentation.

The European Union maintains separate regulatory frameworks through EFSA (European Food Safety Authority). Regulatory status varies by jurisdiction, and manufacturers seeking to use this ingredient internationally must comply with the specific requirements of each market.

Flavor manufacturers typically maintain proprietary safety documentation for their ingredients, and regulatory compliance is the responsibility of companies incorporating these substances into food products. Consumers should note that inclusion in commercial products suggests manufacturers have determined compliance with applicable food safety regulations.

Key Studies

Publicly available peer-reviewed literature specifically evaluating this compound's safety profile is limited. The chemical structure suggests potential routes of metabolism similar to other thiophene derivatives, though specific kinetic and dynamic studies would be necessary to characterize absorption, distribution, metabolism, and excretion in humans.

Structure-activity relationship data from related thiophene compounds may provide indirect information about potential biological activity, but direct safety assessment would require dedicated toxicological testing including acute and chronic exposure studies, genotoxicity assessments, and allergenicity evaluation.

Flavor manufacturers typically conduct or commission appropriate safety studies to support regulatory compliance in their target markets, though such studies may not be published in the public scientific literature due to proprietary considerations.

Frequently Asked Questions

What is 1-(3-hydroxy-5-methyl-2-thienyl)ethanone?

1-(3-hydroxy-5-methyl-2-thienyl)ethanone is a synthetic flavoring compound with a thiophene ring structure used to create specific taste and aroma profiles in food products. This substance functions as a flavoring agent or adjuvant in the food industry.

Is 1-(3-hydroxy-5-methyl-2-thienyl)ethanone safe?

1-(3-hydroxy-5-methyl-2-thienyl)ethanone 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 1-(3-hydroxy-5-methyl-2-thienyl)ethanone banned in any country?

1-(3-hydroxy-5-methyl-2-thienyl)ethanone 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.