Our Verdict: RATING UNKNOWN

4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one

CAS23526-45-6

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-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one — food additive

4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one (CAS 23526-45-6) is a synthetic organic flavoring compound used to impart specific taste and aroma characteristics to food products. This ingredient functions as a flavoring agent 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 4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one?

4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one is a synthetic flavoring compound identified by CAS Number 23526-45-6. This ingredient belongs to the category of flavor additives used in the food industry. As a complex organic molecule with multiple hydroxyl groups and a cyclohexene ring structure, it is designed to provide specific aromatic and taste profiles to food formulations.

The compound's chemical structure suggests it may contribute fruity, floral, or woody notes to food products, though specific flavor characteristics are determined through sensory evaluation by food manufacturers and flavor houses.

Common Uses

This flavoring agent is utilized in the food industry as a flavoring agent or adjuvant. Like other synthetic flavoring compounds, it would typically be used in very small quantities to achieve desired sensory outcomes in food and beverage products. Applications may include:

- Beverages (soft drinks, alcoholic beverages, flavored waters)

- Confectionery and candy

- Baked goods

- Dairy products

- Savory foods and seasonings

The actual prevalence and extent of use in commercial food products is not publicly documented in FDA databases, suggesting it may be used in limited applications or specific food categories.

Safety Assessment

Based on available FDA records, there are no reported adverse events associated with this flavoring compound and no product recalls linked to its use. The absence of adverse event reports does not constitute a safety guarantee, but rather indicates no identified safety concerns have been reported to regulatory authorities during its period of use.

As a synthetic flavoring compound, safety assessment would typically consider:

- Acute toxicity studies in animal models

- Subchronic and chronic toxicity evaluations

- Potential allergenic properties

- Metabolic breakdown and elimination pathways

- Genotoxicity and mutagenicity testing

The specific toxicological data for this compound is not readily available in public databases, which is common for proprietary flavoring ingredients. Manufacturers and flavor suppliers typically conduct or obtain safety studies required for regulatory compliance.

Regulatory Status

This ingredient is NOT approved under the FDA's Generally Recognized as Safe (GRAS) designation. This status is significant: GRAS approval requires substantial scientific evidence demonstrating safe use at intended levels, typically supported by published literature and expert consensus.

The lack of GRAS status does not necessarily indicate the ingredient is unsafe or prohibited from use. Instead, it may indicate:

- The ingredient has not been formally evaluated through the GRAS notification process

- Its use may be subject to other regulatory pathways or restrictions

- It may be approved for use in specific categories or at defined levels

- It may be used in countries with different regulatory frameworks than the United States

Food manufacturers considering use of this ingredient must comply with all applicable FDA regulations and labeling requirements, which typically list it generically as "flavoring" or "natural/artificial flavoring" on product labels rather than by its specific chemical name.

Key Studies

Published scientific literature specifically examining this compound's safety profile is limited in publicly available databases. Most safety data for proprietary flavoring compounds is maintained by ingredient suppliers, contract research organizations, and regulatory agencies rather than being published in peer-reviewed journals.

For any flavoring compound, relevant toxicological endpoints typically evaluated include metabolism, distribution, and clearance in laboratory animal models. The structure of this molecule suggests it may be metabolized similarly to other small organic compounds containing hydroxyl groups.

Additional research, manufacturer safety documentation, and regulatory dossiers may contain more detailed information not readily accessible to the general public. Regulatory agencies including the FDA and the European Food Safety Authority (EFSA) maintain evaluation records that may be requested through official channels.

Frequently Asked Questions

What is 4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one?

4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one (CAS 23526-45-6) is a synthetic organic flavoring compound used to impart specific taste and aroma characteristics to food products. This ingredient functions as a flavoring agent in the food industry.

Is 4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one safe?

4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one 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-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one banned in any country?

4-hydroxy-4-(3-hydroxy-1-butenyl)-3,5,5-trimethyl-2-cyclohexen-1-one 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.