Our Verdict: RATING UNKNOWN

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone

CAS34545-88-5

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

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone — food additive

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone (CAS 34545-88-5) is a synthetic flavoring compound used to impart specific aromatic characteristics to food and beverage products. This naphthalenone derivative 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 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone?

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone is a synthetic organic compound belonging to the naphthalenone chemical family. Identified by CAS Number 34545-88-5, this molecule is a partially hydrogenated naphthalenone derivative with a methyl substituent at the 7-position. It is a colorless to pale yellow liquid or solid used exclusively as a flavoring agent in the food industry.

Common Uses

This compound is employed primarily in the flavor and fragrance industry to create or enhance specific taste and aroma profiles in food and beverage applications. Like other synthetic flavoring compounds, it is used in small quantities to achieve desired sensory characteristics. Common applications may include:

- Beverages (both alcoholic and non-alcoholic)

- Baked goods and confectionery

- Dairy products

- Savory snack foods

- Condiments and sauces

The specific concentration and application would depend on the desired flavor profile and regulatory allowances in different jurisdictions.

Safety Assessment

According to FDA records, there are no reported adverse events associated with 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone, and no product recalls have been issued involving this additive. This absence of documented safety incidents suggests a favorable safety profile based on available evidence.

However, it is important to note that this compound is not on the FDA's Generally Recognized as Safe (GRAS) list. This status does not necessarily indicate a safety concern; rather, it means the additive has not undergone the specific formal GRAS affirmation process or determination. Many flavoring compounds operate under alternative regulatory pathways, such as the Flavor and Extract Manufacturers Association (FEMA) GRAS determination process for flavoring substances.

The absence of GRAS status may reflect that the compound has limited historical use data, specific regulatory pathways in different countries, or that formal GRAS petitions have not been pursued. Different regulatory frameworks worldwide may recognize this substance through alternative mechanisms.

Data on toxicological studies specific to this compound appear limited in publicly available literature. The structural class (naphthalenone derivatives) has been studied in various contexts, but substance-specific safety documentation would be necessary for comprehensive risk assessment.

Regulatory Status

In the United States, 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone is not FDA GRAS-affirmed. However, it may be permitted under FDA regulations for use as a flavoring substance under 21 CFR 182.60 (Synthetic flavoring substances and adjuvants) if it meets specific criteria and has been properly notified through appropriate regulatory channels.

Regulatory status varies by country and region. The European Union, under the SCF (Scientific Committee on Food) and EFSA (European Food Safety Authority) frameworks, maintains its own approved list of flavoring substances. Approval in one jurisdiction does not guarantee approval in another, and manufacturers must comply with local regulations where products are marketed.

Key Studies

Publicly available peer-reviewed literature specifically examining 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone appears limited. Most safety information derives from:

- FDA adverse event monitoring databases (showing zero reported incidents)

- Regulatory submission data maintained by food safety authorities

- Industry safety assessments conducted during product development

- Structure-activity relationship (SAR) data comparing similar naphthalenone compounds

For manufacturers and regulatory agencies seeking detailed toxicological information, substance-specific safety data sheets and studies would be available through industry sources and regulatory files. The chemical's use history, while undocumented in major public health literature, has not generated safety signals sufficient to warrant restriction or warning.

Frequently Asked Questions

What is 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone?

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone (CAS 34545-88-5) is a synthetic flavoring compound used to impart specific aromatic characteristics to food and beverage products. This naphthalenone derivative functions as a flavoring agent or adjuvant in the food industry.

Is 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone safe?

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone 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 7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone banned in any country?

7-methyl-4,4a,5,6-tetrahydro-2(3h)-naphthalenone 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.