Our Verdict: RATING UNKNOWN

3,7-dimethyl-6-octenoic Acid

CAS502-47-6

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

3,7-dimethyl-6-octenoic Acid โ€” food additive

3,7-dimethyl-6-octenoic acid is a naturally occurring organic compound used as a flavoring agent in food products. It is not currently approved by the FDA as Generally Recognized as Safe (GRAS), though it has no reported adverse events or recalls in FDA databases.

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 3,7-dimethyl-6-octenoic Acid?

3,7-dimethyl-6-octenoic acid (CAS Number: 502-47-6) is an organic compound belonging to the class of unsaturated fatty acids. It is a branched-chain carboxylic acid with a characteristic structure that includes a double bond in its carbon backbone. This compound is used primarily in the flavor industry as a flavoring agent or flavor adjuvant. Due to its chemical structure, it may have naturally occurring analogs in certain plant and animal sources, though commercial use typically involves synthesized forms.

Common Uses

As a flavoring agent, 3,7-dimethyl-6-octenoic acid is employed in the formulation of food and beverage products to contribute to overall flavor profiles. Its use falls within the broader category of synthetic flavoring substances. Like other flavoring agents, it is typically used in very small quantities to achieve desired sensory characteristics. The specific flavor notes it contributes and its typical concentration levels in food products are proprietary to manufacturers and may vary based on product type and intended taste profile.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 3,7-dimethyl-6-octenoic acid, and no food recalls have been issued relating to this substance. However, it is important to note that this additive does not have FDA GRAS (Generally Recognized as Safe) status, which means it has not undergone the formal GRAS notification process or been approved as a food additive through the traditional FDA petition pathway.

The absence of reported adverse events in FDA databases does not necessarily indicate comprehensive safety data exists. Rather, it reflects that no safety incidents have been formally documented or reported to the FDA. The lack of GRAS status suggests that either the substance has not been formally evaluated through established safety review processes, or that such evaluation has not been completed and submitted to FDA.

For synthetic flavoring substances, safety evaluations typically consider acute toxicity, potential metabolic pathways, and allergenicity. The molecular structure of 3,7-dimethyl-6-octenoic acidโ€”as an unsaturated branched-chain carboxylic acidโ€”does not immediately suggest obvious structural alerts for toxicity, though comprehensive toxicological data would be necessary for formal safety determination.

Regulatory Status

In the United States, 3,7-dimethyl-6-octenoic acid is not on the FDA's GRAS list, meaning it is not formally recognized as safe for use in food. This distinction is important: the additive may be used in some food products, but it operates without the regulatory clearance that GRAS status provides. Some manufacturers may be using this substance based on its presumed safety or under specific regulatory allowances, but official FDA approval through standard pathways has not been documented.

Regulatory status in other jurisdictions, including the European Union, may differ. The EFSA (European Food Safety Authority) maintains separate evaluations of food additives, and this substance may have different approval status in European markets.

Key Studies

Published peer-reviewed studies specifically evaluating the safety and toxicology of 3,7-dimethyl-6-octenoic acid are limited in public databases. Comprehensive toxicological studies, including acute and subchronic toxicity assessments, would typically be required before formal GRAS determination or FDA approval as a food additive. The absence of published safety data in mainstream scientific literature is notable and suggests that formal safety evaluation may not have been conducted or made publicly available.

Any organization considering use of this substance in food products should conduct appropriate safety assessments or consult existing proprietary safety data that may be available through ingredient suppliers or manufacturers.

Frequently Asked Questions

What is 3,7-dimethyl-6-octenoic Acid?

3,7-dimethyl-6-octenoic acid is a naturally occurring organic compound used as a flavoring agent in food products. It is not currently approved by the FDA as Generally Recognized as Safe (GRAS), though it has no reported adverse events or recalls in FDA databases.

Is 3,7-dimethyl-6-octenoic Acid safe?

3,7-dimethyl-6-octenoic Acid 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 3,7-dimethyl-6-octenoic Acid banned in any country?

3,7-dimethyl-6-octenoic Acid 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.