Our Verdict: RATING UNKNOWN

Hexylamine

CAS111-26-2

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

Hexylamine — food additive

Hexylamine (CAS 111-26-2) is an organic compound used as a flavoring agent or flavor adjuvant in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA and has limited commercial use in food applications.

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 Hexylamine?

Hexylamine is a primary aliphatic amine with the chemical formula C6H15N. It is a colorless to slightly yellow liquid with a characteristic fishy or ammonia-like odor. The compound consists of a six-carbon alkyl chain attached to an amino group. Hexylamine is synthesized through various chemical processes and exists as both a pure chemical substance and in various formulations used across industrial applications.

Common Uses

In the food industry, hexylamine is classified as a flavoring agent or flavor adjuvant. Its primary function would be to contribute to or modify the flavor profile of food products. However, its actual use in commercial food products is extremely limited compared to other approved flavoring agents. The compound is more commonly found in industrial applications, including rubber manufacturing, pesticide production, and pharmaceutical synthesis, rather than in food applications.

The limited adoption of hexylamine in food flavoring is largely due to its regulatory status and the availability of numerous alternative approved flavoring agents that can achieve similar sensory results.

Safety Assessment

Hexylamine has not been designated as GRAS (Generally Recognized as Safe) by the U.S. Food and Drug Administration. This classification means that the FDA has not established a consensus among qualified experts that the substance is safe for its intended use in food at current or proposed levels.

According to FDA records, there are no reported adverse events associated with hexylamine consumption, and no product recalls have been attributed to this substance. This absence of reported incidents suggests either minimal commercial use in food or lack of reported safety concerns from the limited applications where it may be used.

Toxicological data on hexylamine from occupational and industrial exposure studies indicates the compound can be irritating to skin, eyes, and mucous membranes at high concentrations. Animal studies have examined various health endpoints, though comprehensive chronic toxicity data specific to food consumption at low levels remains limited in the public domain.

Regulatory Status

In the United States, hexylamine is not listed on the FDA's GRAS (Generally Recognized as Safe) list for food use. This means products containing hexylamine as an intentional food additive would require specific FDA approval through the food additive petition process before legal use in food could be permitted.

The European Food Safety Authority (EFSA) does not list hexylamine among approved flavoring substances in the EU's flavor regulation framework. This regulatory absence in major markets reflects the compound's limited acceptance for food applications.

Because hexylamine lacks GRAS status in the U.S. and is not approved in other major regulatory jurisdictions, any food manufacturer wishing to use it would need to pursue formal regulatory approval, which explains its near-absence in commercial food products.

Key Studies

Comprehensive peer-reviewed studies specifically evaluating hexylamine's safety as a food additive are limited in the scientific literature. Most toxicological data comes from occupational health research examining workplace exposure to the chemical in industrial settings rather than dietary consumption studies.

Occupational exposure studies have documented the compound's irritant properties and its absorption through various exposure routes. However, the dose levels examined in occupational settings are typically much higher than would occur through food consumption.

The lack of extensive food-specific safety studies, combined with the availability of numerous pre-approved alternative flavoring agents, has likely contributed to hexylamine's non-adoption in the food industry. Manufacturers generally prefer approved substances with established safety records to minimize regulatory and liability risks.

Frequently Asked Questions

What is Hexylamine?

Hexylamine (CAS 111-26-2) is an organic compound used as a flavoring agent or flavor adjuvant in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA and has limited commercial use in food applications.

Is Hexylamine safe?

Hexylamine 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 Hexylamine banned in any country?

Hexylamine 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.