Our Verdict: RATING UNKNOWN

2-isopropyl-n,2,3-trimethylbutyramide

CAS51115-67-4

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

2-isopropyl-n,2,3-trimethylbutyramide — food additive

2-isopropyl-n,2,3-trimethylbutyramide is a synthetic flavoring compound used to create specific taste and aroma profiles in food products. It functions as a flavoring agent or adjuvant with no reported adverse events or recalls in FDA records.

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 2-isopropyl-n,2,3-trimethylbutyramide?

2-isopropyl-n,2,3-trimethylbutyramide (CAS Number 51115-67-4) is a synthetic organic compound belonging to the amide class of chemicals. It is primarily used in the food industry as a flavoring agent or flavor adjuvant. The compound's structure contains multiple methyl groups and an isopropyl substituent attached to a butyramide backbone, which contributes to its specific sensory properties.

Common Uses

This additive is used in food manufacturing as a flavoring agent intended to enhance or modify the taste and aroma characteristics of various food products. Like other synthetic flavor compounds, it would typically be used in very small quantities to achieve desired sensory effects. The specific flavor profile it imparts and the food categories in which it is applied are determined by food manufacturers based on product development and consumer preference testing. Such compounds are common ingredients in processed foods, beverages, confectionery, and dairy products where precise flavor control is desired.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 2-isopropyl-n,2,3-trimethylbutyramide and zero recalls involving this substance. This absence of reported incidents in post-market surveillance data suggests no identified safety concerns have emerged from its use in the food supply.

It is important to note that this compound does not currently hold GRAS (Generally Recognized as Safe) status with the FDA. GRAS status indicates that a substance has been determined safe for human consumption through either substantial scientific agreement or long history of safe use. The absence of GRAS status does not necessarily indicate a substance is unsafe; rather, it may reflect limited submission of safety data, restricted use authorization, or lack of formal FDA petition. Many food additives are used under FDA authorization without GRAS designation through various regulatory pathways.

The compound's use would be subject to FDA food additive regulations and limitations on quantity and food categories where it may be applied. Food manufacturers using such additives must comply with all applicable regulations regarding identification, safe use levels, and labeling requirements.

Regulatory Status

2-isopropyl-n,2,3-trimethylbutyramide is not listed as a banned or prohibited substance by the FDA. Its regulatory status indicates it may be used as a food additive under specified conditions, though without explicit GRAS designation. The European Food Safety Authority (EFSA) may have separate assessments for flavoring compounds used in EU-regulated products.

Manufacturers seeking to use this substance in food products must ensure compliance with all applicable food additive regulations, including limitations on approved food categories, maximum use levels, and proper labeling. The specific authorization for use would depend on regulatory submissions and approvals in the relevant jurisdictions.

Key Studies

Limited publicly available scientific literature appears to exist specifically focused on this particular compound's safety profile. The absence of adverse event reports and recalls suggests either safe use history or limited widespread application. For food additives without extensive published research, safety determination often relies on structure-activity relationship data, analogous compound testing, and manufacturer-submitted safety dossiers reviewed by regulatory agencies.

Additional information regarding permitted use levels, approved food applications, and detailed safety data would typically be found in FDA additive petitions or regulatory submissions associated with this compound's authorization.

Frequently Asked Questions

What is 2-isopropyl-n,2,3-trimethylbutyramide?

2-isopropyl-n,2,3-trimethylbutyramide is a synthetic flavoring compound used to create specific taste and aroma profiles in food products. It functions as a flavoring agent or adjuvant with no reported adverse events or recalls in FDA records.

Is 2-isopropyl-n,2,3-trimethylbutyramide safe?

2-isopropyl-n,2,3-trimethylbutyramide 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 2-isopropyl-n,2,3-trimethylbutyramide banned in any country?

2-isopropyl-n,2,3-trimethylbutyramide 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.