Our Verdict: RATING UNKNOWN

Diisobutyl Ketone

CAS108-83-8

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

Diisobutyl Ketone — food additive

Diisobutyl ketone is an organic compound used as a flavoring agent or adjuvant in food products. It functions to enhance or modify flavor profiles in various 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 Diisobutyl Ketone?

Diisobutyl ketone (DIBK), also known as 2,6-dimethyl-4-heptanone, is a colorless liquid organic compound with the chemical formula C₁₁H₂₂O. It is classified as a ketone, a category of organic compounds containing a carbonyl group. The compound has a CAS number of 108-83-8 and is primarily used in the food industry as a flavoring agent or flavoring adjuvant.

Common Uses

Diisobutyl ketone is used in food manufacturing as a flavoring agent to enhance or modify taste and aroma characteristics. As a flavoring adjuvant, it may be used to improve the sensory properties of processed foods, beverages, and other food products. The compound is typically used in very small quantities, as is standard practice with flavoring agents in the food industry. Its specific applications depend on the flavor profile desired by food manufacturers.

Safety Assessment

According to FDA records, there have been zero adverse events reported and zero recalls associated with diisobutyl ketone. This absence of reported adverse events suggests that at the exposure levels present in food products, the compound has not been identified as causing health problems in consumers.

The toxicological profile of diisobutyl ketone has been studied, primarily in occupational and industrial contexts where exposure levels may be significantly higher than in food applications. In such settings, the compound is generally considered to have relatively low acute toxicity. The primary route of concern in industrial settings is typically inhalation exposure rather than ingestion through food.

Data on chronic toxicity, carcinogenicity, and reproductive effects remain limited, which is typical for many minor food flavoring agents. The compound is not listed as a known human carcinogen by major health authorities.

Regulatory Status

Diisobutyl ketone is not currently on the FDA's GRAS (Generally Recognized as Safe) list. This designation indicates that the compound has not undergone the formal GRAS affirmation process through the FDA. However, the absence of a GRAS designation does not necessarily indicate the substance is unsafe; rather, it reflects the regulatory pathway and approval status.

The compound's regulatory status may vary by jurisdiction. Food manufacturers using diisobutyl ketone in food products are expected to comply with applicable food safety regulations in their respective markets. In the European Union, flavoring substances are subject to the Flavourings Regulation (EC) No 1334/2008, which maintains lists of approved flavoring substances.

The lack of reported adverse events and recalls in FDA databases suggests that any use of this compound in food products has not generated safety concerns at the regulatory level.

Key Studies

Limited peer-reviewed literature is available specifically addressing diisobutyl ketone in food applications. Most toxicological data comes from industrial hygiene and occupational safety research, where exposure levels are substantially higher than would occur from food consumption.

Occupational health studies indicate that the compound has relatively low acute toxicity via inhalation. Chronic toxicity studies in animal models have been conducted, though results are not extensively published in the mainstream food safety literature.

The absence of established ADI (Acceptable Daily Intake) values through major regulatory bodies like EFSA reflects the limited formal safety evaluation for food use, though this is not uncommon for minor flavoring agents used at very low concentrations.

Frequently Asked Questions

What is Diisobutyl Ketone?

Diisobutyl ketone is an organic compound used as a flavoring agent or adjuvant in food products. It functions to enhance or modify flavor profiles in various food applications.

Is Diisobutyl Ketone safe?

Diisobutyl Ketone 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 Diisobutyl Ketone banned in any country?

Diisobutyl Ketone 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.