What is 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1h-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione?
This additive is a complex synthetic organic compound classified as a flavoring agent or flavoring adjuvant. Its chemical structure contains multiple heterocyclic rings, including an imidazolidine core, a pyrazole ring, and an isoxazole moiety. The compound is designed to interact with taste receptors to produce specific flavor sensations in food and beverage products.
Common Uses
As a flavoring agent, this compound is intended for use in food products where it would contribute to overall flavor profiles. Flavoring agents of this type are typically used in small quantities—often measured in parts per million (ppm)—to achieve desired taste characteristics. The specific flavor contribution of this particular compound would depend on its sensory properties and receptor interactions, which are determined during flavor development and sensory evaluation.
Due to its synthetic nature and complex structure, use would be limited to food systems where synthetic flavoring is acceptable and where regulatory approval has been obtained.
Safety Assessment
According to available FDA records, there have been zero reported adverse events associated with this additive and zero recalls. This suggests either limited market use or an absence of safety concerns identified through post-market surveillance.
However, it is important to note that this compound has not received FDA GRAS (Generally Recognized as Safe) status. GRAS designation requires substantial evidence of safety based on common use in food prior to 1958, or through petition submission with toxicological data. The absence of GRAS status indicates this additive does not meet that particular threshold.
The lack of adverse event reports does not necessarily mean extensive safety data exists in the public domain. Safety assessment of novel flavoring compounds typically involves:
- Acute toxicity studies in animal models
- Repeated-dose toxicity studies
- Genotoxicity assessment
- Reproductive and developmental toxicity evaluation
- Metabolism and kinetics studies
- Sensory evaluation and consumer safety margins
Regulatory Status
This compound operates in a regulatory gray area. In the United States, flavoring substances that do not have GRAS status may be used under FDA's flavor regulations if they meet specific conditions, including being used at levels that do not exceed safe exposure limits. The FDA maintains a list of approved flavoring substances, and manufacturers using novel flavorings bear responsibility for ensuring safety through appropriate toxicological assessment.
In the European Union, flavoring substances are regulated under EU Regulation (EC) No 1334/2008. The European Commission maintains a register of approved flavoring substances. This particular compound would need to be evaluated and approved through the EFSA (European Food Safety Authority) if it is to be marketed in EU member states.
The regulatory pathway for this compound would depend on:
- Market jurisdiction (US, EU, or other regions)
- Intended food applications
- Consumption estimates
- Available safety data
Key Studies
Published scientific literature specifically evaluating this compound appears limited in the public domain. Its CAS number (1119831-25-2) and chemical complexity suggest it may be a relatively recent development in flavor chemistry.
For novel flavoring substances, safety assessment typically relies on:
- Structure-activity relationship (SAR) evaluation—comparing the compound to chemically similar substances with established safety profiles
- In vitro toxicity screening
- Computational toxicology predictions
- Animal toxicity studies when warranted
- Human consumption safety margins based on anticipated use levels
Any manufacturer or entity seeking to use this compound commercially would be responsible for generating or obtaining adequate safety data to support its use under applicable regulations.