What is 2(4)-isopropyl-4(2),6-dimethyldihydro-4h-1,3,5-dithiazine?
2(4)-isopropyl-4(2),6-dimethyldihydro-4h-1,3,5-dithiazine (CAS Number: 977161-99-1) is a synthetic organic compound belonging to the dithiazine chemical class. The molecule contains a six-membered heterocyclic ring with two sulfur atoms and four carbon atoms, with isopropyl and dimethyl substituents. This structural composition gives it potential flavor and aroma properties that may be useful in food applications.
Common Uses
This additive is classified as a flavoring agent or flavor adjuvant, indicating its intended purpose is to provide or enhance taste and aroma characteristics in food products. However, due to its non-GRAS status in the United States, its commercial application in food is extremely limited. When flavoring agents are used in foods, they are typically present in very small quantities—often measured in parts per million (ppm)—to achieve desired sensory effects. The specific flavor profile associated with this compound has not been widely documented in publicly available food safety literature.
Safety Assessment
As of the latest available data, there have been zero adverse events reported to the FDA related to this additive, and no recalls have been issued. However, the absence of reported adverse events does not automatically indicate safety approval, as this compound may simply have minimal to no use history in the commercial food supply in regulated markets.
The compound's safety profile remains largely undocumented in peer-reviewed literature accessible to regulatory agencies. Toxicological studies, including acute and chronic toxicity assessments, subchronic studies, and genotoxicity evaluations, would typically be required to establish a comprehensive safety database for food use approval. The presence of sulfur in the molecular structure is not inherently concerning, as sulfur-containing compounds are found naturally in foods (such as garlic and onions) and are used in various approved food additives.
Regulatory Status
In the United States, this substance has not been granted GRAS status by the FDA. GRAS determination requires either a history of safe use in food before 1958 (prior sanctioned use) or submission of a GRAS notice with supporting scientific data demonstrating safety at intended levels of use. The lack of GRAS status means it cannot be legally used as a direct food additive in the U.S. without prior FDA approval through the food additive petition process.
Regulatory status in other jurisdictions (European Union, Canada, Japan, etc.) is not currently documented in this profile. Different regulatory bodies maintain separate approval lists for flavoring substances, and approval in one region does not automatically translate to approval elsewhere.
Key Studies
Publicly available peer-reviewed toxicological or safety studies specifically evaluating this compound in food applications are not readily documented in major scientific databases. This is consistent with its non-GRAS classification and apparent limited commercial history. Any future regulatory approval would likely require submission of safety data to the FDA or relevant regulatory authority, including:
- Acute oral toxicity studies
- 28-day oral toxicity studies (short-term)
- 90-day subchronic oral toxicity studies
- Genotoxicity assessment
- Metabolism and kinetic data
- Intended use levels and dietary exposure analysis
Manufacturers or petitioners seeking approval would need to demonstrate that the additive is safe at proposed use levels based on contemporary toxicological standards.