Our Verdict: RATING UNKNOWN

(+/-)-4-methyl-2-propyl-1,3-oxathiane

CAS1064678-08-5

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

(+/-)-4-methyl-2-propyl-1,3-oxathiane — food additive

(+/-)-4-methyl-2-propyl-1,3-oxathiane is a synthetic flavoring compound used to impart specific taste and aroma characteristics to food products. It belongs to the class of organosulfur flavoring agents and is employed in small quantities to enhance or modify the sensory profile of processed foods.

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 (+/-)-4-methyl-2-propyl-1,3-oxathiane?

(+/-)-4-methyl-2-propyl-1,3-oxathiane is a synthetic organic compound with the CAS number 1064678-08-5. It belongs to the oxathiane family of chemicals, which are heterocyclic compounds containing both oxygen and sulfur atoms in their molecular structure. The compound exists as a racemic mixture, meaning it contains equal proportions of two mirror-image molecular forms (indicated by the (+/-) prefix). This particular compound is classified and used as a flavoring agent in the food industry.

Common Uses

As a flavoring agent, (+/-)-4-methyl-2-propyl-1,3-oxathiane is incorporated into various food and beverage products to provide specific taste and aroma profiles. Its sulfur-containing structure typically contributes savory, meaty, or umami-like sensory notes that appeal to consumers. The compound is used in very small concentrations—measured in parts per million—to achieve desired flavor effects without contributing significant nutritional content. Common applications include processed savory foods, seasonings, meat analogs, and specialty food products where complex flavor development is desired.

Safety Assessment

The safety profile of (+/-)-4-methyl-2-propyl-1,3-oxathiane is characterized by limited but available data. According to FDA records, there have been zero reported adverse events associated with this additive and zero recalls involving its use. This absence of reported safety incidents suggests that the compound, when used at permitted levels, has not generated consumer health concerns that reached regulatory attention.

However, it is important to note that the lack of adverse event reports does not constitute formal FDA approval under the Generally Recognized As Safe (GRAS) designation. The compound has not been formally evaluated and confirmed as GRAS by the FDA, which means it operates in a different regulatory framework than additives with explicit GRAS status. This distinction is important for manufacturers and regulators to understand regarding permitted usage and documentation requirements.

The toxicological profile of oxathiane derivatives generally suggests low acute toxicity, though comprehensive chronic toxicity and long-term safety studies specific to this exact compound may be limited. Food manufacturers using this ingredient are responsible for ensuring appropriate safety documentation and compliance with applicable regulations in their respective markets.

Regulatory Status

In the United States, (+/-)-4-methyl-2-propyl-1,3-oxathiane does not hold official GRAS status from the FDA. This means it cannot be marketed under the standard GRAS exemption. However, it may be permitted for use under FDA regulations if proper pre-market approval has been obtained through alternative pathways, including food additive petitions or compliance with other regulatory frameworks.

The regulatory landscape for this compound may vary internationally. The European Food Safety Authority (EFSA) and other regulatory bodies in different countries may have different classifications, permitted use levels, and documentation requirements. Manufacturers considering use of this flavoring agent must ensure compliance with regulations in all target markets.

Key Studies

Published scientific literature specifically addressing (+/-)-4-methyl-2-propyl-1,3-oxathiane appears limited in the publicly accessible domain. The compound's development and use appear to be relatively specialized within the flavor chemistry industry. Most information regarding its safety and efficacy exists within proprietary technical literature from flavor manufacturers and regulatory submissions.

General research on oxathiane compounds and organosulfur flavoring agents indicates that compounds in this chemical family are typically rapidly metabolized and eliminated from the body due to their volatile nature and chemical reactivity. However, additive-specific safety data would be necessary to make definitive conclusions about this particular compound's metabolic fate and long-term safety profile.

Frequently Asked Questions

What is (+/-)-4-methyl-2-propyl-1,3-oxathiane?

(+/-)-4-methyl-2-propyl-1,3-oxathiane is a synthetic flavoring compound used to impart specific taste and aroma characteristics to food products. It belongs to the class of organosulfur flavoring agents and is employed in small quantities to enhance or modify the sensory profile of processed foods.

Is (+/-)-4-methyl-2-propyl-1,3-oxathiane safe?

(+/-)-4-methyl-2-propyl-1,3-oxathiane 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 (+/-)-4-methyl-2-propyl-1,3-oxathiane banned in any country?

(+/-)-4-methyl-2-propyl-1,3-oxathiane 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.