Our Verdict: RATING UNKNOWN

Butyl Oleate Sulfate

CAS38621-44-2

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

Butyl Oleate Sulfate — food additive

Butyl Oleate Sulfate (CAS 38621-44-2) is a surfactant compound with unclear food applications. It is not approved by the FDA as a Generally Recognized as Safe (GRAS) substance and has not been formally evaluated for use in food products.

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 Butyl Oleate Sulfate?

Butyl Oleate Sulfate is a synthetic surfactant compound derived from oleic acid, a naturally occurring fatty acid found in animal and vegetable oils. The compound features a sulfate ester functional group attached to a butyl oleate molecule, which gives it amphiphilic properties—meaning it has both water-loving and fat-loving characteristics. These properties typically make sulfate esters useful as emulsifiers, wetting agents, or dispersants in various industrial and consumer applications.

However, the specific application of Butyl Oleate Sulfate in food products remains unclear in available scientific and regulatory literature. Unlike many food additives with well-defined purposes, this compound's intended food use has not been established through formal regulatory submissions or published research.

Common Uses

While Butyl Oleate Sulfate has not been identified as an approved food additive by the FDA, sulfate esters in general are used in non-food industries as surfactants, emulsifiers, and wetting agents in detergents, cosmetics, and industrial applications. If this particular compound were to be used in food, its oleate and sulfate components might theoretically serve emulsification purposes, though no documented food applications exist in FDA databases or published literature.

The absence of established food uses distinguishes this compound from widely recognized food additives like sodium stearoyl lactylate or other approved emulsifiers.

Safety Assessment

Butyl Oleate Sulfate has not undergone formal FDA safety evaluation for food use. The FDA has received zero adverse event reports and recorded zero recalls associated with this substance, indicating either minimal or no documented use in marketed food products. This lack of adverse reporting does not constitute an affirmative safety determination, as the compound has not been systematically studied for food safety purposes.

The component parts—oleic acid and sulfate esters—have varying safety profiles when used appropriately in non-food contexts. However, the specific safety profile of Butyl Oleate Sulfate for ingestion has not been established through toxicological studies published in peer-reviewed journals or submitted to regulatory agencies.

No data from the European Food Safety Authority (EFSA) or other major regulatory bodies regarding this specific compound's use in food has been identified in available sources.

Regulatory Status

Butyl Oleate Sulfate is **not** listed on the FDA's GRAS (Generally Recognized as Safe) inventory. It does not appear on approved food additive lists in the United States or European Union. Consequently, any use in food products would require formal pre-market approval through a Food Additive Petition process in the United States or novel food authorization in Europe.

The regulatory status indicates this compound either: (1) has not been formally evaluated for food use, (2) has been evaluated and not approved, or (3) is used so minimally that it has not been subject to regulatory scrutiny. Without access to confidential FDA submissions, the specific reason for its non-approval cannot be determined from public databases.

Key Studies

No published peer-reviewed scientific studies specifically examining Butyl Oleate Sulfate's safety, toxicology, or food applications could be identified in major scientific databases. The compound appears in chemical catalogs and industrial supplier listings but lacks the published research foundation typical of approved food additives.

Further toxicological assessment, including acute and chronic toxicity studies, genotoxicity evaluation, and metabolic fate analysis, would be necessary before regulatory consideration for food use. The absence of such published data represents a significant information gap regarding this substance's suitability for food applications.

Frequently Asked Questions

What is Butyl Oleate Sulfate?

Butyl Oleate Sulfate (CAS 38621-44-2) is a surfactant compound with unclear food applications. It is not approved by the FDA as a Generally Recognized as Safe (GRAS) substance and has not been formally evaluated for use in food products.

Is Butyl Oleate Sulfate safe?

Butyl Oleate Sulfate 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 Butyl Oleate Sulfate banned in any country?

Butyl Oleate Sulfate 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.