Our Verdict: RATING UNKNOWN

O-tolyl Acetate

CAS533-18-6

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

O-tolyl Acetate — food additive

O-tolyl acetate (CAS 533-18-6) is an organic compound used as a flavoring agent in food products. It functions as a flavoring adjuvant to impart or enhance taste and aroma characteristics 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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 O-tolyl Acetate?

O-tolyl acetate, also known as 2-methylphenyl acetate, is an organic ester compound with the molecular formula C9H10O2. It is a synthetic flavoring substance classified as a flavoring agent or adjuvant. The compound consists of a methyl-substituted phenol (o-cresol) esterified with acetic acid. O-tolyl acetate is a volatile organic compound with characteristic aromatic properties that make it useful in flavoring applications.

Common Uses

O-tolyl acetate is used primarily in the food industry as a flavoring agent and flavoring adjuvant. Its aromatic properties allow it to contribute to the sensory profile of foods by enhancing or modifying flavor and aroma characteristics. The compound may be used in various food categories where subtle aromatic notes are desired. As with many synthetic flavoring compounds, it is typically used in small quantities to achieve the desired flavor effect. The specific applications and maximum use levels would be determined by individual food manufacturers based on intended flavor profiles and regulatory allowances in their respective jurisdictions.

Safety Assessment

O-tolyl acetate has not been formally evaluated and approved by the FDA as a Generally Recognized As Safe (GRAS) substance. However, the absence of an FDA GRAS designation does not necessarily indicate safety concerns. According to FDA records, there have been zero reported adverse events associated with O-tolyl acetate and zero product recalls linked to this ingredient. This lack of reported safety incidents suggests that any exposures that may have occurred have not resulted in identified health problems at the population level.

The compound is a synthetic substance, and like many flavor compounds used in food, its safety profile is based on chemical properties, structural analysis, and available toxicological data. Many synthetic flavoring agents undergo safety assessment through expert panels, such as the Flavor and Extract Manufacturers' Association (FEMA) Expert Panel, which evaluates flavoring substances under a GRAS framework separate from FDA formal approval. The structural similarity of O-tolyl acetate to other approved acetate esters and phenolic compounds provides some basis for understanding its potential safety characteristics.

Regulatory Status

O-tolyl acetate does not hold FDA GRAS status, which means it cannot be added to food products in the United States under the GRAS exemption from food additive regulations. If used in food products marketed in the U.S., it would require formal food additive approval or be marketed under other applicable regulatory frameworks. The regulatory status may vary in other countries; some international jurisdictions may permit its use under different regulatory pathways.

Manufacturers seeking to use O-tolyl acetate in food products would need to comply with applicable regulations in their target markets. In the European Union, flavor substances must be evaluated and listed in the EU flavoring regulations to be legally used. The specific regulatory requirements depend on the intended market and applicable food safety laws.

Key Studies

Published scientific literature on O-tolyl acetate specifically is limited in public databases. Most safety information regarding similar acetate esters and o-cresol derivatives comes from broader toxicological studies of related compounds. The lack of reported adverse events in FDA databases and absence of recalls suggests that if O-tolyl acetate has been used in food applications, it has not generated documented safety concerns under typical use conditions.

For manufacturers or regulatory agencies seeking additional safety data, toxicological studies would typically examine acute toxicity, subchronic or chronic toxicity, genotoxicity, and reproductive/developmental effects. Such evaluations would be conducted according to established guidelines for food additive safety assessment.

Frequently Asked Questions

What is O-tolyl Acetate?

O-tolyl acetate (CAS 533-18-6) is an organic compound used as a flavoring agent in food products. It functions as a flavoring adjuvant to impart or enhance taste and aroma characteristics in various food applications.

Is O-tolyl Acetate safe?

O-tolyl Acetate 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 O-tolyl Acetate banned in any country?

O-tolyl Acetate 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.