Our Verdict: AVOID

Ethylene Glycol Monoethyl Ether

CAS110-80-5

Significant regulatory concerns

This additive is banned, restricted, or under active review in one or more major jurisdictions. The data below explains what we know.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Ethylene Glycol Monoethyl Ether — food additive

Ethylene Glycol Monoethyl Ether, also known as 2-ethoxyethanol or EGMEE, is an organic chemical primarily recognized as a solvent. While it possesses properties that could classify it as a formulation aid or vehicle, it is not approved for direct use as a food additive. Its principal applications are found in industrial sectors, notably in paints, coatings, and cleaning 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 Ethylene Glycol Monoethyl Ether?

Ethylene Glycol Monoethyl Ether (EGMEE), chemically known as 2-ethoxyethanol (CAS: 110-80-5), is a clear, colorless liquid with a faint, characteristic odor. It belongs to the class of glycol ethers, which are solvents characterized by both an ether and an alcohol functional group. This dual nature allows EGMEE to dissolve a wide range of substances, making it a versatile solvent. It is miscible with water and many organic solvents, and its moderate evaporation rate contributes to its utility in various formulations.

Common Uses

Ethylene Glycol Monoethyl Ether is predominantly used in industrial applications, leveraging its strong solvent properties. Its primary uses include being a solvent for lacquers, enamels, varnishes, dyes, and resins. It is also found in surface coatings, cleaning products, hydraulic fluids, and anti-icing additives. Furthermore, it serves as a solvent in certain printing inks and as an intermediate in the synthesis of other chemicals. Despite its functional properties as a 'FORMULATION AID' and 'SOLVENT OR VEHICLE' in a general chemical context, it is crucial to note that Ethylene Glycol Monoethyl Ether is not approved for direct addition to food products. Its potential presence in food would generally be considered unintended contamination rather than an approved additive.

Safety Assessment

The safety assessment of Ethylene Glycol Monoethyl Ether has primarily focused on its occupational and environmental exposure, given its widespread industrial use. Studies have consistently demonstrated that EGMEE can pose significant health risks upon exposure, particularly concerning reproductive and developmental toxicity. It is readily absorbed through the skin, by inhalation, and orally. Once absorbed, it is metabolized into ethoxyacetic acid, which is believed to be responsible for many of its toxic effects. Acute exposure can lead to central nervous system depression, irritation of the eyes and respiratory tract, and hematological changes. Chronic exposure, particularly at higher levels, has been associated with effects on the hematopoietic system (blood cell production), kidneys, and liver in animal studies. Of significant concern is its classification as a reproductive toxicant, meaning it can impair fertility or cause adverse developmental effects in offspring. Regulatory bodies worldwide have established occupational exposure limits to protect workers from these hazards. Due to these well-documented toxicological profiles, its use in consumer products and direct food applications is highly restricted or prohibited.

Regulatory Status

In the United States, Ethylene Glycol Monoethyl Ether is explicitly listed as 'FDA GRAS: No,' indicating that it is not Generally Recognized As Safe for use as a food ingredient or additive. The U.S. Food and Drug Administration (FDA) does not list it among approved direct food additives. Its potential presence in food packaging materials would also be subject to strict regulatory review to prevent migration into food products. Similarly, within the European Union, Ethylene Glycol Monoethyl Ether (2-ethoxyethanol) is classified under the CLP Regulation (EC No 1272/2008) as a Category 1B reproductive toxicant (Repr. 1B), indicating a presumption of adverse effects on human reproduction based on animal data. It is not authorized as a food additive by the European Food Safety Authority (EFSA). The absence of approvals from major food safety authorities underscores its unsuitability for direct food use globally. The provided data indicates 'Adverse Events (FDA): 0' and 'Recalls (FDA): 0', which is expected given its lack of approval for use in food, meaning there would be no official reports related to its approved food use.

Key Studies

Numerous toxicological studies, primarily involving animal models and occupational epidemiology, have characterized the risks associated with Ethylene Glycol Monoethyl Ether. Early studies in the 1980s and 1990s by organizations like the U.S. Environmental Protection Agency (EPA) and the National Toxicology Program (NTP) identified its reproductive and developmental toxicity. For instance, studies in rodents demonstrated testicular damage, reduced sperm counts, and developmental abnormalities in offspring following exposure. Human epidemiological studies of workers exposed to glycol ethers have corroborated some of these findings, noting associations with reproductive health issues. These comprehensive toxicological assessments form the basis for its classification as a hazardous chemical and the strict regulatory controls surrounding its industrial handling and its prohibition from direct food contact.

Frequently Asked Questions

What is Ethylene Glycol Monoethyl Ether?

Ethylene Glycol Monoethyl Ether, also known as 2-ethoxyethanol or EGMEE, is an organic chemical primarily recognized as a solvent. While it possesses properties that could classify it as a formulation aid or vehicle, it is not approved for direct use as a food additive. Its principal applications are found in industrial sectors, notably in paints, coatings, and cleaning products.

Is Ethylene Glycol Monoethyl Ether safe?

Ethylene Glycol Monoethyl Ether is currently rated "avoid" 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 Ethylene Glycol Monoethyl Ether banned in any country?

Ethylene Glycol Monoethyl Ether 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.