Moderate Cosmetic Ingredient Sensitization Data

Methylene Glycol

INCI: METHYLENE GLYCOL

CAS Number
463-57-0
Function
Antimicrobial, nail care agent, nail sculpting agent
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.2%
🇺🇸 US Status restricted
US Notes Restricted - the CIR Expert Panel concluded formaldehyde/methylene glycol are safe when formaldehyde equivalents do not exceed 0.074% (w/w); California Assembly Bill No. 496 bans methylene glycol in cosmetics sold or manufactured in California; a new federal regulation will prohibit intentional addition effective January 1, 2027

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Methylene Glycol based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.4%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20; IVDK; FDA

Expert Verdict

Potential skin, lung, and eye irritant; classified as a potential carcinogen by inhalation; exists in chemical equilibrium with formaldehyde in aqueous solution. Methylene glycol (methanediol) is the hydrated form of formaldehyde - in water it reversibly converts to formaldehyde, making any concentration limit functionally a formaldehyde limit

⚠️
Concern Level: High

Regulatory Flags

eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Methylene Glycol safe in cosmetics?

Potential skin, lung, and eye irritant; classified as a potential carcinogen by inhalation; exists in chemical equilibrium with formaldehyde in aqueous solution. Methylene glycol (methanediol) is the hydrated form of formaldehyde - in water it reversibly converts to formaldehyde, making any concentration limit functionally a formaldehyde limit The EU classifies Methylene Glycol as "restricted". Safety rating: MODERATE.

Is Methylene Glycol allowed in the EU?

Methylene Glycol EU regulatory status: restricted. Maximum allowed concentration: 0.2%. This is based on EU Regulation 1223/2009 and its amendments.

What does Methylene Glycol do in cosmetics?

Methylene Glycol functions as: Antimicrobial, nail care agent, nail sculpting agent. It is classified as a cosmetic ingredient in our database. CAS number: 463-57-0.

What is the Margin of Safety for Methylene Glycol?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

Compliance Tools

Check Methylene Glycol compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

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Poor
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Moderate
Phytin
Good
Laccase
Moderate
2,3-Xylenol (2,3-Dimethylphenol)
Poor
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