Moderate Preservative Sensitization Data Dermal Penetration

Imidazolidinyl Urea

INCI: IMIDAZOLIDINYL UREA

CAS Number
39236-46-9
Function
Preservative; formaldehyde-releasing agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.6%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; no concentration cap under FDA/MoCRA; associated with heavier microbial growth in mascara contamination studies

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

Safety Data

Margin of Safety (MoS)
Releases formaldehyde under product-use conditions (hydrolysis rate pH- and temperature-dependent). At 0.5% use concentration: estimated 0.01โ€“0.05% free formaldehyde. MoS for non-sensitized individuals generally >100 via dermal route. No acceptable MoS for sensitized individuals.
Dermal Absorption
moderate
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Imidazolidinyl Urea based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
1.2%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20; IVDK; FDA

Dermal Penetration Profile

Skin absorption and penetration characteristics of Imidazolidinyl Urea, relevant to systemic exposure and MoS calculations.

Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
388.3 Da
Log P
-3.2
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: CIR

Expert Verdict

Formaldehyde-releasing preservative used in mascara and eye cosmetics with EU Annex V restriction at max 0.6%. Dual concerns in eye-area applications: formaldehyde release causes recognized contact sensitization and ocular irritation, and mascara contamination studies document heavier microbial growth compared to alternative preservation strategies. Poor preservation efficacy combined with high sensitization potential makes this non-preferred for eye-area cosmetics.

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Concern Level: High

Regulatory Flags

preservative formaldehyde-releaser eu-annex-v eye-area sensitization-risk formaldehyde-release mascara-contamination-concern ocular-irritant eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is Imidazolidinyl Urea safe in cosmetics?

Formaldehyde-releasing preservative used in mascara and eye cosmetics with EU Annex V restriction at max 0.6%. Dual concerns in eye-area applications: formaldehyde release causes recognized contact sensitization and ocular irritation, and mascara contamination studies document heavier microbial growth compared to alternative preservation strategies. Poor preservation efficacy combined with high sensitization potential makes this non-preferred for eye-area cosmetics. The EU classifies Imidazolidinyl Urea as "restricted". Safety rating: MODERATE.

Is Imidazolidinyl Urea allowed in the EU?

Imidazolidinyl Urea EU regulatory status: restricted. Maximum allowed concentration: 0.6%. This is based on EU Regulation 1223/2009 and its amendments.

What does Imidazolidinyl Urea do in cosmetics?

Imidazolidinyl Urea functions as: Preservative; formaldehyde-releasing agent. It is classified as a Preservative in our database. CAS number: 39236-46-9.

What is the Margin of Safety for Imidazolidinyl Urea?

Releases formaldehyde under product-use conditions (hydrolysis rate pH- and temperature-dependent). At 0.5% use concentration: estimated 0.01โ€“0.05% free formaldehyde. MoS for non-sensitized individuals generally >100 via dermal route. No acceptable MoS for sensitized individuals. 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.

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