Moderate Preservative SCCS/CIR Reviewed Sensitization Data Dermal Penetration

Diazolidinyl Urea

INCI: DIAZOLIDINYL UREA

CAS Number
78491-02-8
Function
Preservative
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.5% (face leave-on); 0.6% (rinse-off)
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Washington State: banned effective January 1, 2027 (Aug 2025 rule, WAC 246-930). No federal cosmetic concentration limit. CIR Expert Panel: safe up to 0.5% in cosmetics. Multiple states moving toward restricting formaldehyde releasers.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: safe

Urea along with the comments that were received. The Panel concluded that this ingredient could be safely used in cosmetic products at the minimum effective concentration. The effective use and safety test data indicate that the potential of this ingredient to produce adverse reactions should be min

Sensitization Profile

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

Sensitization Rate
moderate
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
1.5%
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 Diazolidinyl Urea, relevant to systemic exposure and MoS calculations.

Absorption %
1-4%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
278.2 Da
Log P
-2.8
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 releaser restricted under EU Annex V (maximum 0.5% leave-on products). Washington State ban effective January 1, 2027. High contact sensitization potential (2-4% positive patch test rate) due to formaldehyde release. IARC Group 1 carcinogen concern. No longer justifiable where alternatives available; federal US restriction expected to follow state-level bans.

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Concern Level: High

Regulatory Flags

formaldehyde-releaser iarc-group-1-related contact-allergen preservative washington-state-ban-2027 eu-restricted annex-v federal-ban-pending high-sensitization eu_children_restricted eu_cosing_listed

Frequently Asked Questions

Is Diazolidinyl Urea safe in cosmetics?

Formaldehyde releaser restricted under EU Annex V (maximum 0.5% leave-on products). Washington State ban effective January 1, 2027. High contact sensitization potential (2-4% positive patch test rate) due to formaldehyde release. IARC Group 1 carcinogen concern. No longer justifiable where alternatives available; federal US restriction expected to follow state-level bans. The EU classifies Diazolidinyl Urea as "restricted". Safety rating: MODERATE. This ingredient has been reviewed by cir.

Is Diazolidinyl Urea allowed in the EU?

Diazolidinyl Urea EU regulatory status: restricted. Maximum allowed concentration: 0.5% (face leave-on); 0.6% (rinse-off). This is based on EU Regulation 1223/2009 and its amendments.

What does Diazolidinyl Urea do in cosmetics?

Diazolidinyl Urea functions as: Preservative. It is classified as a Preservative in our database. CAS number: 78491-02-8.

What is the Margin of Safety for Diazolidinyl Urea?

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.

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