Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Dimethyl Urea

INCI: DIMETHYL UREA

CAS Number
96-31-1
Function
Humectant / buffering (proposed); primarily industrial intermediate
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” no specific CFR prohibition; no CIR review for cosmetic use

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Dimethyl Urea. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 50 mg/kg bw/day oral rat oral REACH
LOAEL 1000 mg/kg bw/day other dog other REACH
LOAEL 500 mg/kg bw/day oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Hazard Statements
Causes mild skin irritation Causes eye irritation
Short-term Exposure Effects
The substance is mildly irritating to the eyes and skin.

Expert Verdict

Major data gap: cosmetic use was proposed but no confirmation of actual application; no CIR or SCCS monograph; OECD SIDS available but not cosmetic-specific; not to be confused with diazolidinyl urea or DMDM hydantoin (formaldehyde donors) โ€” 1,3-dimethylurea is NOT a formaldehyde donor.

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Concern Level: Moderate

Frequently Asked Questions

Is Dimethyl Urea safe in cosmetics?

Major data gap: cosmetic use was proposed but no confirmation of actual application; no CIR or SCCS monograph; OECD SIDS available but not cosmetic-specific; not to be confused with diazolidinyl urea or DMDM hydantoin (formaldehyde donors) โ€” 1,3-dimethylurea is NOT a formaldehyde donor. The EU classifies Dimethyl Urea as "permitted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.

Is Dimethyl Urea allowed in the EU?

Dimethyl Urea EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Dimethyl Urea do in cosmetics?

Dimethyl Urea functions as: Humectant / buffering (proposed); primarily industrial intermediate. It is classified as a cosmetic ingredient in our database. CAS number: 96-31-1.

What is the Margin of Safety for Dimethyl 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.

What is the NOAEL for Dimethyl Urea?

The NOAEL (No Observed Adverse Effect Level) for Dimethyl Urea is 50 mg/kg bw/day based on a oral study via oral route in rat. A total of 3 study endpoints are available. Source: REACH.

Is Dimethyl Urea classified as hazardous under GHS?

Dimethyl Urea carries a GHS signal word of "WARNING". Hazard statements: Causes mild skin irritation Causes eye irritation. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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