Is Urea safe in cosmetics?
Urea has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 8 toxicological study endpoint(s) are available in our database.
Urea
Also known as: Aqua Care HP, Caswell No. 902, EINECS 200-315-5, EPA Pesticide Chemical Code 085702, NCI-C02119 (+15 more)
INCI: UREA
Urea (CAS 57-13-6) is a cosmetic humectant functioning as Humectant (≤2%), moisturizer/mild keratolytic (5–10%), keratolytic (10–30%),. NOAEL 2250 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max No concentration restriction for cosmetic use; ≥10% exerts keratolytic activity — label accordingly; ≥30% debriding use requires appropriate regulatory framing. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Function
Humectant (≤2%), moisturizer/mild keratolytic (5–10%), keratolytic (10–30%), debriding agent (30–40%), filaggrin upregulator, antimicrobial peptide inducer
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
No concentration restriction for cosmetic use; ≥10% exerts keratolytic activity — label accordingly; ≥30% debriding use requires appropriate regulatory framing
US US Status
permitted
US Notes
Natural NMF component (~7% of total NMF by weight). No FDA restriction at cosmetic concentrations. OTC drug rules apply only if keratolytic or therapeutic claims are made. RCT showed 4% urea superior to 20% glycerin in reducing TEWL in atopic dermatitis patients.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Urea.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
8 study endpoints found for 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 | 440 mg/kg bw/day | oral | cattle | Special Toxicology Study | COSMOS DB |
| NOAEL | 900 mg/kg bw/day | oral | mouse | Special Toxicology Study | COSMOS DB |
| NOAEL | 2000 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | 3309 mg/kg bw/day | oral | horse | Short Term Toxicity | COSMOS DB |
| NOAEL | 5000 mg/kg bw/day | oral | rabbit | Special Toxicology Study | COSMOS DB |
| NOAEL | 6750 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS DB |
| NOAEL | =3510 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =8325 mg/kg bw/day | oral | Mouse | chronic | ECHA |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Urea across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Urea, relevant to systemic exposure and MoS calculations.
Absorption %
8-15%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
60.1 Da
Log P
-2.11
Systemic Absorption
minimal
Topical Bioavailability
5-12%
Safety Margin Factor
moderate
Source: Skin Res Technol 2008
EPA ToxValDB — Toxicity Values
6 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | =14300 mg/kg-day | Rat | oral | - | EFSA |
| NOEL | =2250 mg/kg-day | Rat | oral | - | EFSA |
| NOAEL | =8325 mg/kg-day | Mouse | oral | chronic | ECHA |
| NOAEL | =3510 mg/kg-day | Rat | oral | chronic | ECHA |
| LD50 | =11000 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =8471 mg/kg | Rat | oral | - | ChemIDplus |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000,000 - 100,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | halal_prohibited | - | All cosmetics |
| AE | restricted | 10.0 | Leave-on skin products |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Roberts Skin Permeation (Mendeley 2022)
MW: 60.1
Log Kow: -2.11
Log Kp: -3.55495653854982
Log Jmax: -5.408828502871582
Source: Roberts Cheruvu Mendeley 2022
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Body Lotion | 5–20 | 40 | CIR Expert Panel |
| Hand Cream | 5–20 | 40 | CIR Expert Panel |
| Foot Cream | 10–40 | 40 | CIR Expert Panel |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Binder
Chelating agent
Dye
Flame retardant
Fragrance
Freeze-thaw additive
Humectant
No specific technical function
Other
Regulatory List Membership (5)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Urea — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
nmf-component
keratolytic-high-conc
filaggrin-upregulator
antimicrobial-peptide-induction
concentration-dependent-function
vehicle-dependent
ph-sensitive-above-8
kosmotrope
ammonia-risk-instability
dual-function
atopic-dermatitis-evidence
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
jecfa_safe
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Urea by CAS number or substance name.
Studies
8
Lowest NOAEL
440 mg/kg bw/day
Highest NOAEL
8325 mg/kg bw/day
COSMOS DB
ECHA
Known Synonyms
Aqua Care HP
Caswell No. 902
EINECS 200-315-5
EPA Pesticide Chemical Code 085702
NCI-C02119
Prespersion, 75 urea
Supercel 3000
Ultra Mide
Ureacin-40 Creme
Ureacin-10 lotion
Sterile urea
UNII-8W8T17847W
Antisepsis bolus
ARF
Alphadrate
B-I-k
Bromisovalum
Bubber shet
Calmurid
Calmurid HC
Chemical Function
pH regulating agent
Humectant
Anti-static agent
Softener and conditioner
Regulatory Lists
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Europe; Pesticides
active_ingredient; Australia
inert_ingredient; Pesticides
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
UREA
ChEMBL ID
CHEMBL985
Max Phase
4
Adverse Event Associations
691
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
UREA
ADI
NOT SPECIFIED mg/kg bw
Food Category
food_additive
Frequently Asked Questions
Is Urea allowed in the EU?
Urea EU regulatory status: permitted. Maximum allowed concentration: No concentration restriction for cosmetic use; ≥10% exerts keratolytic activity — label accordingly; ≥30% debriding use requires appropriate regulatory framing. This is based on EU Regulation 1223/2009 and its amendments.
What does Urea do in cosmetics?
Urea functions as: Humectant (≤2%), moisturizer/mild keratolytic (5–10%), keratolytic (10–30%), debriding agent (30–40%), filaggrin upregulator, antimicrobial peptide inducer. It is classified as a Humectant in our database. CAS number: 57-13-6.
What is the NOAEL for Urea?
The NOAEL (No Observed Adverse Effect Level) for Urea is 440 mg/kg bw/day based on a Special Toxicology Study study via oral route in cattle. A total of 8 study endpoints are available. Source: COSMOS DB.
Is Urea used outside cosmetics?
Urea also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Urea compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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