Is Imidazolidinyl urea safe for babies and kids?
Elevated risk for kidsInfants are exposed to Imidazolidinyl urea through personal care products (lotions, wipes) and food. Immature skin barrier and hepatic metabolism increase effective dose per body weight.
What is imidazolidinyl urea?
The IUPAC name is 1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-3-[[[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]carbamoylamino]methyl]urea.
Also known as: 1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-3-[[[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]carbamoylamino]methyl]urea, IMIDUREA, Germall 115, M629807ATL.
- IUPAC name
- 1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-3-[[[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]carbamoylamino]methyl]urea
- CAS number
- 39236-46-9
- Molecular formula
- C11H16N8O8
- Molecular weight
- 388.29 g/mol
- SMILES
- C(NC(=O)NC1C(=O)NC(=O)N1CO)NC(=O)NC2C(=O)NC(=O)N2CO
- PubChem CID
- 38258
Risk for babies
Elevated riskInfants are exposed to Imidazolidinyl urea through personal care products (lotions, wipes) and food. Immature skin barrier and hepatic metabolism increase effective dose per body weight.
Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.
Risk for pregnant and nursing people
Context-dependentPrenatal exposure to Imidazolidinyl urea through personal care products and food is a concern. Some preservatives (parabens) exhibit weak estrogenic activity that may affect fetal endocrine development.
No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.
Regulatory consensus
10 regulatory and scientific bodies have classified Imidazolidinyl urea. The classifications differ — that's the data.
| Agency | Year | Classification | Notes |
|---|---|---|---|
| US EPA | 2000 | not classifiable as to human carcinogenicity (Group D) | |
| EFSA | 2014 | not evaluated for carcinogenicity; contact sensitizer and formaldehyde releaser regulated under EU Cosmetics Regulation (EC) No 1223/2009 Annex V; maximum authorized concentration 0.6% in cosmetics; mandatory labeling above 0.05% free formaldehyde; SCCS opinion 2014 confirmed safety at current use levels for non-sensitized consumers | |
| EPA CTX / Genetox | — | Genotoxicity: positive (Ames: positive, 1 positive / 5 negative reports) | |
| EPA CTX / Genetox | — | Genotoxicity: positive (Ames: positive, 1 positive / 5 negative reports) | |
| EPA CTX / Skin-Eye | — | Skin Sensitization: SkinSens1 (score: high) | |
| EPA CTX / Skin-Eye | — | Eye Irritation: Category 6.4A (Category 2A) (score: high) | |
| EPA CTX / Skin-Eye | — | skin sensitisation: in vivo (LLNA): High Frequency of Sensitization (score: high) | |
| EPA CTX / Skin-Eye | — | skin sensitisation: in vivo (non-LLNA): High Frequency of Sensitization (score: high) | |
| EPA CTX / Skin-Eye | — | eye irritation: in vivo: Studies Indicate No Significant Irritation (score: low) | |
| EPA CTX / Skin-Eye | — | skin irritation: in vivo: Studies Indicate No Significant Irritation (score: low) |
Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.
Where kids encounter imidazolidinyl urea
- Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
- Occupational Environments — Factories, Warehouses, Transportation vehicles
- Personal Care — shampoo, conditioner, lotion, cosmetics, sunscreen
Safer alternatives
Lower-risk approaches that achieve a similar outcome to Imidazolidinyl urea:
-
Phenoxyethanol
Trade-offs: Alternative preservation system; spectrum of antimicrobial activity differs (gram+/gram-, yeasts, molds); pH range of efficacy varies; challenge testing per ISO 11930 required for cosmetics.Relative cost: 1.2-2×
-
Ethylhexylglycerin
Trade-offs: Alternative preservation system; spectrum of antimicrobial activity differs (gram+/gram-, yeasts, molds); pH range of efficacy varies; challenge testing per ISO 11930 required for cosmetics.Relative cost: 1.2-2×
-
Caprylyl glycol
Trade-offs: Alternative preservation system; spectrum of antimicrobial activity differs (gram+/gram-, yeasts, molds); pH range of efficacy varies; challenge testing per ISO 11930 required for cosmetics.Relative cost: 1.2-2×
Frequently asked questions
Is imidazolidinyl urea safe for kids?
Infants are exposed to Imidazolidinyl urea through personal care products (lotions, wipes) and food. Immature skin barrier and hepatic metabolism increase effective dose per body weight.
What products contain imidazolidinyl urea?
Imidazolidinyl urea appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); shampoo (Personal care).
What should I do if my child is exposed to imidazolidinyl urea?
Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.
Why do regulators disagree about imidazolidinyl urea?
Imidazolidinyl urea has been classified by 10 agencies including US EPA, EFSA, EPA CTX / Genetox, EPA CTX / Genetox, EPA CTX / Skin-Eye, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.
See Imidazolidinyl urea in the baby app
Look up products containing imidazolidinyl urea, compare to alternatives, and explore the full data record.
Open in baby View raw API dataSources (2)
- US EPA Imidazolidinyl Urea: Group D Not Classifiable; Formaldehyde-Releasing Preservative Germall 115; Contact Sensitizer; Patch Test Positivity 2–5%; Cumulative Formaldehyde Exposure Assessment; FDA Adverse Event Reports (2000) — regulatory
- EFSA/SCCS Imidazolidinyl Urea: EU Cosmetics Regulation Annex V No. 26; Maximum 0.6% Permitted; Mandatory Formaldehyde Labeling; Infant Skin Barrier Concern; Eczema Risk Factor; Baby Product Reformulation Trend (2014) — regulatory
Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →