Chemical Properties
solid with a mild odour
Uses
Antimicrobial preservative in cosmetics and topical pharmaceutical preparations.
Description
Imidazolidinyl urea, a formaldehyde releaser, is mainly contained in cosmetics and liquid soaps.
Definition
ChEBI: Imidazolidinyl urea is a member of ureas. It has a role as an antimicrobial agent. It is an antimicrobial preservative used in cosmetics. It acts as a formaldehyde releaser.
Production Methods
Imidurea is produced by the condensation of allantoin with
formaldehyde.
General Description
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Flammability and Explosibility
Nonflammable
Pharmaceutical Applications
N,N-methylenebis N'-1-(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl urea is a broad-spectrum antimicrobial preservative used in cosmetics and topical pharmaceutical formulations; typical concentrations used are 0.03–0.5% w/w. It is effective between pH 3–9 and is reported to have synergistic effects when used with parabens.
Safety
Imidurea is widely used in cosmetics and topical pharmaceutical
formulations, and is generally regarded as a nontoxic and
nonirritant material. However, there have been some reports of
contact dermatitis associated with imidurea, although these are
relatively few considering its widespread use in cosmetics.
Although imidurea releases formaldehyde, it does not appear to
be associated with cross-sensitization with formaldehyde or other
formaldehyde-releasing compounds.
LD50 (mouse, oral): 7.2 g/kg
LD50 (rabbit, skin): > 8 g/kg
LD50 (rat, oral): 11.3 g/kg
storage
Imidurea is hygroscopic and should be stored in a well-closed
container in a cool, dry place.
Incompatibilities
N,N-methylenebis N'-1-(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl urea is incompatible with strong oxidants. It is compatible with other preservatives including sorbic acid and quaternary ammonium compounds. It is also compatible with other pharmaceutical and cosmetic excipients including proteins, nonionic surfactants, and lecithin.
Regulatory Status
Included in the FDA Inactive Ingredients Database (topical
preparations). Accepted for use in cosmetics in Europe and the
USA. Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
