Allantoin Biotin

Safety Information

The U.S. Food and Drug Administration (FDA) has reviewed the safety of allantoin and permits its use as an active ingredient in Over-The-Counter (OTC) skin protectant drug products at concentrations of 0.5 to 2%.

The safety of allantoin, allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin polygalacturonic acid, allantoin glycyrrhetinic acid and allantoin panthenol has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and based on the available information concluded that allantoin and the compounds containing allantoin were safe for use as cosmetic ingredients.

Allantoin was not an eye or skin irritant and it was not phototoxic. In genotoxicity tests in bacteria, allantoin was not mutagenic. Allantoin has been shown to reduce the mutagenic activity of hydrogen peroxide. Allantoin was not carcinogenic. The dermal penetration of allantoin in humans was shown to be dependent on the formulation. The greatest penetration observed was from a water/oil ointment. Therapeutic use studies of formulations containing 2-4% allantoin did not report any adverse effects. Although no data were identified on the compounds containing allantoin, the Expert Panel has previously reviewed the safety of ascorbic acid, biotin, glycyrrhetinic acid and panthenol. Galacturonic acid as its polymer, polygalacturonic acid, is a major component of pectin, a polysaccharide found in the cell walls of plants and a common component of food.

Because of its common occurrence in food, the Expert Panel was not concerned with the safety of galacturonic acid or polygalacturonic acid following lower exposure through cosmetics and personal care products. Based on the data on allantoin, and the Expert Panel’s knowledge of the safety of the components in the other compounds included in the report, the Expert Panel concluded that allantoin, allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin polygalacturonic acid, allantoin glycyrrhetinic acid and allantoin panthenol were safe for use cosmetic ingredients.

Allantoin and the allantoin-containing ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.

Resources

Allantoin Biotin

What Is It?

Allantoin is a white odorless powder. Other allantoin containing compounds that may be used in cosmetics and personal care products, include the allanotin salt of vitamin C, allantoin ascorbate, and the allantoin salt of vitamin B7, allantoin biotin. Allantoin complexes that may be used in cosmetics and personal care products include allantoin galacturonic acid, allanotoin polygalacturonic acid, allantoin glycyrrhetinic acid and allantoin panthenol. Among the allantoin containing ingredients, allantoin itself is most likely to be used in cosmetics and personal care products. It is used in the formulation of bath products, eye makeup, hair care products, oral hygiene products and skin care products.

Why Is It Used?

Allantoin, allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin polygalacturonic acid, allantoin glycyrrhetinic acid and allanotin panthenol all function as skin-conditioning agents. Allantoin also functions as a skin protectant.

Scientific Facts

With the exception of humans and higher apes, allanotin is found in the urine of mammals. It is the primary form in which nitrogen-containing waste is excreted in the urine of these animals. Allantoin is also found in many plants, such as comfrey, horse chestnut and bearberry. Although allantoin can be isolated from these plants, most allantoin used in cosmetics and personal care products is made from urea and glyoxylic acid.

Allantoin, which is a component of many plants including comfrey, has been reported to provide healing, soothing, and anti-irritating properties and to help to heal wounds and skin irritations and stimulate growth of healthy tissue. When used in skin protectant products, it is regulated by the FDA as a drug. Allantoin, or (2,5-dioxo-4-imidazolidinyl) urea, is a heterocyclic organic compound. In cosmetics and personal care products, allantoin functions as a skin protectant and skin conditioning agent. The other compounds containing allantoin all function as skin conditioning agents.