Glutaral

What Is It?

Glutaral, also called glutaraldehyde, occurs as a colorless liquid in its pure form. In cosmetics and personal care products, Glutaral is used in the formulation of bath products, cleansing products, hair conditioners, wave sets and other hair products.

Why Is It Used?

Glutaral prevents or retards bacterial growth, and thus protects cosmetics and personal care products from spoilage.

Follow this link for more information about how preservatives protect cosmetics and personal care products.

Scientific Facts

Glutaral, commonly called Glutaraldehyde, is commonly available as 2, 25 or 50% aqueous solutions. These solutions often have an amber tint and an odor similar to spoiled fruit.

Safety Information

The Food and Drug Administration (FDA) includes Glutaral on its lists of direct and indirect food additives. As a direct food additive, Glutaral may be used as a cross-linking agent to make microcapsules for flavoring substances, and it can be used to control microorganisms in cane-sugar and beet-sugar mills. As an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage., it can be used as a component of adhesives. The safety of Glutaral has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Glutaral was safe for use at concentrations up to 0.5% in rinse-off products. There were insufficient data to determine the safety of Glutaral in leave-on products. Glutaral should not be used in aerosolized products.

CIR Safety Review: In vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal. dermal penetration studies of Glutaral indicate low penetration through skin. A 28-day dermal toxicity study of Glutaral produced skin irritation and slight effects on weight and blood chemistry with doses as low as 50 mg/kg/day. Skin irritation was dose-dependent, with a no-effect concentration of 1%. Ocular exposure to Glutaral caused severe irritation at concentrations greater than 1%, with a no-effect level of 0.1%. Glutaral was a developmental toxicant at doses that did not cause severe maternal toxicity. The no observable adverse effect level for reproductive and developmental toxicity was greater than 1,000 ppm.

Bacterial mutagenesis tests produced mixed results, as would be expected for a preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage. that kills or retards the growth of bactiera. In most other mutagenesis test systems, Glutaral was not genotoxic. A 2-year laboratory drinking water study was not conclusive as to whether Glutaral was carcinogenic. Clinical studies reported some evidence of dermal irritation and sensitization, but no photosensitization. Occupational data and other studies indicated that inhalation of Glutaral can cause respiratory irritation, in addition to skin effects.

For rinse-off products, the CIR Expert Panel concluded that the ocular and dermal irritancy of Glutaral could be substantially avoided if the concentration did not exceed 0.5% and exposure was only brief and discontinuous. Because it can cause respiratory irritation, it was concluded that Glutaral should not be used in aerosolized cosmetics and personal care products. The lack of conclusive data regarding carcinogenicity, resulted in the CIR Expert Panel concluding that the data were insufficient to support the use of Glutaral in leave-on products. They requested a 2-year dermal carcinogenicity study.

Link to FDA Code of Federal Regulations for Glutaraldehyde

Glutaraldehyde is listed as a preservative in the Cosmetics Directive of the European Union (see Annex VI) and may be used at a maximum concentration of 0.1%. When concentrations exceed 0.05%, the product must be labeled “contains Glutaraldhyde.” Glutaraldehyde is prohibited in aerosols.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

Glutaral is a saturated 5-carbon dialdehyde. In cosmetics and personal care products, Glutaral functions as a cosmetic biocideIngredients that help to cleanse the skin or to prevent odor by destroying or inhibiting the growth of microorganisms. and preservative. Glutaral solutions are broad-spectrum antimicrobials that destroy bacterial and fungal spores, as well as viruses, and are used to sterilize medical and dental equipment.

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/