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 in cosmetics and personal care products?
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.
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.
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 additive, it can be used as a component of adhesives. The safety of Glutaral has been assessed by the Cosmetic Ingredient Review (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.
More safety Information:
CIR Safety Review: In vitro 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 preservative 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:
More Scientific Information:
Glutaral is a saturated 5-carbon dialdehyde. In cosmetics and personal care products, Glutaral functions as a cosmetic biocide 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.
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): 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/