What Is It?
In cosmetics and personal-care products, Hexamidine and Hexamidine Diisethionate function as a preservatives and are used in the formulation of hair, nail, and skin-care products, as well as eye makeup and baby products.
Why Is It Used?
Hexamidine Diisethionate helps cleanse the skin or prevent odor by destroying or inhibiting the growth of microorganisms.
Hexamidine Diisethionate is an organic salt of Hexamidine. Hexamidine is soluble in water and insoluble in organic solvents. These ingredients function as preservatives, which help cleanse the skin or prevent odor by inhibiting the growth of or destroying microorganisms, such as bacteria, fungi and yeast.
The safety of Hexamidine Diisethionate and Hexamidine have been assessed by the The 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 Hexamidine and Hexamidine Diisethionate were safe for use in cosmetic products in the practices and concentrations of use as described in their safety assessment, if used at concentrations less than or equal to 0.1%.
CIR Safety Review: The CIR Expert Panel noted that genotoxicity studies were negative and that there were no structural alerts suggesting that Hexamidine or Hexamidine Diisethionate would possess carcinogenic potential; therefore, it was unlikely these ingredients would be carcinogenic. Because the rate of absorption of Hexamidine is slow and there was no toxicity in a subchronic study, the CIR Expert Panel concluded that dermal exposures would not likely present a risk of reproductive or developmental toxicity.
The CIR Expert Panel noted that that there were no data for concentration of use for eye makeup and baby products, and cautioned there should not be unrestricted concentration levels in these product categories. To address this concern, the CIR Expert Panel established a concentration limitation. The CIR Expert Panel noted that small amounts of 1,4-dioxane may be found in Hexamidine and Hexamidine Diisethionate.
The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.
Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.
In Europe, the use of Hexamidine and its salts, including Hexamidine Diisethionate, as preservatives is allowed according to the provisions of Annex VI of the Cosmetics Directive of the European Union. These ingredients are permitted at concentrations up to 0.1%.
Link to the EU Cosmetic Regulation:
More Scientific Information
Hexamidine and Hexamidine Diisethionate function as a cosmetic biocides. Cosmetic biocides are ingredients used in cosmetic products to help cleanse the skin or prevent odor by inhibiting the growth of or destroying microorganisms such as bacteria, fungi and yeast. Cosmetic biocides may be cidal or static.
Cidal agents kill microbiota and act as disinfectants. Static agents inhibit the growth of microorganisms, but do not kill them.
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/