Chlorhexidine Dihydrochloride

What Is It?

Chlorhexidine is an odorless, white crystalline powder. In cosmetics and personal care products, Chlorhexidine and its salts (Chlorohexidine Dihydrochloride, Chlorhexidine Digluconate, Chlorhexidine Diacetate) are used in the formulation of eye makeup, makeup foundations, mouthwashes, hair dyes and bleaches, and other skin care and hair care products.

Why Is It Used?

Chlorhexidine, Chlorhexidine Dihydrochloride, Chlorhexidine Digluconate and Chlorhexidine Diacetate are used as cosmetic biocides, oral care agents and preservatives.

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

Scientific Facts

Chlorhexidine has a strong bactericidal effect which has led to its widespread use. In addition to its use in cosmetics and personal care products, Chlorhexidine has been used in medical practice and these ingredients, particularly the Digluconate salt, have extensive use in dentistry because they inhibit plaque formation.
Safety Information

The safety of Chlorhexidine and its salts has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Chlorhexidine and its salts were safe for use in cosmetics and personal care products at concentrations up to: 0.14% calculated as Chlorhexidine free base; 0.19% as Chlorhexidine Diacetate; 0.20% as Chlorhexidine Digluconate; and 0.16% as Chlorhexidine Dihydrochloride.

CIR Safety Review: Chlorhexidine Digluconate was slightly toxic in oral and inhalation studies. At concentrations used in cosmetics and personal care products, Chlorhexidine Digluconate was not irritating to the eyes or skin.

Positive sensitization reactions were cited in provocative patch testing at 1.0% in patients with eczema, but not in predictive patch testing of 0.05% in normal subjects. In bacterial assays, Chlorhexidine tested both positive and negative for mutagenesis.

In two other systems, Chlorhexidine Digluconate was not genotoxic. Chlorhexidine Digluconate was not carcinogenic in a 2-year drinking water study. In 1998, the Food and Drug Administration (FDA) issued a public health notice regarding potential hypersensitivity reactions to Chlorhexidine-impregnated medical devices. The CIR Expert Panel considered this information and it did not suggest to the CIR Expert Panel a need to change its conclusion, the CIR

Expert Panel did reiterate the importance of limiting the use of these ingredients to the concentrations specified (0.14% calculated as Chlorhexidine free base; 0.19% as Chlorhexidine Diacetate; 0.20% as Chlorhexidine Digluconate; and 0.16% as Chlorhexidine Dihydrochloride). Chlorhexidine and its Digluconate, Diacetate and Dihydrochloride salts are listed in the Cosmetics Directive of the European Union (see Annex VI) and may be used as preservatives at concentrations not to exceed 0.3%, expressed as Chlorhexidine.

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

Health Canada permits the use of Chlorhexidine and its salts in cosmetics and personal care products at concentrations equal to or less than: 0.14%, calculated as Chlorhexidine free base; 0.19%, calculated as Chlorhexidine Diacetate; 0.20%, calculated as Chlorhexidine Digluconate; and 0.16%, calculated as Chlorhexidine Dihydrochloride.

http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…

More Scientific Information

Chlorhexidine is an organic compound and Chlorhexidine Dihydrochloride, Digluconate and Diacetate are the corresponding salts of Chlorhexidine. In cosmetics and personal care products, these ingredients function as cosmetic biocides, oral care agents and preservatives.
Resources

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/