Chlorophene

What Is It?

Dichlorophene is a white or light-tan powder, whereas Chlorophene occurs as white or off-white crystals. In cosmetics and personal care products, Dichlorophene and Chlorophene are used in the formulation of hair tonics, dressings and other hair grooming aids, as well as foot powders and sprays.

Why Is It Used?

Dichlorophene and Chlorophene help to cleanse the skin or to prevent odor by destroying or inhibiting the growth of microorganisms. Chlorophene also 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

Dichlorophene may also be used to kill intestinal worms in cats and dogs.

Safety Information

The Food and Drug Administration (FDA) includes Dichlorophene on its list of indirect food additives. It is permitted for use as a component of adhesives having incidental contact with food. The safety of Dichlorophene and Chlorophene has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that additional data were needed to determine the safety of Dichlorophene or Chlorophene as they are used in cosmetics and personal care products.

CIR Safety Review: Sulfate and glucuronide conjugates were the major metabolites of both Dichlorophene and Chlorophene. These metabolites were excreted in the urine. Chlorophene was incompletely absorbed through the skin. These chemicals exhibited low toxicity in acute oral toxicity studies. Some evidence of toxicity with both chemicals was found in short-term oral toxicity studies; kidney effects were the principal finding. Exposure to Chlorophene for 2 years resulted in a dose-related and gender-related increase in the severity of kidney effects.

Dichlorophene and Chlorophene were ocular irritants. No inhalation toxicity data were available for these ingredients. Dichlorophene up to 10% resulted in no to minimal irritation when applied to intact and abraded skin. Chlorophene was severely irritating in most dermal irritation studies. Studies gave positive and negative results in sensitization tests of Dichlorophene.

A dose-related contact hypersensitivity response to Chlorophene was reported. No reproductive or developmental toxicity data were available for Dichlorophene, but there was some evidence of non-dose-dependent developmental toxicity with Chlorophene. Dichlorophene was positive in a bacterial mutagenicity assay, but not in other test systems. Chlorophene was mutagenic in four in vitro test systems. Carcinogenicity studies for Dichlorophene were not found. Neoplasms were not observed after treatment with Chlorophene for two years; however a significant incidence of neoplasms was observed in another study. A 1-year National Toxicology Program (NTP) study concluded that Chlorophene was a cutaneous irritant and a weak skin tumor promoter but had no activity as an initiator or complete carcinogen. Dichlorophene was not a sensitizer in clinical dermal sensitization tests.

Some reactions to Chlorophene occurred in some, but not all, clinical dermal sensitization tests. Positive photopatch tests to Dichlorophene were found in 13/469 patients. While these ingredients were ocular irritants at high concentrations, the risk at concentrations which are actually used in cosmetic formulations was uncertain. Overall, the CIR Expert Panel considered the available data insufficient to complete a safety assessment for Dichlorophene or Chlorophene. Data requested by the CIR Expert Panel included photosensitization data, and dermal reproductive and developmental toxicity data for Dihlorophene.

Link to FDA Code of Federal Regulations for 2,2 “-Dihydroxy-5,5”-Dichlorodiphenylmethane (Dichlorophene)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Dichlorophene, listed as Dichlorophen, and Chlorophene, listed as 2-Benzyl-4-chlorophenol, are listed in the Cosmetics Directive of the European Union and may be used at maximum concentrations of 0.5% and 0.2%, respectively (see Annex VI). Cosmetics and personal care products containing Dichlorophene must indicate this on the product label.

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

More Scientific Information

Dichlorophene and Chlorophene are halogenated phenolic compounds. A major impurity of Dichlorophene is the trimer 4-chloro-2,6-bis(5-chloro-2-hydroxybenzyl)-phenol. In cosmetics and personal care products, Dichlorophene and Chlorophene function as cosmetic biocides and preservatives. Dichlorophene may also function as a deodorant agent.