Chlorophene

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 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 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 vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal. 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 ToxicologyToxicology is the study of the adverse effects of chemical and physical agents on living organisms. 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…