Chloroxylenol
What Is It?
Chloroxylenol is a crystalline powder used in the formulation of bath products, makeup, skin cleansers, shampoos, deodorants and feminine hygiene products.
Why Is It Used?
Chloroxylenol functions as a cosmetic biocideIngredients that help to cleanse the skin or to prevent odor by destroying or inhibiting the growth of microorganisms., a deodorant agents and as a preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage.. Follow this link for more information about how preservatives protect cosmetics and personal care products.
Scientific Facts
The antimicrobial and antifungal properties of Chloroxylenol have also led to its use as a disinfectant.
Safety Information
The Food and Drug Administration (FDA) includes Chloroxylenol (4-Chloro-3,5-dimethylphenol) on its list of indirect food additives. It is permited for use as a preservative in adhesives that have incidental contact with food. The safety of Chloroxylenol 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 Chloroxylenol is safe as a cosmetic ingredient. In 2004, as part of the scheduled re-review of ingredients, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.
CIR Safety Review: Chloroxylenol at 100% was a moderate ocular irritant whereas a 0.1% aqueous Chloroxylenol solution was a nonirritant to skin. Chloroxylenol was nonmutagenic in a bacterial mutagenesis assay, both with and without metabolic activation. In clinical studies, formulations containing up to 1.0% Chloroxylenol were nonsensitizing and essentially nonirritating to the skin. The CIR Expert Panel concluded that Chloroxylenol was safe for use in cosmetic products.
FDA: Link to Code of Federal Regulations for 4-Chloro-3,5-dimethylphenol (Chloroxylenol) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
In the European Union, Chloroxylenol (4-Chloro-3,5-xylenol) is permitted for use as a preservative in cosmetics and personal care products at a maximum concentration of 0.5% (see Annex VI).
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
Chloroxylenol, also known as 4-chloro-3,5-dimethylphenol, is a substituted phenol used as an antimicrobial agentIngredients that kill microorganisms, or prevent or inhibit their growth and reproduction. In the United States, antimicrobial agents are regulated as Over-The-Counter (OTC) drug ingredients..
Resources
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“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): 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/