What Is It?
In cosmetics and personal care products, m-Phenylenediamine and m-Phenylenediamine Sulfate are used in the formulation of hair dyes and colors.
Why Is It Used?
m-Phenylenediamine and m-Phenylenediamine Sulfate impart color to hair. The exact color obtained will depend on the other ingredients that are used in the preparation and the starting color of the hair.
m-Phenylenediamine and m-Phenylenediamine Sulfate are used in permanent hair coloring systems where color is produced inside the hair A slender, threadlike structure that forms animal or plant tissue. This is accomplished through careful formulation of the product so that the ingredients interact in a highly controlled process.
The Food and Drug Administration (FDA) has reviewed the safety of m-Phenylenediamine and permits its use as a component of resins for incidental contact with food. The safety of m-Phenylenediamine and m-Phenylenediamine Sulfate has 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 m-Phenylenediamine and m-Phenylenediamine Sulfate were safe for use in hair dyes at concentrations of up to 10%.
CIR Safety Review:
Percutaneous absorption of m-Phenylenediamine was measured and three metabolites were identified. One dermal study failed to show any liver or kidney toxicity while another indicated some liver and kidney toxicity. Subchronic oral studies indicated some liver effects but no kidney toxicity. m-Phenylenediamine produced some skin irritation and sensitization was observed. Clinical data indicated some evidence of sensitization. A short-term oral study reported an absence of any neurotoxicity. In one study, fetal deaths were reported, although no evidence of birth defects was reported. Other studies reported neither birth defects nor fetal deaths. Both positive and negative results were found in various mutagenesis assay systems. Neither m-Phenylenediamine (both oral and dermal exposure) nor hair dye formulations (dermal exposure only) containing m-Phenylenediamine were carcinogenic. Based on the concentrations of m-Phenylenediamine shown to produce sensitization, it was concluded that these ingredients can be used safely in hair dyes at concentrations of up to 10%.
Additional information about the hair dyes.
Link to FDA Code of Federal Regulations for m-Phenylenediamine http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
m-Phenylenediamine and its salts are listed in the Cosmetics Directive of the European Union and may not be used in cosmetics and personal care products marketed in the European Union (see Annex II).
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm
More Scientific Information
Hair dyeing formulations belong to three categories – temporary, semi-permanent and permanent coloring of hair. The permanent hair dyeing formulations are often referred to as oxidative hair dyes which are generally marketed as two-component products. One component contains the dye precursors and couplers and the other component is a stabilized solution of hydrogen peroxide. The two components are mixed immediately prior to use. The precursors and peroxide diffuse into the hair shaft, where color formation takes place after the ingredients combine to produce the coloring mixture. The dye precursors are oxidized by the hydrogen peroxide to form reactive intermediates which then combine with the couplers resulting in Ingredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics. molecules. These molecules are too large to escape from the hair structure. The hydrogen peroxide in the oxidative hair dye product also serves as bleaching agent for the natural pigment of the hair. The color that is formed depends on the precursors and direct dyes present in the dyeing solution, A measurement of the acidity or basicity of a substance. pH is the negative logarithm (base 10) of the concentration of hydrogen ions in solution. Water has a concentration of hydrogen ions of 1.0 x 10-7, and thus has a pH of 7. A pH of 7 is considered neutral, a pH lower than 7 is considered acidic, and a pH higher than 7 is considered basic. of the dyeing solution and the time of contact of the dyeing solution with the hair. m-Phenylenediamine and m-Phenylenediamine Sulfate are aromatic amines. m-Phenylenediamine in the white, crystalline form becomes red after exposure to air. Both ingredients function as hair colorants.
EU Cosmetic Ingredients Inventory http://ec.europa.eu/consumers/cosmetics/cosing/
Search the FDA Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm