HC Yellow No. 2

The safety of HC Yellow No. 2 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 HC Yellow No. 2 was safe for use in hair dyes at concentrations up to 3%.

The limitation on the concentration was based upon the available clinical sensitization data. In 2011, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on HC Yellow No. 2 and reaffirmed the above conclusion.

CIR Safety Review:

The CIR Expert Panel reviewed data on subchronic and chronic feeding studies with 1.25% HC Yellow No. 2 in which reduced body weight gain was observed and changes in various organ sizes and clinical chemistry values were induced. The only histologic change attributed to this hair dye ingredient was a small increase in pigment in the spleen.

The compound was only a minor ocular irritant when tested at a concentration of 10%. It was neither a sensitizer nor photosensitizing agent at 10%. It was not a developmental toxicant. HC Yellow No. 2 was negative in a dominant lethal assay and it was not mutagenic in the four bacteria strains tested, both with or without metabolic activation. In a repeat insult patch test (RIPTRIPT stands for Repeat Insult Patch Test. In RIPT, a small amount of product is applied to the skin of each individual subject and monitored for its effect. Over a certain interval of time, the skin is observed, graded, and tested again.) using 3% HC Yellow No. 2, two volunteers of 98 had a positive reaction to the test substance. In another RIPT study, 1 of 104 volunteers had a sensitization reaction to 3% HC Yellow No. 2. It was concluded that HC Yellow No. 2 was safe for use in hair dyes at concentrations up to 3%.

More information about the safety of hair dyes

In Europe, HC Yellow No. 2 may be used in non-oxidative hair dyes at a maximum concentration of 1% and in oxidative hair dyes at a maximum concentration of 0.75%. Please see Annex III for additional information concerning the use of HC Yellow No. 2 in hair dye products in Europe.

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm